AstraZeneca Reports Results of Calquence (acalabrutinib) in P-III ELEVATE TN Study for Previously Untreated Chronic Lymphocytic Leukemia
Shots:
- The P-III ELEVATE TN study involves assessing of Calquence + obinutuzumab / Calquence as monothx. vs chlorambucil + obinutuzumab in 535 patients in a ratio (1:1:1) with previously untreated CLL aged ≥65yrs. or b/w 18-65yrs. with CIRS> 6 or creatinine clearance of 30-69 mL/min
- Results: @24mos.patients remained free of disease progression or death (93%/ 87% vs 47%); ORR (93.9% /85.5% vs 78.5%); OS (5%/ 6.1% vs 9.6%); AEs (11.2%/ 8.9% vs 14.1%); @ median follow-up of 28.3 mos.- reduction in diseases progression or death (90% vs 80%) in both combinations i.e- Calquence + obinutuzumab vs chlorambucil + obinutuzumab respectively
- Calquence is a BTK inhibitor- act by binding covalently to BTK further inhibiting its activity in the beta cell and is an approved therapy for MCL who have received at least one prior therapy and was approved under accelerated review in the US
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