Infinity’s Phase III CLL study of duvelisib has PFS success potential; chances undiminished by iNHL results – experts

16 Jun 2016

Infinity Pharmaceuticals (NASDAQ:INFI) and AbbVie's (NYSE:ABBV) Phase III duvelisib study in relapsed/refractory chronic lymphocytic leukemia (CLL) may show improved progression-free survival (PFS) given earlier data and an easy-to-beat comparator, experts said.

The positive response rate seen in a Phase I study (NCT01476657) of duvelisib and the low comparator efficacy of Novartis' (VTX:NOVN) and Genmab's (CPH:GEN) CD20-targeting monoclonal antibody Arzerra (ofatumumab) gird their opinions. DUO is a 300-patient randomized, open-label study in which patients receive either duvelisib or Arzerra, with PFS as the primary endpoint.

Infinity's stock plummeted from USD 4.41 to USD 1.46 per share after it released top-line results on 14 June from the DYNAMO Phase II indolent non-Hodgkin's lymphoma trial (NCT01882803) and partner AbbVie said it was halting development of its Venclexta (venetoclax) with duvelisib in chronic lymphocytic leukemia/small lymphocytic lymphoma. While DYNAMO met the primary endpoint, the negative market reaction was because the data was not as strong as results from Gilead Sciences' (NASDAQ:GILD) now approved drug of the same class, the PI3K inhibitor Zydelig (idelalisib).

Infinity will provide an update based on results of an interim analysis of the Phase III CLL trial in early 2H16, a spokesperson told BPI.

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