China’s Center for Drug Evaluation (CDE) has approved Junshi Biosciences’ (HKG: 1877, SHA: 688180) Tuoyi (toripalimab) as a first-line treatment for advanced non-small cell lung cancer (NSCLC) in tumors with no EGFR/ALK mutations, in combination with chemotherapy. This marks the sixth indication approval for the programmed death-1 (PD-1) inhibitor in China.
Clinical Trial Results
The approval is based on the results of the CHOICE-01 study (NCT03856411), a randomized, double-blinded, placebo-controlled, multi-center Phase III study that enrolled 465 NSCLC patients, including 220 cases of squamous NSCLC (sqNSCLC) and 245 cases of non-squamous NSCLC (nsqNSCLC). Patients with sqNSCLC received toripalimab/placebo plus nab-paclitaxel + carboplatin, while patients with nsqNSCLC received toripalimab/placebo plus pemetrexed + cisplatin/carboplatin therapy. After disease progression, eligible control subjects received the toripalimab crossover treatment.
The results showed that compared with chemotherapy alone, toripalimab combined with chemotherapy significantly prolonged the median progression-free survival (PFS), reduced the risk of disease progression by 51%, significantly improved overall survival (immature vs 17.1 months), reduced the risk of death by 31%, and demonstrated significant survival benefits. Additionally, the survival benefit of toripalimab combined with chemotherapy was observed regardless of the patient’s PD-L1 expression level.
Future Outlook
The approval of Tuoyi for first-line treatment of advanced NSCLC underscores Junshi Biosciences’ commitment to advancing innovative cancer therapies. With its robust clinical data and multiple indications, toripalimab is well-positioned to address significant unmet needs in the treatment of non-small cell lung cancer.-Fineline Info & Tech
