Bristol‑Myers Squibb and BioNTech disclosed that the first interim analysis of the bispecific antibody pumitamig (BNT327/BMS986545) was presented at the 2025 San Antonio Breast Cancer Symposium. The global, randomized Phase 2 study (NCT06449222) enrolled 74 patients with locally advanced or metastatic triple‑negative breast cancer (TNBC) and evaluated two dosing regimens: 15 mg/kg or 20 mg/kg every two weeks with nab‑paclitaxel, and a flat 20 mg/kg dose combined with one of three chemotherapy backbones (paclitaxel, gemcitabine + carboplatin, or eribulin).
The interim data, cut off October 1 2025, showed a confirmed objective response rate (cORR) of 61.5 %, an unconfirmed ORR (uORR) of 71.8 %, and a disease‑control rate (DCR) of 92.3 %. These figures represent some of the highest response rates reported in early‑line TNBC trials and underscore the dual‑mechanism activity of pumitamig against both PD‑L1 and VEGF‑A pathways.
Safety outcomes were described as manageable, with no new safety signals identified. The most frequently reported treatment‑related adverse events were fatigue, nausea, and hypertension, each occurring in fewer than 20 % of patients. The safety profile aligns with the known tolerability of the individual components and supports continued development in this patient population.
A Phase 3, randomized, double‑blind, placebo‑controlled trial—ROSETTA‑BREAST‑01—is already underway. It will compare pumitamig plus chemotherapy versus placebo plus chemotherapy in a larger cohort of TNBC patients, providing the definitive evidence needed for regulatory approval and market entry.
For Bristol‑Myers Squibb, pumitamig represents a potentially high‑margin oncology asset that could diversify its portfolio beyond its current immuno‑oncology leaders. The encouraging early data strengthen the company’s pipeline narrative and may accelerate the drug’s regulatory path, positioning BMY to capture a share of the growing TNBC market, which is estimated to reach several billion dollars in the next decade.
BioNTech’s Q3 2025 results showed €1.5 billion in revenue, driven largely by the BMS collaboration, but the company posted a net loss as it continues to invest heavily in its oncology pipeline. Bristol‑Myers Squibb reported Q3 2025 revenue of $12.2 billion and a non‑GAAP EPS of $1.63, both above analyst expectations, and it raised its full‑year guidance, reflecting confidence in its oncology and vaccine businesses.
Clear Street maintained a “Buy” rating for BioNTech with a $181.00 price target, citing the company’s oncology pipeline—including pumitamig—as undervalued. The positive analyst view reflects the potential upside from the interim data and the broader pipeline strength.
While no immediate market reaction to the announcement was documented, the favorable data and analyst sentiment suggest that investors view pumitamig as a promising addition to the oncology landscape, potentially influencing future valuation and investment decisions.
The combination of strong clinical signals, a clear regulatory pathway, and supportive financial performance underscores the significance of this interim report for both Bristol‑Myers Squibb and BioNTech, marking a pivotal step toward a new high‑margin oncology asset.
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