TG Therapeutics Inc. (NASDAQ:TGTX) has announced final GENUINE third Phase study results for the evaluation of ublituximab’s combination and ibrutinb relative to using ibrutinib alone in treating patients that had been treated before for chronic lymphocytic leukemia.
TG Therapeutics report encouraging Third Phase GENUINE study results
Ublituximab is TG Therapeutics proprietary glycoengineered anti-CD20 monoclonal antibody whose results the company presented at the 56th Annual Meeting of the American Society of Clinical Oncology. The company’s CEO and executive chairman Michael Weiss indicated that they were delighted to present the final data from the third Phase GENUINE study at the meeting.
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The study was the first randomized study demonstrating improved PFS benefit following the combination of an anti-CD20 antibody, with ibrutinib relative to ibrutinib only. Weiss indicated that the results were encouraging as they observed significant improvement in complete response rate, overall response rates as well as enhanced rates of unnoticeable residual disease.
Further, the CEO confirmed that they hope that this promising data will support the possibility of combination therapies in improving the outcomes of high-risk CLL patients. This is especially so for patients with TP53 mutation/17p deletion that continue showing more rapid progression than patients without high-risk cytogenetics.
Combination of ublituximab and ibrutinib showed improved ORR
The third Phase GENUINE study was an open-label, randomized, multicentre trial in refractory or relapsed high-risk CLL. With 117 patients enrolled in the study, 59 were treated using a combination of ublituximab and ibrutinib while the other 58 received only ibrutinib. The primary endpoint in the study was ORR, as determined by the ORC, while the secondary endpoints include complete response and progression-free survival.
Patients that received combination of ibrutinib and ublituximab ORR was 93%, while those that received ibrutinib monotherapy showed ORR of 78%. Ublituximab did not change the safety profile of ibrutinib when used in combination but there was a slight increase in neutropenia rates and atrial fibrillation.