Afami-cel is the first new treatment for synovial sarcoma in more than 10 years, ending a long-standing therapeutic gap.
The FDA has granted accelerated approval to Adaptimmune Therapeutics for afamitresgene autoleucel (afami-cel [Tecelra]), the company announced in a release.1 The drug is indicated for the treatment of adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.
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Afami-cel is the first engineered cell therapy for a solid tumor cancer approved in the US, and the first new treatment for synovial sarcoma in more than 10 years, ending a long-standing therapeutic gap.
About SPEARHEAD-1
Trial Name: Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/Round Cell Liposarcoma
Clinicaltrials.gov Identifier: NCT04044768
Sponsor: Adaptimmune
Summary: This is a study to investigate the efficacy and safety of ADP-A2M4 in HLA-A*02 eligible and MAGE-A4 positive subjects with metastatic or inoperable (advanced) Synovial Sarcoma (Cohort 1, 2 and 3) or MRCLS (Cohort 1).
“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 [research and development],” said Adrian Rawcliffe, chief executive officer at Adaptimmune, in the release.1 “I want to thank the patients, caregivers, investigators, and clinical teams as well as everyone at Adaptimmune and our partners who made possible this watershed moment for cell therapy and for people with synovial sarcoma.”
“We are committed to advancing our robust clinical pipeline to serve more patients in need and 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.”
The approval of afami-cel is supported by results of the SPEARHEAD-1 (NCT04044768 [Cohort 1]) multicenter, open-label, phase 2 clinical trial.2 Between December 2019 and July 2021, 44 patients with cytogenically confirmed synovial sarcoma were enrolled and received afami-cel.
Afami-cel achieved a 43% overall response rate, with a complete response rate of 4.5%. Patients experienced a median response duration of 4 months (95% CI: 4.6, not reached) and 39% of responders had a duration of response of 12 months or longer.
“This study shows that T-cell receptor therapy can be used to effectively target solid tumours and provides rationale to expand this approach to other solid malignancies,” wrote investigators.2
The approval of afami-cel enables health care providers to start identifying potential candidates for treatment. To prepare for its incorporation into the synovial sarcoma landscape, Adaptimune has launched AdaptimmuneAssist, a support program available to guide patients through a “seamless and personalized” treatment journey.1
Further, Adaptimmune plans to expand its treatment center network to support its growing portfolio, anticipating at least 5 to 10 authorized centers by the end of this year and a total of 30 within the first 2 years.
Synovial sarcoma, representing 5 to 10% of all soft tissue sarcomas with diagnoses concentrated in young people,3 is often characterized by disease recurrence and multiple lines of therapy for patients with advanced disease undergoing standard treatment. The approval of afami-cel aims to redefine and address treatment challenges associated with the rare cancer.
“For decades, therapeutic options for people diagnosed with synovial sarcoma have been limited. With a current 5-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,” said Brandi Felser, chief executive officer at the Sarcoma Foundation of America, in the same release.1 “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.”
Afamitresgene autoleucel is contraindicated in adults who are heterozygous or homozygous for HLA-A*02:05P.
READ MORE: Oncology Resource Center
