Amgen presents data from global Phase 2 DeLLphi-301 study

Amgen announced results from the global Phase 2 DeLLphi-301 study, evaluating tarlatamab, an investigational delta-like ligand 3 targeting BiTE molecule, in patients with advanced stage small cell lung cancer who had failed two or more prior lines of treatment. The data are being presented Oct. 20 at 3:20 PM CEST at a Proffered Paper session as a late-breaking oral presentation during the European Society for Medical Oncology Congress 2023 in Madrid, Spain, with publication in the New England Journal of Medicine. With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10 mg dose for tarlatamab demonstrated an objective response rate of 40%. For key secondary endpoints, median progression-free survival was 4.9 months and median overall survival was 14.3 months. Median response duration was not reached. Of the patients who responded to treatment with tarlatamab at 10 mg dose, 58% experienced at least six months of response and 55% of responses were ongoing at data cutoff. There were no new safety signals observed compared to Phase 1 study. Discontinuations due to treatment-related adverse events were infrequent. The most common treatment-emergent adverse events reported among patients in the tarlatamab 10 mg group, were cytokine release syndrome, pyrexia, decreased appetite and dysgeusia. CRS was largely confined to the first and second dose, predominantly grade 1 or 2 and were generally managed with supportive care. At the tarlatamab 10 mg dose, grade 3 CRS was low and grade 3 immune effector cell-associated neurotoxicity syndrome and associated neurologic events were not observed. There were no reported grade 4 or 5 cases for either of these two adverse events.