KEY TAKEAWAYS
- Afami-cell [formerly ADP-A2M4]) (Spearhead – 1) is a phase II trial that evaluated the efficacy and safety of afami-cell in patients with advanced synovial sarcoma.
- Patients with advanced synovial sarcoma, specifically those who tested positive for HLA-A and MAGE-A4, were treated with afami-cel after receiving lymphodepleting chemotherapy.
- The result demonstrated the median overall survival was 15.4 months, and the 12-month overall survival probability was 60%.
- These findings showed promising survival results in patients with advanced synovial sarcoma, especially those who responded to treatment.
TFami-cel is a T-cell therapy (TCR) being tested in a Phase 2 trial (SPEARHEAD-1) for advanced solid tumors. The study targeted human leukocyte antigen (HLA) A*02 patients with tumors positive for the cancer testis antigen melanoma-associated antigen A4(MAGE-A4). The trial evaluates its efficacy and safety in pretreated patients with synovial sarcoma or myxoid/round-cell liposarcoma. This study presents interim overall survival (OS) results for patients (Pts) with advanced synovial sarcoma.
Pts with advanced synovial sarcoma who were HLA-A*02 positive and had evidence of clinical or radiological progression received afami-cell after lymphodepleting chemotherapy with fludarabine and cyclophosphamide. The study assessed the overall response rate based on RECIST v1.1 by independent review as the primary endpoint. Secondary endpoints included OS and progression-free survival (PFS), calculated using the Kaplan-Meier method.
A total of 44 pts with synovial sarcoma were treated with afami-cel (2.68–9.99×109 transduced T-cells) in Cohort 1. Pts had a median age of 41 years (ranging from 19 to 73 years), with 50% of them being female. Most Pts (89%) were of white ethnicity, and 96% were identified as having the HLA-A*02:01P type. The median tumor MAGE-A4 expression H-score was 257 (ranging from 132 to 300). Before receiving afami-cel, Pts had undergone a median of 3 previous lines of therapy (ranging from 1 to 12). At the time of data analysis, the median follow-up period was 20.8 months. According to both independent and investigator reviews, the median progression-free survival (PFS) was 3.8 months (95% CI: 2.8, 5.8) and 4.1 months (95% CI: 2.8, 6.9), respectively. Median OS was 15.4 months (95% CI: 10.9, not estimable) for the patients, with 52% of them being censored at the data cut-off. The probability of surviving at 12 months was 60%, and at 24 months, it was 40%. During long-term follow-up, 21 patients received additional therapy, including systemic therapy (20 Pts), radiation (6 Pts), and other treatments (4 Pts). Among the 17 patients who showed a RECIST response, according to an independent review, the median OS was not reached. The probability of surviving at 12 months was 90%, and at 24 months, it was 60%.
The study concluded that Pts with advanced synovial sarcoma who received afami-cel in the SPEARHEAD-1 trial had more prolonged survival, especially those who responded to treatment.
Source: https://meetings.asco.org/abstracts-presentations/219898
Clinical Trial: https://clinicaltrials.gov/study/NCT04044768?term=%20NCT04044768&rank=1
Brian Andrew Van Tine, Kristen N. Ganjoo, Jean-Yves Blay, Claudia Valverde, Dejka M. Araujo, Albiruni Ryan Abdul Razak, Axel Le Cesne, Scott Schuetze, Michael J Wagner, Steven Attia, Edouard Forcade, Mihaela Druta, Seth Pollack, Jane Bai, Paige Bayer, Erin Van Winkle, Elliot Norry, Cheryl McAlpine, Dennis Williams, and Sandra P. D’Angelo
Journal of Clinical Oncology 2023 41:16_suppl, 11563-11563
