Patients with diffuse large B-cell lymphoma (DLBCL) who respond to first line Rituxan/Mabthera (rituximab) plus CHOP chemotherapy (R-CHOP) induction therapy may have increased progression-free survival when treated with Revlimid (lenalidomide) as maintenance therapy. But, based on Revlimid’s failure to increase overall survival in those patients, Celgene will not seek approval for the indication.
The interim data from the Phase 3 trial was reported by the Lymphoma Academic Research Organization (LYSARC).
The REMARC Phase 3 trial is a randomized, double-blind, placebo-controlled, multicentre, international study that was sponsored by LYSARC under a Clinical Trial Agreement with Celgene. It was designed to assess the effects of maintenance therapy (given after a patient reaches remission with induction therapies) with Revlimid versus placebo.
The study enrolled 650 patients who received 6 to 8 cycles of R-CHOP therapy plus 2 cycles of Rituxan and responded to therapy as assessed through the Revised Response Criteria for malignant lymphoma. REMARC’s primary endpoint was progression-free survival (PFS); and secondary endpoints included overall survival, response at the end of maintenance, event-free survival, and improvement in response and safety.
Initial data from the study revealed it achieved its primary endpoint with Revlimid inducing a statistically significant improvement in PFS compared to placebo — but did not show any benefits in overall survival.
“We thank the patients and their families for participating in the REMARC trial and look forward to presenting these important data at a future hematology conference,” Bertrand Coiffier, professor of hematology, Hospices de Lyon and University Claude Bernard Lyon and principal investigator, REMARC, said in a press release.
Revlimid is currently approved in combination with dexamethasone for patients with multiple myeloma or as monotherapy for patients with transfusion-dependent anemia due to myelodysplastic syndromes. It is also approved in the U.S. for patients with mantle cell lymphoma who progressed or relapsed after two prior therapies.
In addition to REMARC, Celgene is also evaluating Revlimid in four other clinical trials in multiple areas of non-Hodgkin lymphoma.
RELEVANCE is assessing Revlimid in combination with Rituxan in previously untreated follicular lymphoma patients; and AUGMENT is evaluating Revlimid plus Rituxan in relapsed/refractory follicular and marginal zone lymphoma. Data from the studies is expected in the first and second half of 2017.
In the other two trials, MAGNIFY will examine Revlimid in combination with Rituxan in relapsed/refractory follicular, marginal zone, and mantle cell lymphoma; and ROBUST will assess the effects of Revlimid plus R-CHOP in untreated ABC-subtype DLBCL patients.
“We are continuing to partner with LYSA to complete the analyses of the REMARC study,” said Michael Pehl, president hematology and oncology of Celgene. “We remain committed to finishing the four ongoing phase III trials evaluating Revlimid and are confident about its potential as a treatment option across different settings in lymphoma.”