One piece of news wasn't enough for Verastem, Inc. (NASDAQ:VSTM) Wednesday morning. Just after 6:00 a.m. EDT, the Boston-based drug maker released two separate releases on positive developments of duvelisib, the company's flagship cancer drug. Duvelisib, a novel oral inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, is currently being evaluated in mid- and late-stage clinical trials.
The first press release disclosed that a 319-patient phase 3 study of duvelisib for patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) met its primary endpoint of progression free survival.
As a monotherapy, the oral drug outperformed the CLL/SLL standard of care, ofatumumab, a human monoclonal antibody treatment marketed under the trade name Arzerra by the Danish biotech Genmab.
In the trial, patients on duvelisib achieved a progression free survival rate of 13.3 months, substantially better than the 9.9 months for those in the ofatumumab arm.
A look deeper into the data should that a within a particular subset of patients, those with 17p depletion, the PFS rate for the duvelisib group was also significantly better at 12.7 months compared to nine months.
Verastem hopes to have a new drug application filed with the FDA for duvelisib for relapsed or refractory CLL/SLL in the first half of 2018.
In a subsequent release minutes later, Verastem said that duvelisib received a "Fast Track" designation from the FDA for patients with Peripheral T-Cell Lymphoma that have failed at least one prior therapy. A Fast Track designation creates opportunities to expedite drug development for areas of unmet medical need and include incentives, such as priority review, to encourage drug makers to pursue these indications.
Building on a previous phase 1 study already successfully completed, Verastem hopes to initiate a mid-stage study by the end of this year.
Shares of VSTM shot to a nearly two-year high on the news this morning, printing as high as $5.55 right after the opening bell. As the closing bell approaches, shares have slipped back some to $4.96 for a gain of 29.2% on the day.
