BioNTech and Duality Biologics have announced a significant advance in cancer drug development with the successful outcome of a Phase III trial for their investigational therapy BNT323, also known as trastuzumab pamirtecan. The study, carried out in China, compared BNT323 with Roche’s established drug Kadcyla in patients with inoperable HER2-positive breast cancer who had previously undergone treatment. An independent monitoring committee confirmed that the trial achieved its primary goal of extending progression-free survival.

This marks BioNTech’s first successful late-stage oncology trial, underlining the company’s renewed focus on cancer therapies following its prominent role in COVID-19 vaccine development. News of the results prompted a surge of nearly 10 per cent in BioNTech’s share price.

BNT323 is an antibody-drug conjugate designed to deliver chemotherapy directly to tumour cells while sparing healthy tissue. The therapy is positioned alongside other high-profile ADC treatments such as AstraZeneca and Daiichi Sankyo’s Enhertu, which also targets HER2-positive breast cancer and is projected to achieve multibillion-dollar sales.

Analysts have hailed the achievement as a milestone for BioNTech. Industry experts emphasised that it is the company’s first pivotal Phase III oncology programme to meet its primary endpoint, with expectations now turning to the release of full data and results from a larger global trial that could support regulatory approval in the USA and Europe.