Trastuzumab pamirtecan, an investigational HER2\u2011targeted antibody-drug conjugate developed by BioNTech and DualityBio, has met the primary efficacy endpoint in a Phase II cohort of patients with advanced or metastatic endometrial cancer who had progressed after first\u2011line chemotherapy, with or without prior checkpoint\u2011inhibitor treatment. The results, presented at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting on Women\u2019s Cancers, show a confirmed objective response rate of 49.3% in centrally HER2\u2011tested patients with prior immune checkpoint\u2011inhibitor exposure and 47.9% across all centrally tested evaluable patients, with a median progression\u2011free survival of 8.1 months.<\/p>\n
\u201cEndometrial cancer is one of the few cancers with an increasing mortality rate,\u00b9 and there is an urgent need for new treatment options, especially for patients with recurrent disease with lower HER2 expression levels where current standard\u2011of\u2011care chemotherapy offers only a 15% response rate,\u201d said Bhavana Pothuri, M.D., Medical Director of the Clinical Trials Office (CTO) and Director of Gynecologic Oncology Research at the NYU Langone Perlmutter Cancer Center. \u201cWe are encouraged by these results for trastuzumab pamirtecan, which showed clinically meaningful responses across all HER2 levels. Importantly, these results were seen in a broad patient population that reflects real\u2011world clinical practice, including patients who have received prior immune checkpoint\u2011inhibitor treatment and those with visceral metastases.\u201d<\/p>\n
\u201cThese positive results in patients with endometrial cancer, including those with lower HER2 expression levels, support the potential of trastuzumab pamirtecan,\u201d added \u00d6zlem T\u00fcreci, Co\u2011Founder and Chief Medical Officer at BioNTech, who recently announced he and \u00d6zlem T\u00fcreci plan to step aside from the company<\/a>. \u201cHER2 remains an important therapeutic target, particularly in gynaecologic cancers and breast cancer. We are continuing to advance trastuzumab pamirtecan, both as a monotherapy and in novel treatment\u2011combination approaches, with the aim of addressing the significant unmet medical needs in the treatment of patients with HER2\u2011driven tumours.\u201d<\/p>\n