BioNTech Advances On Positive Phase 3 Breast Cancer Drug Data

On Friday, BioNTech SE (NASDAQ:BNTX) and its partner Duality Biologics (Suzhou) Co., Ltd. released topline data from a Phase 3 trial in China evaluating trastuzumab pamirtecan (BNT323/DB-1303) versus trastuzumab emtansine (T-DM1) for HER2-positive unresectable or metastatic breast cancer patients who have previously received trastuzumab and a taxane-based chemotherapy.

The trial met its primary endpoint of progression-free survival at a pre-specified interim analysis.

Trastuzumab pamirtecan is a next-generation antibody-drug conjugate candidate targeting the cancer cell surface protein Human Epidermal Growth Factor Receptor 2 (HER2).

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The clinical trial compares the candidate to the approved ADC, Roche Holdings AG (OTC:RHHBY) Kadcyla (trastuzumab emtansine, T-DM1).

Based on the results from the interim analysis which were shared by the Independent Data Monitoring Committee (IDMC) with DualityBio and evaluated by the Blinded Independent Central Review (BICR), DualityBio plans to discuss the next steps with the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of China regarding the submission of a Biologics License Application (BLA) of trastuzumab pamirtecan. 

This is the first positive Phase 3 data readout achieved in BioNTech’s and DualityBio’s strategic collaboration initiated in April 2023.

The collaboration aims to accelerate the development of differentiated ADC therapeutics for solid tumors.

In January 2024, the partners initiated a global Phase 3 DYNASTY-Breast02 trial program for trastuzumab pamirtecan in HR-positive, HER2-low metastatic breast cancer (DYNASTY-Breast02) following Phase 1/2 safety and efficacy data in patients with HER2-expressing advanced solid tumors.

BioNTech holds global commercial rights, while DualityBio has commercial rights for Mainland China, Hong Kong Special Administrative Region, and Macau Special Administrative Region.

Price Action: BNTX stock is trading higher by 9.47% to $113.30 premarket at last check Friday.

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