Junshi Biological released the first-line Phase III study data of teriprizumab in the first-line treatment of esophageal cancer at the annual meeting of the European Society of Medical Oncology (ESMO)

Shanghai, September 18, 2021/PRNewswire/ - From September 16 to 21, 2021, the 2021 European Society for Medical Oncology (ESMO) annual meeting will be held in the form of an online conference

At this ESMO annual meeting, Junshi Bio-Treplimumab presented a total of 11 latest studies, covering gastrointestinal tumors, lung cancer, gynecological tumors, urothelial cancer, head and neck tumors and other tumor types.

The JUPITER-06 study refreshes the "longest median overall survival" and is expected to rewrite the first-line standard treatment

Esophageal cancer is one of the most common malignant tumors in the digestive tract

Professor Wang Feng from the Cancer Center of Sun Yat-sen University presented a randomized, double-blind, placebo-controlled, multi-center phase III study (JUPITER-06 study, NCT03829969) in the form of an oral presentation (No.

A total of 514 patients with advanced or metastatic ESCC who had not received treatment were included in the JUPITER-06 study, and they were randomly assigned to the teriprizumab plus chemotherapy group (n=257) or placebo plus chemotherapy group (n=257), respectively Receive teriprizumab (240 mg) or placebo combined with TP chemotherapy (Q3W) for up to 6 cycles, and then receive teriprizumab or placebo for maintenance treatment

As of March 22, 2021, as assessed by the BICR, the median PFS of the teriprolizumab group and the placebo group were 5.

At the same time, compared with chemotherapy alone, teriprizumab combined with chemotherapy significantly prolonged the patient's survival time, with a median OS of 17.

The results of the study show that the addition of teriprizumab to the standard first-line TP chemotherapy regimen can enable patients with advanced or metastatic ESCC to obtain better PFS and OS, significantly reduce the patient’s risk of disease progression or death, and significantly improve survival benefits , And benefit regardless of PD-L1 expression

Professor Wang Feng said: “Esophageal cancer is a common malignant tumor of the digestive tract

Dr.

Junshi Biosciences and its partner Coherus plan to submit to the US Food and Drug Administration in 2022 a biologics license application (BLA) for teriprizumab combined with platinum-containing chemotherapy for the first-line treatment of advanced or metastatic ESCC indications

First release of gynecological tumor research data, breakthrough in the layout of multiple tumor types

At this ESMO annual meeting, teriplizumab once again showed a multi-level and multi-tumor layout.

The team of Professor Yan Cheng from the First Affiliated Hospital of Zhengzhou University presented a retrospective study on the treatment of refractory cervical cancer with teriprizumab combined with concurrent radiotherapy and chemotherapy in the poster (No.

Post-marketing monitoring of anti-tumor drugs is of great significance for evaluating the actual efficacy and safety of the drugs on patients

references:

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Liang H, Fan JH, Qiao YL.
Epidemiology, etiology, and prevention of esophageal squamous cell carcinoma in China.
Cancer Biol Med.
2017;14(1):33-41.

About Teriprolizumab Injection (Tuoyi®)

As the first domestically-made monoclonal antibody drug targeting PD-1 that was approved for marketing in China, 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 medical insurance 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 been awarded 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", "CSCO Guidelines for the Diagnosis and Treatment of Urothelial Carcinoma", and "CSCO Nasopharyngeal Carcinoma Recommendations in the “Guidelines for Diagnosis and Treatment” and “Guidelines for Clinical Application of CSCO Immune Checkpoint Inhibitors”
.

In February 2021, the marketing application for new indications for the first-line treatment of teriprizumab combined with cisplatin and gemcitabine for patients with locally recurring or metastatic nasopharyngeal carcinoma was accepted by the NMPA
.
In July 2021, the new indication for the first-line treatment of locally advanced or metastatic esophageal squamous cell carcinoma with teriprizumab combined with platinum-containing chemotherapy was accepted by the NMPA
.
In terms of international layout, the first listing application (BLA) of Tereprizumab in the U.
S.
Food and Drug Administration (FDA) has been submitted.
Tereprizumab is also the first domestically produced BLA to be submitted to the FDA.
Anti-PD-1 monoclonal antibody
.
At present, teriprizumab has been granted 2 breakthrough therapy designations, 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.
Immunotherapy
.

About Junshi Bio

Junshi Bio (688180.
SH, 1877.
HK) 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 R&D pipeline consisting of 44 products under research, 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 The tumor anti-BTLA blocking antibody was approved by the Chinese NMPA and the US FDA for clinical application, and the phase I clinical study was conducted in China and the United States
.
In 2020, Junshi Biosciences will also join 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, and has obtained emergency use authorization in more than 12 countries and regions around the world.
, And use local innovation to contribute to disease prevention and control in China and the world
.
At present, Junshi Bio has more than 2,500 employees worldwide, distributed in San Francisco and Maryland, Shanghai, Suzhou, Beijing and Guangzhou in China
.

Source: Junshi Bio