Hong Kong-listed Sino Biopharmaceutical Limited (Sino Biopharm, 01177) reported positive Phase III data for its in-house regimen of benmelstobart and anlotinib in previously untreated, non-squamous non-small cell lung cancer (NSCLC) at the 2026 ASCO Annual Meeting.
The multicentre, randomised trial enrolled 596 patients with stage IIIB/C or recurrent/metastatic disease. Participants received either: • Study arm: benmelstobart plus platinum-based chemotherapy followed by benmelstobart plus anlotinib • Control arm: tislelizumab plus platinum-based chemotherapy
Primary Endpoint – Progression-Free Survival (PFS) • Median PFS: 14.42 months (study arm) vs 8.34 months (control) • Hazard ratio: 0.67 (95% CI 0.52–0.86)
Key Subgroup (PD-L1 TPS < 1%) • Median PFS: 12.45 months (study arm) vs 6.54 months (control) • Hazard ratio: 0.61 (95% CI 0.43–0.86)
Safety Incidence of treatment-emergent adverse events leading to discontinuation or death was comparable between arms; the overall safety profile remained manageable.
Strategic Context • This is the second head-to-head Phase III study in which the benmelstobart + anlotinib combination has surpassed tislelizumab + chemotherapy, and the first global Phase III to show superiority over an immune checkpoint inhibitor plus chemotherapy in first-line non-squamous NSCLC. • NSCLC accounts for 80-85% of lung cancers worldwide; non-squamous histology represents roughly 65% of NSCLC cases. Current standard first-line therapy (immune checkpoint inhibitor plus platinum chemotherapy) delivers a typical PFS of 8-9 months. • The benmelstobart-anlotinib regimen is already approved in China for extensive-stage small cell lung cancer, endometrial cancer, renal cell carcinoma and alveolar soft part sarcoma, and a marketing application is under review for first-line squamous NSCLC.
Subsidiary Involvement Trial sponsorship and data presentation were led by Chia Tai Tianqing Pharmaceutical Group Co., Ltd., a wholly owned subsidiary of Sino Biopharm.
The latest results reinforce the Group’s strategy of combining anti-angiogenic therapy with PD-L1 blockade to expand treatment options across lung-cancer subtypes.
Comments