Share this article
Hodgkin lymphoma, nodular lymphocyte predominant – low power view. Credit: Gabriel Caponetti.

US-based TG Therapeutics has reported positive interim results from the ongoing Phase IIb UNITY-NHL clinical trial of umbralisib involving patients with marginal zone lymphoma (MZL).

Data from the MZL cohort showed that umbralisib led to a 52% overall response rate (ORR), with a complete response (CR) rate of 19% and partial response rate of 33%.

Go deeper with GlobalData

Premium Insights

The gold standard of business intelligence.

Find out more

Related Company Profiles

View all

Umbralisib is an investigational, oral, small molecule PI3K delta inhibitor being developed to treat non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia (CLL).

“We look forward to presenting the final data from the entire MZL cohort later this year when all patients have had the opportunity to be followed for at least nine cycles.”

As of 20 October 2018, the UNITY-NHL trial enrolled 69 patients with relapsed / refractory marginal zone lymphoma. Participants were given an 800mg once daily umbralisib until disease progression or unacceptable toxicity.

Among the 38 patients who had at least six months of follow-up, four were observed to have a complete response and 17 experienced a partial response.

Results showed that median duration of response had not been reached.

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData

TG Therapeutics executive chairman and CEO Michael Weiss said: “As announced previously, the efficacy for the entire population has already reached our target range of 40%-50% ORR and we look forward to presenting the final data from the entire MZL cohort later this year when all patients have had the opportunity to be followed for at least nine cycles.”

Furthermore, interim safety data revealed no unexpected toxicities. The most common adverse events were diarrhoea, nausea and fatigue.

The UNITY-NHL interim data has been presented at the American Association of Cancer Research (AACR) Annual Meeting 2019.

Share