Global Finance News
13 Apr 2026, 14:41
BioNTech announced positive Phase 2 trial results for its experimental cancer therapy trastuzumab pamirtecan, developed in partnership with DualityBio, showing promising efficacy in patients with advanced, HER2-expressing endometrial cancer.
In the study, the antibody-drug conjugate achieved a confirmed objective response rate of approximately 48% among evaluable patients, with median progression-free survival of about 8 months. The treatment demonstrated consistent antitumor activity across all HER2 expression levels, including patients previously treated with checkpoint inhibitors.
The trial, involving 145 heavily pre-treated patients, also showed a manageable safety profile, with most adverse effects being low-grade and consistent with similar therapies.
The results, presented at the 2026 Society of Gynecologic Oncology Annual Meeting, highlight the drug’s potential to address a significant unmet need in endometrial cancer, where current treatment options remain limited.
BioNTech plans to advance the therapy into ongoing Phase 3 trials and is targeting a regulatory filing in 2026, subject to feedback from the U.S. Food and Drug Administration.
In the study, the antibody-drug conjugate achieved a confirmed objective response rate of approximately 48% among evaluable patients, with median progression-free survival of about 8 months. The treatment demonstrated consistent antitumor activity across all HER2 expression levels, including patients previously treated with checkpoint inhibitors.
The trial, involving 145 heavily pre-treated patients, also showed a manageable safety profile, with most adverse effects being low-grade and consistent with similar therapies.
The results, presented at the 2026 Society of Gynecologic Oncology Annual Meeting, highlight the drug’s potential to address a significant unmet need in endometrial cancer, where current treatment options remain limited.
BioNTech plans to advance the therapy into ongoing Phase 3 trials and is targeting a regulatory filing in 2026, subject to feedback from the U.S. Food and Drug Administration.