Revlimid in combination with Rituximab for the treatment of adult patients with previously treated follicular lymphoma
The European Medicines Agency's ( EMA ) Committee for Medicinal Products for Human Use ( CHMP ) has adopted a positive opinion, recommending the approval of Revlimid ( Lenalidomide ) in combination with Rituximab ( anti-CD20 antibody ) for the treatment of adult patients with previously treated follicular lymphoma ( grade 1-3a ).
The combination of Lenalidomide and Rituxumab is the first combination treatment regimen for patients with follicular lymphoma that does not include chemotherapy.
In follicular lymphoma, a subtype of indolent NHL, the immune system is not functioning optimally. When this dysfunction occurs, the immune system either fails to detect or attack cancerous cells.
Rituximab is a monoclonal antibody that targets the CD 20 antigen on the surface of pre-B and mature B-lymphocytes. Upon binding to CD20, Rituximab causes B-cell lysis.
Lenalidomide is an immunomodulator that increases the number and activation of T and natural killer ( NK ) cells, resulting in the lysis of tumor cells.
The Lenalidomide and Rituximab combination regimen acts by complementary mechanisms to help the patient’s immune system to find and destroy the cancer cells.
Given the incurable nature of follicular lymphoma, a high unmet medical need exists for the development of novel treatment options with new mechanisms of action and a tolerable safety profile to help improve progression-free survival ( PFS ) especially in the setting of previously treated follicular lymphoma.
The estimated incidence of NHL ( non-Hodgkin lymphoma ) in Europe was 100,055 cases in 2018; follicular lymphoma accounts for approximately 25% of all NHL cases and is the most common form of indolent NHL.
The CHMP positive opinion is based primarily on results from the randomized, multi-center, double-blind, phase 3 AUGMENT study, which has evaluated the efficacy and safety of the Lenalidomide and Rituximab combination versus Rituximab plus placebo in patients with previously treated follicular lymphoma ( n=295 ).
Additionally, findings from the MAGNIFY study were included as support for the safety and the efficacy of Lenalidomide plus Rituximab in patients with relapsed or refractory follicular lymphoma, including Rituximab refractory FL patients.
AUGMENT included patients diagnosed with grade 1, 2 or 3a follicular lymphoma, who were previously treated with at least 1 prior systemic therapy and two previous doses of Rituximab.
Patients were documented relapsed, refractory or progressive disease following systemic therapy, but were not Rituximab-refractory.
The primary endpoint was progression-free survival, defined as the time from date of randomization to the first observation of disease progression or death due to any cause. Secondary and exploratory endpoints included overall response rate, durable complete response rate, complete response rate, duration of response, duration of complete response, overall survival, event-free survival and time to next anti-lymphoma therapy. ( Xagena )
Source: Celgene, 2019