Lenalidomide Administration in Heavily Pretreated Patients with Non Hodgkin Lymphoma – First Report of the REVEAL Study (REVlimid® Effectiveness of Administration in patients with Lymphoma)

Abstract 4979 Lenalidomide (Revlimid®) is an oral treatment authorized in the US and EU for use in relapse/refractory multiple myeloma. Since March 2008, lenalidomide, in combination with Dexamethasone, is marketed in Italy in the aforementioned indication. The Italian Drug Agency (AIFA) has also granted authorization for the off-label use of lenalidomide in patients with Non Hodgkin Lymphoma (NHL) who have no residual therapeutic option, provided these patients are tracked in a registry, in order to ensure their compliance with the Risk Management Plan (RMP) already in place for the multiple myeloma indication. The authorization was granted based on preliminary published favorable phase 2 data (Wiernik, 2008; Habermann, 2009). April 2008 to November 2010 lenalidomide was prescribed (following the 94/98 Italian law) to over 200 NHL patients, mainly diagnosed as Diffuse Large B Cell Lymphoma (DLBCL) and Mantle Cell Lymphoma (MCL). This retrospective observational study was undertaken to gather clinic-pathological and laboratory data about this cohort of NHL patients, with the objective to evaluate the safety and the efficacy of lenalidomide administered, in the context of routine clinical practice, to a heavily pretreated patient population with no remaining therapeutic alternative. Also, efforts will be done in order to identify prognostic factors which can affect response to lenalidomide treatment. As of today, data on 30 patients treated at 6 sites have been collected and analyzed. Patient demographics and disease characteristics are summarized in Table 1. Patient median age was 70.5 years (range 36.0 – 90.0); median number of previous treatments was 5 (range 1 – 17). Over ninety three per cent (93.3%.) of the patients were previously treated with Rituximab. Forty per cent (40%) had DLBC histology, 16.7% MCL, 13.3% follicular histology and 16.7% were transformed lymphomas. As expected, 60% of the patients had stage IV disease, in keeping with the highly unfavorable characteristics of a heavily pretreated patient population. Responses were assessed according to the International Workshop on Lymphoma Response Criteria (IWRC). The number of lenalidomide cycles administered varied between 1 and 15 in this small patient group; 69.2% of the patients, evaluated at cycle 3, showed an objective response (OR). Data on approximately 180 patients treated at 46 sites throughout Italy will be analysed and presented. Only subjects who refuse to make their data available for review and analysis, or are currently participating in an interventional clinical study (from the date of enrollment into the interventional study) will be excluded. Although very preliminary, this experience indicates that lenalidomide has interesting anti- lymphoma efficacy, even in patients who have exhausted all available therapeutic options. Disclosures: Off Label Use: The Italian Drug Agency (AIFA) has also granted authorization for the off-label use of lenalidomide in patients with Non Hodgkin Lymphoma (NHL) who have no residual therapeutic option, provided these patients are tracked in a registry, in order to ensure their compliance with the Risk Management Plan (RMP) already in place for the multiple myeloma indication.