Adaptimmune Therapeutics plc (NASDAQ: ADAP) has announced that the U.S. FDA has granted accelerated approval for TECELRA® (afamitresgene autoleucel) as the first engineered cell therapy for treating solid tumors. This approval is specifically for adults with unresectable or metastatic synovial sarcoma who have previously undergone chemotherapy and are positive for HLA-A02:01P, -A02:02P, -A02:03P, or -A02:06P, with tumors expressing the MAGE-A4 antigen. The approval is based on overall response rate and duration of response, with continued approval contingent on further clinical validation. TECELRA marks the first new therapy for synovial sarcoma in over a decade.
Adrian Rawcliffe, Adaptimmune’s CEO, expressed excitement about the approval, highlighting it as a significant milestone in cancer treatment and a culmination of a decade of research and development. He thanked all involved in making this advancement possible and mentioned plans to advance their clinical pipeline, including a rolling BLA submission for the next investigational treatment.
The approval of TECELRA follows results from the SPEARHEAD-1 (Cohort 1) trial, involving 44 patients. The treatment demonstrated a 43% overall response rate, with a 4.5% complete response rate and a median duration of response of 6 months. Among those who responded, 39% had a response lasting 12 months or more. Data from this trial was published in The Lancet earlier this year.
Adaptimmune is preparing to have TECELRA available through a network of authorized treatment centers (ATCs), aiming for 6 to 10 centers by the end of the year and around 30 within two years. An integrated support program, AdaptimmuneAssist, will facilitate a personalized treatment experience.
Brandi Felser of the Sarcoma Foundation of America praised the approval as a vital new option for patients with limited therapeutic choices and a low survival rate, emphasizing its potential impact on young patients.
Dr. Sandra D’Angelo, a principal investigator of the SPEARHEAD trial, noted that TECELRA offers a novel treatment approach, using patients’ own immune cells to target cancer, and represents a significant advancement in cell therapy for solid tumors.
TECELRA is not recommended for individuals with HLA-A*02:05P and may cause serious side effects such as cytokine release syndrome (CRS) and immune effector cell–associated neurotoxicity syndrome (ICANS). Common adverse reactions include CRS, nausea, vomiting, and fatigue. Biomarker tests for HLA type and MAGE-A4 expression are required before treatment. Adaptimmune has partnered with Agilent Technologies and Thermo Fisher Scientific to provide necessary companion diagnostics for TECELRA.
