TG Therapeutics shares rocket up on successful PhIII leukemia study, teeing up a shot at accelerated FDA OK

Michael S. Weiss

Shares of TG Therapeutics $TGTX rocketed up 64% this morning after the New York-based biotech reported that its lead cancer drug scored a win in Phase III. And now the biotech plans to pursue an accelerated approval at the FDA.

Investigators say that TG-1101 (ublituximab), their anti-CD20 monoclonal antibody, plus Imbruvica beat Imbruvica alone in treating high-risk chronic lymphocytic leukemia, or CLL. The combination arm scored an overall response rate of 80% compared to only 47% in the solo drug arm. A total of 126 patients were recruited for the Phase III.

The next step involves presenting the data later in H1 with a meeting at the FDA planned for H2.

The biotech reported:

The absolute difference between the arms was approximately 30% resulting in a p-value of ≤ 0.001.  Results from registration directed studies included in the ibrutinib prescribing information demonstrate single agent ibrutinib response rates ranging from 43% to 58% in patients with previously treated CLL, with the findings from the GENUINE study of 47% ORR for ibrutinib fitting well within historical experience.

But not everyone was as impressed as the biotech’s investors.

“We believe the results observed in the combination arm are extremely compelling and the regimen has the potential to become the standard of care for treating patients with high risk CLL that have progressed from other therapies,” said TG CEO Michael S. Weiss in a statement. “We believe that using combination therapy to accelerate and deepen response in poor prognosis high risk CLL is critically important for patient outcomes and we look forward to sharing these data with the FDA in the coming months to discuss filing for accelerated approval.

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