SUZHOU - CStone Pharmaceuticals ('CStone', HKEX: 2616), a leading biopharmaceutical company focused on developing and commercializing innovative immuno-oncology (IO) therapies and precision medicines, today announced that positive clinical data based on a pre-planned interim analysis of GEMSTONE-302 study were disclosed in an oral presentation at European Society for Medical Oncology (ESMO) Asia Virtual Congress 2020.

The results showed sugemalimab plus chemotherapy as first-line treatment for advanced non-small cell lung cancer (NSCLC) demonstrated statistically significant and clinically meaningful benefit in PFS with a well-tolerated safety profile compared to chemotherapy across PD-L1 expression levels and histologies.

Cancer Type: Thoracic tumors

Date: November 21, 2020

Presentation Type: Proffered Paper Oral Presentation

Title: LBA-4 GEMSTONE-302: Randomized, Double-Blind, Phase 3 Study of Sugemalimab or Placebo Plus Platinum-Based Chemotherapy as First-Line Treatment for Metastatic NSCLC

Presentation #: 415

Leading PI: Professor Caicun Zhou

GEMSTONE-302 is the first randomized, double-blind, phase III study of anti-PD-L1 monoclonal antibody plus platinum-based chemotherapy as first-line treatment for stage IV squamous or non-squamous non-small cell lung cancer (NSCLC). The study aimed to evaluate the efficacy and safety of sugemalimab combined with chemotherapy vs. placebo combined with chemotherapy in first-line treatment naive patients with stage IV NSCLC. The primary endpoint of the study was investigator-assessed PFS. Secondary endpoints included overall survival, blinded independent central review (BICR)-assessed PFS and safety.

As of June 8, 2020, a total of 479 patients were enrolled in the study. The data from the interim analysis showed that compared with placebo plus chemotherapy, sugemalimab plus chemotherapy significantly prolonged PFS and reached the primary endpoint of this study. In all the patients with squamous or non-squamous NSCLC,

Investigator-assessed median PFS: 7.9 vs 4.9 months, hazard ratio (HR)=0.50 (95% CI: 0.39, 0.64), p

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