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AstraZeneca's Imfinzi Gets EU Approval for First-Line SCLC

AstraZeneca plc’s AZN PD-L1 inhibitor, Imfinzi has been approved in the European Union for the first-line treatment of extensive-stage small cell lung cancer — the most aggressive type of lung cancer — based on CASPIAN study data. The drug has been approved to treat this lung cancer patient population in combination with standard-of-care (SoC) chemotherapies, etoposide plus either carboplatin or cisplatin.

Imfinzi was approved for the same indication in the United States in March and in Japan in August.

Data from the CASPIAN study, presented previously, showed that treatment with Imfinzi plus platinum-based chemotherapy led to a statistically-significant and clinically-meaningful improvement in overall survival (OS) versus chemotherapy alone. Data from an updated analysis published recently showed that after a median follow up of more than two years, the median OS was 12.9 months in the Imfinzi plus chemotherapy arm versus 10.5 months for chemotherapy alone.

AstraZeneca shares have risen 11.1% so far this year compared with the industry’s increase of 1.6%.


Other than SCLC, Imfinzi is approved for unresectable, stage III NSCLC and advanced bladder cancer in second-line settings. Imfinzi is also being evaluated for multiple cancers, either alone or in combination with other regimens,

Imfinzi generated sales of $954 million in the first half of 2020, up 52% year over year mainly driven by strong demand in advance lung cancer patients. The majority of Imfinzi sales came from the United States driven by the lung cancer indication.

Other PD-L1 inhibitors on the market are Merck’s MRK Keytruda, Bristol Myers’ BMY Opdivo, Roche’s Tecentriq and Pfizer’s PFE Bavencio. While Opdivo and Keytruda are approved to treat SCLC in third- or later-line setting in the United States, Tecentriq in combination with chemotherapy was approved in 2019 for first-line extensive-stage SCLC indication. In January this year, Keytruda failed to meet one of the two primary endpoints in a phase III study evaluating it as first-line treatment for extensive stage SCLC.

AstraZeneca currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here

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