BioPharma

AstraZeneca lung cancer drug, competitor to Roche, gets FDA nod

The drugmaker said Monday that the FDA had approved Imfinzi, its PD-L1 inhibitor, for first-line extensive-stage small cell lung cancer, with platinum chemotherapy. The drug creates a new competitive threat to Roche’s Tecentriq, which is approved for the same disease setting.

By Alaric DeArment on March 30, 2020

Red seal and imprint "FDA APPROVED" on white surface. FDA - Food and Drug Administration is a federal agency of the United States Department of Health and Human Services.

The Food and Drug Administration has approved an immunotherapy-chemotherapy combination for certain patients with lung cancer that will compete against a similar combination made by Roche.

London-based AstraZeneca said Monday that the FDA had approved the PD-L1 inhibitor Imfinzi (durvalumab) in combination with etoposide and either cisplatin or carboplatin chemotherapy for first-line treatment of extensive-stage small-cell lung cancer, or ES-SCLC. Roche’s Tecentriq (atezolizumab) is also approved for first-line ES-SCLC, but only in combination with etoposide and carboplatin.

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Shares of AstraZeneca were up more than 3% on the London Stock Exchange and New York Stock Exchange Monday morning following the news.

“The US approval of Imfinzi brings a new medicine to extensive-stage small-cell lung cancer patients in urgent need of new options,” AstraZeneca oncology business unit executive vice president Dave Frederickson said in a statement. “Imfinzi is the only immunotherapy to show both a significant survival benefit and improved response rate in combination with chemotherapy for these patients, an important step forward in treating this devastating disease.”

The approval was based on the Phase III CASPIAN trial, results of which have since been published in The Lancet. The results showed a median overall survival of 13 months for patients receiving the immunotherapy-chemotherapy combination, compared with 10.3 months for those receiving the standard of care alone. The objective response rate for the Imfinzi arm was 68%, compared with 58% among patients in the control group.

In the Phase III IMpower133 trial that led to the approval of Roche’s Tecentriq in ES-SCLC, patients receiving the immunotherapy combination achieved a median overall survival of 12.3 months, compared with 10.3 months among those receiving carboplatin and etoposide alone, according to the drug’s package insert. The objective response rate for the Tecentriq arm was 60%, compared with 64% for the combination arm, with partial responses in particular being lower among those who received the Roche drug – 58%, compared with 63% for the control. However, the Tecentriq arm showed a slightly higher rate of complete responses, 2%, compared with 1% in the control arm.

Two PD-1 checkpoint inhibitors, Merck’s Keytruda (pembrolizumab) and Bristol-Myers Squibb’s Opdivo (nivolumab), are approved for SCLC, but for patients who have progressed after or while receiving chemotherapy.

Photo: Waldemarus, Getty Images