SBP GROUP (01177) has announced that its subsidiary, Chia Tai Tianqing Pharmaceutical Group Co., Ltd., presented Phase III clinical study data in a Late-Breaking Abstract at the 2026 American Society of Clinical Oncology (ASCO) annual meeting. The data is for bemusobart combined with platinum-based chemotherapy followed by bemusobart plus anlotinib as a first-line treatment for non-squamous non-small cell lung cancer. Following its success in squamous NSCLC, this head-to-head Phase III study once again demonstrated that the bemusobart and anlotinib combination is superior to tislelizumab combined with standard chemotherapy. It is the first Phase III study globally to show positive results in first-line treatment of non-squamous NSCLC compared to an "immune checkpoint inhibitor plus chemotherapy" regimen. This randomized, controlled Phase III trial enrolled 596 subjects with locally advanced (stage IIIB/C) or recurrent/metastatic NSCLC. Subjects were randomized 1:1 to either the experimental arm, receiving bemusobart plus platinum-based chemotherapy followed by bemusobart and anlotinib, or the control arm, receiving tislelizumab plus platinum-based chemotherapy. The primary endpoint was progression-free survival as assessed by an Independent Review Committee using RECIST 1.1 criteria. In the overall population, the median PFS was 14.42 months for the experimental arm versus 8.34 months for the control arm, with a hazard ratio of 0.67. Subgroup analyses indicated that nearly all subgroups benefited from the bemusobart and anlotinib regimen. Notably, in the PD-L1 TPS<1% population, the median PFS was 12.45 months for the experimental arm compared to 6.54 months for the control arm, with a hazard ratio of 0.61. Regarding safety, the incidence of treatment-emergent adverse events leading to study discontinuation or death showed no significant difference between the two arms, and the overall safety profile was manageable. The combination of anti-angiogenic agents with immune checkpoint inhibitors has demonstrated synergistic effects in multiple indications. The combination of the group's self-developed bemusobart (a humanized anti-PD-L1 monoclonal antibody) and anlotinib (a small-molecule multi-target tyrosine kinase inhibitor) has previously been approved for the treatment of extensive-stage small cell lung cancer, endometrial carcinoma, renal cell carcinoma, and alveolar soft part sarcoma. In the field of NSCLC, this combination regimen has now been proven superior to PD-1 inhibitor plus chemotherapy in two head-to-head Phase III studies. Among these, a marketing application for the first-line treatment of squamous NSCLC has been submitted to the Center for Drug Evaluation and is expected to provide a new treatment option for more lung cancer patients.
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