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Phase IIIB Randomized Study of Lenalidomide Plus Rituximab Followed By Maintenance in Relapsed/Refractory NHL
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Dr. David Andorsky discusses Phase IIIB Randomized Study of Lenalidomide Plus Rituximab Followed By Maintenance in Relapsed/Refractory NHL at ASCO 2017. For the ability to view on your mobile phone please visit us at MinuteCE.com.

This transcript is software driven, please understand there may be errors.  Should any inaccuracies or omissions be found, please notify transcripts@MedEdOTG.com for correction.

Good afternoon my name is Dr. David Andorsky, I'm a medical oncologist with the Rocky Mountain Cancer Center in Colorado as well as the US Oncology Research Network and I'm happy today to talk to you a bit about the findings from my abstract from a selection of patients from the MAGNIFY trial, which is revlimid and rituximab followed by maintenance therapy in relapsed and refractory non-Hodgkin's lymphoma. We'll specifically be looking at subsets of patients with follicular lymphoma who are either double refractory to earlier lines of therapy or early relapse after first diagnosis.

In general follicular lymphoma these days has a good prognosis but some patients who can be identified who have adverse prognostic factors. In particular patients who relapse within two years of the initial diagnosis have adverse outcomes as well as patients who are refractory to both rituximab and chemotherapy. Lenalidomide and rituximab is active and well tolerated in first line and relapse and refractory follicular lymphoma.

Both these agents both have direct effect on the tumor as well as immunomodulatory effects and works synergistically to improve the efficacy of the immune response to the lymphoma. This is the design of the MAGNIFY trial overall, and it's enrolling patients with relapsed and refractory non-Hodgkin's lymphomas either follicular lymphoma, marginal zone lymphoma, or mantle cell lymphoma. All patients receive induction therapy with lenalidomide and rituximab and then after 12 cycles are randomized to either the R squared combination as maintenance therapy or rituximab alone. The primary endpoint for the study is progression free survival.

Here's a snapshot of the patients we'll be discussing today. Of the 234 patients accrued to date on the study, 160 had follicular lymphoma, 52 of them were early relapsers, meaning that they had relapse or progression within two years of diagnosis and 50 were double refractory meaning that they were refractory to any alkylating agent and rituximab.

You can see the overall response rate for the follicular lymphoma cohort as a whole was 67%, the double refractory patients had an overall response rate of 45% with 21% complete responses and the early relapsers also an overall response rate of 47% with a complete response rate of 21% as well.

Here's a waterfall plot showing the responses among double refractory, early relapsers and patients patients who are both double refractory and early relapsers. As you can see, most patients had some degree of tumor response. The patients who were rituximab refractory are marked with an asterisk and those patients too also tended to have favorable responses including fairly deep ones. This was also true of patients who were both double refractory and early relapsers denoted by the purple bars.

One year progression free survival for the overall follicular lymphoma cohort was 70%, among the double relapse patients it was 65% and among the early relapsers 49%. And the median duration of overall response was not yet reached in either cohort of patients so the followup for this study is relatively early with 10.2 months of median followup on study to date.

In conclusion, the R squared induction therapy followed by maintenance showed favorable activity and a tolerable safety profile in follicular lymphoma patients who are double refractory or at early relapse less than two years after the initial diagnosis. The most common grade three or four adverse events were hematologic, including neutropenia, leukopenia, thrombocytopenia and lymphopenia. Enrollment in MAGNIFY is ongoing.

Thank you for your time and attention.