ASCO 2014: Promising Results with Lenalidomide Plus Rituximab for Patients with Previously Untreated Follicular Lymphoma

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By Peter Martin, MD

On May 30, 2014, at the 50th annual meeting of the American Society of Clinical Oncology (ASCO) I had the pleasure of presenting updated, preliminary results from the multi-center, national cooperative group CALGB 50803 phase II trial of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma. This trial represents an important step as we move away from traditional cytotoxic chemotherapy towards a future with novel, better-tolerated regimens for treatment of patients with follicular lymphoma.

Patients in this trial received oral lenalidomide on days 1-21 of each 28-day cycle for a total of twelve cycles plus four weekly infusions of rituximab during cycle 1 followed by four additional infusions at the start of cycles 4, 6, 8, and 10. The primary objective was to measure the patient’s complete response rate. Overall, we found that the regimen was well tolerated, with very low rates of infection or other significant adverse events. Preliminary data from patients evaluable for complete response suggests that over 90% of patients responded, including roughly 70% complete responses. At two years, 89% of patients continued to respond. These efficacy data are consistent with what is typically seen with cytotoxic chemotherapy-based regimens and they support further evaluation of lenalidomide plus rituximab compared to chemotherapy in an ongoing phase III trial.

New Educational Resource: Targeted Therapy Approval Timeline

As an internationally recognized center for research and clinical care of patients with blood cancers, who conduct more clinical research studies than our regional peers, we believe in the importance of patient education. To this end we have created a Targeted Therapy Approval subsection for our websites Clinical Trials page.

This page will be updated with information about the newest, next generation of targeted therapies as they receive FDA Breakthrough Therapy Designation, and FDA approval. It is intended as an educational resource.

If you have any questions please contact Robert Birchard at rob2052@med.cornell.edu or 212-746-2919.

Nivolumab Receives U.S. FDA Breakthrough Therapy Designation for Hodgkin Lymphoma

Yesterday, investigators announced the U.S. FDA  “Breakthrough Therapy Designation” approval for the investigational PD-1 immune checkpoint inhibitor nivolumab in the treatment of patients with Hodgkin lymphoma after failure of autologous stem cell transplant and brentuximab. The FDA designation was created to expedite the development process of drugs aimed at treating serious and life-threatening conditions. These new  findings for nivolumab are based on an ongoing Phase 1b trial. Nivolumab also known as BMS-936558 or MDX1106 is an,

“…investigational, fully-human PD-1 immune checkpoint inhibitor that binds to the checkpoint receptor PD-1 (programmed death-1) expressed on activated T-cells. We are investigating whether by blocking this pathway, nivolumab would enable the immune system to resume its ability to recognize, attack and destroy cancer cells.”

Look to this blog and our clinical trials page for further developments regarding the use of nivolumab in the treatment of Hodgkin lymphoma.