First engineered cell therapy for a solid tumour gets US approval

Adaptimmune Therapeutics’ Tecelra (afamitresgene autoleucel) has become the first engineered cell therapy for a solid tumour cancer approved in the US. It is also the first new therapy option in more than a decade for synovial sarcoma, which is a rare, soft tissue cancer that most commonly impacts young adults. Peter Marks, Director of the Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER), said the approval of the “state-of-the-art immunotherapy technology” provides a “critical new option for a patient population in need”. The FDA approval is limited to patients who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumour expresses the MAGE-A4 antigen. “The approval of Tecelra is a momentous step in Adaptimmune’s journey to redefine the way cancer is treated and the culmination of a decade of groundbreaking R&D,” said Adrian Rawcliffe, Adaptimmune's Chief Executive Officer. “We plan to progress lete-cel, the next late-stage investigational treatment in our sarcoma franchise, with a rolling BLA submission to the FDA next year.” A milestone for cell therapies The approval of Tecelra was based on results of the SPEARHEAD-1 (Cohort 1) trial, which included 44 patients. Tecelra treatment resulted in an overall response rate (ORR) of 43% with a complete response rate of 4.5%. The median duration of response was six months. Among patients who were responsive to the treatment, 39% had a duration of response of 12 months or longer. Sandra D’Angelo, Sarcoma Medical Oncologist and Cell Therapist, Memorial Sloan Kettering Cancer Center, and SPEARHEAD Trial Principal Investigator, commented: “Tecelra (afami-cel), which uses each patient’s own immune cells to recognise and attack their cancer cells in a one-time infusion treatment, is significantly different than the current standards of care for advanced synovial sarcoma. This approval represents a much-needed new option for people diagnosed with this sarcoma and an important milestone for the use of cell therapies in solid tumour cancers.” Diana Spencer, Senior Digital Content Editor, DDW