FDA Accepts Priority Review for Novel Synovial Sarcoma Drug

The FDA accepted a priority review for the Biologics License Application for afami-cel to treat patients with advanced synovial sarcoma.

The Food and Drug Administration (FDA) has accepted a priority review for the Biologics License Application (BLA) for the novel drug afami-cel to treat patients with advanced synovial sarcoma, according to a news release.

Afami-cel is a novel T-cell therapy that has been engineered for advanced synovial sarcoma, the release reported. It has been designed to be a single-dose treatment, specifically for patients with advanced synovial sarcoma.

Synovial sarcoma is a type of cancer that forms in soft tissue, including muscles or ligaments, and is often found in areas such as the arms, legs, feet, and joints at the wrist and ankles, the National Cancer Institute defines. Common treatments for this cancer type include surgery, radiation therapy and chemotherapy.

The manufacturer of afami-cel, Adaptimmune Therapeutics, stated that if the novel drug is approved by the FDA, it will be the first engineered T-cell therapy for solid tumors. They also claimed that afami-cel would also be the first effective treatment option in more than a decade for synovial sarcoma.

“The FDA’s acceptance of the BLA submission brings us one step closer to redefining treatment for people with synovial sarcoma,” Adrian Rawcliffe, chief executive officer of Adaptimmune Therapeutics, said in the news release. “Our franchise has great potential and, if approved, we have the capabilities and the capital to launch afami-cel — the first engineered T-cell therapy on the market for a solid tumor cancer.”

Positive data observed in the phase 2 SPEARHEAD-1 trial led to the FDA’s acceptance of the BLA for afami-cel, according to the news release.

The SPEARHEAD-1 trial included approximately 120 patients with either synovial carcinoma or myxoid/round cell liposarcoma, ClinicalTrials.gov reported. Results from the trial — published in the Journal of Clinical Oncology — showed that 44 patients with synovial sarcoma received afami-cel.

The median progression-free survival (PFS; time when patients with cancer live without the cancer worsening) was found to be 3.8 months based on an independent review and was 4.1 months after the researcher review, according to the study.

Researchers found that the median overall survival (OS; time when patients with cancer are still alive) after an independent review was 15.4 months. The 12-month OS probability was 60% and the 24-month OS probability was 40%, researchers noted.

The National Cancer Institute also notes that synovial sarcoma is rare and occurs in one or two out of a million people each year in the U.S. This type of sarcoma accounts for about 5% to 10% of all soft tissue tumors.

“Historic outcomes are poor for advanced synovial sarcoma, with low objective response rates (percentage of patients who have a partial or complete response to treatment) for second-line therapies and overall survival of less than 12 months for people who have received two or more prior lines of therapy,” said Dennis Williams, senior vice president of late-stage development at Adaptimmune Therapeutics.

“In clinical trials, afami-cel has demonstrated an impressive response rate of (approximately) 39% among heavily pre-treated patients with advanced synovial sarcoma and about a 17-month median survival,” he continued. “This regulatory milestone is a testament to our teams’ relentless work to deliver a novel treatment option to more diagnosed with synovial sarcoma.”

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