Dr. Sharman on the Potential Future of Acalabrutinib in CLL

Jeff Sharman, MD
Published: Monday, Aug 12, 2019



Jeff Sharman, MD, director of research at Willamette Valley Cancer Institute and medical director of hematology research for The US Oncology Network, discusses the potential future roles of acalabrutinib (Calquence) in chronic lymphocytic leukemia (CLL).

Acalabrutinib is not currently approved for patients with CLL, but Sharman believes that could change with 3 pivotal studies. At the 2019 European Hematology Association Congress, data from the phase III ASCEND trial showed the superiority of acalabrutinib monotherapy to bendamustine/rituximab (Rituxan) and idelalisib (Zydelig)/rituximab in the relapsed/refractory setting. Sharman believes these results will lead to the FDA approval of acalabrutinib in the relapsed/refractory setting.

Additionally, a press release stated that the combination of acalabrutinib and obinutuzumab (Gazyva) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus obinutuzumab/chlorambucil in patients with treatment-naive CLL, meeting the primary endpoint of the phase III ELEVATE-TN trial. Moreover, single-agent acalabrutinib showed a statistically significant and clinically meaningful improvement in PFS versus obinutuzumab/chlorambucil, which was a secondary endpoint. The full findings have not been released yet, but Sharman anticipates acalabrutinib could receive regulatory approval in the frontline setting. 
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Jeff Sharman, MD, director of research at Willamette Valley Cancer Institute and medical director of hematology research for The US Oncology Network, discusses the potential future roles of acalabrutinib (Calquence) in chronic lymphocytic leukemia (CLL).

Acalabrutinib is not currently approved for patients with CLL, but Sharman believes that could change with 3 pivotal studies. At the 2019 European Hematology Association Congress, data from the phase III ASCEND trial showed the superiority of acalabrutinib monotherapy to bendamustine/rituximab (Rituxan) and idelalisib (Zydelig)/rituximab in the relapsed/refractory setting. Sharman believes these results will lead to the FDA approval of acalabrutinib in the relapsed/refractory setting.

Additionally, a press release stated that the combination of acalabrutinib and obinutuzumab (Gazyva) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival (PFS) versus obinutuzumab/chlorambucil in patients with treatment-naive CLL, meeting the primary endpoint of the phase III ELEVATE-TN trial. Moreover, single-agent acalabrutinib showed a statistically significant and clinically meaningful improvement in PFS versus obinutuzumab/chlorambucil, which was a secondary endpoint. The full findings have not been released yet, but Sharman anticipates acalabrutinib could receive regulatory approval in the frontline setting. 

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