Amgen (AMGN) 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 an interim analysis. In comparison to local standard-of-care (SOC) chemotherapy, IMDELLTRA showed a statistically significant and clinically meaningful improvement in overall survival (OS).
Small cell lung cancer 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 benefit for people living with this devastating disease and affirm IMDELLTRA as 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.
Jay Bradner
IMDELLTRA’s safety profile was consistent with the recognized profile. Detailed DeLLphi-304 results will be presented at an upcoming medical congress.
DeLLphi-304 is a global Phase 3 randomized controlled open-label clinical trial that will assess the efficacy and safety of IMDELLTRA as a treatment for SCLC patients who progressed on or after a single course of platinum-based chemotherapy. Patients were randomly assigned to receive IMDELLTRA or local SOC chemotherapy (topotecan in all countries except Japan, lurbinectedin in the United States, Canada, Australia, Singapore, and Korea, and amrubicin in Japan). The primary outcome measure in the experiment is OS.
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IMDELLTRA, a first-in-class immunotherapy developed by Amgen researchers, binds to both DLL3 on tumor cells and CD3 on T cells, activating T cells to kill DLL3-expressing SCLC cells. This leads to the establishment of a cytolytic synapse and the lysis of the cancer cell. DLL3 is a protein present on the surface of SCLC cells in ~85-96% of patients, but is barely expressed on healthy cells, making it an intriguing target.
Amgen’s comprehensive tarlatamab development program includes the DeLLphi clinical trials, which assess tarlatamab as a monotherapy and in combination regimens in earlier stages of SCLC.
Tarlatamab is being investigated in multiple studies, including DeLLphi-303, a Phase 1b study investigating tarlatamab in combination with standard of care therapies in first-line ES-SCLC; DeLLphi-304, a randomized Phase 3 trial comparing tarlatamab monotherapy with standard of care chemotherapy in second-line treatment of SCLC; and DeLLphi-305, a randomized Phase 3 trial comparing tarlatamab in combination with durvalumab versus durvalumab alone as first-line maintenance treatment.
Source: Amgen
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Graduated from the University of Kerala with B.Sc. Botany and Biotechnology. Attained Post-Graduation in Biotechnology from the Kerala University of Fisheries and Ocean Science (KUFOS) with the third rank. Conducted various seminars and attended major Science conferences. Done 6 months of internship in ICMR – National Institute of Nutrition, Hyderabad. 5 years of tutoring experience.
