Sino Biopharmaceutical Limited has announced positive results from its Phase III clinical trial (TQB2450-III-12) evaluating Benmelstobart Injection in combination with chemotherapy followed by sequential combination with Anlotinib Hydrochloride Capsules, compared to Tislelizumab Injection in combination with chemotherapy, for the first-line treatment of advanced squamous non-small cell lung cancer (sq-NSCLC). The Independent Data Monitoring Committee (IDMC) determined that the study met its primary endpoint of progression-free survival (PFS), demonstrating a statistically significant improvement with the Benmelstobart regimen.
The study is a multicenter, randomized, double-blind, parallel-controlled Phase III clinical trial designed to assess the efficacy and safety of Benmelstobart in combination with chemotherapy followed by sequential combination with Anlotinib versus Tislelizumab in combination with chemotherapy for the first-line treatment of advanced sq-NSCLC. The interim analysis revealed that Benmelstobart, combined with chemotherapy and sequential Anlotinib, significantly prolonged patients' PFS and reduced the risk of disease progression compared to the Tislelizumab arm. The safety profile was consistent with previously known risks, and no new safety signals were identified.
Regulatory Path and Clinical Significance
Sino Biopharmaceutical has communicated with the Centre for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) of the PRC and has received written consent to submit a marketing application for the new first-line indication of Benmelstobart Injection and Anlotinib hydrochloride Capsules. This marks the 13th indication for Anlotinib and the 6th for Benmelstobart for which the Group has submitted a marketing application.
Current Landscape and Future Directions
Benmelstobart in combination with Anlotinib is already approved by the NMPA for first-line extensive-stage small cell lung cancer and second- and third-line endometrial cancer, with a marketing application under review for first-line renal cell carcinoma. Several Phase III studies in non-small cell lung cancer are ongoing. The company plans to present detailed data from the TQB2450-III-12 study at a future international academic conference. Sino Biopharmaceutical aims to accelerate the clinical development of this combination therapy, leveraging immunotherapy with anti-angiogenic therapy to improve outcomes for more cancer patients.
