Trial Outcomes & Findings for Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec (NCT NCT02014441)
NCT ID: NCT02014441
Last Updated: 2019-11-20
Results Overview
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported. The first cycle was 21 days in length, and subsequent cycles were 14 days in length.
COMPLETED
PHASE2
61 participants
Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).
2019-11-20
Participant Flow
This study was conducted at 11 centers in the United States and Canada. The first participant was enrolled on 07 April 2014 and the last participant was enrolled on 07 December 2015.
Participant milestones
| Measure |
Talimogene Laherparepvec
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
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|---|---|
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Overall Study
STARTED
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61
|
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Overall Study
Received Treatment
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60
|
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Overall Study
COMPLETED
|
49
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Overall Study
NOT COMPLETED
|
12
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Reasons for withdrawal
| Measure |
Talimogene Laherparepvec
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
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|---|---|
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Overall Study
Withdrawal by Subject
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12
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Baseline Characteristics
Single-arm Trial to Evaluate the Biodistribution and Shedding of Talimogene Laherparepvec
Baseline characteristics by cohort
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
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|---|---|
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Age, Continuous
|
63.3 years
STANDARD_DEVIATION 16.7 • n=99 Participants
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Sex: Female, Male
Female
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27 Participants
n=99 Participants
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Sex: Female, Male
Male
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33 Participants
n=99 Participants
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Race/Ethnicity, Customized
White
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60 Participants
n=99 Participants
|
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Eastern Cooperative Oncology Group (ECOG) Performance
0 (Fully active)
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45 Participants
n=99 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance
1 (Restrictive but ambulatory)
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15 Participants
n=99 Participants
|
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Herpes Simplex Virus Type 1 (HSV-1) Status
Negative
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17 Participants
n=99 Participants
|
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Herpes Simplex Virus Type 1 (HSV-1) Status
Positive
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40 Participants
n=99 Participants
|
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Herpes Simplex Virus Type 1 (HSV-1) Status
Unknown
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3 Participants
n=99 Participants
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PRIMARY outcome
Timeframe: Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least 1 dose of talimogene laherparepvec, and had at least 1 postdose blood/urine sample collected.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in blood or urine at any time during cycles 1 to 3 is reported. The first cycle was 21 days in length, and subsequent cycles were 14 days in length.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=17 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=40 Participants
Participants who were seropositive at baseline for HSV-1.
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|---|---|---|---|
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Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles
Blood
|
98.3 percentage of participants
Interval 91.1 to 100.0
|
100.0 percentage of participants
Interval 80.5 to 100.0
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97.5 percentage of participants
Interval 86.8 to 99.9
|
|
Percentage of Participants With Detectable Talimogene Laherparepvec Deoxyribonucleic Acid (DNA) During the First Three Cycles
Urine
|
31.7 percentage of participants
Interval 20.3 to 45.0
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29.4 percentage of participants
Interval 10.3 to 56.0
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35.0 percentage of participants
Interval 20.6 to 51.7
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SECONDARY outcome
Timeframe: Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants must have received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose blood samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.
A participant was defined as having cleared talimogene laherparepvec if a negative blood sample was obtained following a prior positive test and if there were no subsequent positive tests.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=59 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=17 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=39 Participants
Participants who were seropositive at baseline for HSV-1.
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|---|---|---|---|
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Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood
Cycle 1
|
92.7 percentage of participants
Interval 80.1 to 98.5
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78.6 percentage of participants
Interval 49.2 to 95.3
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100.0 percentage of participants
Interval 86.3 to 100.0
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|
Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood
Cycle 2
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86.0 percentage of participants
Interval 74.2 to 93.7
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64.7 percentage of participants
Interval 38.3 to 85.8
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94.7 percentage of participants
Interval 82.3 to 99.4
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|
Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Blood
Cycle 3
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33.3 percentage of participants
Interval 0.8 to 90.6
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50.0 percentage of participants
Interval 1.3 to 98.7
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0.0 percentage of participants
Interval 0.0 to 97.5
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SECONDARY outcome
Timeframe: Cycles 1 and 2 on days 1 (pre-dose and 1, 4, and 8 hours post-dose), 2, 3, 8, and 15 (cycle 1 only), cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants received at least 1 dose of talimogene laherparepvec, had at least 2 post-dose urine samples collected within the same dosing cycle with at least 1 positive talimogene laherparepvec DNA sample and at least 1 subsequent sample at any time during the cycle.
