A Phase III, randomized, multi-site, open-label trial of BNT323/DB-1303 versus investigator’s choice of chemotherapy in previously treated patients with HER2- expressing recurrent endometrial cancer

Endometrial cancer

Progression-free survival (PFS) by BICR defined as the time from randomization to the first objective tumor progression (per RECIST 1.1) or death from any cause, whichever occurs first.

PFS by BICR defined as the time from randomization to the first objective tumor progression (per RECIST 1.1) or death from any cause, whichever occurs first., Overall survival (OS) defined as the time from randomization to death from any cause., Progression-free survival (PFS) assessed by the investigator defined as the time from randomization to the first objective tumor progression (per RECIST 1.1) or death from any cause, whichever occurs first., Objective response rate (ORR) defined as the proportion of participants in whom a complete response (CR) or partial response (PR) (per RECIST 1.1) is observed as best overall response with confirmation., Duration of response (DoR) defined as the time from first objective response (CR or PR per RECIST 1.1) to first occurrence of objective tumor progression (progressive disease [PD] per RECIST 1.1) or death from any cause, whichever occurs first., Occurrence of treatment-emergent adverse events (TEAEs) including Grade 3 or above, serious, and fatal TEAEs, by relationship., Occurrences of TEAEs leading to drug interruption, dose reduction, or discontinuation of trial treatment.

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