Adding Revlimid (lenalidomide) to Rituxan (rituximab) in the treatment of follicular lymphoma and marginal zone lymphoma patients who failed at least one prior therapy significantly delays disease progression or death, a Phase 3 study shows.
Rituxan, alone or in combination with chemotherapy, is the standard therapy after patients have failed prior treatments. Rituxan is an antibody that targets the CD20 molecule, widely produced by lymphoma cells.
Response rates to Rituxan alone are 40-60%, but rise as high as 90% when it is used along with chemotherapy. However, chemotherapy can produce toxicity that compromises patients’ immune systems, putting them at higher risk of infections. Researchers have been trying to replace chemotherapy with other biologic agents.
Revlimid restores the function of immune cells in the tumors of follicular lymphoma patients. Phase 2 studies have shown response rates ranging from 73-93% in patients treated with a combination of Revlimid and Rituxan.
To study this combination, researchers designed Augment, a controlled trial, which included 358 patients, and randomly assigned them to either Rituxan plus Revlimid, or Rituxan plus a placebo.
Participants had either follicular lymphoma or marginal zone lymphoma and had failed at least one prior treatment with chemotherapy or immunotherapy. They also had received at least two prior doses of Rituxan and demonstrated a response to this therapy.
The study’s primary goal was to determine whether the combination extended a patient’s life without the disease worsening, compared to Rituxan alone. Secondary goals included response rates, overall survival, adverse events, and time to next anti-lymphoma therapy.
The combination showed a trend toward better survival rates in these patients. Its safety profile was consistent with the known profiles of both medications, Revlimid’s maker, Celgene, announced.
“[Slow-growing] non-Hodgkin’s lymphomas, such as follicular lymphoma and marginal zone lymphoma, are diseases of underlying immune dysfunction with a need for new options beyond currently available therapies,” Jay Backstrom, MD, and chief medical officer for Celgene, said in a press release.
“We are encouraged by the highly significant improvement in progression-free survival observed in this study and look forward to engaging with regulatory authorities as soon as possible,” he said. “The R2 regimen represents a potentially new chemotherapy-free option for these patients.”
Data from the study will be submitted to a future medical meeting, while Celgene prepares to submit the combination for approval in the first quarter of 2019.