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Celgene To Present Revlimid Results at ASH

Primary endpoint met in NDMM trial

By: Gil Roth

President, Pharma & Biopharma Outsourcing Association

Celgene will present data from FIRST, its Phase III study of Revlimid (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma (NDMM) ineligible for stem cell transplant, on Sunday, Dec. 8 during the plenary session of the American Society of Hematology annual meeting. Revlimid is not indicated for newly-diagnosed multiple myeloma in any country.

A total of 1,623 patients either 65 years or older or not candidates for stem cell transplant were randomized 1:1:1 into three arms: lenalidomide plus low-dose dexamethasone (Rd) in 28-day cycles until disease progression (Arm A); Rd in 28-day cycles for 72 weeks (18 cycles, Arm B); or melphalan, prednisone and thalidomide in 42-day cycles for 72 weeks (12 cycles, Arm C). Assessments by International Myeloma Working Group (IMWG) criteria were done after each cycle. Patients with renal impairment were enrolled, however, patients on dialysis were excluded. Starting doses of lenalidomide and dexamethasone were adjusted based on renal function and age, respectively. Melphalan starting dose was adjusted based on age, absolute neutrophil count, platelet count, and renal function; and thalidomide was adjusted for age. Dose adjustments were permitted for adverse events. All patients were required to receive anti-thrombotic prophylaxis. Stratification factors included age, International Stage System and country.

The primary endpoint was a comparison of progression-free survival (PFS) in Arm A vs. Arm C. Secondary endpoints included overall survival (OS), overall response rate (ORR), time to response, duration of response (DOR), safety and quality of life (QOL). A preplanned additional analysis included time from randomization to second progression event or death (PFS2). After a median follow-up of 37 months, the trial met its primary endpoint (PFS), demonstrating a 28% reduction in risk of progression or death. The preplanned interim analysis of OS demonstrated a 22% reduction in risk of death in favor of Arm A vs. Arm C.

As of the publication of the abstract, 121 patients continue to receive lenalidomide on study (Arm A). The median age was 73 (40.0–92.0) years; 35% of patients were aged ≥75 years; and 41% of patients had ISS stage 3 disease.

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