Verastem announces publication of Phase 2 DYNAMO study results
Verastem announced that the results of the Phase 2 DYNAMO study, which evaluated COPIKTRA capsules in patients with indolent non-Hodgkin lymphoma who were refractory to both rituximab and chemotherapy or radioimmunotherapy, was published online in the Journal of Clinical Oncology. COPIKTRA received accelerated approval from the U.S. Food and Drug Administration on September 24, 2018 for the treatment of adult patients with relapsed or refractory follicular lymphoma after at least two prior systemic therapies. Additionally, COPIKTRA is indicated for the treatment of adult patients with chronic lymphocytic leukemia or small lymphocytic leukemia after at least two prior therapies. COPIKTRA is an oral inhibitor of phosphoinositide 3-kinase, a dual inhibitor of both PI3K-delta and PI3K-gamma. The COPIKTRA New Drug Application was supported by clinical data from the open-label, single-arm Phase 2 DYNAMO study, which evaluated the efficacy and safety of COPIKTRA as a monotherapy in 129 adult patients with various types of iNHL, including follicular lymphoma, small lymphocytic lymphoma or marginal zone lymphoma, whose disease had progressed and who were refractory to rituximab and to either chemotherapy or radioimmunotherapy. The primary endpoint of the study was ORR as assessed by an independent review committee. While MZL patients were included in the DYNAMO study, COPIKTRA has not been deemed safe and effective by the FDA for use in treating patients suffering from MZL, however, MZL represents a potential new patient indication that may benefit from COPIKTRA. The National Comprehensive Cancer Network has added COPIKTRA to the Clinical Practice Guidelines in Oncology for CLL/SLL, FL and MZL. The NCCN Guidelines are the standard physician resource for determining the appropriate course of treatment for patients.