BioNTech and Gilead partner to evaluate Pumitamig plus Trodelvy in 1L TNBC

CAR-T Digest - August 2020

Weekly Digest - October 2026

22 October 2026: BioNTech and Gilead partner to evaluate Pumitamig plus Trodelvy in 1L TNBC

BioNTech announced a clinical trial collaboration and supply agreement with Gilead Sciences to evaluate pumitamig in combination with Trodelvy as first-line treatment for locally advanced or metastatic PD-L1-low or PD-L1-negative triple-negative breast cancer, with the global phase 3 ROSETTA Breast-01 trial planned to transition from chemotherapy to the ADC combination, pending regulatory approval
The phase 3 ROSETTA Breast-01 trial will evaluate pumitamig plus sacituzumab govitecan against chemotherapy in patients with PD-L1-low or PD-L1-negative TNBC (CPS <10). BioNTech will continue to sponsor and lead the trial, while Gilead will supply Trodelvy; the combination’s safety and efficacy have not yet been established
The collaboration addresses an unmet need in advanced TNBC, particularly among patients with low or absent PD-L1 expression, who have limited first-line immunotherapy options and require more effective treatments to improve disease control and survival
Trodelvy is a TROP2-directed ADC that delivers the topoisomerase I inhibitor SN-38 to tumor cells while Pumitamig is an investigational PD-L1 × VEGF-A bispecific antibody designed to combine immune checkpoint inhibition with anti-angiogenic activity, providing a rationale for combining targeted cytotoxic delivery with dual immunomodulatory effects
Strategically, ROSETTA Breast-01 will become the first global phase 3 trial evaluating pumitamig in combination with an ADC, marking an expansion of BioNTech and Bristol Myers Squibb’s development strategy toward novel combination regimens. Gilead’s participation further connects its TROP2 ADC franchise with an investigational bispecific immunotherapy approach