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AstraZeneca (NASDAQ:AZN) announced Tuesday that its blockbuster immunotherapy Imfinzi failed in a late-stage trial for patients with early-stage non-small cell lung cancer whose tumors have been surgically removed.
Citing data from a Phase 3 trial called ADJUVANT BR.31, the company said Imfinzi did not demonstrate statistical significance for the primary endpoint of disease-free survival (DFS), measured as the time until new cancer or death.
Imfinzi, designed to target the PD-L1 protein and counter cancer cells’ immune-evading mechanism, added $4.2B in sales for the Anglo-Swedish drugmaker in 2023.
The treatment is already indicated in the U.S. as a single agent for adults with unresectable Stage III NSCLC whose cancer has not progressed after chemoradiation therapy.
ADJUVANT BR.31, sponsored by the Canadian Cancer Trials Group, evaluated Imfinzi in an adjuvant setting (after surgery), with its primary goal being DFS in patients whose tumors express PD-L1 on 25% or more tumor cells.
The company said there were no new safety signals, and Imfinzi indicated a safety profile in line with past data.