Amgen announced the presentation of new data on IMDELLTRA TM (tarlatamab-dlle), a first-in-class delta-like ligand 3 (DLL3)-targeting Bispecific T-cell Engager (BiTE ® ) molecule, at the 2024 World Conference on Lung Cancer (WCLC) in San Diego. IMDELLTRA will be featured in two oral presentations at the “DLL3 Targeting BiTE Therapies in SCLC” session, happening today at 2:00 p.m. PDT. New data from the global Phase 1b DeLLphi-303 study of IMDELLTRA combined with PD-L1 inhibitors in first-line maintenance extensive-stage small cell lung cancer (ES-SCLC) will be presented as a late-breaking abstract (#LBA OA10.04). Additionally, long-term results from the Phase 2 DeLLphi-301 study in previously treated ES-SCLC will be highlighted as an oral presentation (#OA10.03).
Dr. Jay Bradner, executive vice president, Research and Development, and chief scientific officer at Amgen, stated, “Earlier this year, the FDA approved IMDELLTRA for patients with extensive-stage small cell lung cancer who progressed on or after platinum-based chemotherapy. Today, we are thrilled to share results showing long-term sustained benefit in this setting as well as initial evidence supporting a combination approach in front-line maintenance therapy.”
The DeLLphi-303 Phase 1b Study Data in First-Line Maintenance Therapy demonstrated a manageable safety profile with sustained disease control and positive survival outcomes when IMDELLTRA was combined with a PD-L1 inhibitor in ES-SCLC patients. Key findings included a positive benefit-risk profile with no new or unexpected safety findings, and promising disease control rate (DCR) and median duration of disease control (DoDC) when combined with different PD-L1 inhibitors.
Results from the DeLLphi-301 Phase 2 Extended Follow-up Data in ES-SCLC showcased sustained anticancer activity and a manageable safety profile with IMDELLTRA in patients previously treated with platinum-based chemotherapy.
IMDELLTRA received accelerated approval from the U.S. Food and Drug Administration on May 16, 2024, and is indicated for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy.
The data presented at the 2024 WCLC contribute to the growing body of evidence supporting the effectiveness of IMDELLTRA in the treatment of ES-SCLC. Further research and clinical trials are ongoing to explore the potential of IMDELLTRA in different treatment regimens and patient populations.
