On Jan. 30, data from phase 1 trials evaluating TG Therapeutics' ublituximab and umbralisib alongside J&J and AbbVie's Imbruvica was published in Lancet, a respected industry journal.
The data showed an 84% overall response rate in 44 blood cancer patients, including a 100% response rate in 22 chronic lymphocytic leukemia or small lymphocytic lymphoma patients.
That success was followed by positive interim data on Feb. 28 suggesting umbralisib is effective as a monotherapy in marginal zone lymphoma (MZL) patients.
Umbralisib delivered an overall response rate of between 40% to 50% in 69 MZL patients, prompting management to say it plans to discuss the possibility of an accelerated OK in this indication with the Food and Drug Administration (FDA) later this year.
Imbruvica is a multibillion-dollar-per-year cancer drug, so the potential to improve upon it and become standard care alongside it is commercially significant. The MZL market is small, with only 7,500 Americans newly diagnosed each year, but that market could still be meaningful for umbralisib, if it wins an FDA OK.
That data improves the odds of TG Therapeutics' cancer drugs crossing the regulatory finish line, but there's no guarantee that final data will confirm the data reported so far or that the FDA will approve a speedy review.
Nevertheless, there's more data coming from TG Therapeutics in the next year that could help its stock climb higher, including data in follicular lymphoma (FL) and small lymphocytic lymphoma (SLL) and maturing progression-free survival data from its phase 3 trial of ublituximab and umbralisib in chronic lymphocytic leukemia. Given the data so far and the possibility for more positive data in the coming 12 months, risk-tolerant investors might want to keep close tabs on this biotech.