FDA Approval of Amgen’s Imdelltra for Lung Cancer Amidst Challenges and Market Competition

FDA Approval of Imdelltra:

Amgen's bispecific T-cell engager, Imdelltra, has been approved by the FDA for the treatment of extensive-stage small lung cancer (ES-SCLC) under the accelerated approval pathway.

Mechanism of Action:

Imdelltra binds to both the DLL3 protein on tumor cells and the CD3 antigen on T cells, activating the immune system to destroy DLL3-expressing cancer cells.

Clinical Data:

The approval was based on promising response data from the Phase II DeLLphi-301 trial, showing an objective response rate of 40% and 32% in the 10-mg and 100-mg dose groups, respectively.

Adverse Events:

The FDA noted a large number of missing adverse events (AEs) in Amgen's application, including two deaths related to SCLC itself.

Market Competition:

Merck & Co. has paid $700 million upfront to acquire global rights to Curon's CD3xCD19 bispecific antibody, positioning it as a competitor to Amgen in the blood cancer market.

Future Development:

Amgen is required to conduct a Phase III confirmatory trial to verify the clinical benefits of Imdelltra to maintain its approval.
Legend Biotech and Novartis are also developing a DLL3-targeting CAR-T therapy, further increasing competition in the SCLC treatment landscape.

Financial Impact:

Amgen's stock has faced challenges despite the FDA approval, with investors expressing concerns over the company's quarterly earnings and future growth prospects.