China's National Medical Products Administration (NMPA) has approved a new first-line regimen for locally advanced or metastatic squamous non-small cell lung cancer (sq-NSCLC): benmelstobart injection, a PD-L1 inhibitor developed by Chia Tai Tianqing Pharmaceutical Group (CTTQ), a subsidiary of Sino Biopharmaceutical Limited (HKEX: 01177), in combination with paclitaxel and carboplatin chemotherapy, followed sequentially by anlotinib hydrochloride plus benmelstobart as maintenance. The company said this is the sixth approved indication for benmelstobart and the twelfth for anlotinib.
The approved regimen uses benmelstobart with paclitaxel and carboplatin as induction, then transitions to benmelstobart combined with anlotinib — a multi-target anti-angiogenic tyrosine kinase inhibitor — as sequential maintenance. Benmelstobart blocks PD-L1, preventing its engagement with PD-1 and CD80 to restore T-cell anti-tumor activity, while anlotinib targets VEGFR, FGFR, PDGFR, and c-Kit to promote vascular normalization and remodel the tumor microenvironment. Originally approved in 2024, benmelstobart has now accumulated six approved indications in China, making it one of Sino Biopharmaceutical's flagship immuno-oncology assets.
The approval is based on the Phase III ETER700 trial, a randomized, double-blind, multicenter study comparing the benmelstobart-anlotinib sequential regimen against tislelizumab plus paclitaxel and carboplatin as the control arm. The study group achieved a median progression-free survival (PFS) of 11.20 months versus 8.28 months in the control group (HR = 0.68; 95% CI: 0.53–0.88; P = 0.0026), meeting the primary endpoint. Median overall survival had not been reached in the study group versus 26.45 months in controls (HR = 0.75; P = 0.0199). PFS benefit was consistent across PD-L1 expression subgroups, with no biomarker restriction in the approved indication.
The sequential maintenance design — adding anlotinib after immunochemotherapy induction rather than concurrently — reflects a strategy intended to leverage the complementary effects of immune checkpoint blockade and angiogenic pathway inhibition during the maintenance phase, as previously reported in CAMPASS trial coverage for the same drug combination in a related NSCLC setting.