Date: 2016-11-22
Type of
information: DSMB assessment
phase: 3
Announcement: DSMB assessment
Company: TG Therapeutics (USA - NY)
Product: TG-1101 (ublituximab) and TGR-1202
Action
mechanism:
- monoclonal antibody/phosphoinositide 3-kinase (PI3K) inhibitor.
- TG-1101 (ublituximab) is a monoclonal antibody that targets a unique epitope on the B-lymphocyte CD20 antigen.
- TGR-1202 (formerly known as RP5264) is an orally available PI3K delta inhibitor, targeting the delta isoform with nanomolar potency and several fold selectivity over the alpha, beta, and gamma isoforms of phosphoinositide 3-kinase. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B-cell lymphocytes. Inhibition of PI3K delta signaling with TGR-1202 has demonstrated robust activity in numerous pre-clinical models and primary cells from patients with hematologic malignancies.
Disease: chronic lymphocytic leukemia (CLL)
Therapeutic
area: Cancer - Oncology
Country: USA
Trial
details:
- This research study will evaluate the safety and efficacy of TGR-1202 in combination with ublituximab compared to TGR-1202 alone as a possible treatment for Diffuse Large B-cell Lymphoma (DLBCL) that has come back or that has not responded to standard treatment.(NCT02612311)
Latest
news:
- • On November 22, 2016, TG Therapeutics announced that the independent Data Safety Monitoring Board (DSMB) providing oversight for the UNITY-CLL Phase 3 trial reviewed the cumulative safety data from the ongoing clinical study and informed the Company that it has identified no safety concerns, and recommended the continuation of the study with no modifications. Per the protocol's pre-specified DSMB charter, the DSMB is scheduled to meet approximately every 6-9 months to review cumulative safety data. The UNITY-CLL study continues to enroll and TG Therapeutics is still targeting completion of enrollment in the first half of 2018.
- • On November 18, 2015, a Phase 3 trial sponsored by TG Therapeutics was published on the NIH website ClinicalTrials.gov for ublituximab plus TGR-1202 and is currently recruiting participants.
- • On September 17, 2015, TG Therapeutics announced that it has reached an agreement with the FDA regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 clinical trial for its proprietary combination of TG-1101 (ublituximab), its glycoengineered anti-CD20 monoclonal antibody, plus TGR-1202, the Company's once-daily PI3K-delta inhibitor, for the treatment of Chronic Lymphocytic Leukemia (CLL). The SPA provides agreement that the Phase 3 trial design adequately addresses objectives that, if met, would support the regulatory submission for drug approval of both TG-1101 and TGR-1202 in combination.
- Full details of the Phase 3 clinical trial, called the UNITY-CLL trial, will be released at the launch of the study. The general study design is a randomized controlled clinical trial that includes two key objectives: first, to demonstrate contribution of each agent in the TG-1101 + TGR-1202 regimen (the combination sometimes referred to as "1303"), and second, to demonstrate superiority in Progression Free Survival (PFS) over the standard of care to support the submission for full approval of the combination. The study will randomize patients into four treatment arms: TG-1101 + TGR-1202, TG-1101 alone, TGR-1202 alone, and an active control arm of obinutuzumab + chlorambucil. An early interim analysis will assess contribution of each single agent in the TG-1101 + TGR-1202 combination regimen, which, if successful, will allow early termination of both single agent arms. A second interim analysis will be conducted following full enrollment into the study, which, if positive, the Company plans to utilize for accelerated approval. Assuming early termination of the TG-1101 and TGR-1202 single agent arms, the study will enroll approximately 450 patients.
Is
general: Yes
