Coherus and Junshi Report Interim Results of Toripalimab + CT in P-III CHOICE-01 Trial as 1L Treatment for Non-Small Cell Lung Cancer

August 19, 2021 Auto Bot Clinical Trials, Coherus, CT, Junshi, Non-Small Cell Lung Cancer, P-III, Toripalimab 0

Shots:

  • The P-III CHOICE-01 trial evaluates toripalimab + CT vs PBO + CT in 465 patients in a ratio (2:1) with advanced sq./nonsq. NSCLC. The results of the study will be presented at WCLC 2021
  • Results: improvement in PFS with m-PFS (8.3 vs 5.6mos.), m-OS (21.0 vs 16.0mos.). In sq. & nonsq. NSCLC patients – ORR (68.7% vs 58.9%) & (58.6% vs 26.5%), m-DoR (6.9 vs 4.2mos.) & (8.6 vs 5.1mos.), no new safety signal identified, discontinuation due to AEs (12.3% vs 1.9%) respectively
  • The companies plan to discuss with US FDA for the submission of toripalimab’s BLA to treat NSCLC. Additionally, a rolling submission of 1st BLA for recurrent or metastatic NPC is ongoing in the US

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