A participant was defined as having cleared talimogene laherparepvec if a negative urine sample was obtained following a prior positive test and if there were no subsequent positive tests.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=18 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=4 Participants
Participants who were seronegative at baseline for HSV-1.
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Talimogene Laherparepvec: HSV-1 Positive
n=14 Participants
Participants who were seropositive at baseline for HSV-1.
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|---|---|---|---|
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Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine
Cycle 1
|
100.0 percentage of participants
Interval 29.2 to 100.0
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100.0 percentage of participants
Interval 2.5 to 100.0
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100.0 percentage of participants
Interval 15.8 to 100.0
|
|
Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine
Cycle 2
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92.9 percentage of participants
Interval 66.1 to 99.8
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100.0 percentage of participants
Interval 29.2 to 100.0
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90.9 percentage of participants
Interval 58.7 to 99.8
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Percentage of Participants With Clearance of Talimogene Laherparepvec DNA From Urine
Cycle 3
|
100.0 percentage of participants
Interval 15.8 to 100.0
|
—
|
100.0 percentage of participants
Interval 15.8 to 100.0
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SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=1085 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=289 samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=741 samples
Participants who were seropositive at baseline for HSV-1.
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|---|---|---|---|
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Percentage of Samples With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles
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19.5 percentage of samples
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17.6 percentage of samples
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19.6 percentage of samples
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SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of swab samples from the exterior of the occlusive dressing with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=211 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=51 samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=144 samples
Participants who were seropositive at baseline for HSV-1.
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|---|---|---|---|
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Percentage of Samples With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing During the First Three Cycles
|
0.0 percentage of samples
|
0.0 percentage of samples
|
0.0 percentage of samples
|
SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=17 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=40 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
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Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Exterior of the Occlusive Dressing During the First Three Cycles
|
80.0 percentage of participants
|
76.5 percentage of participants
|
82.5 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab collected from the exterior of the occlusive dressing with a detectable qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on the exterior of the occlusive dressing at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=48 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=13 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=33 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Exterior of the Occlusive Dressing During the First Three Cycles
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the surface of injected lesions with detectable talimogene laherparepvec DNA at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=1260 Samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=307 Samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=885 Samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
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Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec DNA During the First Three Cycles
|
57.6 percentage of samples
|
53.7 percentage of samples
|
57.3 percentage of samples
|
SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from the surface of injected lesions with detectable talimogene laherparepvec virus at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=725 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=165 samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=506 samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Samples From the Surface of Injected Lesions With Detectable Talimogene Laherparepvec Virus During the First Three Cycles
|
1.1 percentage of samples
|
3.0 percentage of samples
|
0.6 percentage of samples
|
SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=17 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=40 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec DNA on the Surface of Injected Lesions During the First Three Cycles
|
100.0 percentage of participants
|
100.0 percentage of participants
|
100.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 on days 2, 3, 8, and 15, cycle 2 on days 1 (pre-dose), 2, 3, and 8, cycle 3 on day 1 (pre-dose) and day 8, and cycle 4 on day 1 (pre-dose).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one injected lesion swab collected with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus on swabs taken from the surface of injected lesions at any time during cycles 1 to 3 is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=17 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=40 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec Virus on the Surface of Injected Lesions During the First Three Cycles
|
11.7 percentage of participants
|
23.5 percentage of participants
|
7.5 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=964 Samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=302 Samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=599 Samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA During Treatment
|
1.2 percentage of samples
|
2.6 percentage of samples
|
0.5 percentage of samples
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples taken from oral mucosa with detectable talimogene laherparepvec virus at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=12 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=8 samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=3 samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec Virus During Treatment
