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ASH 2019: Acalabrutinib Combination Therapy and Monotherapy in Treatment-Naive CLL

By: Cordi Craig
Posted: Wednesday, December 11, 2019

Based on the findings of the phase III ELEVATE TN trial, presented at the 2019 American Society of Hematology (ASH) Annual Meeting & Exposition in Orlando, Florida (Abstract 31), the combination therapy of acalabrutinib plus obinutuzumab as well as acalabrutinib monotherapy improved progression-free survival outcomes in patients with treatment-naive chronic lymphocytic leukemia (CLL) compared with obinutuzumab plus chlorambucil. Jeff P. Sharman, MD, of the Willamette Valley Cancer Institute and Research Center, Eugene, Oregon, and colleagues reported that the acalabrutinib treatments appeared to be safe and effective in this patient population. 

The investigators randomly assigned 535 patients to receive acalabrutinib plus obinutuzumab (n = 179), acalabrutinib alone (n = 179), or obinutuzumab plus chlorambucil (n = 177). The median follow-up was 28 months.

Patients treated with acalabrutinib plus obinutuzumab achieved significantly longer progression-free survival than patients who received obinutuzumab plus chlorambucil (median not reached vs. 22.6 months, respectively; P < .0001). Similarly, acalabrutinib monotherapy prolonged progression-free survival (median not reached; P < .0001). The overall response rate was significantly higher with acalabrutinib plus obinutuzumab than with obinutuzumab plus chlorambucil (94% vs. 79%; P < .0001). The complete response rates were also higher in the acalabrutinib combination group (13%) than in the chlorambucil group (5%). Of those receiving chlorambucil, 45 patients (25%) crossed over to the acalabrutinib monotherapy. 

The investigators observed adverse events in all treatment groups, including atrial fibrillation, bleeding, and hypertension. Treatment discontinuation due to adverse events occurred in 20 patients in the acalabrutinib-plus-obinutuzumab group, 16 patients in the monotherapy group, and 25 patients in the chlorambucil group.

“Despite crossover for disease progression in the obinutuzumab-plus-chlorambucil arm, a trend toward improved overall survival was observed in both acalabrutinib arms, though longer follow-up is needed,” the authors concluded.

Disclosure: For full disclosures of the study authors, visit ash.confex.com.



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