In a conversation with CancerNetwork®, Brian A. Van Tine, MD, PhD, spoke about the FDA accelerated approval of afamitresgene autoleucel (afami-cel; Tecelra) for patients with metastatic or unresectable synovial sarcoma expressing MAGE-A4. He discussed the data from the phase 2 SPEARHEAD-1 trial (NCT04044768) supporting the agent’s use in this patient population and highlighted how this approval might pave the way for other potential developments in the sarcoma landscape.

Van Tine, a professor of medicine and pediatrics and a medical oncologist at Siteman Cancer Center of Washington University in St. Louis, detailed results from SPEARHEAD-1 leading to the FDA’s approval of afami-cel. Based on these findings and the agent’s potential availability as a one-time intravenous fusion, afami-cel may offer improvements in quality of life to patients with synovial sarcoma compared with standard treatment options such as chemotherapy.

Topline data from cohort 1 of the SPEARHEAD-1 trial showed that treatment with afami-cel produced an objective response rate of 43% among 44 evaluable patients, which included a complete response rate of 4.5%. Additionally, the median duration of response was 6 months (95% CI, 4.6-not reached). Of patients with a response, durable responses lasting for 12 months or longer occurred in 39%. 

In terms of other potential benefits following the accelerated approval of afami-cel, Van Tine said that the T-cell therapy may increase treatment access to specific subsets of patients. For those who are unable to relocate and live near certain treatment centers during their therapy, afami-cel may offer a more readily accessible alternative that can allow patients to undergo treatment at home. Van Tine also described how this accelerated approval may “open the gateway” for other advancements related to the use of afami-cel and similar agents in solid tumors.

 “We’re all working hard to get these therapies open at our institutions,” Van Tine said regarding the next steps for increasing access to afami-cel following the accelerated approval. “Knowing who [has] HLA-A*02–positive [disease], knowing who has synovial sarcoma, and being ready to trigger the screening for MAGE-A4 is in every patient's best interest. If you’re one of the patients who have synovial sarcoma, you need to know your status [to determine] how we’re going to integrate this into your care plan.”

Reference

Adaptimmune receives U.S. FDA accelerated approval of TECELRA® (afamitresgene autoleucel), the first approved engineered cell therapy for a solid tumor. News release. Adaptimmune Therapeutics. August 2, 2024. Accessed August 14, 2024. https://tinyurl.com/mw6k4hjh