Oct 29, 2021 (Shanghai, China) – Jiangsu Hengrui Pharmaceuticals Co., Ltd. announced positive data of a Phase III study, demonstrating that the investigational anti-PD-L1 mAb adebrelimab (SHR-1316) in combination with etoposide and carboplatin (EC) compared with placebo in combination with EC met the primary endpoint of overall survival (OS) as first-line treatment for extensive-stage small cell lung cancer (ES-SCLC). Hengrui is submitting a pre-New Drug Application meeting request to China National Medical Products Administration (NMPA) based on the positive data.

About the Study

SHR-1316-III-301 was a multicenter, randomized, double-blind, and placebo-controlled Phase III study to evaluate the efficacy and safety of adebrelimab in combination with EC in ES-SCLC patients compared with placebo in combination with EC. The study enrolled 462 patients who were randomized 1:1 to receive either adebrelimab plus EC or placebo plus EC from 49 sites in China. Patients received the combination therapy once every three weeks for 4-6 cycles, followed by maintenance therapy of adebrelimab or placebo until disease progression, unacceptable toxicity, or other circumstances leading to treatment discontinuation. This study was initiated in December 2018. The primary endpoint was OS; the secondary endpoints included progression-free survival (PFS), objective response rate (ORR), duration of response (DoR), disease control rate (DCR), safety, etc.

About Extensive-Stage Small Cell Lung Cancer

Lung cancer is the second most common type of cancer and is the leading cause of cancer mortality worldwide. According to the World Health Organization, there were approximately 2.21 million new cases of lung cancer and approximately 1.80 million lung cancer deaths worldwide in 2020.¹ SCLC represents approximately 15% of lung cancer. ES-SCLC is the most common type of SCLC, which accounts for 70%.² According to the American Cancer Society, the 5-year relative survival rate for ES-SCLC was around 3%-16%.³

About Adebrelimab

Adebrelimab is a proprietary anti-PD-L1 mAb developed by Hengrui. Adebrelimab specifically binds to PD-L1 to inhibit the PD-L1/PD-1 signaling pathway and stimulates CD4+ helper T cells to secrete IFN-γ. In addition to the SHR-1316-III-301 study, there are several other clinical studies ongoing to investigate adebrelimab in combination with other therapies.

About Jiangsu Hengrui Pharmaceuticals Co., Ltd.

Hengrui is a leading global pharmaceutical company headquartered in China with a focus on research, development, manufacturing, and commercialization of innovative and high-quality healthcare products. Innovation is the core development strategy. Hengrui ranked the 21st among the top 1,000 global pharma companies in 2020. Hengrui has been on the Pharma Exec’s annual listing of the top global pharmaceutical companies for the third consecutive year, rising from the 47th in 2019 to the 38th in 2021.

1. https://www.who.int/news-room/fact-sheets/detail/cancer

2. Oncologist. 2020 Nov; 25(11): 981–992. Doi: 10.1634/theoncologist.2020-0193

3. https://www.cancer.org/cancer/lung-cancer/detection-diagnosis-staging/survival-rates.html

BD Contact

Email: bd@hengrui.com

Phone: +86-21-61053532