BioNTech and DualityBio Achieve Phase 3 Success with ADC Therapy for HER2-Positive Breast Cancer, Advancing Oncology Pipeline

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BioNTech and DualityBio reported positive Phase 3 results for their ADC therapy, trastuzumab pamirtecan (BNT323/DB-1303), in HER2-positive metastatic or unresectable breast cancer.25

The China-based pivotal trial (NCT06265428) met its primary endpoint of improving progression-free survival (PFS) in patients pre-treated with trastuzumab and taxane chemotherapy.25

Trastuzumab pamirtecan demonstrated significantly better efficacy than Roche's approved ADC trastuzumab emtansine (Kadcyla) in this patient population.45

This represents the first late-stage clinical success for BioNTech’s oncology pipeline and marks a breakthrough in their collaboration with DualityBio, which began in April 2023.24

The achievement led to a notable increase in BioNTech's stock and is viewed as pivotal in positioning the company as a leading competitor in the rapidly growing ADC therapeutics space, challenging current standards like AstraZeneca’s Enhertu.4

DualityBio announced plans to move towards regulatory approval in China after the trial’s success.5

Additional ADC candidates developed by BioNTech and DualityBio, including those targeting other tumor antigens such as B7-H3, are also advancing in early-phase clinical studies, indicating broader ambitions in solid tumor oncology.13

Sources:

1. https://en.dualitybiologics.com/news/587.html

2. https://www.asiabiztoday.com/2025/09/06/biontech-and-dualitybio-report-phase-3-success-in-her2-positive-breast-cancer-trial/

3. https://www.oncologypipeline.com/apexonco/asco-2025-biontech-has-prostate-decision-make

4. https://www.ainvest.com/news/biontech-breakthrough-oncology-implications-long-term-growth-2509/

5. https://www.insideprecisionmedicine.com/topics/oncology/biontech-and-dualitybio-score-at-phase-iii-with-breast-cancer-therapy/