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Hengrui Pharmaceuticals PD-L1 in the treatment of extensive-stage small cell lung cancer phase III clinical study reached the primary endpoint

 Last Update: 2021-11-15
 Source: Internet
 Author: User

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Recently, Hengrui Medicine's new class 1 drug PD-L1 monoclonal antibody SHR-1316 (Adbelizumab injection) combined with chemotherapy for the first-line treatment of extensive-stage small cell lung cancer is a randomized, double-blind, placebo-controlled, multi-center phase III The main research endpoint of the clinical study (SHR-1316-III-301) reached the pre-specified superiority standard
.

The results of the study showed that Adbelizumab combined with chemotherapy has a significant and clinically significant prolonged overall survival (OS) compared with placebo combined with chemotherapy
.

The company will submit an application for communication and exchange of new indications to the Drug Evaluation Center of the State Drug Administration in the near future

About the SHR-1316-III-301 study

The SHR-1316-III-301 study is an evaluation of the effectiveness and safety of SHR-1316 (Adbelizumab injection) or placebo combined with etoposide and carboplatin in the first-line treatment of extensive-stage small cell lung cancer A randomized, double-blind, phase III controlled clinical study
.

Professor Cheng Ying from the Jilin Cancer Hospital and Professor Wang Jie from the Cancer Hospital of the Chinese Academy of Medical Sciences served as the principal investigators

A total of 462 subjects were enrolled in this study.
They were randomly enrolled at 1:1 and received adbelizumab or placebo combined with etoposide and carboplatin.
They were administered once every 3 weeks, completing 4-6 After two cycles of combined treatment, enter Adbelizumab or placebo for maintenance treatment until the disease progresses, toxicity is intolerable or other conditions that require termination of treatment
.

About Extensive Stage Small Cell Lung Cancer (ES-SCLC)

Lung cancer is currently the number one malignant tumor in China in terms of morbidity and mortality
.

Small cell lung cancer (SCLC) accounts for 10%-15% of new lung cancers.

About SHR-1316 (Adbelizumab Injection)

Adbelizumab injection is a humanized anti-PD-L1 monoclonal antibody independently developed by Hengrui Medicine, which can specifically bind to PD-L1 molecules to block PD-1/PD- which leads to tumor immune tolerance.
The L1 pathway reactivates the anti-tumor activity of the immune system to achieve the purpose of treating tumors
.

At present, a number of clinical studies of Adbelizumab injection are underway to evaluate its anti-tumor effect on various solid tumors

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