• 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

BioNTech SE (Nasdaq: BNTX, “BioNTech”) 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”).

ROSETTA Breast-01 is a global, double-blinded Phase 3 clinical trial (NCT07173751) currently evaluating pumitamig in combination with chemotherapy versus chemotherapy in patients with locally advanced or metastatic PD-L1 low or negative TNBC (CPS < 10), initiated based on positive results from a global Phase 2 trial. In line with the evolving treatment landscape in this indication, BioNTech and BMS plan to adapt ROSETTA Breast-01 replacing chemotherapy with sacituzumab govitecan, pending regulatory authority approval, to ensure that patients are receiving the latest standard of care treatment.

Under the terms of the agreement, BioNTech will continue to sponsor and lead the ROSETTA Breast-01 trial. Gilead will supply sacituzumab govitecan for the combination trial.

“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,” said Peter Schmid, M.D., Ph.D., Lead Investigator and Director of the Breast Cancer Centre at St. Bartholomew’s Hospital.

Pumitamig is currently being investigated in seven ongoing global Phase 3 trials and 10+ Phase 2 novel-novel combination trials. ROSETTA Breast-01 will be the first global Phase 3 trial of pumitamig in combination with an ADC. BioNTech and Bristol Myers Squibb plan to evaluate the full potential of pumitamig in additional Phase 3 novel combination trials in multiple solid tumors, leveraging their broad oncology pipelines and exploring other potential additional collaborations.

“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," said Prof. Özlem Türeci, M.D., 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."

The use of pumitamig and sacituzumab govitecan in patients with first-line PD-L1 negative metastatic TNBC is investigational, and the safety and efficacy of this combination has not been established.