Lenalidomide plus rituximab failed to demonstrate superiority over standard of care for follicular lymphoma in the randomized, open-label, phase III RELEVANCE trial.
At 120 weeks, neither complete response nor unconfirmed complete response, nor progression-free survival, were superior for lenalidomide plus rituximab compared with standard-of-care rituximab chemotherapy regimens, including R-CHOP (rituximab plus cyclophosphamide, doxorubicin, vincristine, and prednisone), rituximab plus bendamustine, or R-CVP (rituximab plus cyclophosphamide, vincristine, and prednisolone).
“This is the first phase III trial to evaluate a chemotherapy-free regimen to the established standard of care in patients with previously untreated follicular lymphoma and represents a landmark study in this disease setting,” said Gilles Salles, MD, PhD, president of Lymphoma Study Association (LYSA), in a press release.
Neither study arm was superior to the other. Additional analyses are ongoing and planned, according to the press release. Statistical details will be reported at an unspecified future medical conference.
Follicular lymphoma is an incurable, slowly progressing, and common form of non-Hodgkin lymphoma. Lenalidomide was approved by the US Food and Drug Administration in 2013 for the treatment of patients with relapsed or refractory mantle cell lymphoma. It is also indicated as part of the treatment for multiple myeloma and myelodysplastic syndromes with specific genomic abnormalities.
In a previous clinical trial of patients with del(5q) myelodysplastic syndromes, lenalidomide was associated with grade 3 or 4 hematologic toxicity, including neutropenia and thrombocytopenia, in 80% of patients, leading to treatment delay or dose reduction. Lenalidomide is also associated with venous and arterial thromboembolism, including significantly elevated risks of deep vein thrombosis and pulmonary embolism, as well as myocardial infarction and stroke, among patients with multiple myeloma.