CStone's PD-L1 antibody non-small cell lung cancer global phase 3 clinical registration reaches the primary endpoint

Article source: Pharmaceutical Guanlan

On May 28, CStone Pharmaceuticals announced that its anti-PD-L1 monoclonal antibody suglimumab has reached the pre-determined major in a registered clinical trial for patients with stage III non-small cell lung cancer (NSCLC).

Suglizumab (CS1001) is an anti-PD-L1 monoclonal antibody developed by CStone Pharmaceuticals.

Earlier, CStone Pharmaceuticals has exclusively authorized EQRx to develop and commercialize suglizumab outside of Greater China, and authorized Pfizer to be exclusively responsible for the commercialization of suglizumab in China.

According to the press release, the primary endpoint is a multi-center, randomized, double-blind phase 3 clinical trial called GEMSTONE-301, which aims to evaluate sugarizumab as a consolidation therapy in concurrent or sequential radiotherapy and chemotherapy Efficacy and safety in locally advanced/unresectable stage III non-small cell lung cancer patients without disease progression afterwards.

In the planned interim analysis, the independent data monitoring committee (iDMC) assessed that the pre-set primary research endpoint was reached.

Professor Wu Yilong, the principal investigator of the GEMSTONE-301 study and Professor Wu Yilong of Guangdong Provincial People’s Hospital, said: “The mortality rate of lung cancer ranks first among all malignant tumors in the world.

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According to the press release, CStone Pharmaceuticals plans to submit a new drug application (NDA) for sugarizumab to the NMPA for the treatment of phase III NSCLC indications in the near future, and will work closely with EQRx to cooperate with multiple countries including the US FDA.

At present, Shuglizumab is carrying out a number of clinical trials for a variety of cancers, with indications covering lymphoma, non-small cell lung cancer, gastric cancer and esophageal cancer.

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Reference materials:

[1]Inside information-CStone Pharmaceuticals announced that the world's first registered clinical trial of sugarizumab for the treatment of phase III non-small cell lung cancer has reached the primary endpoint and plans to submit a new drug listing application.

[2] CStone Pharmaceuticals Suglizumab has been recognized as a breakthrough treatment drug again, and relapsed and refractory lymphoma usher in new hope.

[3] CStone Pharmaceuticals announced that the National Medical Products Administration has accepted the anti-PD-L1 monoclonal antibody sugarizumab for the first-line treatment of non-small cell lung cancer.