SHANGHAI, China, Dec. 14, 2020 (GLOBE NEWSWIRE) — Junshi Biosciences (HKEX: 1877; SSE: 688180), an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, is pleased to announce that the Independent Data Monitoring Committee (IDMC) has determined that Toripalimab (product code: JS001) in combination with standard chemotherapy as the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) has reached its pre-specified primary endpoint of Progression Free Survival (PFS) at the interim analysis of a randomized, double-blind, multi-center, phase III clinical study “CHOICE-01” (Clinicaltrial.gov identifier: NCT03856411). The Company will initiate the process to submit a supplemental New Drug Application (NDA) to the National Medical Products Administration (NMPA) in the near future.
About CHOICE-01 STUDY
The CHOICE-01 Study is a randomized, double-blind, multi-center, phase III clinical study to evaluate the efficacy and safety of Toripalimab versus placebo in combination with standard first-line chemotherapy in patients with previously untreated advanced NSCLC, including both squamous and non-squamous subtypes. Professor Jie Wang from Cancer Hospital Chinese Academy of Medical Sciences is the leading principal investigator for the study.
CHOICE-01 is the first domestic anti-PD-1 chemotherapy combo phase III clinical study that recruits both major histological subtypes of advanced NSCL, the squamous and non-squamous subtypes. The Study enrolled a total of 465 NSCLC patients, including 220 squamous and 245 non-squamous NSCLC patients. The primary endpoint of the study is progression-free survival (PFS), and secondary endpoints include overall survival (OS), objective response rate (ORR), duration of response (DOR), disease control rate (DCR) and safety.
Based on the interim analysis of the Study, the Independent Data Monitoring Committee (IDMC) determined that the primary endpoint of PFS has crossed the pre-defined efficacy boundary. The safety profile of Toripalimab in the study was consistent with the known risks. No new safety signals were identified.
Toripalimab is the first domestic anti-PD-1 monoclonal antibody to obtain marketing approval in China. So far, more than thirty company sponsored clinical studies covering more than fifteen indications have been conducted globally including in China and the United States. On December17 ,2018, Toripalimab obtained conditional approval from the NMPA, for the 2nd line treatment of patients with unresectable or metastatic melanoma. Supplemental NDAs of toripalimab for the 3rd line treatment of recurrent/metastatic nasopharyngeal carcinoma and 2nd line treatment of metastatic urothelial carcinoma were accepted by the NMPA in April and May 2020 respectively. Both supplemental NDAs received priority review status by the NMPA in July 2020. In addition, toripalimab for the treatment of recurrent/metastatic nasopharyngeal carcinoma was granted the Breakthrough Therapy designation by the US Food and Drug Administration in September 2020.
About Junshi Biosciences
Founded in December 2012, Junshi Biosciences (HK: 1877; SH: 688180) is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapeutics. The company has established a diversified R & D pipeline comprising 26 innovative drug candidates and 2 biosimilars, with five therapeutic focus areas covering cancer, autoimmune, metabolic, neurologic, and infectious diseases. Junshi Biosciences was the first Chinese pharmaceutical company to obtain marketing approval for PD-1 monoclonal antibody in China and clinical trial application approval for PCSK9 monoclonal antibody from the NMPA. The world’s first-in-human, first-in-class BTLA blocking antibody for solid tumors is currently in phase I clinical trials in the US and China. In early 2020, Junshi Biosciences joined forces with Institute of Microbiology Chinese Academy of Science and Eli Lilly to co-develop JS016, China’s first neutralizing fully human monoclonal antibody against SARS-CoV-2, which has entered clinical trials and is now a part of our continuous innovation for disease control and prevention of the global pandemic. Junshi Biosciences has about 2,000 full time employees in the United States and China, including research and development centers in San Francisco, Maryland, Shanghai, Suzhou, Beijing and Guangzhou. For more information, please visit: http://junshipharma.com.
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