1. Pumitamig shows 61.5% objective response rate in TNBC patients. 2. High disease control rate indicates significant therapeutic potential. 3. Trial data will be presented at the San Antonio Symposium. 4. Encouraging efficacy for patients with PD-L1 low tumors. 5. Pivotal Phase 3 trial planned for pumitamig in TNBC.
FAQ
Why Bullish?
The promising clinical data for pumitamig could enhance BMY's market position in oncology, potentially leading to increased revenue post-approval. Historical instances like Opdivo’s approval, which similarly shifted market dynamics for BMY, support this optimism.
How important is it?
The significance of pumitamig's interim results aligns closely with BMY's therapeutic goals, outlining a path toward robust financial returns justifies a high impact score.
Why Long Term?
The impact is primarily long-term, as successful trials and subsequent approval could lead to revenue increases over years, similar to how new cancer therapies usually drive market performance after regulatory approval and market introduction.
BioNTech and Bristol Myers Squibb Share Promising Phase 2 Data on Pumitamig for Triple-Negative Breast Cancer
MAINZ, Germany, and PRINCETON, USA, December 9, 2025 – BioNTech SE (Nasdaq: BNTX, “BioNTech”) and Bristol Myers Squibb Company (NYSE: BMY, “BMS”) have unveiled encouraging interim results from their global Phase 2 clinical trial (NCT06449222) of pumitamig (BNT327/BMS986545), a novel bispecific antibody. This investigational therapy, when used in combination with chemotherapy, demonstrates impressive antitumor activity in patients suffering from locally advanced or metastatic triple-negative breast cancer (TNBC), regardless of PD-L1 expression levels.
Key Findings from the Interim Analysis
The interim analysis revealed that pumitamig combined with chemotherapy achieved:
- Confirmed Objective Response Rate (cORR): 61.5%
- Unconfirmed Objective Response Rate (uORR): 71.8%
- Disease Control Rate (DCR): 92.3%
These results highlight the significant potential of pumitamig, particularly for patients with PD-L1 low or negative TNBC (CPS<10), a group that currently has limited treatment options.
Implications for Triple-Negative Breast Cancer Treatment
Triple-negative breast cancer is known for its aggressive nature and poor prognosis, with a dismal 5-year survival rate of just 15% in advanced stages. According to Dr. Peter Schmid, the Lead Investigator and Director of the Breast Cancer Centre at St. Bartholomew's Hospital, London, “There remains an urgent need for new treatment options – particularly for patients with PD-L1 low or negative tumors.” Both BioNTech and BMS are optimistic that pumitamig's promising efficacy in interim analyses will support its continued investigation in the pivotal Phase 3 ROSETTA BREAST-01 trial.
Details of the Clinical Trial
The trial assessed two dose levels of pumitamig combined with four different chemotherapy regimens. Specifically:
- Cohort 1: Patients received pumitamig (15 or 20 mg/kg Q2W) combined with nab-paclitaxel until disease progression.
- Cohort 2: Patients received a flat-dose equivalent of 20 mg/kg in conjunction with paclitaxel, gemcitabine + carboplatin, or eribulin.
The analysis included 74 patients, with notable outcomes indicating that higher doses correlated with increased response rates across various PD-L1 expression levels and treatment lines.
Safety Profile
Pumitamig demonstrated a manageable safety profile across both cohorts. The incidence of grade ≥3 treatment-related adverse events (TRAEs) was recorded at 42.54% in Cohort 1 and 38.2% in Cohort 2, with no reported deaths related to pumitamig.
Future Prospects for Pumitamig
The encouraging findings from this study could lead to significant advancements in TNBC treatment, especially for patients who have previously faced limited options. Professor Özlem Türeci, Co-Founder and Chief Medical Officer at BioNTech, stated, “We are encouraged by these first locally advanced/metastatic TNBC data from a global patient population.” Pumitamig is also being studied in over 20 clinical trials as a monotherapy and in combination with various treatment modalities across more than 10 solid tumor indications.
About Pumitamig
Pumitamig, developed jointly by BioNTech and BMS, is a bispecific antibody that integrates two validated mechanisms in oncology to enhance T cell activation against tumors. Given its synergy in targeting PD-L1 and VEGF-A pathways, pumitamig holds promise for addressing the high unmet needs in TNBC.
Conclusion
The data presented marks a pivotal moment in cancer research and treatment, particularly for those grappling with the aggressive nature of TNBC. As the Phase 3 ROSETTA-BREAST-01 trial progresses, there is renewed hope for innovative therapies that could reshape outcomes for patients with this challenging disease.