Lenalidomide plus rituximab induction therapy followed by maintenance appears to provide favorable activity and a tolerable safety profile in follicular lymphoma patients who are double-refractory or had early relapse after initial diagnosis.
Lenalidomide plus rituximab (R2) induction therapy followed by maintenance appears to provide favorable activity and a tolerable safety profile in follicular lymphoma patients who are double-refractory or had early relapse after initial diagnosis, according to new data from the MAGNIFY Trial.
Investigators reported at the 2017 American Society of Clinical Oncology (ASCO) Annual Meeting, held June 2–6 in Chicago that the overall response rates were 45% or higher in those patients who were evaluable. The most common grade 3/4 grade adverse events were hematologic and mainly included neutropenia, leukopenia, thrombocytopenia, and lymphopenia.
Follicular lymphoma patients, who progress within 24 months of initial diagnosis after treatment with immunotherapy or chemoimmunotherapy, are known to have poor outcomes. Patients refractory to rituximab and chemotherapy have limited treatment options and poor outcomes. R2 is active and well-tolerated in first-line and refractory follicular lymphoma patients.
The latest findings from this study were presented (abstract 7502) by study investigator David Jacob Andorsky, MD, who is with the Rocky Mountain Cancer Centers/US Oncology Research in Boulder, Colorado.
MAGNIFY is an ongoing phase IIIb, multicenter, open-label study of relapsed/refractory non-Hodgkin lymphoma (NHL) patients, including patients with grades 1–3b or transformed follicular lymphoma. In this trial, patients receive 12 cycles of R2 and patients with stable disease or better are randomized 1:1 to maintenance R2 or rituximab alone.
The primary endpoint is progression-free survival (PFS). For this current analysis, the team focused on double-refractory patients, who were refractory to both rituximab (as monotherapy or combination) and an alkylating agent. The researchers also looked specifically at the early relapse patients, who were defined as those patients who progressed or relapsed within 2 years of initial diagnosis.
The researchers reported on 234 patients (160 follicular lymphoma patients, 52 early relapse patients, and 50 double-refractory patients). The median number of prior regimens was two (range: 0–9) for all patients. For the double-refractory subgroup the number of prior regimens was three (range: 1–8) and for the early relapse subgroup it was two (range: 1–5). Among the early relapse patients, 39 out of 52 had frontline rituximab/chemotherapy and 13 had rituximab (mono/other).
The researchers found that among the 160 follicular lymphoma patients, 70% experienced PFS at 1 year. The rate was 65% for double-refractory patients and 49% for early relapse patients. The 1-year PFS was similar in the subgroups of early relapse patients treated with first-line rituximab/chemotherapy and first-line non-rituximab therapy.
In terms of treatment emergent adverse events, the most common for double-refractory and early relapse patients were neutropenia (42% and 37%, respectively), leukopenia (8% and 10%), thrombocytopenia (8% and 4%), and lymphopenia (6% and 4%). Other grade 4 adverse events, included febrile neutropenia (4% and 4%), and thrombosis (2% and 0%).