BioNTech's Cancer Drug Trastuzumab Pamirtecan Meets Primary Endpoint in Phase 3 Breast Cancer Trial

Key Insights

• BioNTech and Duality Biologics announced their antibody-drug conjugate trastuzumab pamirtecan met its primary endpoint of progression-free survival in a phase 3 trial for unresectable or metastatic breast cancer.
• The head-to-head study compared the experimental ADC treatment against trastuzumab emtansine in patients who had previously received chemotherapy.
• This marks BioNTech's first late-stage oncology drug to achieve its primary endpoint in a phase 3 study, with plans to file for regulatory approval in China, the EU, and the United States.

BioNTech and Chinese partner Duality Biologics reported positive results from a phase 3 clinical trial of their cancer drug trastuzumab pamirtecan, marking a significant milestone for the German biotech company's oncology pipeline. The antibody-drug conjugate (ADC) met its primary endpoint of progression-free survival in patients with unresectable or metastatic breast cancer who had previously received certain types of chemotherapy.

The news drove BioNTech's American depositary receipts up 10% on Friday, as investors responded positively to the company's first successful late-stage oncology trial.

Trial Design and Results

The phase 3 study, conducted by Duality Biologics in China, evaluated trastuzumab pamirtecan in a head-to-head comparison with trastuzumab emtansine, a related medicine. The ADC treatment targets a surface protein on cancer cells and was administered to patients with advanced breast cancer who had exhausted previous chemotherapy options.

BioNTech co-founder and chief medical officer Özlem Türeci emphasized the significance of the results, stating that the treatment has "enormous potential which makes it an important asset in our global oncology strategy including combinational approaches."

Regulatory Path Forward

Following the positive trial results, Duality Biologics plans to engage with China's Center for Drug Evaluation to discuss filing a biologics license application (BLA) for trastuzumab pamirtecan. The partnership also intends to submit regulatory applications in other major jurisdictions, including the European Union and the United States.

This represents BioNTech's first late-stage oncology drug to meet its primary endpoint in a phase 3 study, marking a crucial step in the company's diversification beyond its COVID-19 vaccine success with Pfizer.

Market Opportunity

The companies highlighted the substantial market opportunity for breast cancer treatments, noting that China alone reports more than 350,000 new cases of breast cancer annually. Combined with significant case numbers in the United States and other markets, the addressable patient population represents a potentially large commercial opportunity for the ADC treatment.

The positive trial results position trastuzumab pamirtecan as a potential addition to the growing ADC market, which has seen increased interest from both pharmaceutical companies and investors due to the targeted nature of these therapies and their ability to deliver cytotoxic payloads directly to cancer cells.