COMPARATIVE EFFECTIVENESS OF AFAMI-CEL IN SYNOVIAL SARCOMA USING UNANCHORED MATCHING-ADJUSTED INDIRECT COMPARISONS
Author(s)
Michael J. Nathenson, MD1, Agnieszka Kopiec, MSc2, Noemi Hummel, PhD3, Emi Naslazi, MSc4, Sara Stover, PharmD5, Robert James, PharmD5, Erin van Winkle, BS6, Thomas Clinch, BS7, Sandra D'Angelo, MD8.
1US Worldmeds, Boston, MA, USA, 2Certara, Krakow, Poland, 3Director, Certara Germany GmbH, Lörrach, Germany, 4Certara, Breda, Netherlands, 5US Worldmeds, Louisville, KY, USA, 6US Worldmeds, Philadelphia, PA, USA, 7US WorldMeds, Louisville, KY, USA, 8Memorial Sloan Kettering Cancer Center, New York, NJ, USA.
1US Worldmeds, Boston, MA, USA, 2Certara, Krakow, Poland, 3Director, Certara Germany GmbH, Lörrach, Germany, 4Certara, Breda, Netherlands, 5US Worldmeds, Louisville, KY, USA, 6US Worldmeds, Philadelphia, PA, USA, 7US WorldMeds, Louisville, KY, USA, 8Memorial Sloan Kettering Cancer Center, New York, NJ, USA.
OBJECTIVES: Comparative evidence for afamitresgene autoleucel (afami-cel) in synovial sarcoma (SyS) has been limited by the paucity of randomized controlled trials in this rare population. Therefore, we compared afami-cel with historical 2L+ comparators in SyS using unanchored matching-adjusted indirect comparison (MAIC).
METHODS: A targeted literature review (TLR) and feasibility assessment (FA) was conducted to identify comparator studies suitable for comparison with afami-cel. Unanchored MAICs were performed using patient-level data from SPEARHEAD-1 (NCT04044768) and published aggregate data from comparator trials. Afami-cel patients were weighted to match comparator trial baseline characteristics on age, sex, race, ECOG performance status and prior lines of therapy. Relative treatment effects were estimated for objective response rate (ORR) and overall survival (OS). Effective sample size (ESS) was calculated to assess the robustness of the weighted comparisons.
RESULTS: The TLR and FA identified 10 studies on the following comparators: pazopanib, trabectedin, gemcitabine/docetaxel, regorafenib and catequentinib. Data from 137 patients receiving afami-cel from SPEARHEAD-1 were included in the analysis. ESS was acceptable for 8 out of 10 comparator studies and ranged from 40.82 to 118.29. Afami-cel showed favorable effectiveness vs comparators, with statistically significant odds ratios (95% confidence interval) for ORR of 4.10 (1.47-11.42) vs pazopanib, 10.09 (2.84-35.82) and 11.48 (1.46-90.26) vs trabectedin, 14.47 (1.87-111.73) vs gemcitabine/docetaxel, 9.59 (1.21-76.14) vs regorafenib, and 13.56 (4.02-45.80) vs catequentinib. Hazard ratios for OS for afami-cel vs comparators were 0.31 (0.16-0.59) and 0.43 (0.25-0.74) vs pazopanib, 0.51 (0.30-0.86) vs trabectedin, 0.59 (0.32-1.08) and 0.74 (0.45-1.23) vs gemcitabine/docetaxel, and 0.75 (0.26-2.15) vs regorafenib.
CONCLUSIONS: Unanchored MAICs support favorable comparative effectiveness in terms of response and survival for afami-cel vs standard sarcoma 2L+ chemotherapy in SyS. These indirect comparisons remain limited by incomplete adjustment for all prognostic factors.
METHODS: A targeted literature review (TLR) and feasibility assessment (FA) was conducted to identify comparator studies suitable for comparison with afami-cel. Unanchored MAICs were performed using patient-level data from SPEARHEAD-1 (NCT04044768) and published aggregate data from comparator trials. Afami-cel patients were weighted to match comparator trial baseline characteristics on age, sex, race, ECOG performance status and prior lines of therapy. Relative treatment effects were estimated for objective response rate (ORR) and overall survival (OS). Effective sample size (ESS) was calculated to assess the robustness of the weighted comparisons.
RESULTS: The TLR and FA identified 10 studies on the following comparators: pazopanib, trabectedin, gemcitabine/docetaxel, regorafenib and catequentinib. Data from 137 patients receiving afami-cel from SPEARHEAD-1 were included in the analysis. ESS was acceptable for 8 out of 10 comparator studies and ranged from 40.82 to 118.29. Afami-cel showed favorable effectiveness vs comparators, with statistically significant odds ratios (95% confidence interval) for ORR of 4.10 (1.47-11.42) vs pazopanib, 10.09 (2.84-35.82) and 11.48 (1.46-90.26) vs trabectedin, 14.47 (1.87-111.73) vs gemcitabine/docetaxel, 9.59 (1.21-76.14) vs regorafenib, and 13.56 (4.02-45.80) vs catequentinib. Hazard ratios for OS for afami-cel vs comparators were 0.31 (0.16-0.59) and 0.43 (0.25-0.74) vs pazopanib, 0.51 (0.30-0.86) vs trabectedin, 0.59 (0.32-1.08) and 0.74 (0.45-1.23) vs gemcitabine/docetaxel, and 0.75 (0.26-2.15) vs regorafenib.
CONCLUSIONS: Unanchored MAICs support favorable comparative effectiveness in terms of response and survival for afami-cel vs standard sarcoma 2L+ chemotherapy in SyS. These indirect comparisons remain limited by incomplete adjustment for all prognostic factors.
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO124
Topic
Clinical Outcomes, Study Approaches
Topic Subcategory
Comparative Effectiveness or Efficacy
Disease
Genetic, Regenerative & Curative Therapies, Musculoskeletal Disorders (Arthritis, Bone Disorders, Osteoporosis, Other Musculoskeletal), Oncology, Personalized & Precision Medicine, Rare & Orphan Diseases