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The journal published the results of the overall survival (OS) interim analysis from the clinical study GEMSTONE-302 that evaluated sugemalimab in the first-line stage IV non-small cell lung cancer (NSCLC).
According to the biopharma company, this publication represents one ‘additional recognition’ from the academic community for sugemalimab, following prior presentations at the American Society of Clinical Oncology (ASCO) annual meeting, World Conference on Lung Cancer (WCLC), and publication in The Lancet Oncology.
Sugemalimab, an anti-PD-L1 monoclonal antibody, was discovered by CStone using OmniRat transgenic animal platform, which allows creation of fully human antibodies in one step.
It is a fully human, full-length anti-PD-L1 immunoglobulin G4 (IgG4) monoclonal antibody, which may reduce the risk of immunogenicity and toxicity for patients, a ‘unique advantage’ over similar drugs.
The treatment is currently approved by the NMPA of China for the treatment of patients with unresectable stage 3 non-small cell lung cancer whose disease has not progressed following concurrent or sequential platinum-based chemoradiotherapy and in combination with chemotherapy for the first-line treatment of patients with metastatic squamous and non-squamous NSCLC.
The marketing authorization applications with the European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom for sugemalimab as a first-line treatment for metastatic NSCLC are under review.
Dr. Jason Yang, CEO of CStone, said: “We are very pleased that the OS results of GEMSTONE-302 have been published again by a renowned academic journal. The innovative trial design and the outstanding clinical results of sugemalimab are the two key factors leading to the acceptance of GEMSTONE-302 by these prestigious journals, by The Lancet Oncology and now in Nature Cancer.”
“We will continue to work closely with global regulatory authorities including US FDA and look forward to seeing more patients world-wide benefitting from sugemalimab.”
Professor Caicun Zhou, principal Investigator of the GEMSTONE-302 study, added: “The prolongation of OS is the ultimate goal of cancer treatment and the gold standard of efficacy evaluation."
“The publication in Nature Cancer further demonstrates the durable clinical benefits and manageable safety profile of sugemalimab-chemotherapy regimen in both advanced squamous and non-squamous NSCLC patients, and the prolongation of median OS by 8.5 months is very significant clinically. Based on the data from GEMSTONE-302, we believe sugemalimab can help more patients with lung cancer achieve long-term survival.”