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First-line phase III clinical trial of Tereprizumab in the treatment of non-small cell lung cancer
First-line phase III clinical trial of Tereprizumab in the treatment of non-small cell lung cancer. China Junshi Biologics’ first-line phase III clinical trial of Tereprizumab (Tuoyi®) in the treatment of non-small cell lung cancer reached the primary endpoint.
On December 13, 2020, Pacific Time, Junshi Bio (1877.HK, 688180.SH) announced that the company’s self-developed anti-PD-1 monoclonal antibody, teriprizumab (Tuoyi®) combined with chemotherapy, is the first-line treatment of advanced stage In the interim analysis of the randomized, double-blind, placebo-controlled, multicenter phase III clinical study of non-small cell lung cancer (CHOICE-01 study), the Independent Data Monitoring Committee (IDMC) determined that it reached the preset primary study endpoint. Junshi Bio will submit a marketing application to the National Medical Products Administration (NMPA) in the near future.
Lung cancer is the malignant tumor with the highest morbidity and mortality in the world. According to statistics, in 2018, the number of lung cancer cases in China accounted for 18.1% (770,000) of new cancer cases, and 24.1% (690,000) of cancer deaths.① NSCLC is the main subtype of lung cancer, accounting for approximately 85% of all cases. Among them, about 70% of NSCLC patients have been diagnosed with locally advanced or metastatic disease that cannot be surgically removed, and 30 to 60% of NSCLC patients with stage I to III undergoing radical surgery also have recurrence or remote disease. Transfer ②. Existing domestic and foreign studies have shown that PD-(L)1 monotherapy or combination chemotherapy is expected to become the new standard treatment for first-line non-small cell lung cancer.
The CHOICE-01 study is the first randomized, double-blind, multi-center study in China that uses anti-PD-1 monoclonal antibody combined with chemotherapy as the first-line treatment in patients with two histological subtypes of advanced squamous and non-squamous non-small cell lung cancer Phase III clinical study. According to the results of the mid-term analysis of the CHOICE-01 study, the Independent Data Monitoring Committee (IDMC) determined that the main research endpoint of the study, the progression-free survival (PFS), reached the superiority cut-off value preset by the protocol. Benefit®) combined with chemotherapy in the first-line treatment of patients with advanced non-small cell lung cancer can significantly prolong the progression-free survival of patients compared with chemotherapy. The safety data of toriplimumab are consistent with known risks, and no new safety signals have been found.
-  Bray F, et al. CA Cancer J Clin. 2018 Nov;68(6):394-424.
-  Molina JR, et al. Mayo Clin. Proc. 2008; 83(5), 584–594.
About the CHOICE-01 study
The CHOICE-01 study (NCT03856411) is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study designed to evaluate teriprizumab (Tuoyi®) combined with standard first-line chemotherapy versus placebo combined with chemotherapy. The effectiveness and safety of first-line treatment in untreated patients with advanced squamous and non-squamous non-small cell lung cancer (NSCLC) is led by Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences as the principal investigator.
The primary study endpoint is progression-free survival (PFS) assessed by the investigator based on the RECIST 1.1 standard. Secondary research endpoints include overall survival (OS), BIRC based on RECIST 1.1 assessment of PFS, objective response rate (ORR), safety, etc.
The study enrolled a total of 465 NSCLC patients in 63 centers across the country, including 220 squamous cancer subjects and 245 non-squamous cancer subjects. The subjects were randomly enrolled according to 2:1. Squamous cell carcinoma subjects received Terry Prilimumab/placebo combined with albumin-bound paclitaxel and carboplatin were treated, and patients with non-squamous cell carcinoma received teriprizumab/placebo combined with pemetrexed+cisplatin/carboplatin. After the disease progresses, eligible control subjects can receive cross-treatment with teriprizumab.
About Teriprolizumab Injection (Tuoyi®)
About Teriprolizumab Injection (Tuoyi®)
As the first domestically-made monoclonal antibody drug targeting PD-1, Teriplizumab Injection (Tuoyi®) was approved for marketing in some countries, and it was supported by a major national science and technology project. The first indication approved for this product is the treatment of unresectable or metastatic melanoma that has failed systemic treatment in the past, and it has been recommended in the 2019 and 2020 editions of the Chinese Society of Clinical Oncology (CSCO) Melanoma Diagnosis and Treatment Guidelines. In April 2020, Tuoyi®’s new indication for the treatment of recurrent/metastatic nasopharyngeal carcinoma that had previously failed second-line and above systemic treatment was accepted by the State Food and Drug Administration.
In May 2020, the application for the new indications for the treatment of locally advanced or metastatic urothelial carcinoma that had previously received systemic treatment was accepted by the State Food and Drug Administration. In July 2020, the marketing applications for the above two new indications have been included in the priority review procedure by the State Food and Drug Administration. In September 2020, Tuoyi® was approved as a breakthrough therapy by the US Food and Drug Administration for the treatment of nasopharyngeal cancer.
Tuoyi® has started clinical research and development in early 2016 and has carried out more than 30 clinical studies around the world, actively exploring the use of this product in nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, liver cancer, breast cancer, and kidney cancer. The curative effect of other indications, combined therapy cooperation with leading innovative pharmaceutical companies at home and abroad is also underway, and it is hoped that more patients in China and other countries will receive international advanced tumor immunotherapy.
About Junshi Bio
Junshi Bio (1877.HK, 688180.SH) was established in December 2012. It is an innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies. The company has a rich pipeline of products under research, including 26 innovative drugs and 2 biosimilars, covering five major therapeutic areas, including malignant tumors, autoimmune system diseases, chronic metabolic diseases, neurological diseases and infectious diseases.
Relying on the protein engineering core platform technology, Junshi Bio is at the forefront of international macromolecular drug research and development, and has obtained the first domestic anti-PD-1 monoclonal antibody NMPA approval, the domestic anti-PCSK9 monoclonal antibody NMPA clinical application approval, and the world’s first treatment Tumor anti-BTLA blocking antibody was approved in clinical application by China NMPA and US FDA. This year, Junshi Biotech has also joined hands with domestic scientific research institutions to fight the epidemic. The jointly developed JS016 has entered clinical trials as the first anti-neovirus monoclonal neutralizing antibody in China, using local innovation to contribute to disease prevention and control in China and the world. At present, Junshi Biotechnology has nearly 2,000 employees worldwide, distributed in San Francisco and Maryland, Shanghai, Suzhou, Beijing and Guangzhou, China