Seventy percent of follicular lymphoma patients treated with a combination of Revlimid and Rituxan went a year without their cancer progressing, according to interim Phase 3 clinical trial results.
Researchers told those attending the annual meeting of the American Society of Clinical Oncology that the combo led to solid disease-progression-free survival rates and good overall response rates among patients with relapsed or refractory follicular lymphoma. Overall responses rates are a combination of complete and partial responses to a therapy. The conference was in Chicago, June 2-6.
Presentations at the International Conference on Malignant Lymphoma in Lugano, Switzerland, June 14-17, showed that the combo also worked well against marginal zone lymphomas. Those slow-growing cancers account for about 12 percent of all B-cell lymphomas.
“Interim data from the MAGNIFY study continue to show the clinical potential for the R2 [Revlimid and Rituxan] combination across a broad range of lymphomas,” Michael Pehl, president, of Celgene’s hematology and oncology operation, said in a press release.
About 160 patients with relapsed or refractory follicular lymphoma have taken part in the Phase 3b MAGNIFY trial (NCT01996865) so far. Fifty-two of the 160 had had an early relapse of their cancer before receiving the combo, and 50 had been unable to respond to two earlier treatments.
The follicular lymphoma of 70 percent of those treated with the combo failed to progress in the year that ended January 9, 2017, researchers reported. The figures were 65 percent among those who had had an early relapse of their cancer before receiving the combo, and 49 percent among those who had been unable to respond to two earlier treatments.
Among the 128 patients researchers were able to evaluate, 66 percent responded to the combo and 38 percent achieved a complete response. Again the numbers were lower in patients with an early relapse or a double-refractory disease — that is, one that had failed to respond to treatment twice.
Sixty-six percent of the 32 marginal zone lymphoma patients in the trial responded to the treatment, and the cancer was eradicated in 44 percent. Responses differed among the subgroups in the study. The complete response rate of patients with nodal marginal zone lymphoma was 57 percent of those treated with the combo. It was only 25 percent in those with splenic marginal zone lymphoma.
Meanwhile 80 percent of patients with mucosa-associated lymphoid tissue achieved an overall response to the combo, but only 40 percent had a complete response.
“As we await data from our late-stage programs, including the Phase III AUGMENT and RELEVANCE studies, we hope that the growing volume of evidence for R2 may lead to new options for patients that offer an alternative to traditional cytotoxic chemotherapies,” Pehl said.
As for the combo’s safety, the worst adverse events that many recipients experienced were fatigue and low blood cell counts.
Researchers hope to enroll 500 patients with follicular lymphoma, marginal zone lymphoma, or mantle cell lymphoma before the MAGNIFY trial ends. Those in the study receive 12 cycles of Revlimid and Rituxan, and are then randomly assigned to either 18 cycles of the combo as a maintenance therapy or 18 cycles of Rituxan alone.
Researchers plan to follow patients for five years after the start of the treatment. Final results of the study are expected to be reported in 2021.
“The chemotherapy-free combination of lenalidomide and rituximab, with complementary mechanisms of action that are thought to enhance antibody-dependent cellular cytotoxicity, continues to show encouraging activity and a tolerable safety profile in indolent [slow-moving] lymphomas, and particularly in difficult-to-treat patient subsets,” said Dr. David J. Andorsky, co-principal investigator of the study. He is a medical oncologist at the Rocky Mountain Cancer Centers in Boulder, Colorado.
“These results in patients who had failed multiple therapies or relapsed early, as well as the activity in marginal zone patients, merit further study in this area of indolent lymphoma,” Andorsky added.