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Trial Outcomes & Findings for Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION) (NCT NCT02864992)

NCT ID: NCT02864992

Last Updated: 2026-04-13

Results Overview

Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Recruitment status

ACTIVE_NOT_RECRUITING

Study phase

PHASE2

Target enrollment

337 participants

Primary outcome timeframe

Time from first treatment up to data cutoff (approximately Month 66)

Results posted on

2026-04-13

Participant Flow

For Cohort A: A total of 168 participants were screened of which 152 participants were enrolled to receive the study drug. For Cohort B: A total of 32 participants were screened of which 24 participants were enrolled to receive the study drug. For Cohort C: A total of 175 participants were screened of which 161 participants were enrolled to receive the study drug.

Participant milestones

Participant milestones
Measure
Part 1: Cohort A: METex14 Skipping Alterations
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 1: Cohort B: MET Amplification
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Overall Study
STARTED
152
24
161
Overall Study
COMPLETED
137
23
128
Overall Study
NOT COMPLETED
15
1
33

Reasons for withdrawal

Reasons for withdrawal
Measure
Part 1: Cohort A: METex14 Skipping Alterations
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 1: Cohort B: MET Amplification
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Overall Study
still on treatment
15
1
33

Baseline Characteristics

Tepotinib Phase II in NSCLC Harboring MET Alterations (VISION)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Part 1: Cohort A: METex14 Skipping Alterations
n=152 Participants
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 1: Cohort B: MET Amplification
n=24 Participants
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 2: Cohort C: Confirmatory Part for METex14 Skipping Alterations
n=161 Participants
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Total
n=337 Participants
Total of all reporting groups
Age, Continuous
73.0 years
STANDARD_DEVIATION 8.97 • n=193 Participants
62.3 years
STANDARD_DEVIATION 9.17 • n=193 Participants
71.5 years
STANDARD_DEVIATION 9.24 • n=386 Participants
71.5 years
STANDARD_DEVIATION 9.47 • n=112 Participants
Sex: Female, Male
Female
73 Participants
n=193 Participants
3 Participants
n=193 Participants
86 Participants
n=386 Participants
162 Participants
n=112 Participants
Sex: Female, Male
Male
79 Participants
n=193 Participants
21 Participants
n=193 Participants
75 Participants
n=386 Participants
175 Participants
n=112 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
1 Participants
n=193 Participants
1 Participants
n=193 Participants
1 Participants
n=386 Participants
3 Participants
n=112 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
148 Participants
n=193 Participants
23 Participants
n=193 Participants
157 Participants
n=386 Participants
328 Participants
n=112 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
3 Participants
n=193 Participants
0 Participants
n=193 Participants
3 Participants
n=386 Participants
6 Participants
n=112 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=193 Participants
0 Participants
n=193 Participants
0 Participants
n=386 Participants
0 Participants
n=112 Participants
Race (NIH/OMB)
Asian
38 Participants
n=193 Participants
07 Participants
n=193 Participants
68 Participants
n=386 Participants
113 Participants
n=112 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=193 Participants
0 Participants
n=193 Participants
0 Participants
n=386 Participants
0 Participants
n=112 Participants
Race (NIH/OMB)
Black or African American
01 Participants
n=193 Participants
0 Participants
n=193 Participants
02 Participants
n=386 Participants
3 Participants
n=112 Participants
Race (NIH/OMB)
White
108 Participants
n=193 Participants
17 Participants
n=193 Participants
87 Participants
n=386 Participants
212 Participants
n=112 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=193 Participants
0 Participants
n=193 Participants
0 Participants
n=386 Participants
0 Participants
n=112 Participants
Race (NIH/OMB)
Unknown or Not Reported
05 Participants
n=193 Participants
0 Participants
n=193 Participants
04 Participants
n=386 Participants
9 Participants
n=112 Participants

PRIMARY outcome

Timeframe: Time from first treatment up to data cutoff (approximately Month 66)

Population: Safty Analysis Set included all participants in Cohort A who were administered at least 1 dose of tepotinib, including participants with METex14 skipping alterations not confirmed by a validated central laboratory assay.

Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Part 1: Cohort A: METex14 Skipping Alterations
n=152 Participants
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 1: Cohort A: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST 1.1) as Assessed by Independent Review Committee (IRC)
46.7 percentage of participants
Interval 38.6 to 55.0

PRIMARY outcome

Timeframe: Time from first treatment up to data cutoff (approximately Month 66)

Population: Safety Analysis Set included all participants in Cohort B who were administered at least 1 dose of tepotinib, including participants with a MET Amplification.

Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Part 1: Cohort A: METex14 Skipping Alterations
n=24 Participants
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 1: Cohort B: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
41.7 percentage of participants
Interval 22.1 to 63.4

PRIMARY outcome

Timeframe: Time from first treatment up to data cutoff (approximately Month 66)

Population: Safety analysis set included all participants in Cohort C who were administered at least 1 dose of tepotinib.

