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In the American Journal of Hematology, last month Thomas E. Witzig, MD, from the Mayo Clinic, Rochester, MN, US, and colleagues published a report consolidating data from three phase II trials (NHL-002, NHL-003, and MCL-001) to ultimately provide long-term efficacy and safety data for the immunomodulatory agent lenalidomide in the treatment of Relapsed/Refractory (R/R) Mantle Cell Lymphoma (MCL).
In all three studies, oral lenalidomide monotherapy was given at a dose of 25mg/day on days 1–21 of each 28-day cycle as tolerated for up to 52 weeks in NHL-002 or until disease progression in NHL-003 and MCL-001. Lenalidomide was administered at a 10mg dose for patients with moderate renal insufficiency characterized by creatinine clearance ≥30 to <60mL/min (MCL-001 only). The primary outcome measure for all three studies was best Overall Response Rate (ORR), in addition to Duration of Response (DoR) in the MCL-001 trial.
Patient disposition and baseline characteristics:
Efficacy:
Safety:
The authors concluded that this long-term data indicates that lenalidomide monotherapy achieved a “noteworthy” ORR of 33% and has a “consistent, predictable, and manageable” toxicity profile demonstrated across numerous phase II trials in heavily pre-treated, advanced-stage patients with R/R MCL. The authors emphasized the importance of understanding the long-term outcomes and toxicities of novel agents, which are becoming more frequently used as first-line therapy for the treatment of MCL.
Mantle cell lymphoma (MCL) is a type of non-Hodgkin lymphoma (NHL) with aggressive disease characteristics resulting in multiple relapses after initial treatment. Lenalidomide is an immunomodulatory agent approved in the US for patients with relapsed/refractory MCL following bortezomib based on results from 3 multicenter phase II studies (2 including relapsed/refractory aggressive NHL and 1 focusing on MCL post-bortezomib). The purpose of this report is to provide longer follow-up on the MCL-001 study (follow-ups were 6.8 [NHL-002], 7.6 [NHL-003], and 52.2 [MCL-001] months). The 206 relapsed MCL patients treated with single-agent lenalidomide (25 mg/day PO, days 1-21 every 28 days) had a median age of 67 years (63% ≥65 years), 91% with stage III/IV disease, and 50% with ≥4 previous treatment regimens. With a median follow-up of X, the combined best overall response rate was 33% (including 11% with complete remission [CR]/unconfirmed CR). Lenalidomide produced rapid and durable responses with a median time to response of 2.2 months and median duration of response of 16.6 months (95% CI: 11.1%-29.8%). The safety profile was consistent and manageable; myelosuppression was the most common adverse event. Overall, single-agent lenalidomide showed consistent efficacy and safety in multiple phase II studies of heavily pretreated patients with relapsed/refractory MCL, including those previously treated with bortezomib.
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