Plus   Neg

AstraZeneca's Late-stage Lung Cancer Trial Fails To Meet Primary Endpoint

AstraZeneca plc (AZN.L,AZN) said that a final analysis of the Phase III CASPIAN trial showed the company's Imfinzi or durvalumab in combination with a choice of standard-of-care chemotherapies confirmed a sustained, clinically meaningful overall survival benefit for patients with extensive-stage small cell lung cancer treated in the 1st-line setting.

But, the second experimental arm testing tremelimumab, an anti-CTLA4 monoclonal antibody, added to Imfinzi and standard-of-care did not meet its primary endpoint of demonstrating a statistically significant improvement in overall survival in this analysis.

The US Food and Drug Administration has granted a Priority Review with a Prescription Drug User Fee Act date set for the first quarter of 2020.

As part of a broad development programme, Imfinzi is also being tested following concurrent chemoradiation therapy in patients with limited-stage SCLC in the Phase III ADRIATIC trial with data anticipated in 2021.

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