Trial Outcomes & Findings for ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2) (NCT NCT04752358)

This was a Phase 2 open-label, single treatment, clinical trial of ADP-A2M4CD8 in participants with advanced esophageal or esophagogastric junction cancers

All participants were assigned to one treatment (ADP-A2M4CD8)

ADP-A2M4CD8 in HLA-A2+ Subjects With MAGE-A4 Positive Esophageal or Esophagogastric Junction Cancers (SURPASS-2)

Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by IRAC

An AE was defined as any untoward medical occurrence in a subject or clinical study participant temporally associated with the use of the study intervention, whether or not considered related to the study intervention. Therefore, an AE could have been any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants with AEs (including SAEs), SAEs and AESI including cytokine release syndrome, ICANS, and prolonged cytopenia are presented.

TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR.

DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by IRAC.

BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by IRAC. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).

PFS is defined as time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by IRAC or death due to any cause, whichever occurs first.

Confirmed tumor response (complete response \[CR\] or partial response \[PR\]) to treatment as assessed using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 by Investigator Assessment

TTR (CR or PR) was defined as the interval between the date of first T-cell infusion and the earliest date of first documented confirmed CR or confirmed PR

DoR is defined as duration between the initial date of the confirmed complete or partial response to the date of progressive disease or death, where tumor response and disease progression were assessed by Investigator Assessment.

BOR is the best response recorded from the start of T-cell infusion until disease progression as assessed by the Investigator. Response categories are confirmed CR, confirmed PR, stable disease (SD) and confirmed progressive disease (PD).

PFS is defined as the time from the T-cell infusion to the date of the first documentation of progressive disease (PD) as assessed by investigator assessment or death due to any cause, whichever occurs first.

OS is defined as the time from the date of first T-cell infusion to the date of death (due to any cause).

The presence of RCL was assessed by qPCR targeting a segment of the vesicular stomatitis virus glycoprotein (VSV G) coding sequence. 1 participant had at least 1 post-infusion sample tested for RCL. The count of participants with RCL post-infusion is presented.

Deoxyribonucleic acid (DNA) from participants peripheral blood mononuclear cell (PBMC) samples are subjected to lentiviral vector integration site analysis by next-generation sequencing, thus evaluating both the clonality status of the transduced cell population and the genomic localization of individual integration sites. The outcome measure is the number of participants with integration sites representing more than 5% of all unique sites.

Peak persistence of ADP-A2M4CD8 cells was reported as vector copy numbers per microgram of genomic DNA from peripheral blood mononuclear cell (PBMC).

Time from ADP-A2M4CD8 T-cell infusion to peak persistence of cells.

Concordance of the MAGE A-4 clinical trial assay and in vitro diagnostic (IVD) kit.