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FDA Approves IMDELLTRA for Lung Cancer After a 40% Response Rate

The FDA has granted accelerated approval to Imdelltra for treating extensive-stage small cell lung cancer following platinum-based chemotherapy. This novel T-cell engager therapy targets DLL3 on tumor cells, demonstrating a 40% response rate and a median survival of 14.3 months in trials.

Amgen announced that the U.S. Food and Drug Administration (FDA) has granted accelerated approval to IMDELLTRA™ (tarlatamab-dlle), marking a significant advancement in the treatment of extensive-stage small cell lung cancer (ES-SCLC). This approval heralds IMDELLTRA as the first and only T-cell engager therapy targeting DLL3, a protein predominantly expressed on the surface of SCLC cells.

IMDELLTRA has demonstrated promising outcomes in clinical trials, notably in patients who have previously undergone platinum-based chemotherapy without success. The therapy exhibited an objective response rate of 40% and a median duration of response of 9.7 months, with a median overall survival reaching 14.3 months in the pivotal DeLLphi-301 study.

A New Era in SCLC Treatment

Small cell lung cancer, particularly the extensive-stage disease, has long been a formidable challenge in oncology, with fewer than 3% of patients surviving beyond five years post-diagnosis. IMDELLTRA's mechanism of action involves the activation of the patient's own T-cells to attack cancer cells expressing DLL3, offering a new hope for durable treatment responses.

Dr. Jay Bradner, executive vice president of Research and Development at Amgen, emphasized the therapy's role as a transformative option for pretreated patients. He stated “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.”

IMDELLTRA’s approval was based on its impressive performance in the Phase 2 DeLLphi-301 clinical trial. Administered biweekly, the 10 mg dose of the drug was evaluated in patients who had failed two or more prior lines of treatment. The trial's findings have positioned IMDELLTRA as a major advancement in the SCLC treatment paradigm, bridging decades of minimal progress in the disease's management.

"Lung cancer is a complex and devastating disease, and less than 3% of patients with ES-SCLC live longer than five years. 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," said Dr. David P. Carbone, professor of internal medicine.

The FDA has flagged potential severe side effects, including cytokine release syndrome and neurologic toxicities, which were predominantly observed between the first and second doses and were mostly manageable with supportive care.
Amgen has committed to supporting patients and healthcare providers through Amgen® SupportPlus, offering tools, resources, and patient assistance programs, particularly for uninsured or under-insured patients.

Further validation of IMDELLTRA’s clinical benefits will be required, as continued FDA approval is contingent upon the outcomes of confirmatory trials. This ongoing research will be crucial in firmly establishing the therapy’s role in the treatment of ES-SCLC.

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