Breakthrough Cancer Cell Therapy Shows 37% Overall Response Rate in Key Trial
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Breakthrough Cancer Cell Therapy Shows 37% Overall Response Rate in Key Trial
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Breakthrough Cancer Cell Therapy Shows 37% Overall Response Rate in Key Trial
Adaptimmune Therapeutics has announced the publication of positive data from the pivotal Phase 2 clinical trial, SPEARHEAD-1, of its investigational engineered T-cell therapy, afami-cel, in The Lancet.
The U.S. FDA has accepted the biologics license application (BLA) for afami-cel and granted it priority review designation. The PDUFA date for this application is August 4, 2024. If approved, afami-cel will be the first engineered T-cell therapy for solid tumors and the first effective treatment for synovial sarcoma in over a decade.
Between December 17, 2019, and July 27, 2021, a total of 52 patients with synovial sarcoma (n=44) and myxoid/round cell liposarcoma (n=8), confirmed by cytogenetics, were enrolled in cohort 1 and received afami-cel treatment. These patients had received a median of 3 prior lines of systemic therapy. The median follow-up for the trial was 32.6 months. The overall response rate (ORR) for all patients was 37% (19/52; 95% CI: 24-51), with an ORR of 39% (17/44; 95% CI: 24-55) for synovial sarcoma patients and 25% (2/8; 95% CI: 3-65) for myxoid/round cell liposarcoma patients.
Regarding safety, 37 patients (71%) experienced cytokine release syndrome (one case was a grade 3 event). Hematologic toxicity was the most common grade 3 or higher adverse event. There were no treatment-related deaths.
Afami-cel is an engineered T-cell receptor (TCR) T-cell therapy targeting the MAGE A4 cancer antigen, designed as a one-time therapy for advanced synovial sarcoma.
Previously, the FDA granted orphan drug designation for the treatment of soft tissue sarcoma and regenerative medicine advanced therapy designation for the treatment of synovial sarcoma.
Currently, surgery is the preferred treatment for synovial sarcoma, with some patients receiving radiation therapy before or after surgery. If approved, afami-cel could offer this patient population an alternative treatment with a higher quality of life.
Breakthrough Cancer Cell Therapy Shows 37% Overall Response Rate in Key Trial
(source:internet, reference only)
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