BioNTech Collaborates with Gilead to Evaluate Pumitamig + Trodelvy (Sacituzumab Govitecan) in P-III (ROSETTA Breast-01) Trial for Triple-Negative Breast Cancer | PharmaVoice
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BioNTech Collaborates with Gilead to Evaluate Pumitamig + Trodelvy (Sacituzumab Govitecan) in P-III (ROSETTA Breast-01) Trial for Triple-Negative Breast Cancer
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BioNTech has entered into a clinical trial collaboration & supply agreement with Gilead to evaluate pumitamig + sacituzumab govitecan (Trodelvy), a TROP2-directed ADC, as 1L treatment of locally advanced or metastatic PD-L1 low or negative triple-negative breast cancer (TNBC); pumitamig, a PD-L1×VEGF-A bispecific immunomodulator, is being jointly developed by BioNTech & BMS
The global, double-blinded P-III (ROSETTA Breast-01; NCT07173751) trial, currently evaluating pumitamig + chemotherapy vs chemotherapy in PD-L1 low or negative TNBC (CPS <10), will be adapted to replace chemotherapy with sacituzumab govitecan, pending regulatory approval; BioNTech will continue to sponsor & lead the trial, while Gilead will supply sacituzumab govitecan
ROSETTA Breast-01 will be the 1st global P-III trial of pumitamig in combination with an ADC; pumitamig is being evaluated in 7 ongoing global P-III & 10+ P-II novel-novel combination trials, with >4,000 pts treated in clinical trials to date
Ref: GlobeNewswire | Image: BioNTech & Gilead | Press Release
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