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EUROPEAN COMMISSION APPROVES AMGEN'S IMDYLLTRA® FOR THE TREATMENT OF EXTENSIVE-STAGE SMALL CELL LUNG CANCER

AMGN
  • The European Commission granted marketing authorization for IMDYLLTRA (tarlatamab) as a monotherapy for adults with extensive-stage small cell lung cancer (ES-SCLC) who have progressed on or after first-line platinum-based chemotherapy.
  • Approval was based on the DeLLphi-304 Phase 3 trial results showing a 40% reduction in the risk of death with IMDYLLTRA compared to chemotherapy.
  • The trial demonstrated a median overall survival of 13.6 months for IMDYLLTRA versus 8.3 months for chemotherapy, representing an extension of more than five months.
  • IMDYLLTRA is a first-in-class T-cell engager that binds DLL3 on tumor cells and CD3 on T cells to activate T-cell killing of SCLC cells.
  • Common adverse reactions included cytokine release syndrome (56.7%), decreased appetite (36.4%), pyrexia (31.9%), dysgeusia (31.3%), constipation (30.4%), anaemia (30.0%), fatigue (29.8%), nausea (24.9%), asthenia (19.0%), neutropenia (16.9%), hyponatraemia (16.7%), headache (16.3%), lymphopenia (15.6%), with serious reactions primarily involving CRS (19.7%) pyrexia (4.7%).
  • Cytokine release syndrome (CRS) primarily occurred after the first two doses, with most events happening within 15.9 hours of the most recent dose.
  • Patients must be monitored for 6 to 8 hours during the first two infusions (Cycle 1 Day 1 and Day 8) in a healthcare setting equipped to manage CRS, with instructions to remain near a facility for 24 hours post-infusion.
  • The recommended dosing schedule involves an initial 1 mg dose on Day 1, followed by 10 mg on Days 8, 15, and every 2 weeks thereafter.
  • Safety warnings include risks of CRS, immune effector cell-associated neurotoxicity syndrome (ICANS), neutropenia, serious infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity.
  • The U.S. indication covers IMDELLTRA for ES-SCLC with disease progression after platinum-based chemotherapy, featuring a boxed warning for CRS and neurologic toxicity.
  • Amgen is continuing clinical development with multiple DeLLphi trials evaluating tarlatamab in earlier lines of treatment, combination regimens, and limited-stage SCLC.