1 / 8

Lenalidomide and Rituximab for Untreated Indolent Lymphoma: Final Results of a Phase II Study

Lenalidomide and Rituximab for Untreated Indolent Lymphoma: Final Results of a Phase II Study. Fowler NH et al. Proc ASH 2012; Abstract 901. Background.

delta
Download Presentation

Lenalidomide and Rituximab for Untreated Indolent Lymphoma: Final Results of a Phase II Study

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. Lenalidomide and Rituximab for Untreated Indolent Lymphoma: Final Results of a Phase II Study Fowler NH et al. Proc ASH2012;Abstract 901.

  2. Background • Single-agent lenalidomide (Len) is active in relapsed, indolent non-Hodgkin lymphoma (NHL) while rituximab (R), alone or in combination with chemotherapy, is effective in untreated indolent lymphoma (J NatlComprCancNetw2010;(8 Suppl 6):1). • Preclinical studies using NHL cells suggested that Len may promote natural killer-cell function when R is present (Clin Cancer Res 2005;11:5984). • Study objective:To evaluate the efficacy and safety of Len in combination with R for patients with untreated, advanced-stage indolent NHL Fowler NH et al. Proc ASH2012;Abstract 901.

  3. Phase II Trial Design Len + R (n = 110)* Len: 20 mg/d, d1-21 q4wk x 6 cycles R: 375 mg/m2, d1 q4wk x 6 cycles • *Patients with evidence of tumor response could continue treatment for up to 12 cycles. • To reduce the incidence of tumor flare, patients with small lymphocytic lymphoma (SLL) received Len (10 mg/d), with monthly dose escalation. • Response was assessed every 3 cycles using the 1999 International Working Group Response criteria. Fowler NH et al. Proc ASH2012;Abstract 901.

  4. Best Response Rates (Abstract Only) *All evaluable patients MZL = marginal zone lymphoma; FL = follicular lymphoma; CR = complete response; CRu = CR unconfirmed Fowler NH et al. Proc ASH2012;Abstract 901.

  5. Clinical Outcomes (Abstract Only) • *Median follow-up = 22 months • 42/45 (93%) patients with FL and a positive PET scan prior to therapy attained a complete metabolic response after treatment. • For patients with FL, responses were high regardless of FLIPI score, tumor bulk or GELF criteria at study entry. • At the end of therapy, almost all patients with FL demonstrated molecular response with the absence of detectable BCL-2 by PCR. Fowler NH et al. Proc ASH2012;Abstract 901.

  6. Select Adverse Events (Grade ≥3)(Abstract Only) • There were 2 episodes of neutropenic fever. • Patients discontinuing treatment due to adverse events = 6 Fowler NH et al. Proc ASH2012;Abstract 901.

  7. Author Conclusions • The combination of Len with R therapy is active and tolerable in patients with untreated indolent lymphoma. • In patients with follicular lymphoma, Len in combination with R demonstrated high complete response rates with durable remissions. • Based on these results, randomized studies comparing this treatment schedule to traditional combination chemotherapy regimens are underway (RELEVANCE, NCT01650701). Fowler NH et al. Proc ASH2012;Abstract 901.

  8. Investigator Commentary: Final Results of a Phase II Trial of Lenalidomide and Rituximab for Untreated Indolent Lymphoma This trial of lenalidomide in combination with rituximab produced an overall response rate (ORR) of 90% for all patients, including about two thirds achieving a CR. The most exciting results were observed in patients with FL on the basis of PET scans, with an ORR and CR of 98% and 87%, respectively. These appear to be somewhat durable. In fact the estimated 2-year PFS was over 80% for all patients and 90% for FL. The so-called R-squared regimen will be compared head to head with chemotherapy/rituximab or chemoimmunotherapy in the Phase III RELEVANCE trial, in which physicians can choose from R-CHOP, R-CVP or R-bendamustine with a 1:1 randomization of patients to therapy. RELEVANCE is an international study with the potential to change how we approach patients with FL. Although we don’t know if the R-squared regimen is more effective than rituximab alone for patients with untreated disease, we know that rituximab alone produces about a 50% to 75% response rate at best, lasting for a median of about 18 months. However, the R-squared regimen yields response rates into the mid- to high 90s that appear to be lasting longer. This is the rationale for the randomized RELEVANCE trial evaluating how it compares to other effective regimens. Interview with Bruce D Cheson, MD, January 14, 2013

More Related