SHANGHAI, China, July 19, 2023 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (\u201cJunshi Biosciences,\u201d HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application for toripalimab, the company\u2019s anti-PD-1 monoclonal antibody, in combination with etoposide plus platinum for the first-line treatment of patients with extensive-stage small cell lung cancer (\u201cES-SCLC\u201d), has been accepted for review by the National Medical Products Administration (\u201cNMPA\u201d).<\/p>\n\n\n\n
According to data released by GLOBOCAN 2020, lung cancer is currently the most prevalent malignant tumor with the highest mortality rate in China. Small cell lung cancer (\u201cSCLC\u201d) is the most aggressive subtype of lung cancer, accounting for approximately 15%-20% of all lung cancer cases with characteristics including rapid progression, early metastasis and a poor prognosis. SCLC is divided into limited-stage small cell lung cancer (\u201cLS-SCLC\u201d) and ES-SCLC. For patients with LS-SCLC, standard chemotherapy and radiotherapy can achieve an objective response rate of approximately 90% and a five-year survival rate of approximately 25%. However, most patients are diagnosed with ES-SCLC by the time they seek medical treatment, with a median survival time of less than one year and a two-year survival rate below 10%. SCLC, and particularly ES-SCLC, pose a significant and unresolved medical challenge.<\/p>\n\n\n\n
The supplemental new drug application is mainly based on EXTENTORCH (NCT04012606), a randomized, double-blind, placebo-controlled, multi-center Phase 3 clinical study. EXTENTORCH aims to compare the efficacy and safety of toripalimab or placebo in combination with etoposide plus platinum for the first-line treatment of ES-SCLC. The principal investigator for this study is Professor Ying CHENG, who is from Jilin Cancer Hospital and serves as the vice president of the Chinese Society of Clinical Oncology (CSCO).<\/p>\n\n\n\n
EXTENTORCH was launched in 51 centers nationwide, where patients were randomized in a 1:1 ratio to receive either toripalimab or placebo in combination with etoposide plus platinum. The treatment would be administered for 4-6 cycles, after which patients would receive maintenance treatment with toripalimab or placebo until disease progression, intolerable toxicity or other circumstances requiring termination of treatment as specified in the protocol.<\/p>\n\n\n\n
In May 2023, the primary endpoints of EXTENTORCH met their pre-defined efficacy boundaries, and toripalimab thus became the first PD-1 inhibitor in the world that met the primary endpoints of both overall survival (\u201cOS\u201d) and progression-free survival (\u201cPFS\u201d) in a Phase 3 study for the first-line treatment of ES-SCLC.<\/p>\n\n\n\n
The results showed that, compared to chemotherapy alone, toripalimab in combination with chemotherapy for the first-line treatment of ES-SCLC could significantly prolong the PFS and OS of patients. The safety profile of toripalimab was similar to previous studies, and no new safety signals were identified. Detailed data will be presented at an upcoming international academic conference.<\/p>\n\n\n\n
\u201cSCLC presents with less noticeable early symptoms, and due to its rapid tumor proliferation and high malignancy, many patients are already late-stage or have systemic metastasis at the time of their initial diagnosis,\u201d said Professor Ying CHENG of Jilin Cancer Hospital. \u201cFor those diagnosed with ES-SCLC, their average survival time is only about a year. However, EXTENTORCH has successfully confirmed that combining toripalimab with chemotherapy as a first-line treatment for ES-SCLC can significantly improve patients\u2019 PFS and OS. These results may offer a broader range of more effective treatment options for ES-SCLC patients.\u201d<\/p>\n\n\n\n
\u201cIt was my great pleasure today to witness the successful sNDA submission for toripalimab\u2019s 10th<\/sup> indication,\u201d said Dr. Jianjun ZOU, the Global Research and Development President of Junshi Biosciences. \u201cSince its clinical approval in late 2015, toripalimab has been addressing the unmet medical needs of patients in China and worldwide. Over 40 registered clinical trials have been conducted to further investigate toripalimab, which has continued to demonstrate stable and powerful anti-tumor activity across various tumor types. In lung cancer alone, toripalimab has been involved in 3 successful large-scale phase 3 clinical trials encompassing diverse subtypes and stages of disease progression. We will work diligently on marketing applications relevant to the indication and strive to help more cancer patients with our innovative therapies!\u201d<\/p>\n\n\n\n <\/p>\n\n\n\n\n\n About Toripalimab<\/strong><\/p>\n\n\n\n Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system\u2019s ability to attack and kill tumor cells.<\/p>\n\n\n\n More than forty company-sponsored toripalimab clinical studies covering more than fifteen indications have been conducted globally by Junshi Biosciences, including in China, the United States, Southeast Asia, and Europe. Ongoing or completed pivotal clinical trials evaluating the safety and efficacy of toripalimab cover a broad range of tumor types, including cancers of the lung, nasopharynx, esophagus, stomach, bladder, breast, liver, kidney, and skin.<\/p>\n\n\n\n In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing (approved in China as TUOYI\u00ae). Currently, there are six approved indications for toripalimab in China:<\/p>\n\n\n\n <\/p>\n\n\n\n The first three indications have been included in the National Reimbursement Drug List (NRDL) (2022 Edition). Toripalimab is the only anti-PD-1 monoclonal antibody included in the NRDL for the treatment of melanoma.<\/p>\n\n\n\n In the United States, the Biologics License Application (BLA) for toripalimab in combination with gemcitabine\/cisplatin for the first-line treatment of patients with advanced recurrent or metastatic NPC and toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy is under review by the U.S. Food and Drug Administration (\u201cFDA\u201d). The FDA has granted Breakthrough Therapy designations for toripalimab in combination with chemotherapy for the first-line treatment of recurrent or metastatic NPC as well as for toripalimab monotherapy in the second or third-line treatment of recurrent or metastatic NPC. Additionally, the FDA has granted Fast Track designation for toripalimab for the treatment of mucosal melanoma and Orphan Drug designations for the treatment of esophageal cancer, NPC, mucosal melanoma, soft tissue sarcoma, and small cell lung cancer (SCLC).<\/p>\n\n\n\n In Europe, marketing authorization applications (MAA) were accepted by the European Medicines Agency (EMA) and the United Kingdom\u2019s Medicines and Healthcare products Regulatory Agency (MHRA) for 1) toripalimab combined with cisplatin and gemcitabine for the first-line treatment of patients with locally recurrent or metastatic NPC and 2) toripalimab combined with paclitaxel and cisplatin for the first-line treatment of patients with unresectable locally advanced\/recurrent or metastatic ESCC, in December 2022 and February 2023.<\/p>\n\n\n\n <\/p>\n\n\n","protected":false},"excerpt":{"rendered":" SHANGHAI, China, July 19, 2023 (GLOBE NEWSWIRE) — Shanghai Junshi Biosciences Co., Ltd (\u201cJunshi Biosciences,\u201d HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, announced that the supplemental new drug application for toripalimab, the company\u2019s anti-PD-1 monoclonal antibody, in combination with etoposide plus platinum for the first-line treatment of patients with extensive-stage small cell lung cancer (\u201cES-SCLC\u201d), has been accepted for review by the National Medical Products Administration (\u201cNMPA\u201d).<\/p>\n","protected":false},"author":3,"featured_media":2382,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[22],"tags":[],"class_list":["post-2385","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-uncategorized"],"yoast_head":"\n\n