Duality Biologics and BioNTech Present Encouraging Data for BNT324/DB-1311 at ESMO Asia 2024
Duality Biologics and BioNTech SE presented promising data from their ongoing Phase 1/2a trial of BNT324/DB-1311 at the 2024 European Society of Medical Oncology Asia Annual Meeting in Singapore. The data demonstrated encouraging antitumor activity and a manageable safety profile in heavily pretreated patients with locally advanced or metastatic solid tumors.
The trial included 277 participants across various solid tumor types. The primary endpoints were safety and objective response rate, while secondary endpoints included duration of response, disease control rate, progression-free survival, and overall survival.
Among all evaluable patients, the overall unconfirmed objective response rate (uORR) was 32.4%, and the disease control rate (DCR) was 82.4%. Notably, in patients with small cell lung cancer who had prior immunotherapy but no treatment with topoisomerase I inhibitors, the uORR reached 70.4% at the 9 mg/kg dose level.
BNT324/DB-1311 also demonstrated early antitumor activity in patients with castration-resistant prostate cancer, with an uORR of 28.0% and a DCR of 92.0%. In other tumor types, including cervical cancer, hepatocellular carcinoma, head and neck squamous carcinoma, and melanoma, BNT324/DB-1311 exhibited uORRs of 75.0%, 25.0%, 100.0%, and 36.4%, respectively.
The safety profile of BNT324/DB-1311 was manageable across all evaluated patients and tumor types.
These results suggest that BNT324/DB-1311 has the potential to be a valuable new treatment option for patients with various solid tumors. Further clinical trials are planned to confirm these findings and explore the potential of BNT324/DB-1311 in combination with other therapies.