Verastem says it is eyeing early 2018 for a new drug application to the FDA for its new but troubled oncology asset duvelisib.
Infinity Pharmaceuticals, the original developer, had distinctly finite patience with the blood cancer treatment and sold off the asset to Verastem a year ago in a deal that came with $28 million in biobucks.
Why? Well, in its midstage test last summer, duvelisib, then Infinity’s leading candidate, managed to hit the primary endpoint in non-Hodgkin lymphoma but fell short of expectations. This initially forced the company to pause work on a combo with AbbVie and shutter its discovery efforts to save cash. AbbVie, which had partnered on the med, decided to cut its losses and run; Infinity then wielded the ax on more than half its staff and sold off duvelisib to Verastem in November.
Today, its new owner says it is plotting to submit an NDA for the med in certain blood cancers “during the first quarter of 2018,” specifically for patients with r/r chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL).
It’s also seeking an accelerated approval for r/r follicular lymphoma; this comes after a meeting with the FDA, which it implies has led to this decision.
And it has some positive data in hand, after posting in September that its phase 3 DUO test met the primary endpoint after duvelisib showed superiority over Novartis’ blood cancer drug Arzerra (ofatumumab), for progression-free survival (PFS) in patients with relapsed or refractory CLL/SLL.
In this study, duvelisib hit a statistically significant improvement in median PFS of 13.3 months, compared to 9.9 months for ofatumumab: a 48% reduction in the risk of progression or death. This, along with the phase 2 NHL data, will be used in the submission, the company said in a release.
“With FDA guidance now in hand, we have a defined regulatory path forward for the duvelisib NDA,” said Robert Forrester, CEO of Verastem, in the release. “Obtaining the FDA’s guidance for this submission represents an important milestone for Verastem and for duvelisib as a potential new treatment for patients with relapsed or refractory CLL/SLL and patients with relapsed or refractory FL. Our near-term focus will be on preparing the NDA, which we expect to submit during the first quarter of next year.”
The drug is an oral dual inhibitor of phosphoinositide 3-kinase-delta and PI3K-gamma. If approved, it will need to compete with the likes of new CAR-T meds from Gilead and Novartis, which come with high price tags but also the potential for high responses.
Verastem was up around 2.5% in early trading on the news this morning, while Infinity was up around 1.3%.