A combination of Rituxan (rituximab) and Revlimid (lenalidomide) is similarly effective and has a better safety profile than the standard first-line regimen — chemotherapy and Rituxan — for follicular lymphoma patients, a Phase 3 clinical trial shows.
While the Revlimid combination failed to increase the complete response rate and to delay disease progression or death — the trial’s main objectives — the findings suggest that replacing standard chemotherapy for Revlimid may be suitable for follicular lymphoma patients who choose to skip chemotherapy.
Results from the Phase 3 study, RELEVANCE (NCT01650701), will be presented at the American Society of Clinical Oncology (ASCO) annual meeting June 1-5 in Chicago, Illinois.
The poster, “RELEVANCE: Phase III randomized study of lenalidomide plus rituximab (R2) versus chemotherapy plus rituximab, followed by rituximab maintenance, in patients with previously untreated follicular lymphoma,” will be presented by Nathan Hale Fowler, MD, of the Memorial Sloan Kettering Cancer Center.
Currently, the standard treatment for untreated follicular lymphoma patients is chemotherapy plus Rituxan, followed by Rituxan maintenance. But chemotherapy is linked with several side effects and compromises the patients’ immune system, putting them at higher risk of infections.
Revlimid, an oral drug approved for some blood cancers, has reversed the immune defects caused by follicular lymphoma and has shown promise in combination with Rituxan.
Celgene, the manufacturer of Revlimid, and the Lymphoma Study Association joined forces to conduct the first Phase 3 trial evaluating a chemotherapy-free regimen in previously untreated follicular lymphoma patients.
The purpose of the study was to find out if Revlimid and Rituxan, followed by Rituxan maintenance, could increase complete responses and lengthen the time a patient lived without disease progression, compared to the conventional treatment regimen. Secondary outcomes included safety measurements, including the number of patients who had negative side effects and overall survival.
The 1,030 participants were assigned randomly to Rituxan plus a chemotherapy chosen by the physician (CHOP, CVP, or bendamustine), or Revlimid plus Rituxan. All patients who achieved a partial or complete response after eight weeks received Rituxan as maintenance therapy.
After a median follow-up of 37.9 months, no differences were observed in the two primary outcomes. Complete responses were seen in 48% of patients who received Revlimid compared with 53% in the chemotherapy group. At three years, 77% and 78% of patients, respectively, were alive and without signs of disease progression.
Safety profiles, however, differed between groups. Patients in the chemotherapy group had febrile neutropenia (fever during a period of low levels of neutrophils) and secondary primary cancers more often than those on Revlimid. Meanwhile, patients who received Revlimid had a higher percentage of skin events (7%) compared to the chemotherapy group (1%).
The findings demonstrate that a chemo-free treatment is as effective as the standard chemotherapy for the control of follicular lymphoma, but show a different safety profile.
“Cancer research is at a critical point where advances in cellular immunotherapy may be able to drive previously unattainable advancements,” said Nadim Ahmed, president of hematology and oncology at Celgene, in a press release.
“The studies being shared at ASCO this year reinforce our position of being at the forefront of discoveries that can accelerate our understanding of disease mechanisms with the opportunity to harness a patient’s own immune system to maximize the potential of new therapeutic options for patients,” Ahmed said.
