BioNTech and BMS Disclose Global Phase II Data for PD-L1×VEGF Bispecific Antibody Pumitamig (BNT327) in First-Line Extensive-Stage Small Cell Lung Cancer
BioNTech
Developer of Novel Biologics
Bristol-Myers Squibb
Biopharmaceutical and Nutritional Product R&D and Sales
Held this week inAt the 2025 World Conference on Lung Cancer (WCLC)，BioNTech and BMS Release Interim Results of Global Phase II Study on Their PD-L1 × VEGF Bispecific Antibody Candidate Pumitamig (BNT327) Involving Treatment-Naïve Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Patients, Data ShowsSignificant anti-tumor effects and good safety。The latest data is consistent with the previous data achievements obtained in China, providing strong support for advancing to Phase III trials.
Clinical trial results showed that, as of the data cutoff date of August 7, 2025,Among the 43 patients who underwent safety assessment,The confirmed overall response rate (cORR) among 38 evaluable patients reached 76.3%, with a disease control rate (DCR) of 100%. Data from different dose groups showed some variation: the cORR was as high as 85% in the 20 mg/kg group, while it was 66.7% in the 30 mg/kg group; however, in terms of progression-free survival (PFS),Higher dose group performed better (7 months vs 6.3 months)。The overall PFS was 6.8 months, and the median overall survival (OS) has not yet matured.。
In terms of safety, no new safety signals were found beyond the known adverse reactions of chemotherapy, PD-(L)1 inhibitors, or anti-VEGF drugs. In the safety evaluation, one case of grade 3 or higher hemoptysis adverse event occurred in the 20 mg/kg group, and five cases occurred in the 30 mg/kg group.Including hypertension, decreased platelet count, hemoptysis, proteinuria, and pulmonary embolism, with a discontinuation rate of 14%.And no treatment-related deaths occurred.。
Türeci pointed out that the results were "exciting and compelling."Its efficacy is not inferior to the current standard regimen based on immunotherapy., and acknowledged that the follow-up time was still very short.Compared with the existing treatment landscape, pumitamig has demonstrated outstanding potential. The current first-line standard treatment is Roche's Tecentriq (atezolizumab) combined with chemotherapy, which was approved based on the results of the Phase III IMpower133 study in 2019.Its ORR was 60%, DoR was 4.2 months, and median PFS was 5.2 months.In contrast,The interim results of pumitamig demonstrate a clear advantage in efficacy.，Expected to become the backbone drug of the next generation of immunotherapy.
Notably, the efficacy results of pumitamig are highly consistent with the Chinese Phase II study announced at the European Lung Cancer Conference (ELCC) in March this year. The study achieved an objective response rate (ORR) of 85.4% and a progression-free survival (PFS) of 6.9 months in the 30 mg/kg dose group.BioNTech Chief Medical Officer Dr. Özlem Türeci said that this "highly consistent" global data, once again confirming the reliability of early Chinese research. Bryan Campbell, the BMS project leader, also pointed out,The latest data, consistent with readings from China, provides strong support for advancing to Phase III trials.
Currently, the global pivotal Phase III clinical trial ROSETTA LUNG-01 is underway, primarily evaluating fixed-dose (equivalent to 20 mg/kg) pumitamig in combination with chemotherapy, directly compared to the current first-line standard regimen Tecentriq combined with chemotherapy, to further validate its clinical value.
BioNTech Acquires Global Full Rights to BNT327 by Purchasing Chinese Company Promab BiotechnologiesIn June this year, the company entered into a strategic cooperation with Bristol-Myers Squibb (BMS). BMS made an upfront payment of 1.5 billion US dollars, and the overall value of the partnership could reach up to 11.1 billion US dollars. This deal not only demonstrates the potential of pumitamig in the field of tumor immunotherapy but also provides sufficient funding and resource support for its subsequent clinical advancement.
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