FDA clears AstraZeneca's Imfinzi as first-line treatment for extensive-stage small-cell lung cancer

AstraZeneca said Monday that the FDA approved Imfinzi (durvalumab) as a first-line treatment for adults with extensive-stage small-cell lung cancer (SCLC) in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin. The PD-L1 immunotherapy gained clearance in Singapore in this indication in February, with marketing applications also under review in the EU and Japan.

Dave Fredrickson, executive vice president of AstraZeneca's oncology business unit, noted that "Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients." In the Phase III CASPIAN study, Imfinzi plus SoC chemotherapy reduced the risk of death by 27%, with median overall survival (OS) of 13.0 months versus 10.3 months for SoC chemotherapy alone. Results from the trial also showed an increased confirmed objective response rate in the Imfinzi plus SoC arm, with a rate of 68% versus 58% for SoC alone.

However, earlier this month, AstraZeneca reported that in another arm of the study, the addition of the anti-CTLA4 antibody tremelimumab to Imfinzi and SoC chemotherapy failed to significantly improve OS in patients with extensive-stage SCLC treated in the first-line setting.

Along with extensive-stage SCLC, Imfinzi is approved in the US in the curative-intent setting of unresectable, Stage III non-small-cell lung cancer after chemoradiation therapy, and is also authorised in the country for previously treated patients with advanced bladder cancer.

Last year, Roche's Tecentriq (atezolizumab), in combination with chemotherapy, became the first immunotherapy approved in the US for the first-line treatment of adults with extensive-stage SCLC, while Merck & Co.'s Keytruda (pembrolizumab) gained accelerated clearance as monotherapy for the treatment of metastatic SCLC patients with disease progression on or after platinum-based chemotherapy and at least one other prior line of therapy.  

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