China-based Junshi Biosciences (HKG: 1877, SHA: 688180) has published the results of the Phase III Neotorch study for its programmed death-1 (PD-1) inhibitor Tuoyi (toripalimab) combined with chemotherapy for the perioperative treatment of resectable non-small cell lung cancer (NSCLC) at the American Society of Clinical Oncology (ASCO) Plenary Series this month.
Study Design and Efficacy Comparison
The randomized, double-blind, placebo-controlled Phase III study aimed to compare the efficacy and safety of Tuoyi combined with chemotherapy versus placebo combined with chemotherapy as perioperative treatment for resectable NSCLC. The study completed a pre-set interim analysis in January 2023.
Patient Enrollment and Treatment Regimen
A total of 404 patients with stage III NSCLC were enrolled in the Neotorch study and randomly assigned in a 1:1 ratio to the toripalimab/chemo group (n=202) or the placebo combination chemotherapy group (n=202). Patients received three cycles of treatment before surgery and one cycle of treatment after surgery, followed by 13 cycles of consolidation therapy with toripalimab or placebo. As of November 30, 2022, with a median follow-up time of 18.25 months, the results indicated that the combination of toripalimab and chemotherapy for perioperative treatment, along with subsequent consolidation treatment, significantly prolonged the patient’s event-free survival (EFS) compared to chemotherapy alone. The median EFS was immature for the toripalimab group versus 15.1 months for the placebo group (P<0.001), with a 60% reduction in the risk of progression or death (HR=0.40, 95% CI: 0.277-0.565, bilateral P<0.001). The 1-year and 2-year EFS rates were 84.4% vs 57.0% and 64.7% vs 38.7%, respectively.
Toripalimab’s Market and Clinical Progression
Toripalimab, China’s first domestic PD-1 inhibitor approved as a second-line treatment for melanoma in December 2018, has received six indication approvals in China. The drug is involved in over 30 clinical studies for various cancers, including lung, nasopharyngeal, esophageal, gastric, bladder, breast, liver, kidney, and skin cancers. It entered the National Reimbursement Drug List (NRDL) in December 2022, with three indications covered so far. Market filings for the drug are currently under review in the US, European Union, and UK.-Fineline Info & Tech
