MAINZ, Germany – 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”).
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.
About Triple-Negative Breast Cancer
Triple-negative breast cancer (TNBC), which is defined by a lack of hormone receptors (estrogen or progesterone) and HER2 protein, accounts for about 10-15% of all invasive breast cancer cases.1 It is an aggressive type of breast cancer that tends to grow and spread faster and has a worse prognosis compared to other breast cancer types. TNBC disproportionally impacts younger, premenopausal, and Black and Hispanic women. The 5-year survival rate for patients with metastatic TNBC is only 15%, emphasizing the need for new treatment options.*
About Pumitamig
Pumitamig is an investigational bispecific immunomodulator, jointly developed by BioNTech and BMS, designed to cooperatively bind to PD-L1 and VEGF-A. It is aimed at restoring the immune system’s ability to recognize and destroy tumor cells while simultaneously cutting off the blood and oxygen supply that feeds tumor cells (anti-angiogenesis effect), preventing them from growing and proliferating. By anchoring to PD-L1 receptors on tumor cells, we believe pumitamig localizes VEGF-A blockade within the tumor microenvironment, potentially enhancing antitumor activity while minimizing systemic exposure.
More than 4,000 patients have been treated with pumitamig in clinical trials to date. Seven global Phase 3 trials with registrational potential are currently ongoing, evaluating pumitamig plus chemotherapy compared to standard of care treatments, in first-line small cell lung cancer (ROSETTA Lung-01, NCT06712355); first-line non-small cell lung cancer (ROSETTA Lung-02, NCT06712316); unresectable stage III non-small cell lung cancer (ROSETTA Lung-201, NCT07361497); first-line advanced PD-L1 ≥ 50% non-small cell lung cancer (ROSETTA Lung-202, NCT07361510); first-line triple-negative breast cancer (ROSETTA Breast-01, NCT07173751); first-line microsatellite stable colorectal cancer (ROSETTA CRC-203, NCT07221357); and first-line gastric cancer (ROSETTA Gastric-204, NCT07221149). Pumitamig is also being explored in 10+ novel-novel combination trials with ADCs and other novel modalities, with the aim of expanding its role across tumor types and identifying additional pivotal opportunities.
About BioNTech
BioNTech is a global next generation biopharmaceutical company pioneering novel investigative therapies for cancer and other serious diseases. In oncology, BioNTech is committed to transforming how cancer is treated. Its ambition is to develop innovative medicines with pan-tumor or synergistic potential to address cancer from multiple angles and across the full continuum of the disease from early- to late-stage. Its growing late-stage oncology pipeline comprises complementary treatment approaches spanning immunomodulators, antibody-drug conjugates, and mRNA cancer immunotherapies. BioNTech has partnered with multiple global and specialized pharmaceutical collaborators leveraging complementary expertise and resources to accelerate innovation and drive progress, including Bristol Myers Squibb, Duality Biologics, Genentech, a member of the Roche Group, Genmab, MediLink, OncoC4, and Pfizer.
For more information, please visit www.BioNTech.com.
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Reference
* American Cancer Society. Triple-Negative Breast Cancer. https://www.cancer.org/cancer/types/breast-cancer/about/types-of-breast-cancer/triple-negative.html. Accessed October 15, 2026.