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

Commentary
Video

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.

REFERENCE
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. https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/260/adaptimmune-announces-u-s-fda-acceptance-of-biologics
Recent Videos
Arun Upadhyay, PhD, the chief scientific officer and head of research, development, and Medical at Ocugen
Arun Upadhyay, PhD, the chief scientific officer and head of research, development, and Medical at Ocugen
John Brandsema, MD, a pediatric neurologist in the Division of Neurology at Children’s Hospital of Philadelphia
John Brandsema, MD, a pediatric neurologist in the Division of Neurology at Children’s Hospital of Philadelphia
Barry J. Byrne, MD, PhD, the chief medical advisor of Muscular Dystrophy Association (MDA) and a physician-scientist at the University of Florida
John Brandsema, MD, a pediatric neurologist in the Division of Neurology at Children’s Hospital of Philadelphia
Chun-Yu Chen, PhD, a research scientist at Seattle Children’s Research Institute
William Chou, MD, on Targeting Progranulin With Gene Therapy for Frontotemporal Dementia
Alexandra Collin de l’Hortet, PhD, the head of therapeutics at Epic Bio
Related Content
© 2024 MJH Life Sciences

All rights reserved.