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High-Risk CLL: GENUINE Trial of Ublituximab Plus Ibrutinib Versus Ibrutinib Alone

By: Joseph Cupolo
Posted: Monday, March 29, 2021

According to Jeff P. Sharman, MD, of the Willamette Valley Cancer Institute, US Oncology Research, Eugene, Oregon, and colleagues, adding the investigational monoclonal antibody ublituximab to the Bruton’s tyrosine kinase (BTK) inhibitor ibrutinib resulted in a statistically higher overall response rate without affecting the safety profile of ibrutinib monotherapy in patients with relapsed or refractory high-risk chronic lymphocytic leukemia (CLL). The phase III multicenter GENUINE study enrolled 126 patients with at least one 17p deletion, 11q deletion, or TP53 mutation. These findings were published in The Lancet Haematology.

“These findings provide support for the addition of ublituximab to Bruton’s tyrosine kinase inhibitors for the treatment of these patients,” the study investigators noted.

As for dosing, ublituximab was given intravenously in 28-day cycles, increasing doses during cycle 1 (≤ 150 mg on day 1, 750 mg on day 2, and 900 mg on days 8 and 15) and continuing at 900 mg on day 1 of cycles 2 to 6. After cycle 6, ublituximab was given at 900 mg every three cycles. Ublituximab and ibrutinib were continued until unacceptable toxicity, disease progression, or withdrawn consent.

After a median of 41.6 months, the overall response rate was higher in those given the combination therapy than in those given ibrutinib alone (83% vs. 65%).

Regarding adverse events, the most common serious adverse events were pneumonia (10% in the ublituximab-plus-ibrutinib group and 7% in the ibrutinib group), atrial fibrillation (7% and 2%), sepsis (7% and 2%), and febrile neutropenia (5% and 2%). Two patients in the ublituximab-plus-ibrutinib group died due to adverse events (one cardiac arrest and one failure to thrive), neither of which was considered related to the treatment.

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



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