When Verastem $VSTM CEO Robert Forrester highlighted the positive endpoint from the pivotal study of duvelisib a few months ago, he didn’t want to talk about the secondary data points. That, he said, was being saved for a future scientific conference.
And today at ASH you can see the added data isn’t something you’d want to discuss much.
The drug — which hit statistical significance on progression-free survival — flunked the key overall survival secondary, failing to do any better than Arzerra (ofatumumab) in extending the lives of patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma.
The positive data that Verastem is sticking with is for the median PFS: 13.3 months versus 9.9 months for the control. By the investigator assessment, there was an even better 17.6-month median PFS versus 9.7 months for Arzerra.
This is the data that Verastem is now hustling to the FDA, looking for an approval to treat second-line cases. The p value for the OS data, p=0.4807, demonstrated the drug group was no worse off, something that was “likely due to other available therapies following progression,” according to the company.
This was the drug that AbbVie $ABBV paid $275 million upfront to partner on with Infinity $INFI, but then walked away as the drug proved successful — but extremely disappointing — in a Phase II study. Forrester picked up the rights to the drug for exactly nothing down as Infinity restructured and refocused on something else.
Forrester — and ex-Infinity R&D chief Julian Adams, for that matter — believe the drug can definitely win an approval. And Verastem believes it can market the drug looking for peak sales of several hundred million dollars a year.
Verastem’s PR today outlines the sales model. Diep Le, Verastem’s CMO, said:
CLL/SLL mostly affects elderly patients and many are unable or unwilling to be hospitalized or come into the clinic for frequent IV infusions. The CLL/SLL treatment landscape therefore is moving away from chemotherapies and toward more targeted, preferably oral regimens. While patients are living longer many will be intolerant to, or relapse following, their initial therapy emphasizing the need for new options. Oral duvelisib is the first PI3K inhibitor to show efficacy as an oral monotherapy in a randomized Phase 3 study in patients with relapsed or refractory CLL/SLL and may offer an appealing alternative for patients who have progressed or relapsed.
The NDA will be delivered in Q1.
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