54O - Health state impacts of afamitresgene autoleucel (afami-cel) in advanced synovial sarcoma and myxoid/round cell liposarcoma: SPEARHEAD-1 cohort 1

Background

Afamitresgene autoleucel (afami-cel) is an autologous engineered T-cell receptor T-cell therapy targeting tumors expressing melanoma-associated antigen A4 (MAGE-A4). Cohort 1 of the phase 2 SPEARHEAD-1 trial showed a response rate of 38.6% and 25.0% and a median duration of response of 11.6 months and 4.2 months in advanced synovial sarcoma (SyS) and myxoid/round cell liposarcoma (MRCLS), respectively. We analyzed the effects of treatment on pts’ health state and quality of life.

Methods

Afami-cel was infused into pts following lymphodepletion chemotherapy. ECOG performance status (PS) at baseline; Days 8, 15, 22, 29; Weeks 6, 8, 12, 16, 24; and Months 8, 10, 12, and 14, and EQ-5D-3L at baseline and Weeks 8, 16, and 24 post infusion were recorded. EQ-5D-3L visual analogue scores (VAS) and domain changes, Paretian Classification of Health Change (PCHC), and correlations with clinical response (assessed by RECIST v1.1 by investigators) were analyzed.

Results

Baseline PS was recorded for 52 pts (PS 0, n=27; PS 1, n=25). As of August 30, 2023, at Days 8 and 15 post infusion, 63% (30 of 48 recorded) and 75% (39 of 52 recorded) maintained or improved their PS, respectively, and 38% (18 of 48) and 25% (13 of 52) had a deterioration in PS from baseline. At Days 22 and 29, 78% (40 of 51 recorded) and 78% (38 of 49 recorded), respectively, maintained or improved their PS. From Week 6 to Month 14, 87–100% of pts with reported PS had an improved or maintained PS compared with baseline. Median VAS EQ-5D-3L health score at baseline was 61 in 45 pts, improving to 80 at Week 24 (n=19). Median time to next treatment or death was 10.0 months in the 27 pts with stable/improving VAS and 5.7 months in the 7 pts with worsening VAS. At baseline, of the 45 pts completing EQ-5D-3L domain analysis, 76% had pain/discomfort and 58% had anxiety/depression. 74% (25 of 34) of pts with baseline and ≥1 subsequent time point had a better/no change best PCHC assessment vs baseline. PCHC correlated with disease control.

Conclusions

These pt-reported outcomes suggest that clinical responses to afami-cel in pts with advanced SyS/MRCLS were associated with maintenance or improvement in overall health and quality of life.

Clinical trial identification

NCT04044768.

Editorial acknowledgement

Christine Ingleby, Excel Scientific Solutions, funded by Adaptimmune.

Legal entity responsible for the study

Adaptimmune.

Funding

Adaptimmune.

Disclosure

M. Wagner: Financial Interests, Personal, Advisory Board: Adaptimmune, Deciphera, Aadi, Epizyme, PharmaEssentia. C. Lunt: Financial Interests, Personal, Full or part-time Employment, At the time of study: Adaptimmune; Financial Interests, Personal, Stocks/Shares: Adaptimmune. J-Y. Blay: Financial Interests, Personal and Institutional, Research Grant, and personal honoraria: Adaptimmune, GSK. M. Druta: Financial Interests, Personal and Institutional, Invited Speaker, research funding, and food/beverage: Deciphera; Financial Interests, Personal, Other, Honoraria and food/beverage: Aadi Biosciences; Financial Interests, Personal, Other, Consulting and Food/beverage: Daiichi Sankyo; Financial Interests, Institutional, Principal Investigator: GSK, Blueprint Medicines, Trillium Therapeutics. S. Attia: Financial Interests, Personal, Research Grant: Desmoid Tumor Research Foundation, Guardant; Financial Interests, Institutional, Research Grant: Tracon Pharma, Bayer, Novartis, Lilly, Karyopharm Therapeutics, Epizyme, Blueprint Medicines, Genmab, CBA Pharma, Merck, Philogen, Gradalis, Deciphera, Takeda, Incyte, Springworks, Adaptimmune, Advenchen Laboratories, Bavarian Nordic, BTG, PTC Therapeutics, GSK, Forma Therapeutics, Ayala Pharmaceuticals, Trilium therapeutics, Boehringer Ingelheim, Salarius Pharmaceuticals, Theseus Pharmaceuticals, Monopar Therapeutics, C4 Therapeutics, Inhibrix, Noxopharm, Rain Therapeutics, Cogent Biosciences, Jazz Pharmaceuticals, Shanghai Pharma, PharmaMar. C.M. Valverde Morales: Financial Interests, Institutional, Funding, Clinical trial performance: Adaptimmune; Financial Interests, Personal, Other, consulting fees: Deciphera; Financial Interests, Personal, Other, Honoraria: Bayer; Financial Interests, Personal, Other, travel/meeting support: PharmaMar; Financial Interests, Personal, Advisory Board: PharmaMar, Bayer, Boehringer Ingelheim. K. Ganjoo: Financial Interests, Personal, Advisory Board: Adaptimmune, Deciphera, Daiichi Sankyo, Boehringer Ingelheim. S.M. Schuetze: Financial Interests, Institutional, Research Grant: Adaptimmune, GSK, Tracon, Shanghai Pharma, Rain Oncology; Financial Interests, Institutional, Research Grant, and Principal Investigator: Boehringer Ingelheim; Financial Interests, Personal, Royalties: UpToDate; Financial Interests, Personal, Other, DSMB member: Bioatla. E. Van Winkle, J. Bai, D. Bestul, V. Desai, M. Yule, D. Williams, E. Norry: Financial Interests, Personal, Full or part-time Employment: Adaptimmune. P. Bayer: Financial Interests, Personal, Full or part-time Employment, at the time of study: Adaptimmune. B.A. Van Tine: Financial Interests, Personal, Research Grant, and travel: Polaris; Other, Personal, Other, Patent/licenses: Accuronix Therapeutics; Financial Interests, Personal, Other, Consulting: Deciphera, Putnam, Salarius Pharmaceuticals Inc, Boxer Capital LLC, Acuta Capital Partners, Aadi Biosciences, Race Oncology, Hinge Bio, Sonata Therapeutics; Financial Interests, Personal, Advisory Board: Daiichi Sankyo, EcoR1, Apexigen Inc, Epizyme, Bayer US Medical Affairs Oncology, PTC Therapeutics, Boehringer Ingelheim, Agenus, Regeneron Pharmaceuticals, Curis, Inhibrx; Financial Interests, Personal, Other, Consulting/travel: Advenchen, Kronos Bio; Financial Interests, Personal, Other, Honoraria: Iterion Therapeutics; Financial Interests, Personal, Other, Honoraria/travel: Total Health Conference; Financial Interests, Personal, Other, Travel: Adaptimmune. All other authors have declared no conflicts of interest.