ESMO: Tarlatamab delivers an encouraging 40% objective response rate

US biotech giant Amgen (Nasdaq: AMGN) released new data on its global Phase II DeLLphi-301 study, evaluating its DLL3-targeting bispecific T-cell engager tarlatamab, during the European Society for Medical Oncology (ESMO) Congress 2023 in Madrid, Spain, demonstrating exceptional duration of response in small cell lung cancer patients (SCLC) that could back a regulatory filing.

With a median follow-up of 10.6 months, an intention-to-treat analysis that included 100 patients at the selected 10mg dose for tarlatamab demonstrated an objective response rate (ORR; primary endpoint) of 40% (97.5% Confidence Interval (CI): 29, 52). For key secondary endpoints, median progression-free survival (mPFS) was 4.9 months (95% CI: 2.9, 6.7) and median overall survival (mOS) was 14.3 months (95% CI: 10.8, NE). Median response duration was not reached. Of the patients who responded to treatment with tarlatamab at 10mg dose, 58% experienced at least six months of response and 55% of responses were ongoing at data cut-off.

Will discuss data with regulatory authorities