Pharma BD Deal Intelligence

BioNTech SE / Gilead Sciences, Inc.

2026 · Co-Development · Complete

BioNTech and Gilead Sciences entered a clinical trial collaboration and supply agreement to evaluate BioNTech's pumitamig in combination with Gilead's TROP2-directed antibody-drug conjugate sacituzumab govitecan (Trodelvy) as first-line treatment for locally advanced or metastatic PD-L1-low or PD-L1-negative triple-negative breast cancer. The combination will be incorporated into the ongoing Phase 3 ROSETTA Breast-01 trial, which compares pumitamig plus chemotherapy against chemotherapy alone, making ROSETTA Breast-01 the first global Phase 3 trial of pumitamig in combination with an ADC. BioNTech continues to sponsor and lead the trial; Gilead supplies sacituzumab govitecan for the combination arm. No financial terms were disclosed.

This deal is too recent to grade. Critic Score and Outcome Score are assigned after the announcement-week coverage settles and, for Outcome, after the 5-year post-close assessment window opens — expected 2031 at the earliest for this deal, once/if it closes.

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