Roche's PD-L1 Inhibitor Tecentriq Granted Approval for Four New Clinical Trials in China

Reposted from | Medical Observer

Today, the latest public announcement from the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration revealed that Roche’s PD-L1 inhibitor Tecentriq (atezolizumab) has received approval for four additional clinical trials. The proposed indications under development are:

• Atezolizumab in combination with tiragolumab for patients with locally advanced, unresectable stage III non-small cell lung cancer who have not progressed following platinum-based concurrent chemoradiotherapy.
• Atezolizumab in combination with bevacizumab for the treatment of patients with unresectable hepatocellular carcinoma after transcatheter arterial chemoembolization (TACE).
• Atezolizumab in Combination with Low-Dose Radiotherapy, Cisplatin/Carboplatin, and Etoposide for the Treatment of Extensive-Stage Small Cell Lung Cancer.
• Atezolizumab and Bevacizumab in Combination with Carboplatin or Cisplatin and Etoposide for Untreated Patients with Extensive-Stage Small Cell Lung Cancer

Screenshot source: CDE official website

Atezolizumab is an anti-PD-L1 monoclonal antibody developed by Genentech, a member of the Roche Group. By binding to PD-L1 proteins on the surface of tumor cells and tumor-infiltrating immune cells, it not only blocks the interaction between PD-L1 and the PD-1 receptor but also prevents PD-L1 from binding to the B7.1 receptor. This mechanism helps the human immune system recognize tumor cells and further activates T cells to attack them.

In May 2016, the drug was approved by the U.S. FDA for bladder cancer, becoming the first PD-L1 monoclonal antibody approved for marketing worldwide. Since then, the drug has gained multiple indications in disease areas such as bladder cancer, urothelial carcinoma, non-small cell lung cancer (NSCLC), and extensive-stage small cell lung cancer. Among these, some treatment regimens were granted Priority Review and Breakthrough Therapy Designation by the FDA. This May, the FDA announced approval of atezolizumab monotherapy as a first-line treatment for adult patients with PD-L1-high metastatic NSCLC whose tumors do not harbor EGFR or ALK genomic alterations. This marks the fifth FDA approval for this drug in the field of lung cancer.

According to Roche’s 2019 Annual Report, atezolizumab has become one of the four new drugs driving Roche’s global performance growth.

In China, atezolizumab (brand name: Tecentriq) was approved in February this year for use in combination with chemotherapy as a first-line treatment for extensive-stage small cell lung cancer (ES-SCLC), becoming the first and currently only tumor immunotherapy approved in China for this indication. Meanwhile, Roche has submitted a marketing application for atezolizumab in combination with Avastin as a first-line treatment for advanced unresectable hepatocellular carcinoma, and received priority review status from the Center for Drug Evaluation (CDE) in February this year.

A search of the Chinese Drug Clinical Trial Registration and Information Publicity Platform reveals that more than 30 clinical studies of this drug are currently underway, with indications covering lung cancer, breast cancer, liver cancer, thymic cancer, urothelial carcinoma, and others. These therapeutic areas all present substantial unmet medical needs.

The approval of atezolizumab in China, based on four clinical studies, signifies that the drug is poised to initiate new clinical research programs. We congratulate Roche and hope that the drug’s clinical development proceeds smoothly, thereby benefiting more cancer patients as soon as possible.

References:

[1] Center for Drug Evaluation, National Medical Products Administration of China. Retrieved Sep 8, 2020, from http://www.cde.org.cn/news.do?method=changePage&pageName=service&frameStr=25#

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