1L blinatumomab + ponatinib improves fatigue & HRQoL in adults with Ph+ ALL
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MIMS Editorial Team
MIMS Editorial Team
First-line (1L) blinatumomab + ponatinib improves patient-reported outcomes (PROs), including fatigue and health-related quality of life (HRQoL), vs imatinib + chemotherapy in adults with Philadelphia chromosome–positive (Ph+) acute lymphoblastic leukaemia (ALL), results of the phase III GIMEMA ALL2820 trial have shown.
In the trial, 236 patients (median age, 56 years; male, 53 percent) were randomized 2:1 to receive blinatumomab + ponatinib (experimental arm; n=158) or imatinib + chemotherapy (control arm; n=78). Superior efficacy was demonstrated with the experimental vs control regimen, with higher complete haematologic remission, measurable residual disease responses and 18-month event-free survival, and fewer deaths. [Blood 2025;146(Suppl 1):439]
Fatigue, a prespecified primary PRO endpoint of the trial, was measured using the Functional Assessment of Chronic Illness Therapy–Fatigue (FACIT-F) questionnaire, with higher scores indicating lower fatigue. From baseline to day +133, mean change in FACIT-F score was +4.4 vs +0.6 points in the experimental vs control arm, with a difference of 3.8 points (p=0.018), which exceeded the predefined 3-point threshold considered clinically meaningful. At day +133, self-reported fatigue was significantly lower in the experimental vs control arm, with a mean difference of 4.6 points (p=0.005). [Efficace F, et al, EHA 2026, abstract PS1495]
Significant improvements in HRQoL were also observed in the experimental vs control arm, as measured by European Organization for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) global health status/QoL (Δ, 7.8 points; p=0.044), role functioning (Δ, 11.4 points; p=0.022), fatigue (Δ, 9.4 points; p=0.022), nausea/vomiting (Δ, 8.4 points; p=0.001), and diarrhoea (Δ, 6.3 points; p=0.020) scales at day +133.
“These findings further support adoption of the chemotherapy-free strategy as a new standard of care in this setting,” the investigators concluded.