Objective response will be determined according to RECIST 1.1 and as per IRC. Objective response was defined as number of participants with either a confirmed complete response (CR) or partial response (PR) from first administration of study treatment to first observation of progressive disease (PD) .CR: Disappearance of all evidence of target and non-target lesions. PR: At least 30 percent (%) reduction from baseline in the sum of the longest diameter (SLD) of all lesions. PD was defined as at least a 20% increase in the SLD, taking as reference the smallest SLD recorded from baseline or the appearance of 1 or more new lesions.

Outcome measures

Outcome measures
Measure
Part 1: Cohort A: METex14 Skipping Alterations
n=161 Participants
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Part 2: Cohort C: Objective Response According to Response Evaluation Criteria in Solid Tumors Version 1.1 as Assessed by Independent Review Committee (IRC)
54.7 percentage of participants
Interval 46.6 to 62.5

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Time from first treatment up to end of study (approximately Month 101)

Outcome measures

Outcome data not reported

Adverse Events

Part 1 & 2: Cohort A + B + C

Serious events: 169 serious events
Other events: 331 other events
Deaths: 200 deaths

Serious adverse events

Serious adverse events
Measure
Part 1 & 2: Cohort A + B + C
n=337 participants at risk
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Blood and lymphatic system disorders
Anaemia
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Acute coronary syndrome
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Acute myocardial infarction
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Atrial fibrillation
0.89%
3/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Bradycardia
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Cardiac arrest
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Cardiac failure
0.89%
3/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Cardiac tamponade
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Cardio-respiratory arrest
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Ischaemic cardiomyopathy
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Myocardial infarction
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Cardiac disorders
Myopericarditis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Endocrine disorders
Adrenal insufficiency
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Abdominal discomfort
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Abdominal pain
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Ascites
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Constipation
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Gastrointestinal haemorrhage
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Haemorrhoids
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Ileus
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Inguinal hernia
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Intestinal obstruction
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Large intestinal obstruction
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Nausea
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Umbilical hernia
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Vomiting
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Asthenia
0.89%
3/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Chest pain
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Death
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Disease progression
4.7%
16/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Fatigue
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
General physical health deterioration
3.6%
12/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Generalised oedema
2.4%
8/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Malaise
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Mucosal inflammation
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Non-cardiac chest pain
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Oedema
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Oedema peripheral
3.3%
11/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Pyrexia
0.89%
3/337 • Time from first treatment up to data cutoff (approximately Month 74)
Hepatobiliary disorders
Bile duct stone
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Hepatobiliary disorders
Cholangitis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Hepatobiliary disorders
Cholecystitis acute
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Hepatobiliary disorders
Cholelithiasis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Immune system disorders
Hypersensitivity
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Bacterial infection
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
COVID-19 pneumonia
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Cellulitis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Cholecystitis infective
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Conjunctivitis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Empyema
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Escherichia urinary tract infection
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Infection
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Infectious pleural effusion
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Pleural infection
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Pneumonia
5.3%
18/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Pneumonia aspiration
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Pneumonia bacterial
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Pyelonephritis acute
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Respiratory tract infection
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Sepsis
1.2%
4/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Septic embolus
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Septic shock
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Upper respiratory tract infection
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Urinary tract infection
0.89%
3/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Urinary tract infection bacterial
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Viral upper respiratory tract infection
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Accidental overdose
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Fall
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Femoral neck fracture
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Femur fracture
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Hip fracture
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Humerus fracture
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Radius fracture
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Spinal fracture
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Subdural haematoma
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Subdural haemorrhage
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Alanine aminotransferase increased
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Aspartate aminotransferase increased
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Blood creatinine increased
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Lipase increased
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Lymphocyte count decreased
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Neutrophil count decreased
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Troponin increased
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Decreased appetite
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Dehydration
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Electrolyte imbalance
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Hypoalbuminaemia
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Hypokalaemia
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Hyponatraemia
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Arthralgia
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Back pain
1.2%
4/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Bone pain
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Haematoma muscle
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Pathological fracture
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cancer pain
1.2%
4/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Malignant pleural effusion
1.2%
4/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Metastases to spine
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neoplasm progression
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pericardial effusion malignant
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostatic adenoma
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour associated fever
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour haemorrhage
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Tumour pain
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Aphasia
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Cerebral infarction
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Cerebrovascular accident
1.2%
4/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Dizziness
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Epilepsy
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Haemorrhage intracranial
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Headache
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Neuralgia
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Parkinson's disease
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Presyncope
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Seizure
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Spinal cord compression
0.89%
3/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Vocal cord paresis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Product Issues
Stent malfunction
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Psychiatric disorders
Assisted suicide
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Psychiatric disorders
Confusional state
0.59%
2/337 • Time from first treatment up to data cutoff (approximately Month 74)
Psychiatric disorders
Delusion
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Psychiatric disorders
Mental status changes
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Acute kidney injury
1.2%
4/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Chronic kidney disease
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Hydronephrosis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Renal colic
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Renal failure
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Renal impairment
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Renal pain
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Renal and urinary disorders
Ureteric stenosis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
3.6%
12/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Haemothorax
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Hypoxia
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
0.89%
3/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Pleural effusion
5.3%
18/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Pneumonitis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Pneumothorax
1.5%
5/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
2.1%
7/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Pulmonary haemorrhage
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Respiratory failure
1.2%
4/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Respiratory tract haemorrhage
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Skin and subcutaneous tissue disorders
Rash maculo-papular
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Vascular disorders
Embolism
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Vascular disorders
Phlebitis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)
Vascular disorders
Thrombosis
0.30%
1/337 • Time from first treatment up to data cutoff (approximately Month 74)

