Amgen (AMGN) said Tuesday its phase 3 DeLLphi-305 study met its primary endpoint, with Imdelltra in combination with AstraZeneca's (AZN) Imfinzi showing a statistically significant and clinically meaningful improvement in overall survival in patients with extensive-stage small cell lung cancer.
The study evaluated the combination as first-line maintenance treatment for patients with extensive-stage small cell lung cancer whose disease had not progressed after initial treatment, Amgen said. The combination also improved progression-free survival and objective response rate, the company said.
The safety profile was consistent with the known profiles of the individual medicines, with no new or unexpected safety signals identified, the company said, adding that it plans to present detailed results at an upcoming medical congress and share the data with regulatory authorities.
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