Amgen's Imdelltra receives US FDA approval for extensive-stage SCLC

Published: 17-May-2024

Imdelltra received approval following the positive results of the Phase II DeLLphi-301 clinical trial

Amgen, a global biopharma company, has received approval for Imdelltra (tarlatamab-dlle) for the treatment of adults with extensive-stage small cell lung cancer (ES-SCLC) with disease progression on or after platinum-based chemotherapy, by the US Foof and Drug Administration (FDA).

Imdelltra has received accelerated approval based on the encouraging response rate and duration of response (DoR) observed in clinical studies. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

"Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years,1" said David P. Carbone, professor of Internal Medicine and Director of the James Thoracic Oncology Center at the Ohio State University Medical Centre. "In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with tarlatamab. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm."



The first of its kind

IMDELLTRA is the first and only DLL3-targeting Bispecific T-cell Engager therapy that activates the patient's own T cells to attack DLL3-expressing tumour cells.2 

The FDA accelerated approval of IMDELLTRA is based on results from the Phase II DeLLphi-301 clinical trial that evaluated Imdelltra in patients with SCLC who had failed two or more prior lines of treatment, and who had received the 10 mg every two weeks dosing (Q2W) regimen.

Results from the study found that IMDELLTRA at the 10 mg Q2W dose (N=99) demonstrated a robust objective response rate (ORR) of 40% (95% Confidence Interval [CI]: 31, 51) and median DoR of 9.7 months (CI: 2.7, 20.7+). The median overall survival (mOS) was 14.3 months, with final and complete survival data yet to mature.3


Associated side effects

The IMDELLTRA label includes a Boxed Warning for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), in addition to warnings and precautions for cytopenias, infections, hepatotoxicity, hypersensitivity, and embryo-fetal toxicity.

The most common (> 20%) adverse reactions reported among patients were CRS (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anemia (27%), and nausea (22%). Permanent discontinuations due to treatment-emergent adverse events (TEAEs) were infrequent (7%).

CRS was largely confined to the first and second dose, predominantly grade 1 or 2, and was generally managed with supportive care. Details of the Important Safety Information are included below. 


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