Verastem (VSTM)

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Verastem crashes the lymphoma party

Verastem's big iron in the fire is a PI3K-delta/gamma inhibitor called duvelisib, which follows in line with Gilead's (NASDAQ:GILD) idelalisib. Unsurprisingly, VSTM is making its first big push for duvelisib in the treatment of chronic lymphocytic leukemia (CLL).

The phase 3 DUO study is the registrational trial that the company hopes to use for seeking approval in the treatment of relapsed/refractory disease. And recently VSTM announced top-line data from the study.

These findings showed that duvelisib beat out the second-generation CD20 inhibitor ofatumumab in terms of progression-free survival, both for the whole population (9.9 months versus 13.3 months for ofatumumab and duvelisib, respectively) and in the subgroup of patients with 17p deletion (9.0 months versus 12.7 months), which is typically a sign of poor prognosis.

VSTM stated that it intends to seek approval in 2018 on the basis of these findings. Importantly, it was also safe as a monotherapy, with no outsized risk of infection.

Looking forward: You know, when the failure of idelalisib took down GILD's initial hopes for dominance in non-Hodgkin lymphoma, I kind of figured that would be the end for the drugs targeting these isoforms of PI3K. That was myopic, in hindsight, as now we've seen the emergence of a few effective and seemingly safe PI3K inhibitors in the space. Undoubtedly, if VSTM gets approval here, it'll be poised to make a pretty big case for itself.

https://seekingalpha.com/article/4105517-3-things-biotech-learn-today-september-9-2017?app=1&uprof=51&isDirectRoadblock=false