BioNTech's BNT327 Shows Promise in Small Cell Lung Cancer, Advancing to Phase 3 Trials

BioNTech, the biotechnology company known for its mRNA COVID-19 vaccine, is making significant strides in oncology with its PD-L1xVEGF-A bispecific antibody, BNT327. Recent data presented at the European Lung Cancer Congress (ELCC) has showcased the potential of this drug candidate in small cell lung cancer (SCLC), a challenging subset of lung cancer with limited treatment options.

Impressive Survival Data in Phase 2 Trial

In a Chinese phase 2 trial, BNT327 demonstrated remarkable efficacy when combined with chemotherapy for the treatment of extensive-stage SCLC. The study reported a median overall survival (OS) of 16.8 months, with 72.7% of patients alive at the 12-month mark. These results are particularly noteworthy when compared to current standard-of-care treatments.

AstraZeneca's Imfinzi and Roche's Tecentriq, both FDA-approved checkpoint inhibitors for first-line treatment of extensive-stage SCLC in combination with chemotherapy, have shown median OS of 13 months and 12.3 months, respectively, in their pivotal trials. While cross-trial comparisons should be interpreted cautiously, BNT327's preliminary data suggests a potential improvement over existing therapies.

Advancing to Phase 3 and Expanding Indications

Based on these promising results, BioNTech has initiated a global phase 3 trial to evaluate BNT327 in combination with chemotherapy for previously untreated extensive-stage SCLC. The study aims to enroll 439 patients across multiple sites in the United States.

BioNTech is not limiting its ambitions to SCLC alone. The company has also begun phase 3 trials for BNT327 in non-small cell lung cancer and is preparing to start a first-line study in triple-negative breast cancer. Additionally, phase 2 data in second-line SCLC treatment showed a median OS of 14.3 months and a median duration of response of 5.6 months in 65 evaluable patients.

Strategic Positioning in the Bispecific Antibody Landscape

BioNTech's commitment to BNT327 reflects a broader industry trend towards PD-(L)1xVEGF-A bispecific antibodies. These molecules are increasingly seen as potential replacements for established checkpoint inhibitors like Merck's Keytruda in various cancer indications.

The company's strategy extends beyond monotherapy applications. BioNTech is exploring combinations of BNT327 with antibody-drug conjugates targeting TROP2, HER2, HER3, and B7H3. Future plans include studies with other bispecifics, cell therapies, and additional antibody-drug conjugates.

BioNTech's recent $800 million investment to gain full control of BNT327 underscores the company's confidence in the drug's potential. As the pharmaceutical industry closely watches the development of bispecific antibodies, BNT327's progress could signal a shift in the landscape of cancer immunotherapy.