Date: 2016-10-13
Type of
information: update on patient enrollment
phase: 3
Announcement: update
Company: TG Therapeutics (USA - NY)
Product: ublituximab and ibrutinib
Action
mechanism:
- monoclonal antibody/Bruton tyrosine kinase inhibitor. Ibrutinib is a novel Bruton’s tyrosine kinase (BTK) inhibitor being jointly developed by Janssen and Pharmacyclics, Inc. for the treatment of B-cell malignancies. Ibrutinib is jointly developed and commercialized in the United States by Pharmacyclics and Janssen Biotech, Inc. In Europe, Janssen-Cilag International NV (Janssen) holds the marketing authorization and its affiliates market Imbruvica® in EMEA (Europe, Middle East, Africa), as well as the rest of the world. Imbruvica® is already approved in Europe to treat adult patients with relapsed or refractory mantle cell lymphoma (MCL) and adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy or in first line use in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. In March 2015, Abbvie and Pharmacyclics announced a definitive agreement under which AbbVie will acquire Pharmacyclics, and its flagship asset Imbruvica® (ibrutinib).
TG-1101 (ublituximab) is a monoclonal antibody that targets a unique epitope on the B-lymphocyte CD20 antigen.
Disease: chronic lymphocytic leukemia
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This study evaluates the addition of ublituximab, a novel monoclonal antibody, to ibrutinib compared to ibrutinib alone in previously treated Chronic Lymphocytic Leukemia (CLL) patients with high-risk cytogenetic features. Half of the participants will receive ublituximab in combination with ibrutinib, while the other half will receive ibrutinib alone. (NCT02301156)
Latest
news:
- • On October 13, 2016, TG Therapeutics, announced that it has filed with the FDA an amended protocol for the GENUINE Phase 3 trial. Prior to the amendments, the GENUINE study consisted of two parts:
- Part I to evaluate the effect of the addition of TG-1101 to ibrutinib on overall response rate (ORR) in approximately the first 200 patients enrolled, to support a filing for accelerated approval of TG-1101; and
Part II to evaluate the effect of the addition of TG-1101 to ibrutinib on progression-free survival (PFS) in all study patients (approximately 330), to support a filing for full approval of TG-1101.
The amended protocol contains the following substantive changes:
- Part II of the study has been eliminated, and accordingly, the study's sole primary endpoint will be ORR as originally contemplated in Part I; and target enrollment has been reduced to approximately 120 randomized patients.
At the new study size, the study is 90% powered to show a statistically significant improvement in ORR, with the minimal detectable difference of approximately 20% (absolute difference between the arms). Additionally, patients will be followed until progression, but the study will no longer be powered for PFS.
- The company expects that it will complete enrollment in the revised trial by year end 2016, and will have topline data available in the first half of 2017. If the results of the study are positive, the Company plans to request a pre-BLA meeting to discuss the data and a filing strategy with the FDA. The Company has communicated with the FDA regarding its intention to file a BLA for accelerated approval if the results are positive and the FDA has agreed that a pre-BLA meeting can be requested based on ORR data from the GENUINE study. Assuming a positive outcome of a pre-BLA meeting, targeted to occur in the fourth quarter of 2017, the Company believes it could file a BLA in the first half of 2018.
- • On November 20, 2014, a Phase 3 trial sponsored by TG Therapeutics was published on the NIH website ClinicalTrials.gov for ublituximab and ibrutinib and is currently recruiting participants.
Is
general: Yes
