Roche RHHBY announced that its subsidiary, Chugai, has obtained regulatory approval for its immuno-oncology drug, Tecentriq, in Japan for the treatment of extensive-stage small cell lung cancer (SCLC).
The approval was based on the positive results from the phase I/III IMpower133 study. Tecentriq in combination with chemotherapy met the primary endpoint of overall survival (OS) compared with chemotherapy alone in the intent to treat (ITT) analysis. The study also met co-primary endpoint of progression-free survival (PFS).
Per the company, Tecentriq is the first approved cancer immunotherapy for extensive-stage SCLC in Japan, and hence a strong uptake is expected. Lung cancer is the leading cause of cancer deaths. SCLC accounts for 10-15% of all lung cancer cases in Japan.
We remind investors that the drug is indicated for unresectable, advanced or recurrent non-small cell lung cancer (NSCLC) in Japan. It was also approved for the treatment of untreated unresectable, advanced or recurrent non-squamous NSCLC in December 2018. Additionally, a supplementary application for breast cancer was submitted in December 2018.
Roche has an extensive development program for Tecentriq, including multiple ongoing and planned phase III studies, across lung, genitourinary, skin, breast, gastrointestinal, gynecological, and head and neck cancers.
The company currently has five approved drugs (Tarceva, Avastin and Tecentriq, among others) to treat certain kinds of lung cancer and more than 10 candidates in the pipeline.
Last week, the FDA approved Rozlytrek (entrectinib) for the treatment of adults with ROS1-positive, metastatic NSCLC.
Roche’s stock has gained 11.2% in the year so far against the industry’s decline of 1.2%.
However, competition is stiff in the lung cancer market. Immuno-oncology therapies like Merck’s MRK Keytruda, AstraZeneca’s AZN Imfinzi and Bristol-Myers’ BMY Opdivo are approved for various types of lung cancer.
Roche currently carries a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
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