On Wednesday, Verastem (VSTM) defied the odds when it had reported positive phase 3 results for patients with relapsed or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). What is most remarkable is that not only were these results positive, but there was a major turnaround with the drug in question. With these results on hand, Verastem has a good shot at seeking approval for duvelisib in CLL patients.
Phase 3 Data
The phase 3 study was known as DUO. It recruited a total of 319 patients who were randomized to either receive duvelisib or ofatumumab One quick thing to note is that ofatumumab was developed by Novartis (NVS), and is the current standard of care for patients with CLL (Marketed by Novartis as ARZERRA). Despite that fact, duvelisib came out on top in the trial meeting the primary endpoint of the study. The primary endpoint was to determine progression-free survival (NYSE:PFS) between duvelisib and ofatumumab. Verastem's drug was far better in terms of PFS. Duvelisib achieved a statistically significant PFS rate of 13.3 months. That compares to 9.9 months for those patients treated with ofatumumab. The final p-value was p < 0.0001, with a hazard ratio of 0.52. If you subtract the hazard ratio of 0.52 from 1 you will get 0.48. That means that the drug duvelisib reduced the risk of progression or death in these patients by 48%. In my opinion, this drug has shown great success against another drug that currently acts as standard of care.
