FDA Prioritises Review of Amgen’s Tarlatamab for Advanced Small Cell Lung Cancer

In a significant development for the fight against advanced small cell lung cancer (SCLC), the U.S. Food and Drug Administration (FDA) has granted Priority Review to Amgen’s Biologics License Application (BLA) for tarlatamab.

Tarlatamab, an investigational delta-like ligand 3 (DLL3) targeting Bispecific T-cell Engager (BiTE®) therapy, has the potential to become the first BiTE® therapy designed for a major solid tumor if approved.

Amgen’s Executive Vice President of Research and Development, David M. Reese, M.D., emphasised the urgency of new treatment options for patients facing advanced SCLC after platinum-based chemotherapy, stating:

“The FDA’s Priority Review designation for this application underscores the urgency to provide new treatment options for patients with advanced SCLC who have progressed following treatment with platinum-based chemotherapy. While first-line treatments often show strong responses, patients can experience aggressive recurrences and long-term survival remains a challenge. Unfortunately, for patients who relapse, there are limited treatment options, emphasizing the importance of bringing new therapies to this patient population with advanced disease.”

Breakthrough BiTE® Therapy Awaits Approval with Target Action Date Set for June 12, 2024

The FDA’s Priority Review designation signifies the potential for significant improvements over existing options or the introduction of a treatment where none currently exists. The Prescription Drug User Fee Action (PDUFA) date for tarlatamab is scheduled for June 12, 2024.

The BLA is grounded in Phase 2 results from the DeLLphi-301 clinical trial, which investigated patients with advanced SCLC experiencing disease progression after platinum-based chemotherapy. The trial’s findings, recently presented at the 2023 European Society for Medical Oncology (ESMO) Congress and published in the New England Journal of Medicine, demonstrated promising antitumor activity with a durable response and positive survival outcomes.

Beyond the Phase 2 trial, tarlatamab is undergoing investigation in multiple studies, including DeLLphi-302, DeLLphi-303, DeLLphi-304, DeLLphi-306, and DeLLpro-300, covering various SCLC treatment scenarios. Notably, Amgen has plans to initiate an additional Phase 3 study of tarlatamab for first-line treatment of SCLC.

Tarlatamab’s Breakthrough Therapy Designation in October 2023 and its review under the Project Orbis framework and Real Time Oncology Review (RTOR) underscore the FDA’s commitment to expediting potentially groundbreaking treatments. Project Orbis, an FDA Oncology Center of Excellence initiative, facilitates the concurrent submission of oncology products among certain countries.

Small Cell Lung Cancer (SCLC), accounting for 15% of lung cancer cases worldwide, has a median survival of approximately 12 months post-initial therapy. Despite initial high response rates to platinum-based first-line chemotherapy, patients often experience rapid relapse, necessitating subsequent treatment options.

Tarlatamab is an investigational, targeted therapy engineered by Amgen researchers that brings a patient’s own T cells in close proximity to SCLC cells by binding both CD3 on T cells and DLL3 on SCLC cells. This results in the formation of a cytolytic synapse with lysis of the cancer cell. DLL3 represents an exciting therapeutic target for patients with SCLC, as approximately 85% to 96% of patients have expression of DLL3 on the cell surface of SCLC cells, with minimal expression in normal cells.

Amgen’s BiTE® technology, the backbone of tarlatamab, is a targeted immuno-oncology platform aiming to engage patients’ T cells with tumor-specific antigens, activating cytotoxic potential to eliminate cancer. The BiTE® platform holds promise for treating various tumor types, offering potential off-the-shelf solutions for broader accessibility.

To learn more about BiTE® technology, visit https://www.amgenoncology.com/bite-platform.html.

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