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PhALLCON: An exploratory post hoc analysis of the impact of ponatinib vs imatinib on PROs in Ph+ ALL
Ponatinib, a third-generation BCR::ABL1 TKI, was recently approved by the U.S. Food and Drug Administration (FDA) for the treatment of ND Ph+ ALL. The approval was based on results from the phase III PhALLCON trial (NCT03589326). However, the impact of ponatinib on HRQoL is unknown. An exploratory post hoc analysis from the PhALLCON trial evaluating the effect of ponatinib vs imatinib on PROs in Ph+ ALL was published by Ashaye et al. in Leukemia.1 Eligible patients were randomized 2:1 to receive ponatinib (n = 164; 30 mg once daily) or imatinib (n = 81; 600 mg once daily) in combination with RIC through induction (C1–3), consolidation (C4–9), and maintenance (C10–20) phases in 28-day cycles. The PRO exploratory endpoints were assessed using FACT-Leu and EQ-5D-5L.
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Key learnings |
Differences in LS mean changes from baseline to the EOI were higher in the ponatinib vs imatinib group for FACT-G PWB (1.545; p = 0.024), FACT-LeuS (4.436; p < 0.001), FACT-Leu TOI (6.212; p = 0.008), and FACT-Leu TS (6.311; p = 0.029). |
Ponatinib showed higher differences in LS mean changes from baseline to the EOC compared with imatinib for FACT-G PWB (2.943; p < 0.001), FACT-LeuS (3.122; p = 0.029), FACT-Leu TOI (7.248; p = 0.007), FACT-G TS (5.226; p = 0.024), FACT-Leu TS (8.264; p = 0.016), and EQ-VAS (7.788; p = 0.008). |
The median time to confirmed improvement in FACT-G PWB (p = 0.065), FACT-LeuS (p = 0.023), FACT-Leu TOI (p = 0.040), and EQ-VAS (p = 0.002) was higher, while the median time to confirmed deterioration in EQ-VAS (HR, 0.51; 95% CI 0.27–0.96; p = 0.036) was lower in the ponatinib vs imatinib group. |
The frequency of experiencing at least one level of worsening in FACT-GP5 from baseline was lower with ponatinib vs imatinib. |
Patients with ND Ph+ ALL who received ponatinib vs imatinib plus RIC showed improvements in QoL and leukemia-specific symptoms. The PRO data strengthen the efficacy and safety findings from the PhALLCON trial and support the use of ponatinib in combination with RIC as frontline treatment for Ph+ ALL. |
Abbreviations: CR, complete remission; EOC, end of consolidation; EOI, end of induction; EQ-5D-5L, EuroQol Five-Dimension Five-Level Questionnaire EQ-VAS, EuroQoL Visual Analog Scale; FACT-G, Functional Assessment of Cancer Therapy General; GP5, General Population 5-point scale; HR, hazard ratio; HRQoL, health-related quality of life; LeuS, Leukemia Subscale; Leu TOI, Leukemia Trial Outcome Index; Leu TS, Leukemia Total Score; LS, least squares; MRD, measurable residual disease; ND Ph+ ALL, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia; PRO, patient-reported outcome; PWB, Physical Well-Being; RIC, reduced-intensity chemotherapy; TKI, tyrosine kinase inhibitor; TS, total score.
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