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Acalabrutinib plus chemoimmunotherapy receives FDA approval for adult patients with previously untreated MCL
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On January 17, 2025, it was announced that the U.S. Food and Drug Administration (FDA) granted approval to acalabrutinib, a second-generation BTK inhibitor, in combination with chemoimmunotherapy for the treatment of adult patients with previously untreated mantle cell lymphoma (MCL).1 This approval was based on positive results from the phase III ECHO trial (NCT02972840).1
ECHO trial1,2
ECHO is a randomized, double-blind, placebo (Pbo)-controlled, multicenter phase III trial evaluating the efficacy and safety of acalabrutinib (A) in combination with bendamustine (B) and rituximab (R) in patients with previously untreated MCL. Data presented during the European Hematology Association 2024 Hybrid Congress showed that among the evaluable patients with MCL (n = 598):
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The trial met its primary endpoint of progression-free survival (PFS).
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With a median follow-up of 45 months, PFS was 66.4 months vs 49.6 months in the A+B+R vs Pbo+B+R arms (p = 0.0160).
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Overall response rates were 91% (complete response, 66.6%) vs 88% (complete response, 53.5%) in the A+B+R vs Pbo+B+R arms.
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Overall survival was not reached in either arm (hazard ratio, 0.86; 95% confidence interval, 0.65–1.13; p = 0.2743).
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Grade ≥3 adverse events were comparable between the A+B+R and Pbo+B+R arms, and adverse events of clinical interest were atrial fibrillation (3.7% vs 1.7%), hypertension (5.4% vs 8.4%) major bleeding (2% vs 3.4%), and infections (41.1% vs 34%).
- Businesswire. CALQUENCE® (acalabrutinib) plus chemoimmunotherapy approved in the US for patients with previously untreated mantle cell lymphoma. https://www.businesswire.com/news/home/20250117223765/en/CALQUENCE%C2%AE-acalabrutinib-plus-chemoimmunotherapy-approved-in-the-US-for-patients-with-previously-untreated-mantle-cell-lymphoma. Published Jan 17, 2025. Accessed Jan 20, 2025.
- Wang M. Acalabrutinib (A) plus bendamustine (B) and rituximab (R) in untreated mantle cell lymphoma: Results from the phase 3, double-blind, placebo (P) -controlled ECHO trial. Abstract #LB3439. Presented at: European Hematology Association 2024 Hybrid Congress; Jun 13–16, 2024; Madrid, ES.
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