Efficacy and Safety of Duvelisib Following Disease Progression on Ofatumumab in Patients with Relapsed/Refractory CLL or SLL in the DUO Crossover Extension Study
Matthew S Davids, Bryone J Kuss, Peter Hillmen, Marco Montillo, Carol Moreno, James Essell, Nicole Lamanna, Zsolt Nagy, Constantine S Tam, Stephan Stilgenbauer, Paolo Ghia, Julio Delgado, Stephanie Lustgarten, David T Weaver, Hagop Youssoufian, Ulrich Jaeger
CLINICAL CANCER RESEARCH | AMER ASSOC CANCER RESEARCH | Published : 2020
PURPOSE: In the phase III DUO trial, duvelisib, an oral dual PI3K-δ,γ inhibitor, demonstrated significantly improved efficacy versus ofatumumab [median (m) progression-free survival (PFS), 13.3 vs. 9.9 months (HR, 0.52; P < 0.0001); overall response rate [ORR], 74% vs. 45% (P < 0.0001)], with a manageable safety profile in patients with relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL). We report results from patients with progressive disease (PD) after ofatumumab who crossed over to duvelisib in the DUO trial. PATIENTS AND METHODS: Patients with radiographically confirmed PD after ofatumumab received duvelisib 25 mg twice daily in 28-day cycles un..View full abstract
The authors thank the patients who participated in this study and their families. Acumen Medical Communications, LLC provided biostatistical programming support. Larra Yuelling, PhD, of Chrysalis Medical Communications, Inc provided medical writing and editorial support. This work was supported by Verastem Oncology and Infinity Pharmaceuticals Inc. Financial support was provided by Verastem Oncology.