BioNTech partners with Gilead on Phase 3 breast cancer combination trial

By Public Technologies
  • BioNTech entered a clinical trial collaboration and supply agreement with Gilead to evaluate pumitamig combined with sacituzumab govitecan.
  • The Phase 3 ROSETTA Breast-01 trial targets first-line treatment of locally advanced or metastatic triple-negative breast cancer with low or negative PD-L1 expression.
  • Subject to regulatory approval, sacituzumab govitecan will replace chemotherapy as both the combination partner and comparator treatment.
  • Gilead will supply sacituzumab govitecan; BioNTech will remain trial sponsor and lead the study.
  • Pumitamig, jointly developed with Bristol Myers Squibb, will undergo its first global Phase 3 evaluation in combination with an antibody-drug conjugate.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioNTech SE published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202610220645OMX_____CNEWS_DE_GNW1001279352_de) on October 22, 2026, and is solely responsible for the information contained therein.

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