BioNTech partners with Gilead on Phase 3 breast cancer combination trial

• 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.

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