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New Research - Synovial Sarcoma Treatment

Advancing CAR-T Cell Therapy for Synovial Sarcoma:
​Afami-cel's Promising Results

Rayan Afif | CERI Youth Program and CERI Research Team Member, and 
Aygün Sahin, MSc, PhD  | CEO, President, and Cancer Lead, Cancer Education and Research Institute (CERI)

Advancing CAR-T Cell Therapy for Synovial Sarcoma:
​Afami-cel's Promising Results

The SPEARHEAD-1 trial [1] highlighted afami-cel's potential as a new treatment option for advanced synovial sarcoma, showing a significant overall response rate (ORR)

What is sarcoma?

Sarcomas are tumors that originate in the bones and connective tissues which comprise bone, muscles, fat, and cartilage [2]. They are not very frequent compared to carcinomas, which are cancers originating from epithelia but include a wide range of cancers that can develop in anyone at any age [3]. It makes up for about 20% of all childhood cancers but only 1% of all adult cancers [2].

What is synovial sarcoma?

Synovial sarcoma is a very rare form of soft tissue sarcoma that occurs in the limbs, although it can develop in other parts of the body. It does not receive its name from synovial tissue, which is the specialized connective tissue that lines joints but instead, it is derived from primitive cells [3]. Synovial sarcoma can occur anywhere throughout the body but is often found in the arm, leg, or foot, and near joints such as the wrist or ankle. It is majorly seen in young people, and especially in teenagers, though it can develop in any person at any given time [2].

​What is CAR-T cell immunotherapy?

This form of treatment is known as CAR-T cell immunotherapy where the patient’s T cells are harvested and genetically modified to bind to certain proteins on the cancer cells’ surface. These receptors enable T cells to identify particular proteins on the cancer cells' surface and destroy them. CAR-T cell therapy has been effective, especially for some blood diseases; however, the question of its effectiveness for solid tumors such as synovial sarcoma is still under research [3].

What is afami-cel?

​Afamitresgene autoleucel (afami-cel) is an investigational CAR-T cell therapy developed by Adaptimmune Therapeutics [4]. It targets a protein called MAGE-A4, which is expressed on the surface of synovial sarcoma cells. The therapy involves collecting a patient's T cells, genetically modifying them to express a MAGE-A4-specific receptor which helps Afami-cell target MAGE-A4, infuse them back into the patient and destroy synovial sarcoma cells [3].

What does the study show?

The phase 2 SPEARHEAD-1 trial evaluated afami-cel in patients with advanced synovial sarcoma. Key findings from the study included:
  • An overall response rate (ORR) of approximately 39%, indicating a significant proportion of patients experienced tumor shrinkage.
  • A median duration of response (DOR) of approximately 12 months, suggesting that responses to afami-cel were durable in responding patients.
  • A median overall survival (OS) of approximately 17 months, with an estimated 2-year OS rate of 70% in patients who responded to treatment [3].

​The trial also confirmed the safety profile of afami-cel, with cytokine release syndrome and reversible hematologic toxicities being the most commonly observed adverse effects. [3]

The Importance of the Study

The SPEARHEAD-1 trial's results are significant for several reasons:
  • Potential New Treatment Option: If approved, afami-cel could become the first engineered T-cell therapy approved for a solid tumor, specifically synovial sarcoma.
  • Clinical Benefit: The trial demonstrated clinically meaningful responses in a challenging-to-treat patient population with advanced disease.
  • Advancement in Treatment: CAR-T cell therapy represents a novel approach to treating synovial sarcoma, offering hope to patients who have limited treatment options [3].

References:

  1. Spearhead 1 Study in Subjects With Advanced Synovial Sarcoma or Myxoid/​Round Cell Liposarcoma. ClinicalTrials.gov (accessed on July 23, 2024)
  2. Sahin A. Sarcoma. Cancer Education and Research Institute (CERI). https://www.canceredinstitute.org/sarcoma (accessed on July 14, 2024)
  3. Conroy R. FDA Gives Priority Review to Afami-Cel in Advanced Synovial Sarcoma (accessed on July 18, 2024)
  4. Adaptimmune announces U.S. 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 on July 14, 2024). 

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