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Acalabrutinib plus obinutuzumab versus acalabrutinib versus chlorambucil plus obinutuzumab
Source: Chronic Lymphocytic Leukemia Treatment (PDQ®)–Health Professional Version, National Cancer Institute.
Source updated: April 25, 2025 · Captured 2026-09-09.
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Acalabrutinib is a highly selective covalent irreversible BTK inhibitor, designed to minimize the gastrointestinal toxicities and risk of atrial fibrillation seen with ibrutinib.
Evidence (acalabrutinib plus obinutuzumab vs. acalabrutinib vs. chlorambucil plus obinutuzumab):
The prospective ELEVATE TN trial (NCT02475681) included 535 previously untreated patients aged 65 years or older with comorbidities (e.g., creatinine clearance <70 mL/min). Patients were randomly assigned to one of three arms: acalabrutinib plus obinutuzumab, acalabrutinib alone, or chlorambucil plus obinutuzumab.[17]
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The prospective ELEVATE TN trial (NCT02475681) included 535 previously untreated patients aged 65 years or older with comorbidities (e.g., creatinine clearance <70 mL/min). Patients were randomly assigned to one of three arms: acalabrutinib plus obinutuzumab, acalabrutinib alone, or chlorambucil plus obinutuzumab.[17]
With a median follow-up of 28 months, the 24-month PFS rates were 93% for acalabrutinib plus obinutuzumab (HR, 0.10; 95% CI, 0.06−0.17; P < .0001), 87% for acalabrutinib alone (HR, 0.20; 95% CI, 0.13−0.30; P < .0001), and 47% for chlorambucil plus obinutuzumab.[17][Level of evidence B1]
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The prospective ELEVATE TN trial (NCT02475681) included 535 previously untreated patients aged 65 years or older with comorbidities (e.g., creatinine clearance <70 mL/min). Patients were randomly assigned to one of three arms: acalabrutinib plus obinutuzumab, acalabrutinib alone, or chlorambucil plus obinutuzumab.[17]
There was a small but significant difference in the PFS rates between the two acalabrutinib groups (93% vs. 87% at 24 months), which favored the combination (HR, 0.49; 95% CI, 0.26−0.95).[17]
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Preserved source evidence · Not medical advice