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Association details:
Evidence:
Evidence Level:
Sensitive: C1 - Off-label
  (Approved for Cervical Cancer)
New
Title:

Gloria Biosciences Announces Zimberelimab Approved in China for the Treatment of Recurrent or Metastatic Cervical Cancer

Excerpt:
Guangzhou Gloria Biosciences...announced that its fully human anti-PD-1 monoclonal antibody, Zimberelimab injection (YuTuo, GLS-010) has received marketing approval from the China National Medical Products Administration (NMPA), as monotherapy for the treatment of recurrent or metastatic cervical cancer (R/M CC) patients with positive PD-L1 expression (CPS≥1) who progressed on or after platinum-based chemotherapy.
Evidence Level:
Sensitive: C3 – Early Trials
Title:

Abstract 3275: GLS-010, a novel fully human anti-PD-1 mAb in patients with advanced tumor: Preliminary results of a Phase Ib clinical trial

Published date:
05/15/2020
Excerpt:
In all solid tumor types, pts with PD-L1-positive tumors experienced clinical benefit with significantly higher ORR (39.6% vs 14.5%, p=0.0025) and longer PFS (p=0.0241). ORR was higher for PD-L1 positive (TC≥25%) pts with lung cancer (66.7% vs 20.0%, p=0.051).
DOI:
10.1158/1538-7445.AM2020-3275