Roche Korea said Monday that its anti-PD-L1 immunotherapy anticancer drug Tecentriq won the approval of the U.S. Food and Drug Administration (FDA) in May for the indications for non-small cell lung cancer.

Tecentriq (ingredient name: atezolizumab) is administered intravenously at a dose of 1,200 mg every three weeks to patients with locally advanced or metastatic non-small cell lung cancer, who have progressed during or after treatment with a platinum-based chemotherapeutic agent, until the disease progresses or before unacceptable toxicity.

The indications for Tecentriq are local progressive or metastatic non-small cell lung cancer with the advanced disease during or after treatment with platinum-based chemotherapy. Tecentriq has been shown to prolong overall survival (OS) independent of PD-L1 expression in OAK phase III studies.

The median overall survival time of patients treated with Tecentriq for OAK phase 3 was 13.8 months and improved by 4.2 months compared to Docetaxel which was 9.6 months (HR = 0.73, 95% CI: 0.62-0.87, p = 0.0003).

Also, sub-analysis showed that overall survival improved in patients with low or undetectable PD-L1 expression. Tecentriq exhibited a favorable safety profile compared to Docetaxel, and the incidence of adverse events related to treatment grade 3 and 4 was low, the company said. Tecentriq was consistent with previously reported adverse events, and the incidence of immune-mediated adverse reactions, including pneumonia, was low compared to Docetaxel, it added.

“Tecentriq is an immunosuppressive agent that combines with PD-L1 protein in cancer cells and immune cells to restore the anti-cancer effect of T-cells,” said Kim Su-jeong_김수정, director of medical affairs management department of Roche Korea_한국로슈. "OAK Phase III clinical trials have confirmed that Tecentriq can be a new treatment option for patients with non-small cell lung cancer

The company conducted OAK Phase III clinical trials at 194 institutions in 31 countries to determine the clinical efficacy and safety of Tecentriq in locally advanced and metastatic non-small cell lung cancer patients who were treated with platinum-based chemotherapy. Tecentriq won the license based on a primary analysis of 850 randomly selected 1225 patients who participated in the study

"Roche, which has been a leader in oncology in a variety of cancers and has reestablished the history of oncology, has invested more than 10 trillion won each year in R&D to provide more innovative treatment options for patients,” said Matt Sause, CEO of Roche Korea. "We will do our best to give new hope to patients with metastatic lung cancer through the first anti-PD-L1 immunotherapy system.”

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