Globenewswire·2025-12-09 12:00Core Insights - BioNTech and Bristol Myers Squibb announced promising interim data from a Phase 2 trial evaluating pumitamig, a bispecific antibody targeting PD-L1 and VEGF-A, in combination with chemotherapy for treating locally advanced/metastatic triple-negative breast cancer (TNBC) [1][2][6] Efficacy - The combination of pumitamig and chemotherapy achieved a confirmed objective response rate (cORR) of 61.5%, an unconfirmed objective response rate (uORR) of 71.8%, and a disease control rate (DCR) of 92.3%, regardless of PD-L1 expression levels [6][7] - Efficacy was consistent across different dose levels and treatment lines, with higher doses correlating with better responses: uORR was 63.2% at 15 mg/kg and 80.0% at 20 mg/kg [7] - The progression-free survival (PFS) rate at 9 months was reported at 59.3%, although median PFS and overall survival (OS) data were not mature at the time of analysis [7] Safety - Pumitamig demonstrated a manageable safety profile, with grade ≥3 treatment-related adverse events (TRAEs) reported in 42.5% of patients in Cohort 1 and 38.2% in Cohort 2, with no deaths attributed to pumitamig [7][8] Clinical Trial Details - The trial evaluated two dose levels of pumitamig in combination with four different chemotherapy agents for first- and second-line treatment of TNBC [3][9] - The ongoing Phase 3 trial, ROSETTA BREAST-01, will further investigate pumitamig plus chemotherapy versus placebo plus chemotherapy in patients with PD-L1 negative TNBC [8][12] Industry Context - Triple-negative breast cancer (TNBC) accounts for 10-15% of all invasive breast cancer cases and has a poor prognosis, with a 5-year survival rate of only 15% in advanced stages, highlighting the urgent need for new treatment options [3][10] - Current standard care for PD-L1 low or negative TNBC is chemotherapy alone, as existing PD-(L)1 inhibitors have shown limited efficacy in this subgroup [10][11]