FDA approves Roche’s Tecentriq for first-line, extensive-stage small-cell lung cancer

The PD-L1 inhibitor is the first new drug for ES-SCLC in more than 20 years. Meanwhile, Merck is also running a Phase III study of its PD-1 inhibitor in first-line ES-SCLC.

Slightly more than a week after approving it as the first-ever immunotherapy treatment for breast cancer, the Food and Drug Administration has approved Roche’s Tecentriq (atezolizumab) for a form of lung cancer.

Roche said Tuesday the FDA had approved the drug as an initial treatment for extensive-stage small-cell lung cancer, in combination with the chemotherapy drugs carboplatin and etoposide, marking the first drug approved by the agency for ES-SCLC in more than 20 years.

The approval is based on results of the Phase III IMpower133 study, which showed that median overall survival for patients receiving the Tecentriq-chemotherapy combination was 12.3 months, compared with 10.3 months for those receiving chemotherapy alone. The combination also showed a statistically significant improvement by slightly less than one month in progression-free survival, the amount of time patients survive without their disease worsening. Median PFS in the Tecentriq group was 5.2 months, versus 4.3 months in the control group.

Although lung cancer is the leading cause of cancer death worldwide, SCLC accounts for 15 percent of cases and is further divided into limited and extensive stages. Merck & Co. is running a Phase III study of its checkpoint inhibitor, the PD-1 inhibitor Keytruda (pembrolizumab), in first-line ES-SCLC as well, whose expected primary completion date is in December of this year. Bristol-Myers Squibb’s PD-1 inhibitor, Opdivo (nivolumab), is approved for second-line SCLC.

The majority of lung cancer cases are non-small cell lung cancer, or NSCLC. At the moment, Tecentriq and Keytruda are approved for first-line NSCLC. In the larger NSCLC population, another immune checkpoint inhibitor, AstraZeneca’s PD-L1 inhibitor Imfinzi (durvalumab) failed in a Phase III trial in November, likely taking it out of the running as a competitor.

On March 11, the FDA approved Tecentriq in combination with Celgene’s Abraxane (nab-paclitaxel) for metastatic or locally advanced triple-negative breast cancer that is unresectable and expresses PD-L1, the immune checkpoint protein that Tecentriq targets. However, the labeling for that indication was limited to TNBC patients expressing PD-L1, whom some studies have found to constitute about 26 percent of women with the disease overall. The 300,000 women diagnosed with TNBC globally represent 15 percent of all breast cancer cases.

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