ASCO 2015: Phase III Study Confirms Benefits of Lenalidomide Maintenance Therapy for Patients With Multiple Myeloma
A large, cooperative group study directed by the Alliance for Clinical Trials in Oncology has confirmed previous evidence that the drug lenalidomide (Revlimid) delays time to disease progression for patients with multiple myeloma and is an important treatment option for patients with this rare but increasingly common cancer. Updated results of the ongoing study, which is led by Philip McCarthy, MD, and Sarah Holstein, MD, PhD, of Roswell Park Cancer Institute, were discussed at the 2015 ASCO Annual Meeting in Chicago (Abstract 8523).
Study Background
This randomized phase III study compared maintenance lenalidomide with placebo following autologous stem cell transplantation in patients newly diagnosed with multiple myeloma. The trial’s 461 participants, all younger than 70 years old, showed evidence of stable or controlled disease at 100 days post transplant before they were randomly assigned to either the treatment arm or the placebo arm. Although the incidence of second primary malignancies was elevated among patients who received lenalidomide, the researchers found a marked benefit for those receiving maintenance doses of the drug.
“The results demonstrate that maintenance therapy with lenalidomide significantly improves both time to disease progression and overall survival, and that these benefits apply regardless of whether patients were in complete response at randomization or whether they had previously received thalidomide [Thalomid] or lenalidomide as induction therapy,” said Dr. Holstein, Assistant Professor of Oncology in Roswell Park’s Department of Medicine.
Research Results
The estimated median time to progression was nearly doubled for those receiving treatment, from 27 months for the placebo group to 53 months for those receiving lenalidomide. After a median follow-up of 65 months, the median overall survival has not yet been reached for those receiving lenalidomide and is 76 months for the placebo group. Among those receiving treatment, 25 secondary primary malignancies were observed, compared with 10 in the placebo arm. The study was unblinded at a median follow-up of 18 months, and 86 patients from the placebo arm who showed no evidence of disease progression chose to cross over to the treatment group.
“Our findings provide compelling evidence that this treatment approach represents advancement in our ability to control this disease and generate better outcomes for patients with multiple myeloma,” noted the study’s senior author, Dr. McCarthy, who is Professor of Oncology and Director of the Blood & Marrow Transplant Program at Roswell Park.
The research is supported by grants from the National Institutes of Health and National Cancer Institute and is a collaborative effort among three hematologic research groups: CALGB/The Alliance for Clinical Trials in Oncology, the Eastern Cooperative Oncology Group (ECOG), and the Bone Marrow Transplant Clinical Trials Network (BMT-CTN).
For full disclosures of the study authors, view the study abstract at abstract.asco.org.
The content in this post has not been reviewed by the American Society of Clinical Oncology, Inc. (ASCO®) and does not necessarily reflect the ideas and opinions of ASCO®.
