Amgen has announced that the global Phase 3 DeLLphi-304 clinical trial evaluating IMDELLTRA® (tarlatamab-dlle) as a treatment for patients with small cell lung cancer (SCLC) who progressed on or after a single line of platinum-based chemotherapy met its primary endpoint at a planned interim analysis. 

IMDELLTRA demonstrated statistically significant and clinically meaningful improvement in overall survival (OS) compared to local standard-of-care (SOC) chemotherapy.

"Small cell lung cancer is one of the most aggressive malignancies, with a high unmet need for more effective therapies.1 The topline results from DeLLphi-304 demonstrate overwhelming clinical benefit for people living with this devastating disease and affirm IMDELLTRA as standard of care," said Jay Bradner, M.D., executive vice president, Research and Development, at Amgen. 

"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," added Bradner.

The safety profile for IMDELLTRA was consistent with its known profile. Detailed data from DeLLphi-304 will be presented at an upcoming medical congress.

DeLLphi-304 is a global Phase 3 randomised controlled open-label clinical trial evaluating the efficacy and safety of IMDELLTRA as a treatment for patients with SCLC who progressed on or after a single line of platinum-based chemotherapy.2 Patients were randomised to receive either IMDELLTRA or local SOC chemotherapy (topotecan in all countries except Japan; lurbinectedin in the US, Canada, Australia, Singapore, Korea; and amrubicin in Japan). The primary outcome measure of the trial is OS.