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CStone Announces That OmniAb-derived CS1001 (Anti-PD-L1) Phase 3 Trial Met the Primary Endpoint as First-Line Treatment in Stage IV Squamous and Non-squamous Non-Small Cell Lung Cancer and Announces Plans to Submit a New Drug Application

Published: 2020-08-07 12:30:00 ET

CS1001 is the first anti-PD-L1 mAb to demonstrate overwhelming efficacy as First Line treatment of Stage IV squamous and non-squamous NSCLC in a randomized, double-blind Phase 3 trial

CS1001 combined with chemotherapy had a statistically significant prolongation of progression-free survival (PFS), the primary endpoint of the trial, compared with placebo combined with chemotherapy, reducing the risk of disease progression or death by 50%

SAN DIEGO--(BUSINESS WIRE)-- Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces CStone Pharmaceuticals (“CStone”, HKEX: 2616) recently reported that its OmniAb-derived anti-PD-L1 mAb CS1001 combined with platinum-based chemotherapy met its pre-specified primary endpoint, as assessed by the independent Data Monitoring Committee at the planned interim analysis of CS1001-302, a randomized, double-blind Phase 3 clinical trial for the first-line treatment of stage IV squamous and non-squamous NSCLC patients.

Key data highlights include:

In the overall population containing both squamous and non-squamous NSCLC patients, investigator-assessed progression free survival (PFS) HR (95% CI) was 0.50 (0.39, 0.64), p

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