1107 Background: Bria-IMT is an allogeneic whole cell immunotherapy expressing tumor associated antigens and GM-CSF to stimulate adaptive and innate immunity. The phase 3 Bria-ABC trial (NCT06072612) evaluates Bria-IMT + retifanlimab vs physician’s choice in MBC w/ no meaningful therapeutic options. Characterization of on-trial pt experience, including quality of life (QOL) and tolerability, remains clinically relevant yet underreported. We evaluated QoL and toxicity to assess feasibility of home self administration. Methods: EORTC QLQ-C30 at baseline (BL) and subsequent visits. Raw item responses were aggregated into domain scores. Changes quantified as absolute point differences; domain scores defined as medians of constituent items. Lower functional/symptom and higher global scores indicate better outcomes. Wilcoxon matched pairs test assessed change from BL. Missing QoL data handled by observed cases approach. QoL evaluated at BL, V3, V6, and V9. TWiST and TOX summarized descriptively. TOX defined as cumulative time w/ grade ≥3 TEAEs w/o progression; TWiST as time w/o grade ≥3 toxicity or progression. TOX and TWiST constitute component health states for planned QTWiST analysis pending mature OS. Results: At submission, 251 pts screened, 173 randomized, 147 treated. 75% Caucasian, 20% other, 5% not reported; median 6 prior lines (2-15); ECOG 2 -6%; intracranial mets 9%; 42% HR+, 37% TNBC, 12% HER2+. Median 5 QoL assessments/pt completed. 127 pts completed ≥2 assessments. Paired data available at V3 52%, V6 17%, V9 6%. Global health medians BL 5.0, V3 5.0, V6 5.0, V9 4.5. Score maintenance/improvement: @V3 63% (p=0.7), V6 62%, V9 71%. Functional domains: role (BL 1.5, V3 2.0, V6 2.0, V9 2.0; maintenance 62.7% p=0.02, 52.4%, 71.4%). Physical (BL 1.0, V3 2.0, V6 2.0, V9 2.0; maintenance 68.7% (p=0.002), 47.6% (p=0.03), 71.4%), cognitive (BL 1.5, V3 1.5, V6 1.5, V9 1.5; maintenance 63.6%, 61.9%, 85.7%). Emotional (BL 1.5, V3 1.5, V6 1.5, V9 1.5; maintenance 75.8% (p=0.9), 81.0%, 85.7%). Social (BL 1.5, V3 1.5, V6 2.0, V9 2.5; maintenance 58.5%, 75.0%, 57.1%). Symptoms: nausea/vomiting (1.0 throughout; maintenance V3 73%, V6 86%, V9 86%), fatigue median 2.0 all timepoints; maintenance 61%, 67%, 71%), pain (BL/V3 1.5, V6/V9 2.0; maintenance V3 57% p=0.03, V6 62% p=0.9, V9 86%). TWiST and TOX restricted mean 3.12 mo and 0.63 mo, respectively; 83.2% and 16.8% of observed follow-up. Pts w global health maintenance demonstrated longer median TWiST v deterioration (4.3 v 2.7 mo). ECOG stable in 78% (n=99). Conclusions: Heavily pretreated MBC pts in Bria-ABC demonstrated stable global health and key functional domains. Findings support sustained QoL in advanced disease. TWiST demonstrates meaningful benefit w/o significant toxicity. Ongoing follow up will further characterize durability of pt-reported outcomes and clinical correlation. Results support decentralized care and potential home self administration. Clinical trial information: NCT06072612 .
Chumsri et al. (2026) studied this question.