A collaborative team of interdisciplinary researchers have released results from a clinical trial showing that rituximab in combination with the drug lenalidomide leads to better outcomes for patients with follicular lymphoma (FL). Their study, entitled, “Randomized Trial of Lenalidomide Alone Versus Lenalidomide Plus Rituximab in Patients With Recurrent Follicular Lymphoma: CALGB 50401 (Alliance),” was published in the latest edition of the Journal of Clinical Oncology, a publication of the American Society of Clinical Oncology
The Phase 2 trial assessed a cohort of 157 patients with relapsed or refractory CLL harboring a chromosome deletion known as the 17p deletion, in which 50 of these patients were enrolled in a safety expansion group. The primary study endpoint investigated the drug’s overall response rate (ORR) as determined by an independent review committee. The secondary endpoints included complete response (CR), partial response (PR) and progression-free survival (PFS).
In the first ever phase II study to assess the therapeutic activity of combining two drugs that are currently used in FL treatment, lenalidomide and rituximab, researchers enrolled ninety-one patients with Fl and randomized them into the following treatment groups: patients who were only given one of the drugs and patients receiving the combination therapy.
The primary study endpoint showed that the therapeutic response rate was significantly higher for patients who were receiving both drugs in comparison to those only being treated with one of the two therapies. Other important findings included:
- Patients assigned lenalidomide/rituximab had a median time to progression of 2 years compared with 1.1 years for patients assigned lenalidomide alone
- patients assigned to both arms experienced similar toxicity; however, 22% of patients assigned lenalidomide discontinued therapy as a result of adverse events.
- Higher graded adverse events, such as neutropenia, fatigue, and thrombosis, occurred in 58% of patients assigned lenalidomide and 53% of patients assigned to the combination
In a journal press release, Dr. John P Leonard, MD, the associate dean for clinical research, director of the Joint Clinical Trials Office, New York Presbyterian Hospital/Weill Cornell Medical Center, and lead study author stated, “Our group believes that the results from CALGB (Alliance) 50401 provide sufficient safety and efficacy data to support the use of lenalidomide/rituximab as a backbone to move toward combination biologic triplet therapy as we explore our next generation of chemotherapy-free regimens in indolent and other lymphomas.”
When discussing the results of the study, Dr. Leonard and his colleagues, wrote, “Interestingly, there was a trend toward less thrombosis in the lenalidomide/rituximab arm, which we speculate may be a result of better lymphoma control, reducing venous obstruction and other risks for clot. It is important to stress that the heterogeneous nature of the patient population with respect to thrombosis risk (and associated use of aspirin and anticoagulants as prophylaxis) makes it difficult to assess the effectiveness of ancillary care measures in preventing this complication.”