FDA Approves Amgen's T-Cell Engager for Small Cell Lung Cancer

The FDA has recently approved Amgen's Imdelltra, a T-cell engager therapy, for the treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC) who have experienced disease progression following platinum-based chemotherapy. This approval is notable as it represents the first FDA-sanctioned therapy that targets DLL3 in ES-SCLC.

The FDA granted this approval under its accelerated approval pathway. This means that while the drug has shown promise, its continued approval will be contingent on further validation of its clinical benefits through additional trials.

Imdelltra's approval was informed by data from the phase 2 DeLLphi-301 clinical trial. The trial results demonstrated a 40% objective response rate among patients. Additionally, the median duration of response was noted to be 9.7 months, and the median overall survival rate was observed to be 14.3 months. Imdelltra operates by targeting DLL3, a protein found on the surface of SCLC cells, and engages T-cells to attack these cancerous cells.

The potential of DLL3 as a therapeutic target has garnered interest among several other pharmaceutical companies. Boehringer Ingelheim is developing BI 764532, another DLL3-targeting T-cell engager aimed at treating small cell lung cancer and other neuroendocrine tumors, which is currently in phase 2 trials. Molecular Partners, in alliance with Orano Med, is also developing therapies that target DLL3, utilizing the protein's presence in tumor cells to provide selective treatment options. Furthermore, Zai Lab is exploring ZL-1310, an antibody-drug conjugate designed to target DLL3 for treating solid tumors.

The entrance of Imdelltra into the market marks a significant milestone in the treatment of ES-SCLC. It highlights the potential of novel therapies that focus on specific proteins expressed in cancer cells, providing a new avenue for treatment after traditional chemotherapy options have been exhausted. This new wave of DLL3-targeting therapies holds promise for improving outcomes for patients with limited treatment options. As additional trials continue to validate these treatments, the landscape of cancer therapy could see substantial advancements.