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

Réa, Delphine; Boquimpani, Carla; Mauro, Michael J.; Minami, Yosuke; Allepuz, Alejandro; Maheshwari, Vikalp Kumar; D’Alessio, Denise; Wu, Ying; Lawrance, R.; Narbutas, Šarūnas; Sharf, Giora; Hochhaus, Andreas

doi:10.1038/s41375-023-01888-y

Cited by 5 publications

(3 citation statements)

References 23 publications

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“…The presence of ophthalmic manifestations in patients with CML may be associated with a worse prognosis, as evidenced by a lower survival rate among patients with CML exhibiting such manifestations . Therefore, prompt recognition of the underlying disease is vital to initiate prompt treatment, which is typically associated with an improvement in systemic signs and symptoms, including ocular manifestations . Typical recommendations for ophthalmic follow-up in patients with CML may be as often as monthly for the initial 6 to 12 months following diagnosis.…”

Section: Discussionmentioning

confidence: 99%

“…7 Therefore, prompt recognition of the underlying disease is vital to initiate prompt treatment, which is typically associated with an improvement in systemic signs and symptoms, including ocular manifestations. 8 Typical recommendations for ophthalmic follow-up in patients with CML may be as often as monthly for the initial 6 to 12 months following diagnosis.…”

Section: Discussionmentioning

confidence: 99%

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Bilateral Retinal Vascular Tortuosity and Hemorrhages

Borrelli,

Serafino,

Reibaldi

2024

JAMA Ophthalmol

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Bilateral Retinal Vascular Tortuosity and Hemorrhages

Borrelli,

Serafino,

Reibaldi

2024

JAMA Ophthalmol

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“…The HRQOL reported by patients is key to understanding the benefits and impacts of treatment on their lives and is becoming increasingly important as the life expectancy of patients with chronic-phase CML becomes longer and they require long-term treatment. The CML symptoms and HRQOL remained stable over 48 weeks of treatment with asciminib, with a general trend for a decrease in CML symptom severity, particularly for fatigue, and an improvement in the HRQOL [ 47 ].…”

Section: CML Drugs Expected To Be Used In the Future Asciminibmentioning

confidence: 99%

Genetic Landscape of Chronic Myeloid Leukemia and a Novel Targeted Drug for Overcoming Resistance

Yoshimaru,

Minami

2023

IJMS

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Tyrosine kinase inhibitors (TKIs) exemplify the success of molecular targeted therapy for chronic myeloid leukemia (CML). However, some patients do not respond to TKI therapy. Mutations in the kinase domain of BCR::ABL1 are the most extensively studied mechanism of TKI resistance in CML, but BCR::ABL1-independent mechanisms are involved in some cases. There are two known types of mechanisms that contribute to resistance: mutations in known cancer-related genes; and Philadelphia-associated rearrangements, a novel mechanism of genomic heterogeneity that occurs at the time of the Philadelphia chromosome formation. Most chronic-phase and accelerated-phase CML patients who were treated with the third-generation TKI for drug resistance harbored one or more cancer gene mutations. Cancer gene mutations and additional chromosomal abnormalities were found to be independently associated with progression-free survival. The novel agent asciminib specifically inhibits the ABL myristoyl pocket (STAMP) and shows better efficacy and less toxicity than other TKIs due to its high target specificity. In the future, pooled analyses of various studies should address whether additional genetic analyses could guide risk-adapted therapy and lead to a final cure for CML.

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Asciminib in Patients With CML-CP Previously Treated With ≥ 2 Tyrosine Kinase Inhibitors: 96-Week Results From the Japanese Subgroup Analysis of the ASCEMBL Study

Minami,

Doki,

Matsuoka

et al. 2024

Int J Hematol

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Asciminib is a first-in-class BCR::ABL1 inhibitor that Specifically Targets the ABL1 Myristoyl Pocket (STAMP). It is approved worldwide and in Japan for chronic myeloid leukemia in chronic phase (CML-CP) with resistance or intolerance to previous tyrosine kinase inhibitor (TKI) therapy. In the Phase 3 ASCEMBL study, patients with CML-CP who received ≥ 2 prior ATP-competitive TKIs were randomized (2:1) to asciminib 40 mg twice-daily or bosutinib 500 mg once-daily. Here, we report the 96-week results of the subgroup analysis of Japanese patients (asciminib, n = 13; bosutinib, n = 3) in the ASCEMBL study. The MMR rate at Week 96 was 46.2% in asciminib-treated patients, increasing from Weeks 24 and 48. Patients who achieved MMR at Week 24 remained in MMR up to the Week 96 cutoff. While a high proportion of patients treated with asciminib remained on treatment at cutoff, none randomized to bosutinib were on treatment at Week 96. Despite the longer duration of exposure to asciminib, its safety and tolerability continued to be favorable with no new or worsening safety findings. Overall, the efficacy and safety outcomes in the Japanese subgroup were comparable with the ASCEMBL global study population, which supports the use of asciminib in Japanese patients with previously treated CML-CP.

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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

Cited by 5 publications

References 23 publications

Bilateral Retinal Vascular Tortuosity and Hemorrhages

Bilateral Retinal Vascular Tortuosity and Hemorrhages

Genetic Landscape of Chronic Myeloid Leukemia and a Novel Targeted Drug for Overcoming Resistance

Asciminib in Patients With CML-CP Previously Treated With ≥ 2 Tyrosine Kinase Inhibitors: 96-Week Results From the Japanese Subgroup Analysis of the ASCEMBL Study

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