BioNTech SE and Bristol Myers Squibb disclosed the first interim data from a global, randomized Phase 2 study of the bispecific antibody pumitamig (BNT327) combined with chemotherapy in patients with locally advanced or metastatic triple‑negative breast cancer (TNBC). The analysis, based on an October 1, 2025 data cut, included 74 patients and showed a confirmed objective response rate (cORR) of 61.5 % and an unconfirmed rate of 71.8 %. The disease‑control rate (DCR) reached 92.3 % and the 9‑month progression‑free survival (PFS) rate was 59.3 %. These figures represent the highest response rates reported to date for a PD‑L1‑negative TNBC population and provide a strong signal for the ongoing Phase 3 ROSETTA‑BREAST‑01 trial.
Safety data were described as manageable across all regimens. Grade ≥ 3 treatment‑related adverse events occurred in 42.5 % of patients in Cohort 1 (15 or 20 mg/kg every two weeks with nab‑paclitaxel) and 38.2 % in Cohort 2 (flat 20 mg/kg with paclitaxel, gemcitabine + carboplatin, or eribulin). No new safety signals emerged, and the safety profile aligns with expectations for bispecific antibody therapy combined with standard chemotherapy.
The interim results reinforce the strategic partnership between BioNTech and Bristol Myers Squibb, which has committed up to $11.1 billion in total value for the BNT327 program. BioNTech’s CEO, Prof. Ugur Sahin, emphasized that the data “support the potential of BNT327 to become a foundational immuno‑oncology backbone.” Senior Vice President Anne Kerber of Bristol Myers Squibb noted that the activity “is especially meaningful in patients with PD‑L1 low or negative tumours, expanding the therapeutic window beyond the current immunotherapy‑eligible cohort.” Lead investigator Peter Schmid added that the “aggressive nature of TNBC and the limited options for PD‑L1‑negative disease make these results particularly encouraging.”
From a financial perspective, BioNTech’s oncology pipeline is a key driver of its future growth, offsetting the decline in vaccine‑related revenue. The company reported a net loss in 2024 but maintains a robust cash position, bolstered by the BMS partnership. Bristol Myers Squibb’s oncology portfolio remains stable, with consistent earnings and a strong balance sheet, positioning it to support the Phase 3 program’s development and potential commercialization. The high response rates in the interim data suggest that BNT327 could generate a new oncology revenue stream and accelerate BioNTech’s transition from a pandemic‑era vaccine company to a fully integrated oncology biopharma.
The Phase 3 ROSETTA‑BREAST‑01 trial will enroll patients with PD‑L1‑negative TNBC and compare BNT327 plus chemotherapy to placebo plus chemotherapy. The interim data have already informed the trial’s design and enrollment strategy, and the robust early signals provide a compelling rationale for continued investment in the bispecific antibody platform. If the Phase 3 results confirm the Phase 2 efficacy and safety, BNT327 could become a first‑line therapy for a population with limited approved options, potentially reshaping the treatment landscape for triple‑negative breast cancer.
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