|
0.0 percentage of samples
|
0.0 percentage of samples
|
0.0 percentage of samples
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA on swabs taken from oral mucosa at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=17 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=40 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa During Treatment
|
13.3 percentage of participants
|
23.5 percentage of participants
|
7.5 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 47) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected during treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from oral mucosa at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=8 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=4 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=3 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Oral Mucosa During Treatment
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=448 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=123 samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=244 samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA During Treatment
|
1.6 percentage of samples
|
0.0 percentage of samples
|
2.9 percentage of samples
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of samples with detectable talimogene laherparepvec virus in swabs taken from the anogenital area at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=7 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=7 samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Samples With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area During Treatment
|
0.0 percentage of samples
|
—
|
0.0 percentage of samples
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=26 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=7 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=17 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area During Treatment
|
19.2 percentage of participants
|
0.0 percentage of participants
|
29.4 percentage of participants
|
SECONDARY outcome
Timeframe: Cycle 1 on days 1 (pre-dose), 8, and 15, cycles 2 and 3 on days 1 (pre-dose), and 8, cycle 4 and subsequent cycles (up to 50) on day 1 (pre-dose), Cycle 25 on day 1 (pre-dose) and day 8.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected during treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity. The percentage of participants with detectable talimogene laherparepvec virus in swabs taken from the anogenital area at any time during treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=5 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=5 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec Virus in Swabs From the Anogenital Area During Treatment
|
0.0 percentage of participants
|
—
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from oral mucosa with detectable talimogene laherparepvec DNA after the end of treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=981 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=284 samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=667 samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Samples From Oral Mucosa With Detectable Talimogene Laherparepvec DNA After the End of Treatment
|
0.0 percentage of samples
|
0.0 percentage of samples
|
0.0 percentage of samples
|
SECONDARY outcome
Timeframe: From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs taken from oral mucosa after the end of treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=52 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=16 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=35 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Oral Mucosa After the End of Treatment
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one oral mucosa swab collected after the end of treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after end of treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of swab samples from the anogenital area with detectable talimogene laherparepvec DNA after the end of treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=515 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=187 samples
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=326 samples
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Samples From the Anogenital Area With Detectable Talimogene Laherparepvec DNA After the End of Treatment
|
0.0 percentage of samples
|
0.0 percentage of samples
|
0.0 percentage of samples
|
SECONDARY outcome
Timeframe: 30 toFrom 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks). 60 days after the last dose of talimogene laherparepvec.Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment.
Talimogene laherparepvec DNA was measured using a quantitative polymerase chain reaction (qPCR) method. The percentage of participants with detectable talimogene laherparepvec DNA in swabs from the anogenital area after the end of treatment is reported.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=21 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
n=7 Participants
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
n=13 Participants
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Percentage of Participants With Detectable Talimogene Laherparepvec DNA in Swabs From the Anogenital Area After the End of Treatment
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
SECONDARY outcome
Timeframe: From 30 to 60 days after the last dose of talimogene laherparepvec (the median [minimum, maximum] duration of treatment was 23 [3, 141] weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab from the anogenital area collected after the end of treatment with a positive qPCR result.
If the result of the qPCR testing was positive, then a 50% tissue culture infective dose (TCID50) assay was performed on the swab sample to measure viral infectivity.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 28.9 weeks (range: 4 to 151 weeks).Population: Participants who were enrolled, received at least one dose of talimogene laherparepvec, and had at least one swab sample collected from lesions suspected to be herpetic in origin during the study.
Any lesion such as a cold sore or vesicle thought to be herpetic in origin was evaluated by the investigator and swabbed if HSV infection was suspected. Quantitative PCR was performed on the swab sample to evaluate whether talimogene laherparepvec DNA was detectable in the sample.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=37 samples
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Number of Samples With Detectable Talimogene Laherparepvec in Lesions Suspected to be Herpetic in Origin
|
4 samples
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).Population: All participants who received at least 1 dose of talimogene laherparepvec.
Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography (CT), magnetic resonance imaging (MRI), or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions. Stable disease: Neither sufficient tumor shrinkage of index lesion to qualify for response nor sufficient tumor increase of index lesion to qualify for progressive disease, assessed a minimum interval of 77 days from the first dose of study drug. Progressive Disease: ≥ 25% increase in size of index lesions or appearance of one or more non-index lesions.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Best Overall Response
Complete Response
|
9 participants
|
—
|
—
|
|
Best Overall Response
Partial Response
|
12 participants
|
—
|
—
|
|
Best Overall Response
Stable Disease
|
10 participants
|
—
|
—
|
|
Best Overall Response
Progressive Disease
|
26 participants
|
—
|
—
|
|
Best Overall Response
Unevaluable
|
1 participants
|
—
|
—
|
|
Best Overall Response
Not Done
|
2 participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).Population: All participants who received at least 1 dose of talimogene laherparepvec.
Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Objective response rate is defined as the percentage of participants with either a complete response or partial response. Subsequent confirmation was not required. Complete response: disappearance of all index and non-index lesions. Partial Response: ≥ 50% reduction in size of all index lesions and any new measurable lesions.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Objective Response Rate
|
35.0 percentage of participants
Interval 23.1 to 48.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).Population: All participants who received at least 1 dose of talimogene laherparepvec.
Time to response was defined as the interval from the first dose of talimogene laherparepvec to the first event of complete response or partial response per modified WHO criteria; participants who did not respond were censored at the last evaluable tumor assessment.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Time to Response
|
8.7 months
Interval 5.3 to
Could not be estimated due to the low number of events
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).Population: All participants who received at least 1 dose of talimogene laherparepvec and had an objective response.
Duration of response (DOR) was calculated only for those participants with an objective response and defined as the longest interval from an initial objective response (complete response or partial response) to disease progression per the modified WHO criteria or death, whichever occurred earlier; otherwise, DOR was censored at the last evaluable tumor assessment for participants who did not die or progress.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=21 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Duration of Response
|
NA months
Could not be estimated due to the low number of events
|
—
|
—
|
SECONDARY outcome
Timeframe: Tumor response was assessed at weeks 12 and 24 and then at least every 3 months up to the end of treatment; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).Population: All participants who received at least 1 dose of talimogene laherparepvec.
Response was assessed according to modified World Health Organization (WHO) criteria using both clinical (cutaneous, subcutaneous, or nodal tumor measurement by caliper) and radiological imaging (computed tomography, magnetic resonance imaging or ultrasound of the chest, abdomen, and pelvis and all other sites of disease). Durable response rate is defined as the percentage of participants with a complete response or partial response maintained continuously for at least 6 months (183 days). Complete response: disappearance of all index and non-index lesions. Partial Response:≥ 50% reduction in size of all index lesions and any new measurable lesions.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Durable Response Rate
|
5.0 percentage of participants
Interval 1.0 to 13.9
|
—
|
—
|
SECONDARY outcome
Timeframe: From first dose until 60 days after last dose of talimogene laherparepvec; The median actual follow-up time was 28.9 weeks (range: 4 to 151 weeks).Population: All participants who received at least 1 dose of talimogene laherparepvec.
Overall Survival (OS) was defined as the interval from first dose of talimogene laherparepvec to death from any cause; participants still alive were censored at the last known alive date.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Overall Survival
|
NA months
Could not be estimated due to the low number of events
|
—
|
—
|
SECONDARY outcome
Timeframe: From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).Population: All participants who received at least 1 dose of talimogene laherparepvec.
The Common Terminology Criteria for Adverse Events version 3.0 was used to grade severity of adverse events, based on the following general guideline: Grade 1 = Mild AE Grade 2 = Moderate AE Grade 3 = Severe AE Grade 4 = Life-threatening or disabling AE Grade 5 = Death related to AE. A serious adverse event was defined as an adverse event that meets at least 1 of the following serious criteria: * fatal * life threatening * requires in-patient hospitalization or prolongation of existing hospitalization * results in persistent or significant disability/incapacity * congenital anomaly/birth defect * other medically important serious event Treatment-related adverse events (TRAEs) are defined as adverse events possibly caused by talimogene laherparepvec, as assessed by the investigator.
