Amgen Gains FDA Nod for Tough Lung Cancer Treatment

The FDA has granted Amgen approval for its bispecific T-cell engager, tarlatamab, now branded as Imdelltra, specifically for treating patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum chemotherapy. This approval falls under the FDA's accelerated pathway, contingent upon treatment response and duration of response data. Amgen must confirm the clinical benefits of Imdelltra through a Phase III trial to maintain this approval. The FDA has also issued a boxed warning for Imdelltra, highlighting risks of cytokine release syndrome and neurologic toxicity.

Jay Bradner, Amgen's Chief Scientific Officer and Executive Vice President of R&D, described the approval as a significant milestone for ES-SCLC patients, calling Imdelltra a "transformative option" that offers long-lasting responses, particularly in those who have undergone prior treatments. Imdelltra, an intravenous infusion, is a first-in-class bispecific antibody designed to bind to both the DLL3 protein on tumor cells and the CD3 antigen on T cells. This dual binding mechanism enables the activation of the body's immune system to target and destroy DLL3-expressing cancer cells.

According to Amgen, DLL3 is expressed in 85% to 96% of SCLC cases but is rarely found on healthy cells. Beyond lung cancer, Amgen is also testing tarlatamab for neuroendocrine prostate cancer, with ongoing Phase I trials.

The accelerated approval of Imdelltra is supported by data from the Phase II DeLLphi-301 trial. This study evaluated the effects of Imdelltra administered at 10-mg or 100-mg doses every two weeks. In October 2023, results published in The New England Journal of Medicine showed an objective response rate of 40% in the 10-mg dose group and 32% in the 100-mg dose group. Among those who responded to the treatment, 59% maintained their response for a median duration of at least six months. The median progression-free survival was reported as 4.9 months in the 10-mg group, with an overall survival rate of 14.3 months.

Armed with these promising results, Amgen submitted its Biologics License Application to the FDA, which was accepted in December 2023 and granted priority review. The FDA's decision was initially expected by June 12, 2024.

Imdelltra's approval positions Amgen ahead of competitors like Boehringer Ingelheim, whose bi-specific T-cell engager BI 764532 for SCLC is currently in Phase II trials. Additionally, in November 2023, Novartis and Legend Biotech entered the race with a potential $1-billion agreement to develop a DLL3-targeting CAR-T therapy.

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