TG Therapeutics announced Monday that a Phase III study of ublituximab in combination with AbbVie and Johnson & Johnson's Imbruvica (ibrutinib) in patients with previously treated high risk chronic lymphocytic leukaemia (CLL) met its primary endpoint. Shares in TG Therapeutics jumped as much as 57 percent on the news.
The GENUINE trial randomised 126 patients with high risk CLL, who had received at least one prior therapy for their disease, to treatment with either ublituximab plus Imbruvica, or Imbruvica alone. TG Therapeutics noted that in the study, high risk was defined as having any one or more of the following: 17p deletion, 11q deletion or p53 mutation.
Top-line results showed that for the trial's main goal, the addition of ublituximab to Imbruvica demonstrated a significant improvement in overall response rate (ORR) compared to Imbruvica alone. TG Therapeutics said that the ORRs for the two groups were 80 percent and 47 percent, respectively. The drugmaker added that advantages were also seen for the drug combination in a number of secondary and other efficacy measures, including radiographic complete response rate, progression-free survival and time to response. The company added that a full analysis of the study will be submitted for presentation at a medical meeting in the first half.
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TG Therapeutics' CEO Michael S. Weiss said "we believe that using combination therapy to accelerate and deepen response in poor prognosis high risk CLL is critically important for patient outcomes and we look forward to sharing these data with the FDA in the coming months to discuss filing for accelerated approval." Meanwhile, Jeffrey Sharman, chair of the GENUINE trial, remarked "this study demonstrates that the addition of ublituximab, can significantly enhance the response rates without compromising safety."
Ublituximab, also known as TG-1101, is a next-generation glycoengineered anti-CD20 monoclonal antibody.