BioNTech Advances Phase 3 Clinical Trial of Pumitamig in Combination with Gilead’s TROP2-Directed ADC Sacituzumab Govitecan in Triple-Negative Breast Cancer
Key Highlights
- ➤BioNTech and Gilead enter collaboration for first-line PD-L1-low or negative TNBC
- ➤ROSETTA Breast-01 will replace chemotherapy with sacituzumab govitecan, pending regulatory approval
- ➤BioNTech continues sponsoring and leading the global Phase 3 ROSETTA Breast-01 trial
- ➤ROSETTA Breast-01 becomes pumitamig’s first global Phase 3 trial combined with an ADC
- ➤Pumitamig remains investigational; combination safety and efficacy are not established
Expert Statements
Peter Schmid, Lead Investigator and Director of the Breast Cancer Centre at St. Bartholomew’s Hospital
“When the ROSETTA Breast-01 trial was initiated, chemotherapy was the only option for patients with PD‑L1 negative advanced TNBC. While chemotherapy remains a standard first-line option, TROP2-directed ADCs like sacituzumab govitecan are quickly becoming the new global standard of care. I am excited to evaluate the combination of pumitamig and sacituzumab govitecan in the ROSETTA Breast-01 trial to potentially further amplify the already meaningful improvement in patient outcomes that sacituzumab govitecan has demonstrated over chemotherapy”
Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech
“We aim to maximize potential benefit for patients with triple-negative breast cancer. Adapting ROSETTA Breast-01 to reflect the evolving standard of care gives the trial the best chance to inform clinical practice and, ultimately, treatment decisions for patients”
Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech
“Combining pumitamig as a potential backbone with complementary modalities such as ADCs is central to our therapeutic approach. Sacituzumab govitecan has advanced first‑line treatment of triple-negative breast cancer. By combining pumitamig and sacituzumab govitecan, we aim to determine whether this approach can further improve outcomes of patients.”
* BioNTech enters a clinical trial collaboration with Gilead Sciences with the aim of improving outcomes in patients with PD-L1 low or negative triple-negative breast cancer * The global Phase 3 ROSETTA Breast-01 trial will evolve to evaluate pumitamig in combination with sacituzumab govitecan, a TROP2-directed antibody-drug conjugate, reflecting the new standard of care in first-line treatment of metastatic triple-negative breast cancer * This will be the first global Phase 3 trial of pumitamig in combination with an antibody-drug conjugate MAINZ, Germany, October 22, 2026 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) today announced a clinical trial collaboration and supply agreement with Gilead Sciences Inc. (“Gilead”) to evaluate pumitamig in combination with the TROP2-directed antibody-drug conjugate (“ADC”) sacituzumab govitecan (Trodelvy(®)) as first-line treatment for patients with locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer (“TNBC”). Pumitamig is an investigational bispecific immunomodulator designed to cooperatively bind to PD-L1 and VEGF-A that is being jointly developed by BioNTech and Bristol Myers Squibb (“BMS”).
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