Other adverse events

Other adverse events
Measure
Part 1 & 2: Cohort A + B + C
n=337 participants at risk
Participants received 500 milligram (mg) of tepotinib once daily in cycles of 21-day duration until disease progression, death, adverse event (AE) leading to discontinuation or withdrawal of consent.
Blood and lymphatic system disorders
Anaemia
14.8%
50/337 • Time from first treatment up to data cutoff (approximately Month 74)
Eye disorders
Lacrimation increased
5.6%
19/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Abdominal pain
8.6%
29/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Abdominal pain upper
8.6%
29/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Constipation
20.5%
69/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Diarrhoea
28.2%
95/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Nausea
28.8%
97/337 • Time from first treatment up to data cutoff (approximately Month 74)
Gastrointestinal disorders
Vomiting
13.6%
46/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Asthenia
13.6%
46/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Fatigue
15.1%
51/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Generalised oedema
6.5%
22/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Oedema
9.2%
31/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Oedema peripheral
70.3%
237/337 • Time from first treatment up to data cutoff (approximately Month 74)
General disorders
Pyrexia
9.8%
33/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Pneumonia
7.1%
24/337 • Time from first treatment up to data cutoff (approximately Month 74)
Infections and infestations
Urinary tract infection
6.8%
23/337 • Time from first treatment up to data cutoff (approximately Month 74)
Injury, poisoning and procedural complications
Fall
5.3%
18/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Alanine aminotransferase increased
16.6%
56/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Amylase increased
10.1%
34/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Aspartate aminotransferase increased
11.9%
40/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Blood alkaline phosphatase increased
10.4%
35/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Blood creatinine increased
28.5%
96/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Gamma-glutamyltransferase increased
8.3%
28/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Lipase increased
8.3%
28/337 • Time from first treatment up to data cutoff (approximately Month 74)
Investigations
Weight decreased
6.5%
22/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Decreased appetite
19.3%
65/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Hypoalbuminaemia
32.0%
108/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Hypocalcaemia
9.8%
33/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Hypokalaemia
7.4%
25/337 • Time from first treatment up to data cutoff (approximately Month 74)
Metabolism and nutrition disorders
Hyponatraemia
7.4%
25/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Arthralgia
9.2%
31/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Back pain
11.6%
39/337 • Time from first treatment up to data cutoff (approximately Month 74)
Musculoskeletal and connective tissue disorders
Pain in extremity
5.0%
17/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Dizziness
6.2%
21/337 • Time from first treatment up to data cutoff (approximately Month 74)
Nervous system disorders
Headache
5.0%
17/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Cough
14.5%
49/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Dyspnoea
20.5%
69/337 • Time from first treatment up to data cutoff (approximately Month 74)
Respiratory, thoracic and mediastinal disorders
Pleural effusion
11.0%
37/337 • Time from first treatment up to data cutoff (approximately Month 74)
Skin and subcutaneous tissue disorders
Alopecia
10.7%
36/337 • Time from first treatment up to data cutoff (approximately Month 74)
Skin and subcutaneous tissue disorders
Dry skin
8.9%
30/337 • Time from first treatment up to data cutoff (approximately Month 74)
Skin and subcutaneous tissue disorders
Pruritus
7.7%
26/337 • Time from first treatment up to data cutoff (approximately Month 74)
Skin and subcutaneous tissue disorders
Rash
8.9%
30/337 • Time from first treatment up to data cutoff (approximately Month 74)
Vascular disorders
Hypotension
5.0%
17/337 • Time from first treatment up to data cutoff (approximately Month 74)

Additional Information

Communication Center

Merck Healthcare KGaA, Darmstadt Germany, an affiliate of Merck KGaA, Darmstadt, Germany

Phone: +49-6151-72-5200

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place