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kaz*ヒト投与可能で一斉摘発ｗ

No.32017/9/7 14:24

Verastem planning duvelisib submission

Verastem Inc. (NASDAQ:VSTM) gained $1.08 (28%) to $4.92 on Wednesday after reporting that duvelisib (IPI-145) met the primary endpoint of improving progression-free survival (PFS) in the Phase III DUO trial to treat relapsed or refractory chronic lymphocytic leukemia (CLL) and small lymphocytic leukemia (SLL). Next half, the company plans to submit an NDA to FDA for the product.

In the 319-patient trial, twice-daily 25 mg oral duvelisib led to a median PFS of 13.3 months vs. 9.9 months for Arzerra ofatumumab (HR=0.52, p<0.0001).

Verastem said the NDA submission will include data from DUO and the Phase II DYNAMO trial in indolent non-Hodgkin's lymphoma (NHL) (see BioCentury Extra, June 14, 2016).

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kaz*ヒト投与可能で一斉摘発ｗ
No.42017/9/7 14:25
>>3

The DUO readout triggered a $6 million milestone payment to Infinity Pharmaceuticals Inc. (NASDAQ:INFI), which granted Verastem exclusive, worldwide rights to duvelisib last November. Infinity is eligible for an additional $22 million upon the candidate's first regulatory approval, plus tiered mid- to high-single-digit royalties. Infinity has rights to duvelisib from Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) (see BioCentury Extra, Nov. 2, 2016).

Last June, AbbVie Inc. (NYSE:ABBV) returned to Infinity rights to co-develop duvelisib after the candidate led to a smaller than expected clinical benefit in DYNAMO (see BioCentury Extra, June 28, 2016).

By year end, Verastem also plans to start a Phase II trial of duvelisib to treat peripheral T cell lymphoma (PTCL), for which the product has Fast Track designation in the U.S. Duvelisib is an oral inhibitor of phosphoinositide-3-kinase (PI3K) delta and gamma.
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