Amgen said its Phase III DeLLphi-305 study found that IMDELLTRA, or tarlatamab-dlle, combined with AstraZeneca’s Imfinzi, or durvalumab, improved overall survival compared with durvalumab alone in first-line maintenance treatment for extensive-stage small-cell lung cancer.
The study met its primary endpoint at a pre-specified interim analysis. Amgen said the overall-survival improvement was statistically significant and clinically meaningful, but it did not disclose survival figures, hazard ratios or other detailed data.
The trial enrolled patients whose disease had not progressed after initial treatment with durvalumab, platinum-based chemotherapy and etoposide. Participants received the combination of IMDELLTRA and durvalumab or durvalumab alone as first-line maintenance treatment.
DeLLphi-305 also met secondary endpoints for progression-free survival and objective response rate, Amgen said. Full results are expected to be presented at a future international medical congress and submitted to health authorities.
IMDELLTRA is a bispecific T-cell engager therapy. The study is the first Phase III trial involving a therapy in that class to show an overall-survival benefit in the first-line maintenance setting for extensive-stage small-cell lung cancer, according to Amgen.
The safety profile of the combination was consistent with the known profiles of the individual treatments, the company said, and no new or unexpected safety signals were identified.
The study included post-infusion monitoring in a health-care setting for one to two hours following IMDELLTRA doses on Cycle 1, Day 1 and Cycle 1, Day 8. In certain regions, including Europe, monitoring lasted six to eight hours.
The FDA has previously approved IMDELLTRA for adults with extensive-stage small-cell lung cancer whose disease progressed on or after platinum-based chemotherapy. The DeLLphi program is evaluating the therapy across earlier stages and treatment lines, both as a single agent and in combinations.
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