A Study of Duvelisib in Participants With Refractory Indolent Non-Hodgkin Lymphoma

Summary

This was a Phase 2 clinical trial to evaluate the safety and efficacy of duvelisib as a monotherapy in participants with indolent non-Hodgkin lymphoma (iNHL) (follicular lymphoma \[FL\], marginal zone lymphoma, or small lymphocytic lymphoma) that was refractory to rituximab and to either chemotherapy or radioimmunotherapy (RIT).

Timeline

Start

2013-06-17

Primary completion

2020-11-18

Completion

2020-11-18

Outcome

Met primary endpoint

release “today announced long-term follow-up data from the DYNAMO™ study, which met its primary endpoint of Overall Response Rate (ORR; p=0.0001) at the final analysis” verastem.com ↗

release “DYNAMO™, a single-arm, Phase 2 monotherapy study in patients with refractory iNHL that achieved its primary endpoint of ORR” verastem.com ↗

release “successfully met its primary endpoint in a Phase 2 study in indolent Non-Hodgkin Lymphoma (iNHL)” verastem.com ↗

release “Both DUO and DYNAMO achieved their primary endpoints.” verastem.com ↗

Publications

• Flinn IW, Miller CB, Ardeshna KM, Tetreault S, Assouline SE, Mayer J, Merli M, Lunin SD, Pettitt AR, Nagy Z, Tournilhac O, Abou-Nassar KE, Crump M, Jacobsen ED, de Vos S, Kelly VM, Shi W, Steelman L, Le N, Weaver DT, Lustgarten S, Wagner-Johnston ND, Zinzani PL. DYNAMO: A Phase II Study of Duvelisib (IPI-145) in Patients With Refractory Indolent Non-Hodgkin Lymphoma. J Clin Oncol. 2019 Apr 10;37(11):912-922. doi: 10.1200/JCO.18.00915. Epub 2019 Feb 11.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Duvelisib	Small molecule	25 mg	Oral

Indications