Health-related quality of life of patients with resistant/intolerant chronic phase chronic myeloid leukemia treated with asciminib or bosutinib in the phase 3 ASCEMBL trial

by Selleckchem | May 14 2023

In ASCEMBL, an open-label, randomized Phase 3 study, asciminib demonstrated superior efficacy and better safety profile compared with bosutinib in patients with chronic myeloid leukemia in chronic phase (CML-CP) previously treated with ≥2 tyrosine kinase inhibitors. Health-related quality of life (HRQOL) reported by patients is key to understanding the benefit and impact of treatment on patients' lives, and is becoming increasingly important as the life expectancy of CML-CP patients increases and patients require long-term treatment. In ASCEMBL, patients completed questionnaires to assess CML symptoms and interference with daily life (M.D. Anderson Symptom Inventory - CML [MDASI-CML]), general HRQOL (five-level EQ-5D [EQ-5D-5L], Patient Global Impression of Change - CML [PGIC-CML]), and impact of CML on working life and activity (Work Productivity and Activity Impairment questionnaire - CML [WPAI-CML]). Patients' CML symptoms and HRQOL remained stable during 48 weeks of treatment with asciminib, with a general trend for decreased CML symptom severity, particularly for fatigue, and improvement in HRQOL. A clinically meaningful increase in diarrhea severity was observed in patients treated with bosutinib compared to asciminib. These data provide better understanding of the patient perspective and treatment impact on HRQOL in a later-line setting, where little information has been published to date.

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The ASCEMBL study was a Phase 3 clinical trial that compared the efficacy and safety of asciminib and bosutinib in patients with chronic myeloid leukemia in chronic phase who had previously received two or more tyrosine kinase inhibitors. In addition to assessing the clinical outcomes, the study also evaluated the health-related quality of life (HRQOL) of the patients using several questionnaires.

The MD Anderson Symptom Inventory - CML (MDASI-CML) questionnaire was used to assess the CML symptoms and their interference with daily life. The five-level EQ-5D (EQ-5D-5L) and Patient Global Impression of Change - CML (PGIC-CML) questionnaires were used to evaluate the patients' general HRQOL. The Work Productivity and Activity Impairment questionnaire - CML (WPAI-CML) was used to assess the impact of CML on the patients' working life and activity.

The results showed that patients treated with asciminib had stable CML symptoms and HRQOL during the 48 weeks of treatment, with a general trend for decreased symptom severity, particularly for fatigue, and improvement in HRQOL. On the other hand, patients treated with bosutinib showed a clinically meaningful increase in diarrhea severity compared to those treated with asciminib.

These findings provide important insights into the patient perspective and treatment impact on HRQOL in a later-line setting where little information has been published to date. It highlights the importance of evaluating HRQOL as a key outcome measure in clinical trials, particularly in the context of chronic diseases such as CML where patients require long-term treatment.