SBP GROUP (01177): The Phase III clinical data of Bevacizumab combined with Anlotinib as first-line treatment for non-squamous non-small cell lung cancer will be announced at ASCO in 2026.

SBP GROUP (01177) announced that its subsidiary company Zhongdadianqing Pharmaceutical Group Co., Ltd. (Zhongdadianqing) presented the latest pivotal abstract (LBA) at the American Society of Clinical Oncology (ASCO) meeting in 2026. The abstract disclosed the Phase III clinical research data on the combination of pembrolizumab with platinum-based chemotherapy followed by pembrolizumab in combination with anlotinib as first-line treatment for non-squamous non-small cell lung cancer. Following the confirmation of the efficacy of pembrolizumab in combination with anlotinib in squamous non-small cell lung cancer, this study once again demonstrated superiority over pembrolizumab in combination with standard chemotherapy in a head-to-head Phase III clinical trial, becoming the first global Phase III clinical trial to achieve positive results compared to "immunotherapy combined with chemotherapy" in first-line treatment for non-squamous non-small cell lung cancer. This study was a randomized, controlled Phase III clinical trial that included 596 participants with locally advanced (stage IIIB/C) or recurrent/metastatic non-small cell lung cancer. Participants were randomly assigned in a 1:1 ratio to either the experimental group or the control group, receiving treatment with pembrolizumab in combination with platinum-based chemotherapy followed by anlotinib, or with pembrolizumab in combination with platinum-based chemotherapy followed by pemetrexed. The primary endpoint was progression-free survival (PFS) assessed by an Independent Review Committee (IRC) according to RECIST 1.1. In the overall population, the median PFS for the experimental group vs. the control group was 14.42 months vs. 8.34 months, with an HR of 0.67 (95% CI 0.52, 0.86). Subgroup analysis showed that almost all subgroups benefited from the pembrolizumab in combination with anlotinib regimen. Particularly, for the PD-L1 TPS <1% population, the median PFS for the experimental group vs. the control group was 12.45 months vs. 6.54 months, with an HR of 0.61 (95% CI 0.43, 0.86). In terms of safety, there was no significant difference in the occurrence of treatment-emergent adverse events (TEAEs) leading to study termination or death between the experimental group and the control group, and overall safety was manageable. The combination of anti-angiogenic drugs with immune checkpoint inhibitors has shown synergistic effects in multiple indications. The company's independently developed pembrolizumab (a humanized anti-PD-L1 monoclonal antibody) in combination with anlotinib (a small molecule multi-target tyrosine kinase inhibitor) therapy has been approved for the treatment of extensive-stage small cell lung cancer, endometrial cancer, renal cell carcinoma, and adenoid soft tissue sarcoma. In the field of non-small cell lung cancer, this combination has been confirmed to be superior to PD-1 combined chemotherapy in two head-to-head Phase III clinical trials. The indication for first-line treatment of squamous non-small cell lung cancer has been submitted for market approval to the CDE, offering new treatment options for more lung cancer patients.