Junshi Bio-PD-1 monoclonal antibody first-line treatment of esophageal cancer phase III clinical study reached the primary endpoint

April 23, 2021

On April 22, Junshi Biotechnology issued an announcement that its self-developed anti-PD-1 monoclonal antibody drug teriprizumab combined with chemotherapy for the first-line treatment of advanced esophageal squamous cell carcinoma was a randomized, double-blind, placebo-controlled, multi-center Ⅲ In the interim clinical study (JUPITER-06 study), the independent data monitoring committee (IDMC) determined that the two main research endpoints, progression-free survival (PFS) and overall survival (OS), reached the pre-specified superiority of the protocol Boundary value. It is reported that Junshi Bio will communicate with regulatory authorities in the near future to submit listing applications.

Esophageal cancer is a malignant tumor that originates in the epithelium of the esophageal mucosa and is one of the most common tumors in the world. Relevant data show that in 2020, esophageal cancer is the seventh most common malignant tumor and the sixth leading cause of cancer death in the world①. Among them, China has about 320,000 new cases of esophageal cancer and about 300,000 deaths①②, and the morbidity and mortality rank fifth and fourth among all malignant tumors respectively②. Esophageal squamous cell carcinoma and adenocarcinoma are the two main histological subtypes of esophageal cancer. Among them, esophageal squamous cell carcinoma is the main subtype in Chinese patients, accounting for about 90% of the overall incidence ③. For patients with advanced esophageal squamous cell carcinoma, the current standard first-line chemotherapy is platinum-based chemotherapy, but the 5-year overall survival rate is still less than 20% ④. Domestic and foreign studies have shown that anti-PD-1 monoclonal antibody combined with chemotherapy is expected to become the new first-line standard treatment for esophageal squamous cell carcinoma.

The JUPITER-06 study (NCT03829969) is a randomized, double-blind, placebo-controlled, multi-center phase III clinical study, which aims to compare the effects of teriprizumab combined with paclitaxel/cisplatin with placebo combined with paclitaxel/cisplatin. Efficacy and safety of first-line treatment for advanced esophageal squamous cell carcinoma. According to the results of the mid-term analysis of the JUPITER-06 study, the Independent Data Monitoring Committee (IDMC) determined that the two main research endpoints of the study, Progression-Free Survival (PFS) and Overall Survival (OS), both reached the superiority threshold preset by the protocol. It shows that teriprizumab injection combined with paclitaxel/cisplatin first-line treatment of patients with advanced esophageal squamous cell carcinoma, compared with standard first-line treatment of paclitaxel/cisplatin, can significantly prolong the progression-free survival and overall survival of patients. Regarding detailed research data, Junshi Bio will be announced at a recent international academic conference.

About Teriprolizumab Injection (Tuoyi®)

As the first domestically-made monoclonal antibody drug targeting PD-1 that was approved for marketing in my country, Teriprizumab Injection (Tuoyi®) has won the support of a major national science and technology project. The first indication approved for this product is the treatment of unresectable or metastatic melanoma that has previously failed systemic treatment. In December 2020, Teriplimumab successfully passed the national medical insurance negotiations and was included in the new version of the catalog. In February 2021, Teriplizumab was approved by the National Medical Products Administration (NMPA) for the treatment of patients with recurrent/metastatic nasopharyngeal carcinoma who had previously failed second-line and above systemic treatments. In April 2021, Teriplizumab was approved by the NMPA for the treatment of locally advanced or metastatic urothelial cancer that has failed platinum-containing chemotherapy, including neoadjuvant or adjuvant chemotherapy, which has progressed within 12 months. In addition, Teriplizumab has also been recommended by the "Chinese Society of Clinical Oncology (CSCO) Guidelines for the Diagnosis and Treatment of Melanoma", "CSCO Guidelines for the Diagnosis and Treatment of Head and Neck Tumors", and "CSCO Guidelines for the Diagnosis and Treatment of Urothelial Carcinoma".

In February 2021, the marketing application for new indications of teriprizumab combined with chemotherapy for advanced first-line recurrent and metastatic nasopharyngeal carcinoma that has not received systemic treatment was accepted by the NMPA. In March 2021, Junshi Biosciences began to submit a rolling application for Teriplizumab to the U.S. Food and Drug Administration (FDA). At present, teriprizumab has been granted 1 breakthrough therapy designation, 1 fast track designation and 3 orphan drug designations by the FDA in the fields of mucosal melanoma, nasopharyngeal carcinoma, and soft tissue sarcoma.

Teriprizumab has been clinically developed since the beginning of 2016 and has carried out more than 30 clinical studies around the world, actively exploring the use of this product in melanoma, nasopharyngeal cancer, urothelial cancer, lung cancer, gastric cancer, esophageal cancer, and liver cancer. The efficacy and safety of indications such as, cholangiocarcinoma, breast cancer, kidney cancer, etc., and joint therapy cooperation with leading innovative pharmaceutical companies at home and abroad are also underway. We look forward to allowing more patients in China and other countries to obtain internationally advanced tumors. immunity therapy.

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Ms. Yi

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