John A. Charlson, MD, on Afami-Cel’s Upcoming Review for Synovial Sarcoma


The associate professor of medicine, Medical College of Wisconsin, discussed advantages of afami-cel and data from the pivotal SPEARHEAD-1 trial.

“For synovial sarcoma in the metastatic setting, we've been using the same drugs for quite a while… Some standard cytotoxic chemotherapies have activity for some patients that can be effective... But we haven’t had a lot of new therapies in recent years. So, this T-cell therapy, afami-cel, is essentially a version of immunotherapy, and it’s exciting to see how we're building all these different ways to capture the activity of the immune system against cancers.”

Afamitresgene autoleucel (afami-cel, formerly ADP-A2M4) is up for priority review by the FDA for treating advanced synovial sarcoma. The investigational T-cell receptor (TCR) T-cell therapy, developed by Adaptimmune Therapeutics, has a Prescription Drug User Fee Act (PDUFA) target action date of August 4, 2024.

CGTLive® spoke with John A. Charlson, MD, associate professor of medicine, Medical College of Wisconsin, and primary investigator of the pivotal SPEARHEAD-1 trial (NCT04044768) assessing afami-cel, to learn more about afami-cel and its potential to transform the treatment landscape of synovial sarcoma. He shared his excitement for afami-cel’s potential approval and discussed how it could help address current unmet needs in this patient population. He also went over the therapy’s TCR mechanism, advantages it offers over other kinds of therapies, and data from SPEARHEAD-1 that supported the biologics license application submission.

SPEARHEAD-1 previously met its primary efficacy endpoint of overall objective response (ORR) compared to natural history, with the trial showing a 39% ORR and a median duration of response of around 12 months in patients with advanced synovial sarcoma treated with afami-cel.

Adaptimmune announces U.S. FDA acceptance of biologics license application for afami-cel for the treatment of advanced synovial sarcoma with priority review. News release. Adaptimmune Therapeutics plc. January 31, 2024. Accessed February 2, 2024.
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