Lenalidomide for Mantle Cell Lymphoma

Atlanta—Patients with mantle cell lymphoma who took lenalidomide had a 35% overall response rate to the drug and median progression-free survival of 8.8 months, according to a subset analysis of a phase 2, single-arm, open-label, international trial. The authors also said the drug was well tolerated, although 90% of patients had a treatment-related adverse event.

Results were presented during a poster session at the ASH meeting. The poster was titled Phase II Multicenter Study of the Safety and Efficacy of Single-Agent Lenalidomide in Patients with Relapsed/Refractory Mantle Cell Lymphoma: Long-Term Follow-Up Analysis of the NHL-003 Study.

The NHL-003 trial enrolled 217 patients with relapsed/refractory aggressive B-cell non-Hodgkin’s lymphoma, all of whom received 25 mg of lenalidomide daily on days 1 to 21 of every 28-day cycle until they had disease progression or could not tolerate the drug. Lenalidomide, an oral immunomodulatory agent, has antitumor and antiproliferative activities in patients with mantle cell lymphoma, which is an aggressive type of non-Hodgkin’s lymphoma. The study was conducted from October 2006 through April 2011.

Inclusion criteria included patients ≥18 years of age, with an Eastern Cooperative Oncology Group performance score of 0, 1, or 2, and who received ≥1 prior combination chemotherapy regimen. Patients were excluded if they had used lenalidomide before enrolling, were eligible for and willing to undergo autologous stem cell transplant, had prior grade ≥3 allergic reaction/hypersensitivity to or rash from thalidomide, and grade ≥2 neuropathy.

This analysis examined the 57 patients who had mantle cell lymphoma. Median age was 68 years, 77% were males, and they received a median of 3 prior therapies before enrolling. They received a median lenalidomide dose of 25 mg; median duration of treatment was 100 days.

Of the patients, 60% had ≥1 dose reduction or interruption due to an adverse event, and 18 patients discontinued taking lenalidomide. Median time to the first dose reduction was 42.5 days.

Of the treatment-related adverse events, 58% were grade 3 or 4 and 23% were serious. The most common hematologic adverse events were neutropenia (53%), thrombocytopenia (44%), and anemia (35%).

The overall response rate was 35% according to a central review board and 44% according to the investigators’ review. Patients had a median time to first response of 1.9 months. The authors defined the overall response rate as complete response, unconfirmed complete response, plus partial response.

The median progression-free survival was 8.8 months according to the central review board and 5.7 months according to the investigators’ review. The median progression-free survival had not been met in patients who had a complete response or an unconfirmed complete response. For those who had a complete response, unconfirmed complete response, or partial response, the median progression-free survival was 23.0 months; it was 8.8 months in patients who had stable disease.

The median duration of response was 16.3 months at a median follow-up of 19.96 months according to the central review board, but it had not been reached in the investigators’ review. Median duration of complete response had not been reached in either review.

The authors noted that additional studies should be conducted to examine using lenalidomide as a treatment option in patients with mantle cell lymphoma.

This study was supported by Celgene Corporation.