HQ Team
May 17, 2024: The US Food and Drug Administration has cleared Amgen’s drug to treat adult patients in the extensive stages of small cell lung cancer (ES-SCLC) with disease progression on or after chemotherapy.
Imdelltra, or tarlatamab-dlle, received accelerated approval based on the “encouraging response rate and duration of response observed in clinical studies,” according to a company statement.
According to the company, continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
“Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years,” said David P. Carbone, M.D., Ph.D., professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center.
Median overall survival
“In the…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.”
Imdelltra targets delta-like ligands expressed in small-cell lung cancer and other neuroendocrine tumours but minimally expressed in normal tissues. Amgen’s therapy activates the patient’s T cells to attack ligand-expressing tumour cells.
T-cells are a type of white blood cell called lymphocytes. They help your immune system fight germs and protect you from disease.
“After decades of minimal advancements in the SCLC treatment landscape, there is now an effective and innovative treatment option available,” said Laurie Fenton Ambrose, co-founder, president, and CEO of GO2 for Lung Cancer. “Today’s FDA approval marks a significant milestone for the SCLC community as the availability of a targeted bispecific therapy brings forward new possibilities to those living with this aggressive disease.”
Adverse reactions
The FDA accelerated approval of Imdelltra based on results from the Phase II clinical trial that evaluated it in patients with small cell lung cancer who had failed two or more prior lines of treatment and received the 10 mg every two weeks dosing regimen.
Results from the study found that the therapy demonstrated a robust objective response rate of 40% and a median duration of response of 9.7 months. The median overall survival was 14.3 months, with final and complete survival data yet to mature.
The most common adverse reactions reported among patients were cytokine release syndrome (55%), fatigue (51%), pyrexia (36%), dysgeusia (36%), decreased appetite (34%), musculoskeletal pain (30%), constipation (30%), anaemia (27%), and nausea (22%).