Outcome measures
| Measure |
Talimogene Laherparepvec
n=60 Participants
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
Talimogene Laherparepvec: HSV-1 Negative
Participants who were seronegative at baseline for HSV-1.
|
Talimogene Laherparepvec: HSV-1 Positive
Participants who were seropositive at baseline for HSV-1.
|
|---|---|---|---|
|
Number of Participants With Adverse Events (AEs)
Any adverse event
|
60 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AE grade ≥ 2
|
42 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AE leading to study drug discontinuation
|
5 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related AE grade ≥ 2
|
33 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related AE grade ≥ 3
|
6 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Serious treatment-related AE
|
8 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
TRAE leading to study drug discontinuation
|
3 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AE grade ≥ 3
|
12 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
AE grade ≥ 4
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Serious adverse events
|
13 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Fatal AE
|
0 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related adverse event
|
57 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Treatment-related AE grade ≥ 4
|
1 Participants
|
—
|
—
|
|
Number of Participants With Adverse Events (AEs)
Fatal treatment-related AE
|
0 Participants
|
—
|
—
|
Adverse Events
Talimogene Laherparepvec
Serious adverse events
| Measure |
Talimogene Laherparepvec
n=60 participants at risk
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
|---|---|
|
Cardiac disorders
Atrial fibrillation
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Cardiac disorders
Cardiac failure congestive
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Abdominal pain upper
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Hepatobiliary disorders
Cholelithiasis
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Pneumonia
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Sepsis
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Skin infection
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Body temperature increased
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Posterior reversible encephalopathy syndrome
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Delirium
|
3.3%
2/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Arteriosclerosis
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Deep vein thrombosis
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
1.7%
1/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
3.3%
2/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Other adverse events
| Measure |
Talimogene Laherparepvec
n=60 participants at risk
Talimogene laherparepvec was administered by intralesional injection into injectable cutaneous, subcutaneous, and nodal lesions at an initial dose of 10⁶ plaque-forming units (PFU) per mL followed by a dose of 10⁸ PFU/mL 21 days after the initial dose and every 14 days thereafter.
|
|---|---|
|
Gastrointestinal disorders
Abdominal distension
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Diarrhoea
|
21.7%
13/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Nausea
|
45.0%
27/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Vomiting
|
25.0%
15/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Nasopharyngitis
|
11.7%
7/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Oral herpes
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Contusion
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Investigations
Body temperature increased
|
8.3%
5/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Decreased appetite
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.3%
11/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
13.3%
8/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.3%
5/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
20.0%
12/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
11.7%
7/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
|
10.0%
6/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Dizziness
|
11.7%
7/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Headache
|
45.0%
27/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Somnolence
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Depression
|
10.0%
6/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
8.3%
5/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
10.0%
6/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
10.0%
6/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Rash
|
20.0%
12/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypotension
|
11.7%
7/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Gastrointestinal disorders
Stomatitis
|
8.3%
5/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Asthenia
|
11.7%
7/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chest pain
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Chills
|
65.0%
39/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Fatigue
|
56.7%
34/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Influenza like illness
|
20.0%
12/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site erythema
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site pain
|
25.0%
15/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site rash
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Injection site reaction
|
10.0%
6/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Malaise
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Oedema peripheral
|
8.3%
5/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pain
|
25.0%
15/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
General disorders
Pyrexia
|
38.3%
23/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Infections and infestations
Cellulitis
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Injury, poisoning and procedural complications
Fall
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Hypoaesthesia
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Nervous system disorders
Paraesthesia
|
6.7%
4/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Psychiatric disorders
Anxiety
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
|
Vascular disorders
Hypertension
|
5.0%
3/60 • From the first administration of talimogene laherparepvec up to 30 days after the last administration of talimogene laherparepvec; median duration of treatment was 23.1 weeks (range: 3 to 141 weeks).
Other Adverse Events summarizes the non-serious occurrences of adverse events that exceed the indicated frequency threshold.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Clinical Trial Agreement generally does not restrict an investigator's discussion of trial results after completion. The Agreement permits Amgen a limited period of time to review material discussing trial results (typically up to 45 days and possible extension). Amgen may remove confidential information, but authors have final control and approval of publication content. For multicenter studies, the investigator agrees not to publish any results before the first multi-center publication.
- Publication restrictions are in place
Restriction type: OTHER