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SHANGHAI, China, April 22, 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 Independent Data Monitoring Committee (IDMC) has determined that toripalimab in combination with paclitaxel/cisplatin as the first-line treatment for patients with advanced esophageal squamous cell carcinoma (ESCC) has reached its pre-specified primary endpoints of Progression Free Survival (PFS) and Overall Survival (OS) at the interim analysis of the randomized, double-blind, placebo-controlled, multi-center, phase III clinical study JUPITER-06 (Clinicaltrials.gov identifier: NCT03829969). Junshi Biosciences will communicate with the regulatory authorities regarding the supplemental New Drug Application (sNDA) in the near future.
Toripalimab Plus Chemotherapy as First-Line Treatment for Advanced Esophageal Cancer Reached Primary Endpoints in Phase III Clinical Study biospace.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from biospace.com Daily Mail and Mail on Sunday newspapers.
of patients with early-stage EGFR-mutated lung cancer Tagrisso is the only targeted medicine to show efficacy in the treatment of early-stage lung cancer in a global trial and the first such medicine approved in China where Tagrisso reduced the risk of disease recurrence or death by 80%
AstraZeneca s Tagrisso (osimertinib) has been approved in China for the adjuvant treatment of patients with early-stage (IB, II and IIIA) epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) after tumour resection with curative intent, with or without adjuvant chemotherapy as recommended by the patient s physician. Tagrisso is indicated for EGFRm patients whose tumours have exon 19 deletions or exon 21 (L858R) mutations.
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SAN FRANCISCO and SUZHOU, China, April 12, 2021 /PRNewswire/ Innovent Biologics, Inc. ( Innovent , HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, announced with Eli Lilly and Company ( Lilly ,NYSE: LLY) that the results of the Phase 3 ORIENT-3 study were released today in an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2021.
ORIENT-3 is a randomized, open-label, Phase 3 clinical trial evaluating TYVYT® (sintilimab injection) versus docetaxel as a second-line treatment for advanced or metastatic squamous non-small cell lung cancer (sqNSCLC). A total of 290 patients whose cancer had progressed following first-line treatment with platinum-based chemotherapy were enrolled. Based on the primary analysis population (280 patients, excluding patients on t
Published: Apr 12, 2021
SHANGHAI, China, April 12, 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 granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy. This is the third approved indication for toripalimab in China. In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after fail