Phase 2 Trial Testing Gazyva Combo Regimens in Relapsed Follicular Lymphoma Now Enrolling Participants

Phase 2 Trial Testing Gazyva Combo Regimens in Relapsed Follicular Lymphoma Now Enrolling Participants

Biopharmaceutical company TG Therapeutics and the National Cancer Institute’s SWOG have initiated a Phase 2 trial testing three Gazyva (obinutuzumab) regimens in patients with relapsed or refractory follicular lymphoma.

The trial (NCT03269669) is currently recruiting participants at 184 locations across the United States. It will enroll 150 participants with grade 1, 2 or 3a follicular lymphoma, who failed to achieve complete remission with chemoimmunotherapy or relapsed within two years after treatment.

The study will assess Gazyva in three study arms (groups of people receiving a specific treatment). In one arm, 50 patients will receive Gazyva in combination with TG Therapeutics’ PI3K inhibitor, TGR-1202 (umbralisib). In the other two arms, also with 50 patients each, participants will receive Gazyva in combination with either Revlimid (lenalidomide) or with CHOP chemotherapy.

“This is an extremely important study for patients with early, relapsed follicular lymphoma because they need new treatment options,” Dr. Paul Barr, director of the Clinical Trials Office for Wilmot Cancer Institute at the University of Rochester Medical Center and leader of the trial, said in a press release. “We chose these arms based on the best available clinical research suggesting these were the most promising targets for therapeutic intervention in the treatment of (follicular lymphoma).”

TGR-1202, Revlimid, and chemotherapy have different modes of action, and when combined with Gazyva may represent new therapeutic benefits for people with relapsed or refractory follicular lymphoma.

Gazyva is an anti-CD20 antibody that prevents cancer cells from growing and spreading by blocking cellular signals they rely on. The drug is already approved for previously untreated follicular lymphoma patients.

TGR-1202 blocks the phosphoinositide 3-kinase (PI3K) cell signaling pathway, which promotes the uncontrolled proliferation and survival of B‐cells. Revlimid uses a compound engineered from living organisms that can modulate the immune response against cancer cells.

The trial will assess complete response rates (the percentage of participants with no sign of cancer) following six treatment cycles for each of the combo therapies. Other efficacy measures, such as overall response rate, progression-free survival, duration of response, and treatment safety, will also be determined.

The trial will be independently conducted by SWOG, a global cancer clinical trial group that comprises the National Clinical Trials Network of the National Cancer Institute. TG Therapeutics, developer of TGR-1202, will provide the drug.

“We are extremely pleased that SWOG has selected TGR-1202 for inclusion in this important trial,” said Michael S. Weiss, executive chairman and CEO of TG Therapeutics. “We believe this trial will showcase treatment strategies that may significantly improve outcomes for early relapsing patients and in particular, demonstrate the utility of TGR-1202 in follicular lymphoma.”

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