Regeneron Pharmaceuticals, Inc. has shared encouraging early clinical results from an ongoing Phase I/II trial evaluating ubamatamab, its investigational MUC16×CD3 bispecific T-cell engaging antibody, in patients diagnosed with recurrent low-grade serous ovarian cancer (LGSOC).
The preliminary findings highlight marked anti-tumor activity in a heavily pretreated patient subset with substantial unmet medical needs. Among 11 patients who received the highest evaluated dose level of ubamatamab monotherapy, the clinical data demonstrated an objective response rate (ORR) of 73%, with all recorded responses classified as partial responses, amedian duration of response (DoR) of 9 months and a median progression-free survival (PFS) of 11 months.
Ubamatamab is engineered to bridge T cells directly to tumorcells by binding CD3 on the T cell and MUC16 on the ovarian carcinoma cell surface, triggering targeted cytotoxic cell killing in solid malignancies. The observed response rates and durability underscore the potential of T-cell engaging therapies to expand beyond hematologic cancers into challenging solid tumor microenvironments.
Based on these clinical observations, Regeneron plans to initiate discussions with the U.S. Food and Drug Administration (FDA) to align on the regulatory pathway and advance ubamatamabinto a confirmatory Phase III clinical trial.
Written by: Pragna Biswas
Graphics by: Pramit Hazra
