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Results from a multicenter, open-label phase Ib/II trial (NCT02180711) that evaluated the safety and efficacy of acalabrutinib, a second-generation BTK inhibitor, alone or in combination with rituximab in patients with FL have been published in the British Journal of Haematology by Strati et al.1
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Key learnings |
The most common any grade AEs in the acalabrutinib + rituximab TN cohort, acalabrutinib monotherapy R/R cohort, and acalabrutinib + rituximab R/R cohort included hypertension (25%, 7,7%, 15.4%) and diarrhea (41.7%, 38.5%, 53.8%), while SAEs were reported in 16.7%, 38.5%, 23.1%, respectively. |
The ORR rates were 92.3%, 33.3%, and 30.8% in the acalabrutinib + rituximab TN, acalabrutinib monotherapy R/R, and acalabrutinib + rituximab R/R cohorts, respectively, and the CR rates were 38.5%, 8.3%, and 15.4%. |
Overall, the efficacy and safety data suggest that acalabrutinib monotherapy and in combination with rituximab could be a viable treatment option for patients with FL. |
Abbreviations: AE, adverse event; BTK, Bruton’s tyrosine kinase; CR, complete response; FL, follicular lymphoma; ORR, overall response rate; R/R, relapsed/refractory; SAE, serious adverse event; TN, treatment naïve.
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