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ROSETTA Breast-01: Pumitamig plus chemotherapy vs placebo plus chemotherapy in PD-L1–negative TNBC
jRCT2061250097Phase 3Recruiting
- Sponsor
- BioNTech SE
- Start
- Jun 2026
- Modality
- Bispecific Antibodies → Multispecific Antibodies → Engineered Antibody Formats → Antibody-Based Therapeutics
01
Overview
Phase 3, randomised, double-blind trial in triple-negative breast cancer (TNBC) and breast cancer comparing Pumitamig + chemotherapy with Placebo + chemotherapy (2 arms). Primary endpoints: Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR) and Overall Survival (OS). Started Jun 2026; status: recruiting.
02
Drugs
pumitamig
03
Conditions
triple-negative breast cancer (TNBC)breast cancer
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