TG Therapeutics' Leukemia Drug Clears Key Study, Shares Soar

By Reuters Staff

March 07, 2017

(Reuters) - TG Therapeutics Inc said a combination of its experimental cancer drug ublituximab and AbbVie Inc's ibrutinib (Imbruvica) outperformed Imbruvica alone in high-risk leukemia patients, sending its shares up 63.5 percent in premarket trade.

The late-stage study involved adult patients with high-risk chronic lymphocytic leukemia (CLL), who had undergone at least one prior therapy.

The trial was designed to show that adding ublituximab would induce a statistically significant improvement in overall response rate by at least 20 percent between the two study arms.

The absolute difference between the two groups of patients was about 30 percent, the company said on Monday.

TG said it would meet with the U.S. Food and Drug Administration to chart a path toward accelerated approval.

A separate late-stage study testing ublituximab to treat multiple sclerosis is expected begin later this year, pending the readout of a mid-stage trial.

In 2015, AbbVie forked out $21 billion for Pharmacyclics, giving it joint ownership of the blockbuster leukemia treatment, Imbruvica, with Johnson & Johnson.

Imbruvica, which is also approved to treat mantle cell lymphoma and a type of non-Hodgkin's lymphoma, generated $1.83 billion in sales for AbbVie last year.

The American Cancer Society has estimated that about 20,110 new cases of CLL would be diagnosed in the United States in 2017, and the disease could kill about 4,660 patients.

TG's shares were up about 58 percent at $8.45 before the bell on Monday.

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