FDA Accepts BLA for Afami-Cel for Priority Review as Treatment of Advanced Synovial Sarcoma

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Afami-cel had engineered t-cell receptor T-cells target MAGE-A4+ tumors, which are highly expressed in synovial sarcoma with HLA-A*02.

The FDA accepted a biologics license application (BLA) for priority review for afamitresgene autoleucel (afami-cel; Adaptimmune Therapeutics plc), an investigational engineered T-cell therapy for the treatment of advanced synovial sarcoma, according to a press release. The application has a Prescription Drug User Fee Act target action date of August 4, 2024.1

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Afami-cel has engineered t-cell receptor T-cells that target melanoma-associated antigen A4 positive (MAGE-A4+) tumors, which are highly expressed in synovial sarcoma with HLA-A*02.2

"Historic outcomes are poor for advanced synovial sarcoma, with low objective response rates for second-line therapies and overall survival of less than 12 months for [patients] who have received 2 or more prior lines of therapy. 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. This regulatory milestone is a testament to our teams' relentless work to deliver a novel treatment option to more people diagnosed with synovial sarcoma,” Dennis Williams, PharmD, senior vice president of Late-Stage Development at Adaptimmune Therapeutics, said in the press release.1

The acceptance was supported by data from cohort 1 of the SPEARHEAD-1 trial, meeting its primary endpoint of efficacy.1

At the 2023 Connective Tissue Oncology Society annual meeting in Dublin, Ireland, positive data from the SPEARHEAD-1 trial were shared as an oral presentation. The trial was a phase 2, open-label study that included approximately 90 individuals with advanced synovial sarcoma or myxoid/round cell liposarcoma. Those who were included had an Eastern Cooperative Oncology Group performance status of 0 or 1; were HLA-A*02 positive with MAGE-A4 expression in ≥ 30% of tumor cells ≥ 2+ by immunohistochemistry; were 16 to 75 years of age; and received either an anthracycline- or ifosfamide-containing regimen.2

About the SPEARHEAD-1 Trial

Trial Name: Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/​Round Cell Liposarcoma

ClinicalTrial.gov ID: NCT04044768

Sponsor: Adaptimmune

Primary Completion Date: October 2021

Planned Completion Date: April 2038

Eligible individuals received a single dose of afami-cel after receiving lymphodepleting chemotherapy. Approximately 45 individuals were assigned to be in cohort 1 and 2, with cohort 1 evaluating the efficacy analysis and cohort 2 building on the efficacy and safety data and serving as sub-group analyses, according to a press release. Investigators found that cohort 2 had a response rate nearly identical to cohort 1, with cohort 3 being opened to include access to afami-cel ahead of commercialization.2

Individuals in the study were also heavily pretreated with a median of 3 prior lines of systemic therapy, ranging from 1 to 12. The outcomes showed that the historical control data after a single dose of afami-cel were favorable, according to the press release. Patients also had positive treatment-free intervals and the median time to next treatment was approximately 7 months overall and approximately 17 months for patients with a RECISTv1.1 response, according to the press release.2

The median overall survival (OS) was approximately 17 months overall, and those who responded to the drug were estimated to have a 70% chance of being alive 2 years after treatment. Higher afami-cel cellular persistence was also associated with a longer OS. Toxicities include cytokine release syndrome and reversible hematologic toxicities, which were consistent with previous findings.2

References

  1. Adaptimmune announces US FDA acceptance of biologics license application for afami-cel for the treatment of advanced synovial sarcoma with priority review. News release. Adaptimmune Therapeutics. January 31, 2024. Accessed February 1, 2024. https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/260/adaptimmune-announces-u-s-fda-acceptance-of-biologics
  2. Adaotimmune reports better outcomes for people with synovial sarcoma who received afami-cel compared to historical control. News release. Adaptimmune Therapeutics. October 31, 2023. Accessed February 1, 2024. https://www.adaptimmune.com/investors-and-media/news-center/press-releases/detail/253/adaptimmune-reports-better-outcomes-for-people-with
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