Conference Proceedings

Effect of dose modifications on response to duvelisib in patients with relapsed/refractory (R/R) CLL/SLL in the DUO trial.

Ian Flinn, Marco Montillo, Arpad Illes, Gabriel Etienne, Julio Delgado, Bryone J Kuss, Constantine Si Lun Tam, Fritz Offner, Francesc Bosch, Matthew Steven Davids, Ulrich Jager, Paolo Ghia, Florence Cymbalista, David T Weaver, Stephanie Lustgarten, Hagop Youssoufian, Stephan Stilgenbauer, Nicole Lamanna

JOURNAL OF CLINICAL ONCOLOGY | AMER SOC CLINICAL ONCOLOGY | Published : 2019

Abstract

7523 Background: Duvelisib (DUV), a first-in-class oral dual PI3K-δ,γ inhibitor, is approved for treatment (tx) of R/R CLL/SLL after ≥ 2 prior therapies. In the phase 3 DUO trial, DUV 25 mg BID significantly improved efficacy vs ofatumumab (OFA; mPFS, 13.3 vs 9.9 mo; HR, 0.52 [ P < .0001]; ORR, 74% vs 45% [ P 1 wk (84% [42/50]) or > 2 wk (82% [31/38]) followed by ≥ 3 wk on DUV. In a landmark analysis, median PFS was similar in pts with DI and those without DI for > 1 wk (17.8 vs 16.3 mo) or > 2 wk (17.8 vs 16.3 mo) within the first 3 mo. The median time to DR after CR/PR was 5.6 mo (n = 25) and median duration was 3.4 mo. Median time to onset across AESIs after starting DUV ranged from 2.2..

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University of Melbourne Researchers