MA13.07 GEMSTONE-302: A Phase 3 Study of Platinum-Based Chemotherapy with Placebo or Sugemalimab, a PD-L1 mAb, for metastatic NSCLC

C Zhou,J Chen,H Wang,R Chen,J Wang,Z Wang,W Zhuang,X Chen,Dongmei Lu ,Jiuwei Cui ,Wenxiu Yao ,Yehuan Sun ,Zhiyong Ma ,Lejie Cao ,Hong Shen ,You Lü ,Xiaojian Xu ,Yan Yu ,Rong Wu ,Jianxin Yang

doi:10.1016/j.jtho.2021.08.180

MA13.07 GEMSTONE-302: A Phase 3 Study of Platinum-Based Chemotherapy with Placebo or Sugemalimab, a PD-L1 mAb, for metastatic NSCLC

C Zhou, J Chen + Show 18 more

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https://doi.org/10.1016/j.jtho.2021.08.180

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#Metastatic Squamous NSCLC #Metastatic Non-squamous NSCLC + Show 8 more

Abstract
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Abstract

Sugemalimab is a full-length, fully human PD-L1 targeted immunoglobin G4 (IgG4, s228p) mAb. GEMSTONE-302 is a randomized, double-blind, phase 3 study to evaluate the efficacy and safety of sugemalimab or placebo in combination with chemotherapy as first-line treatment in metastatic squamous (sq) or non-squamous (nsq) NSCLC. The PFS interim analysis data as of 08 June 2020 showed that sugemalimab plus chemotherapy demonstrated a clinically meaningful and statistically significant prolongation of PFS with a well-tolerated safety profile in metastatic NSCLC patients irrespective of tumor pathology and PD-L1 expression.

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