TG Therapeutics’ cancer drug meets primary end point in phase 3 trial
TG Therapeutics’ cancer drug, TG-1101 (ublituximab), in combination with AbbVie’s Imbruvica (ibrutinib), has met its primary end point in a phase 3 study in chronic lymphocytic leukemia (CLL) patients.
TG-1101 is a highly potent next generation glycoengineered anti-CD20 monoclonal antibody to ibrutinib monotherapy in high risk CLL.
The multicenter GENUINE trial, which evaluated the efficacy and safety of TG-1101 plus ibrutinib in patients with previously treated high risk CLL, has showed a significant improvement in overall response rate (ORR) compared against ibrutinib alone in both the intent to treat (ITT) population and treated population.
The ITT population included 126 randomized patients, while the treated population is comprised of all ITT patients that secured at least one dose of either study drug.
By using the iwCLL 2008 guidelines, the independent blinded central review has assessed all responses.
TG Therapeutics has carried out the trial at 160 clinical trial sites in the US and Israel. The company randomized 126 patients in the study.
Patients secured ibrutinib orally at 420mg once daily in both arms, while patients in the treatment arm received intravenous infusions of TG-1101 at 900mg dosed on days one, eight and 15 of cycle one and day one of cycles two to six.
TG Therapeutics executive chairman and CEO Michael 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.
“Most importantly, we would like to thank the investigators and their patients for participating in this significant research."
Image: The phase 3 Genuine trial has assessed the efficacy and safety of TG-1101 plus ibrutinib in patients with previously treated high risk chronic lymphocytic leukemia. Photo: courtesy of ponsulak / FreeDigitalPhotos.net.