BioNTech Announces Promising Phase III Study Results for Recurrent Endometrial Cancer Treatment

BioNTech SE, in collaboration with DualityBio Inc., announced an update on their ongoing Phase III clinical study for recurrent endometrial cancer. The study aims to evaluate the efficacy of BNT323/DB-1303 compared to standard chemotherapy options in improving progression-free survival in patients who have previously received immune checkpoint inhibitor treatment. The study began on June 10, 2025, and the last update was submitted on August 19, 2025. Positive results could positively influence BioNTech's stock performance, enhancing their oncology portfolio.

BioNTech SE, in collaboration with DualityBio Inc., has announced an update on their ongoing Phase III clinical study for recurrent endometrial cancer. The study, titled "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," aims to evaluate the efficacy of BNT323/DB-1303 compared to standard chemotherapy options in improving progression-free survival in patients who have previously received immune checkpoint inhibitor treatment [1].

The study, which began on June 10, 2025, is currently recruiting participants and is expected to complete soon. The last update was submitted on August 19, 2025. The intervention being tested is BNT323/DB-1303, an investigational drug administered via intravenous infusion, which is being compared against standard chemotherapy drugs, doxorubicin or paclitaxel, chosen by the investigator. The study is randomized with a parallel assignment model and is open-label, meaning no masking is involved [1].

Positive results from this study could significantly influence BioNTech's stock performance, potentially enhancing their oncology portfolio. The study's primary completion date is expected soon after the primary completion date of the study, which is crucial for tracking the study’s progress and anticipating results [1].

Investors should also watch for competitor developments in similar cancer treatments, as these could impact market dynamics. The study is currently recruiting, with further details available on the ClinicalTrials portal [1].

References:
[1] https://www.tipranks.com/news/company-announcements/biontechs-promising-phase-iii-study-on-recurrent-endometrial-cancer