BioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 ...

BioNTech, DualityBio say ADC had ‘modest’ benefit in breast cancer study

The companies said the findings suggest the treatment has a “limited” impact in HER2-low breast cancer, an area where AstraZeneca and Daiichi Sankyo’s Enhertu has already set a high bar.

BioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 Clinical Trial Evaluating Trastuzumab Pamirtecan in HR+/HER2-low Metastatic Breast Cancer

MAINZ, Germany and SHANGHAI, China, October 26, 2026 - BioNTech SE (Nasdaq: BNTX, 'BioNTech”) and DualityBiologics (Suzhou) Co., Ltd. ('DualityBio”, HKEX: 9606.HK) announced today that the DYNASTY-Breast02 global Phase 3 clinical trial (NCT06018337) met its primary endpoint demonstrating a statistically significant, yet modest improvement in progression-free survival ('PFS”) with trastuzumab pamirtecan (BNT323/DB-1303) compared to investigator’s…

BioNTech and DualityBio Announce Topline Results of the DYNASTY-Breast02 Global Phase 3 ...

MAINZ, Germany and SHANGHAI, China, October 26, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and DualityBiologics (Suzhou) Co., Ltd. (“DualityBio”, HKEX: 9606.HK) announced today that the DYNASTY-Breast02 global Phase 3 clinical trial ( NCT06018337 ) met its primary endpoint demonstrating…

BioNTech and DualityBio Report Modest Progression-Free Survival Benefit and Elevated ILD Risk in Phase 3 Breast Cancer Trial

DYNASTY-Breast02 met its primary endpoint, but immature overall survival data and lung-safety findings lead partners to reassess the therapy's potential benefit IN BRIEFKEY TAKEAWAYSFAQs BioNTech and DualityBio announced that their 541-patient global Phase 3 DYNASTY-Breast02 study of trastuzumab pamirtecan met … Read the full press release →

BioNTech reports modest breast-cancer benefit and lung risks

BioNTech and DualityBio report a modest endpoint win in the 541-patient DYNASTY-Breast02 trial, with severe and fatal lung-disease events.

BioNTech, DualityBio ponder next steps for HER2 ADC after 'modest' breast cancer results

BioNTech and DualityBio are mulling what to do next with trastuzumab pamirtecan in certain breast cancer patients after the antibody-drug conjugate delivered a “statistically significant, yet modest” success in a Phase 3 trial. The drugmakers ...