Overview
- The open-label, randomized JS001sc-002-III-NSCLC study compared subcutaneous toripalimab (JS001sc) plus chemotherapy with the intravenous formulation plus chemotherapy as first-line therapy for recurrent or metastatic non-squamous NSCLC.
- The trial met its primary pharmacokinetic endpoints, demonstrating non-inferior cycle 1 Ctrough and model-predicted AUC0–21 days, with efficacy and safety reported as comparable between formulations.
- Junshi said full results will be presented at an upcoming international medical conference after the primary endpoint success announcement.
- Professor Lin Wu of Hunan Cancer Hospital served as principal investigator for the multi-center Phase 3 study (NCT06505837).
- Junshi described JS001sc as the first domestic anti-PD-1 subcutaneous formulation to reach Phase 3 in China, positioning it as a more convenient option for patients already treated with toripalimab across 12 approved indications in over 40 countries.