Breaking New Ground in Synovial Sarcoma: Choy on the FDA Approval of Afami-cel
In this episode of Targeted Talks, Edwin Choy, MD, PhD, discussed the FDA approval of afamitresgene autoleucel for the treatment of patients with advanced synovial sarcoma.
In this episode of Targeted Talks, Edwin Choy, MD, PhD, director of the sarcoma program at the Division of Hematology Oncology at Massachusetts General Hospital, a founding member of Mass General Brigham, and associate professor of medicine at Harvard Medical School, delves into the recent approval of afamitresgene autoleucel (afami-cel; Tecelra) for the treatment of patients with advanced synovial sarcoma.
“Afami-cel is a T-cell receptor therapy. What we do is we harvest the cell to the patient and then we modify the receptor to target a cancer protein called MAGE-A4. Once the T-cell receptor is genetically modified, we can reinfuse the T cells back into the cancer patient,” explains Choy.
The engineered T-cell receptor therapy gained accelerated approval from the FDA on August 1, 2024, for the treatment of adult patients with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or -cleared companion diagnostic devices.1
Findings from the phase 2 SPEARHEAD-1 trial (NCT04044768) supported this approval with approximately 39% of patients with heavily pretreated synovial sarcoma responding to afami-cel. In this cohort, the median duration of response was approximately 12 months, and the median overall survival was approximately 17 months.2,3
“The fact that we now have a treatment that has a 39% response rate in synovial sarcoma is a significant advantage over what we had available before this drug,” adds Choy.
REFERENCES:
1. Adaptimmune receives U.S. FDA accelerated approval of TECELRA® (afamitresgene autoleucel), the first approved engineered cell therapy for a solid tumor. News release. Adaptimmune. August 1, 2024. Accessed August 13, 2024. https://tinyurl.com/tch2emrw
2. Adaptimmune reports better outcomes for people with synovial sarcoma who received afami-cel compared to historical control. News release. Adaptimmune. October 31, 2023. Accessed August 13, 2024. http://tinyurl.com/5dt6b9sj
3. Spearhead 1 study in subjects with advanced synovial sarcoma or myxoid/round cell liposarcoma. ClinicalTrials.gov. Updated August 15, 2023. Accessed August 13, 2024. https://classic.clinicaltrials.gov/ct2/show/NCT04044768
FDA Clears SeCore CDx as Companion Diagnostic for Afami-cel in Synovial Sarcoma
August 7th 2024The FDA has granted 510(k) clearance to the SeCore™ CDx HLA A sequencing system as companion diagnostic for afamitresgene autoleucel in synovial sarcoma, paving the way for a first-of-its-kind solid tumor therapy.
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