Junshi Biosciences Announces Acceptance by NMPA of Supplemental New Drug Application for Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced or Metastatic Esophageal Squamous Cell Carcinoma
SHANGHAI, China, July 30, 2021 (GLOBE NEWSWIRE) -- Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, announced today that the National Medical Products Administration (NMPA) of China has accepted its supplemental New Drug Application (sNDA) for toripalimab in combination with platinum-containing chemotherapy as the first-line treatment for patients with locally advanced or metastatic esophageal squamous cell carcinoma (ESCC). It is the fifth NDA submitted for toripalimab in China.
The supplemental NDA is based on the JUPITER-06 study (Clinicaltrials.gov identifier: NCT03829969), which is a randomized, double-blind, placebo-controlled Phase III clinical study led by Professor Ruihua Xu from Sun Yat-sen University Cancer Center. A total of 514 patients were enrolled. The co-primary endpoints were progression-free survival (PFS) as assessed by the Blinded Independent Review Committee (BICR) and overall survival (OS). Secondary endpoints included the PFS assessed by investigator, objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and safety. Based on the results of the interim analysis, the Independent Data Monitoring Committee (IDMC) determined that the co-primary endpoints of PFS and OS have crossed the prespecified efficacy boundaries and that toripalimab combined with standard chemotherapy as the first-line treatment significantly prolonged the PFS and OS of patients with advanced or metastatic ESCC, compared with placebo combined with standard chemotherapy. Data from the JUPITER-06 study will soon be presented at the 2021 ESMO Annual Meeting.
“As an innovation-driven biopharma company who follows the ‘In China, For Global’ strategy, Junshi Biosciences focuses on tumor types that are 1) highly prevalent in China; 2) responsive to immunotherapy; and 3) where there is urgent unmet need for better and safer treatments. China is one of the countries with the highest incidence and mortality of esophageal cancer in the world, and there is a clear and substantial unmet clinical need.” Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences, said, “The results of JUPITER-06 study showed that compared with chemotherapy, toripalimab in combination with chemotherapy significantly improved both progression-free survival (PFS) and overall survival (OS) for patients with advanced or metastatic ESCC, regardless of their PD-L1 expression status. We will continue to work closely with the NMPA to make this exciting new treatment option available for patients with advanced or metastatic ESCC as soon as possible.”
About Esophageal Cancer
In March 2021, Junshi Biosciences started a rolling submission of a Biologics License Application for toripalimab for the second-line treatment of recurrent or metastatic nasopharyngeal carcinoma to the US Food and Drug Administration (“FDA”). Currently, toripalimab has been granted 1 Breakthrough Therapy, 1 Fast Track, and 3 Orphan Drug Designations by the FDA for the treatment of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.
About Junshi Biosciences
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