FDA Approval Insights: Afami-Cel for Pretreated, Unresectable or Metastatic Synovial Sarcoma

OncLive On Air is a podcast from OncLive^®, which provides oncology professionals with the resources and information they need to provide the best patient care. In both digital and print formats, OncLive covers every angle of oncology practice, from new technology to treatment advances to important regulatory decisions.

In today’s episode, supported by Adaptimmune Therapeutics, we had the pleasure of speaking with Allison Betof Warner, MD, PhD, about the FDA approval of afamitresgene autoleucel (afami-cel; Tecelra) for patients with advanced synovial sarcoma. Dr Warner is an assistant professor of medicine (oncology) in the Department of Medicine in the Division of Medical Oncology at Stanford University in California, where she is also the director of Solid Tumor Cellular Therapy.

On August 2, 2024, the FDA granted accelerated approval to afami-cel for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy; have are HLA-A*02:01P–, -A*02:02P–, -A*02:03P–, or -A*02:06P–positive disease; and whose tumors express MAGE-A4. This regulatory decision was backed by findings from cohort 1 of the phase 2 SPEARHEAD-1 trial (NCT04044768), in which patients who received afami-cel (n = 44) had an overall response rate of 43% per independent review, including a complete response rate of 4.5%.

In our exclusive interview, Dr Warner discussed the significance of this approval, key findings from the pivotal SPEARHEAD-1 trial, and the importance of multidisciplinary collaboration when administering cell therapies.

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