Acalabrutinib-Venetoclax Prolongs Survival in Previously Untreated Leukemia
FRIDAY, Feb. 21, 2025 -- For patients with previously untreated chronic lymphocytic leukemia (CLL), fixed-duration acalabrutinib-venetoclax with or without obinutuzumab significantly prolongs progression-free survival compared with chemoimmunotherapy, according to a study published online Feb. 5 in the New England Journal of Medicine.
Jennifer R. Brown, M.D., from Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3, open-label trial involving patients with CLL aged 18 years or older with an Eastern Cooperative Oncology Group performance-status score of 0 to 2, who did not have a 17p deletion or TP53 mutation. Patients were randomly assigned to receive acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, or chemoimmunotherapy with the investigator's choice of fludarabine-cyclophosphamide-rituximab or bendamustine-rituximab (291, 286, and 290 [143 and 147], respectively).
The researchers found that at a median follow-up of 40.8 months, the estimated 36-month progression-free survival was 76.5, 83.1, and 66.5 percent with acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, and chemoimmunotherapy, respectively (hazard ratio for disease progression or death, 0.65 [P = 0.004], for acalabrutinib-venetoclax versus chemoimmunotherapy; P < 0.001 for acalabrutinib-venetoclax-obinutuzumab versus chemoimmunotherapy). The estimated 36-month overall survival was 94.1, 87.7, and 85.9 percent with acalabrutinib-venetoclax, acalabrutinib-venetoclax-obinutuzumab, and chemoimmunotherapy, respectively. The most common adverse event of clinical interest of grade 3 or higher was neutropenia, which was reported in 32.3, 46.1, and 43.2 percent in the three groups, respectively. Ten, 25, and 21 patients died from COVID-19 in the three groups, respectively.
"Continued follow-up will be essential to clarify which patients would be most suitable for acalabrutinib-venetoclax and which for acalabrutinib-venetoclax-obinutuzumab," the authors write.
Several authors disclosed ties to the biopharmaceutical industry, including AstraZeneca, which funded the study.
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