Amgen's Bispecific Therapy Tarlatamab Receives FDA Priority Review for Advanced Small Cell Lung Cancer

▎WuXi

Edited by Kant Content Team

Amgen recently announced that the U.S. FDA has accepted the Biologics License Application for its investigational bispecific T-cell engager (BiTE) tarlatamab.Please (BLA). This therapy aims to treat adult patients with advanced small cell lung cancer (SCLC) whose disease has progressed during or after platinum-based chemotherapy. NewThe press release pointed out,If approved,tarlatamab will become the first treatment for solid tumorsBiTE Therapy.The application has been granted Priority Review status, with a PDUFA target date of June 12, 2024.

This BLA is based on a global Phase 2 clinical trial

Test DeLLphi-301 Results

Fruit.

The test results showed that tarlatamab

Patients with advanced SCLC who experienced disease progression during or after platinum-based chemotherapy demonstrated durable anti-tumor activity, with encouraging median overall survival results and safety outcomes consistent with those observed in Phase 1 clinical trials.

The detailed data has been published in The New England Journal of Medicine (

NEJM).

Data from this Phase 2 clinical trial showed that, with a median follow-up of 10.6 months, the intent-to-treat analysis of 100 patients receiving the selected 10 mg dose of tarlatamab demonstrated an objective response rate (ORR) of 40% (97.5% CI: 29, 52). For key secondary endpoints, the median progression-free survival (mPFS) was 4.9 months (95% CI: 2.9, 6.7), and the median overall survival was 14.3 months (95% CI: 10.8, NE). Among patients who responded to the 10 mg dose of tarlatamab, 58% maintained their response for at least six months as of the data cutoff, with 55% of responses still ongoing.

In terms of safety, no new safety signals were observed compared to Phase 1 clinical trials. Discontinuation due to treatment-related adverse events (TRAE) was uncommon (4%). The most common treatment-emergent adverse events (TEAE) reported by patients in the Tarlatamab 10 mg group were cytokine release syndrome (CRS; 49%), fever (38%), decreased appetite (25%), and dysgeusia (24%). CRS was primarily limited to the first and second doses, mostly Grade 1 or 2, and generally manageable with supportive care. In the Tarlatamab 10 mg dose group, the incidence of Grade 3 CRS was low (0%), and no Grade 3 immune effector cell-associated neurotoxicity syndrome (ICANS) or related neurological events were observed (0%).

NEJM Paper Reports One Patient Death, Considered Treatment-Related.

Tarlatamab is an investigational targeted immunotherapy designed by Amgen researchers. It works by simultaneously binding to CD3 on T cells and DLL3 on SCLC cells, bringing the patient's own T cells into close proximity with SCLC cells. This leads to the formation of immune synapses and the lysis of cancer cells.DLL3 is an exciting target for the treatment of SCLC because approximately 85% to 94% of SCLC patients express DLL3 on the surface of their cancer cells.Expressed minimally in normal cells.Currently, there is no approved therapy for third-line treatment in SCLC.Tarlatamab is expected to provide a new treatment option for such patients.。

References:

[1] 

FDA Grants Priority Review to Amgen'sTarlatamab Application for Advanced Small Cell Lung Cancer. Retrieved December14, 2023, from https://www.prnewswire.com/news-releases/fda-grants-priority-review-to-amgens-tarlatamab-application-for-advanced-small-cell-lung-cancer-3020

14639.html

[2] Ahn et al., (2023). Tarlatamab for Patients with Previously Treated Small-Cell Lung Cancer. New England Journal of Medicine, DOI: 10.1056/NEJMoa2307980

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