FDA Approves Tecelra to Treat Synovial Sarcoma

The Food and Drug Administration (FDA) granted an accelerated approval to Tecelra (afamitresgene autoleucel) to treat adults with unresectable (cannot be removed via surgery) or metastatic synovial sarcoma that has previously been treated with chemotherapy. The approval is specifically for patients with HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P-positive disease that expresses the MAGE-A4 antigen, as determined by an FDA-approved test.

“For decades, therapeutic options for people diagnosed with synovial sarcoma have been limited. With a current five-year survival rate as low as 36%, and for those with metastatic disease at diagnosis, as low as 20%, it is long past time that synovial sarcoma patients have expanded treatment options. Since one third of patients are diagnosed under age 30, improved outcomes can have a tremendous impact. Today, there is a renewed sense of hope for this patient community,” Brandi Felser, CEO of the Sarcoma Foundation of America said in a press release from Adaptimmune, the manufacturer of Tecelra.

The accelerated approval is based on findings from cohort 1 of the SPEARHEAD-1 clinical trial, which included 44 patients. The main goal of the trial was to determine overall response rate (percentage of patients whose disease shrinks or disappears after treatment), as well as duration of response (how long disease responds to the disease before worsening).

Data, which were published in The Lancet, showed that the overall response rate was 43%, which included a 4.5% complete response rate, meaning that there was no sign of the disease after treatment. The average duration of response was six months. Notably, among the group of patients who responded to treatment, 39% experienced a duration of response that lasted 12 months or longer.

Of note, Tecelra is the first engineered cell therapy FDA approved for the treatment of a solid cancer. Additionally, this is the first time in more than a decade that a new therapy was approved for synovial sarcoma.

“Tecelera, which uses each patient’s own immune cells to recognize 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 tumor cancers,” Dr. Sandra D’Angelo, sarcoma medical oncologist and cell therapist at Memorial Sloan Kettering Cancer Center and SPEARHEAD trial principal investigator said in the release.

Tecelra can cause serious side effects, such as cytokine release syndrome (an increase in inflammatory markers called cytokines), neurotoxicity, prolonged severe cytopenia, infections, secondary malignancies and hypersensitivity reactions.

The most common side effects that occurred in 20% or more of patients included: nausea, vomiting, fatigue, infections, pyrexia, constipation, difficulty breathing, abdominal pain, non-cardiac chest pain, decreased appetite, increased heart rate, back pain, hypotension, diarrhea, edema, low white blood cells, low red blood cells and low platelets.

Since the drug was granted an accelerated approval, continued approval may be contingent upon further clinical trial data, according to the release.

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