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Roche Notches FDA Nod in Lung Cancer, Amps Up Competition With Merck

Xconomy San Francisco — 

A Roche immunotherapy has won an additional FDA approval as a first-line treatment for non-small lung cancer, bolstering the product’s competitive stance versus one from Merck.

The FDA approved atezolizumab (Tecentriq) for adults whose non-squamous non-small cell lung cancer (NSCLC) is metastatic, meaning it has spread, and does not have the EGFR or ALK genetic mutations. The regulatory decision covers the treatment in combination with the chemotherapy regimen paclitaxel and carboplatin.

Non-small cell lung cancer accounts for approximately 85 percent of all lung cancers, according to the American Cancer Society. Atezolizumab is an antibody drug designed to bind to PD-L1, a protein that acts as an “off” switch to keep immune cells from attacking. By blocking this protein on tumors, the drug is intended to allow the body’s T cells to fight the cancer.

Merck (NYSE: MRK) immunotherapy pembrolizumab (Keytruda) received FDA approval in 2015 for metastatic NSCLC in patients whose tumors express PD-L1, and whose disease has spread despite treatment with chemotherapy. That decision came within days of a Bristol-Myers Squibb (NYSE: BMY) approval in NSCLC for its immunotherapy nivolumab (Opdivo). But the Bristol drug has since failed late-stage studies aiming to expand its use in lung cancer. Meanwhile, the Merck drug has won subsequent approvals, for use by itself and as part of combination therapies, for NSCLC as well as metastatic small cell lung cancer.

Atezolizumab, developed by Roche subsidiary Genentech, previously won FDA approvals in metastatic non-squamous NSCLC with no EGFR or ALK mutations, and for metastatic NSCLC in adults whose disease has progressed after treatment with platinum-based chemotherapies.

The latest atezolizumab approval is based on results from a Phase 3 study that showed patients treated with the drug, in combination with chemotherapy, lived longer (a median of 18.6 months) than those treated with chemotherapy alone (a median of 13.9 months). The combination treatment also showed an improvement in progress-free survival, a measure of the risk of a worsening of the disease or death.

Roche reported no new safety problems other than the side effects previously observed with the drug. Those side effects include lung problems that show up as a worsening cough or shortness of breath, problems with the liver, hormone gland problems, and infections whose symptoms include flu-like symptoms.

Image by the National Cancer Institute