Higher Overall Response Rates Observed When Adding Ublituximab to Ibrutinib Treatment for CLL

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The combination of ublituximab plus ibrutinib (Imbruvica) led to a statistically higher overall response rate while maintaining the tolerable safety profile over ibrutinib monotherapy to treat patients with relapsed or refractory high-risk chronic lymphocytic leukemia (CLL).

According to data published in The Lancet Haematology from the phase 3, multicenter, GENUINE (NCT02301156) trial, these findings support the addition of ublituximab to Bruton tyrosine kinase (BTK) inhibitors as treatment for patients with this class of CLL.

“Clinically meaningful improvements in overall response rate, complete response, and MRD negative response were observed and translated into improved progression­free survival,” wrote the investigators. “These findings indicate the benefit of adding the next­generation anti­CD20 antibody ublituximab to ibrutinib in patients with relapsed and refractory high-risk chronic lymphocytic leukaemia.”

The overall response rate was 83% of patients in the ublituximab plus ibrutinib group and 65% of patients in the ibrutinib group (P = .020) after a median follow-up of 41.6 months (IQR 36.7–47.3).

While the safety profile consisted mostly of grade 1 or 2 adverse events, neutropenia (19% of patients in the combination group vs 12% in the control group), anemia (8% vs 9%, respectively), and diarrhea (10% vs 5%) were common grade 3 and 4 adverse events among the population of interest.

More, common serious adverse events included pneumonia (10% with ublituximab vs 7% with ibrutinib only), atrial fibrillation (7% vs 2%, respectively), sepsis (7% vs 2%), and febrile neutropenia (5% vs 2%).

Two patients from the ublituximab plus ibrutinib group and 5 patients and from the ibrutinib group died from adverse events. Only 1 death (cardiac arrest) from the ibrutinib group was considered treatment-related.

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