Amgen’s global Phase III DeLLphi-304 trial of Imdelltra (tarlatamab-dlle) has met its primary endpoint at a planned interim analysis for treating small cell lung cancer (SCLC) patients who advanced on or following a single line of platinum-based chemotherapy.
The open-label, randomised, controlled study aims to assess the therapy’s safety and efficacy for this patient population.
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In the trial, the therapy showed a meaningful improvement in overall survival (OS), which is the primary outcome measure of the trial, against local standard-of-care (SOC) chemotherapy.
Subjects received SOC treatment or therapy, with topotecan being received in every nation excluding Japan; amrubicin in Japan; and lurbinectedin in Australia, Canada, Korea, Singapore, and the US.
According to Amgen, Imdelltra’s safety profile was found to be “consistent” with the known profile.
Engineered by the company’s researchers, this immunotherapy targets delta-like ligand 3 (DLL3), a protein prevalent in the majority of SCLC cells but rare in healthy cells.
The therapy works by activating T cells to destroy cancer cells expressing DLL3, offering an approach for SCLC treatment.
Amgen Research and Development executive vice-president Jay Bradner said: “SCLC is one of the most aggressive malignancies, with a high unmet need for more effective therapies. The topline results from DeLLphi-304 demonstrate overwhelming clinical benefits for people living with this devastating disease and affirm Imdelltra as a standard of care.
“We look forward to sharing these results with the scientific community and health authorities as we continue our efforts to bring Imdelltra to patients worldwide.”
The company’s DeLLphi trials encompass several studies investigating tarlatamab as a single agent and as combined regimens in prior SCLC lines.
These include trials for first-line and maintenance treatments, as well as alternative dosing regimens.
Last month, the company reported that the 24-week Phase III IGNITE trial of two dose strengths of rocatinlimab in individuals with moderate to severe atopic dermatitis met the co-primary endpoints.
