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AstraZeneca drug could compete directly against Roche in small-cell lung cancer

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The Food and Drug Administration has given priority review to the regulatory approval application of a drug from AstraZeneca for small-cell lung cancer.

The London-based drugmaker said Friday that the FDA had accepted and given priority review to its application for Imfinzi (durvalumab) as a treatment for first-line, extensive-stage SCLC. The deadline for the agency to decide on approval is in the first quarter of 2020, the company said.

The application is based on results of the Phase III CASPIAN study, which were published Nov. 23 in The Lancet. Data from the study were presented in September at the World Conference on Lung Cancer in Barcelona, Spain.

An FDA approval would position the AstraZeneca drug as a competitor to Roche’s Tecentriq (atezolizumab), which has been approved for first-line extensive-stage SCLC in combination with carboplatin and etoposide since March.

Both drugs are PD-L1 checkpoint inhibitors, a type of immunotherapy. SCLC is the less common of the two main forms of lung cancer, with non-small cell lung cancer being by far the most common. Both drugs are also approved for certain settings of non-small cell lung cancer, with Imfinzi being approved in the curative-intent setting of unresectable, Stage III NSCLC after chemoradiation therapy. In addition, results of the Phase III POSEIDON study announced in October showed that Imfinzi combined with tremelimumab – AstraZeneca’s investigational CTLA-4 inhibitor, another immunotherapy drug class – delayed progression in previously untreated metastatic NSCLC. Bristol-Myers Squibb’s Yervoy (ipilimumab) is a marketed CTLA-4 inhibitor, in combination with the PD-1 inhibitor Opdivo (nivolumab), in melanoma, kidney and colorectal cancers.

Data from CASPIAN in the Nov. 23 Lancet publication showed that patients receiving Imfinzi plus chemotherapy experienced a median overall survival of 13 months, compared with 10.3 months for those receiving chemotherapy alone. In the respective study arms, 34 percent and 25 percent of patients were alive at 18 months, and rates of adverse events were comparable between the two groups.

The Phase III study that led to Tecentriq’s SCLC label showed that patients receiving the drug together with carboplatin and etoposide experienced a median overall survival of 12.3 months, compared with 10.3 months among those who were in the chemotherapy-only arm. The chemotherapy arm showed a higher objective response rate – 64%, compared with the Tecentriq arm’s 60% – though more patients in the Tecentriq arm achieved complete responses.

Photo: blueringmedia, Getty Images

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