UNITY-NHL Trial’s Follicular Lymphoma Cohort Meets Primary Endpoint of Improved ORR

Treatment with umbralisib monotherapy demonstrated improved overall response rates among patients with follicular lymphoma.

Treatment with umbralisib (TGR-1202) monotherapy demonstrated improved overall response rates (ORRs) among patients with follicular lymphoma, meeting a phase IIb trial’s primary endpoint.

“It would be an understatement to say how excited we all are at TG Therapeutics and the potential of umbralisib in the treatment of follicular lymphoma. We believe these new results, coupled with the previously-reported positive results from the marginal zone lymphoma cohort and with the pending CLL cohort results, should put us in a position to potentially offer umbralisib across all three major indolent B-cell cancers,” Michael S. Weiss, executive chairman and chief executive officer of TG Therapeutics, said during a webcast on updates within the company.

In the pivotal, multicenter, open-label phase IIb UNITY-NHL trial, researchers are evaluating efficacy and safety of the once daily, PI3K delta inhibitor in 118 patients who have received at least 2 prior lines of therapy including an anti-CD20 monoclonal antibody and an alkylating agent. This is an umbrella study with multiple cohorts, some of which are exploratory, across 160 sites worldwide.

The primary endpoint is ORR as determined by Independent Review Committee (IRC) for all treated patients. Secondary endpoints include safety, duration of response, and progression-free survival. The results met TG Therapeutics’ prespecified ORR target of 40% to 50% in the follicular lymphoma cohort. Moreover, the agent appeared to be well tolerated among patients and its safety profile was consistent with those previously reported. TG Therapeutics noted that it plans to present the data at a future medical conference and will discuss results with the FDA.

Follicular lymphoma is typically a slow-growing or indolent form of non-Hodgkin lymphoma – the most common indolent lymphoma accounting for approximately 20% of all non-Hodgkin lymphoma cases – with an annual incidence in the United States of approximately 15,000, according to Weiss. 

“Follicular lymphoma is generally regarded as incurable. As a chronic disease, patients can live for many years, during which they will receive multiple lines of therapy to keep their disease in check. In fact, it is estimated that 141,000 Americans are currently living with this disease,” he added, saying that there are currently no fully approved drugs for the treatment of relapsed or refractory follicular lymphoma who have received at least 2 prior systemic therapies. In addition, Weiss said that some agents have received accelerated approval in this setting based on ORRs, but have been hindered by their safety, tolerability and convenience profile.

“Additional drugs that are efficacious, tolerable and conveniently administered are need for the treatment of follicular lymphoma,” Weiss said. “It cannot be emphasized enough that given the chronic nature of this disease that efficacy and tolerability are of the utmost importance. We believe that the convenience of once daily umbralisib could help to fill this unmet medical need.”


TG Therapeutics. TG Therapeutics Announces Positive Results from the UNITY-NHL Phase 2b Pivotal Trial Evaluating Umbralisib Monotherapy in Patients with Relapsed/Refractory Follicular Lymphoma. Available from: http://ir.tgtherapeutics.com/news-releases/news-release-details/tg-therapeutics-announces-positive-results-unity-nhl-phase-2b. Accessed October 30, 2019.