3D Medicines Completes Patient Enrollment Early in Phase III Envafolimab Trial for Resectable Stage III NSCLC

Bulletin Express
May 21

3D Medicines (HK: 01244) announced that patient recruitment for its randomized, controlled, double-blind, multi-center Phase III study of Envafolimab (Study KN035-CN-017) in resectable Stage III non-small cell lung cancer (NSCLC) has been finalized ahead of schedule.

The trial, co-developed with Alphamab Oncology, enrolled approximately 390 patients across about 60 clinical research centers in China under the leadership of Professor Wang Changli of Tianjin Medical University Cancer Institute and Hospital.

Designed to assess Envafolimab combined with platinum-based doublet chemotherapy versus placebo plus identical chemotherapy in both neoadjuvant and adjuvant settings, the study’s primary endpoints include event-free survival, major pathological response rate and pathological complete response rate.

Management reiterated that clinical outcomes remain subject to subsequent statistical analyses, regulatory submissions and approvals, and warned that these steps may be affected by multiple factors. Further updates will be disclosed in accordance with Hong Kong Listing Rules and relevant regulations.

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