FDA Approves Imdelltra For Advanced SCLC

Imdlltra has been FDA approved for certain patients with advanced small cell lung cancer.

The Food and Drug Administration (FDA) approved Imdelltra (tarlatamab) for the treatment of patients with advanced small cell lung cancer (SCLC) that progressed on or after a platinum-based chemotherapy, according to the agency.

"The FDA’s approval of Imdelltra marks a pivotal moment for patients battling ES-SCLC. This DLL3-targeting therapy in ES-SCLC comprises a transformative option demonstrating long-lasting responses in pretreated patients,” said Dr. Jay Bradner, executive vice president, research and development and chief scientific officer at Amgen, the manufacturer of Imdelltra. “Imdelltra offers [hope to] these patients who are in urgent need of new innovative therapies."

The approval is based off findings from the phase 2 results from the DeLLphi-301 clinical trial that were presented at the 2023 European Society for Medical Oncology Congress and published in the New England Journal of Medicine in October 2023. The trial investigated two separate doses of Imdelltra 10 mg and 100 mg.

The objective response rate (ORR; patients whose disease responded partially or completely to treatment) was 40%, with a median duration of response of 9.7 months, the agency reported. Among 69 patients with available data regarding platinum sensitivity, the ORR was 52% for 27 patients with platinum-resistant SCLC and 31% for 42 patients with platinum-sensitive SCLC.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial or trials, Amgen noted in a news release.

Imdelltra is a type of drug called a bispecific T-cell engager, also known as BiTE therapy. According to data published by the National Institutes of Health, the drug works by binding to the Delta-like ligand 3 (DLL3) protein on cancer cells and the CD3 protein on immune T cells. In doing so, it recruits and activates the T cells to destroy tumor cells.

"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, professor of internal medicine and director of the James Thoracic Oncology Center at the Ohio State University Medical Center, in Amgen's news release. "In the DeLLphi-301 trial, the median overall survival was 14.3 months, with 40% of patients responding to treatment with [Imdelltra]. These responses were remarkably durable, representing a major advancement in the SCLC treatment paradigm."

Overall survival is defined as the length of time from diagnosis or the beginning of treatment when patients are alive but still have signs of cancer, according to the National Cancer Institute.

The prescribing information of Imdelltra includes a Boxed Warning for serious or life-threatening cytokine release syndrome (CRS; a potentially serious condition that includes a increase in inflammatory markers, called cytokines, in the blood) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS), according to the FDA, which reported that the most common side effects were CRS, fatigue, fever, taste changes, decreased appetite, musculoskeletal pain, constipation, anemia and nausea.

The most common severe or life-threatening laboratory abnormalities were decreased lymphocytes, decreased sodium, increased uric acid, decreased total neutrophils, decreased hemoglobin, increased activated partial thromboplastin time and decreased potassium.

Imdelltra’s recommended dose is an initial dose of 1 milligram as an intravenous infusion over one hour on cycle one Day one, followed by 10 mg on cycle one day eight and day 15, then every two weeks until disease progression or unacceptable toxicity.

“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, in Amgen’s news release. "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."

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