FDA Approves Imdelltra™, First T-Cell Engager for Extensive-Stage Small Cell Lung Cancer

Amgen has announced the FDA’s approval of IMDELLTRA™ (tarlatamab-dlle), a pioneering treatment for adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression after undergoing platinum-based chemotherapy. This approval, granted on May 16, 2024, in Thousand Oaks, California, reflects the promising results from clinical trials, particularly the Phase 2 DeLLphi-301 study, which showed a significant 40% objective response rate (ORR), a 9.7-month median duration of response (DoR), and a 14.3-month median overall survival (mOS).

Dr. Jay Bradner of Amgen emphasized the transformative impact of IMDELLTRA, citing its ability to deliver long-lasting responses in patients who have limited treatment options. This marks Amgen's second FDA-approved Bispecific T-cell Engager (BiTE®) molecule, reinforcing the company’s dedication to developing innovative cancer therapies.

Dr. David P. Carbone from Ohio State University noted the dire prognosis for ES-SCLC patients, with fewer than 3% surviving beyond five years. The DeLLphi-301 trial results indicate that tarlatamab offers a substantial improvement over existing therapies. The trial demonstrated durable responses in 40% of the participants, representing a significant advancement in treating this aggressive cancer type.

IMDELLTRA operates by targeting DLL3, a protein predominantly expressed on SCLC cells but minimally on healthy cells. By engaging the patient’s T cells to attack these tumor cells, this therapy introduces a novel approach to combat ES-SCLC.

Laurie Fenton Ambrose, president and CEO of GO2 for Lung Cancer, expressed optimism about the new therapy's potential to impact the SCLC treatment landscape, which has seen little progress over decades.

The accelerated approval of IMDELLTRA is based on data from the DeLLphi-301 trial, where patients received a 10 mg dose every two weeks. The study enrolled patients who had failed at least two prior treatments and showed a robust ORR and mOS, although final survival data is still pending. The FDA's approval comes with the condition that continued approval may depend on confirming these clinical benefits in further trials.

However, the use of IMDELLTRA is not without risks. The drug’s label includes warnings for cytokine release syndrome (CRS) and neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS). Patients are advised to be closely monitored for these adverse reactions, which can be severe. The most common side effects reported were CRS, fatigue, pyrexia, and decreased appetite, among others. Permanent discontinuation of the drug due to adverse events was infrequent, occurring in only 7% of patients.

Amgen has also committed to supporting patients and healthcare providers through various assistance programs and resources to ensure appropriate access to IMDELLTRA.

IMDELLTRA represents a significant step forward in the fight against ES-SCLC, offering new hope to patients and caregivers. The development of this therapy underscores Amgen's ongoing commitment to harnessing advanced biotechnology to address the most challenging cancers.

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