Celgene Corp.(CELG) announced Thursday that data from FIRST (MM-020/IFM 07-01), an open-label phase III randomized study of continuous REVLIMID (lenalidomide) in combination with dexamethasone in patients newly diagnosed with multiple myeloma or NDMM who are not candidates for stem cell transplant, have been published in the September 4 issue of the New England Journal of Medicine.
Initial findings, including that the trial had met its primary endpoint of progression free survival or PFS, were reported during the plenary session at the 55th American Society of Hematology annual meeting in December 2013.
The findings, as published in the New England Journal of Medicine, demonstrated that at a median follow-up of 37 months among surviving patients, the median progression-free survival was 25.5 months with continuous oral lenalidomide plus low-dose dexamethasone (Rd), 20.7 months with a fixed course of oral lenalidomide plus low-dose dexamethasone (Rd18) and 21.2 months with melphalan, prednisone and thalidomide or MPT.
This resulted in a 28% reduction in risk of progression or death for patients treated with continuous Rd compared with those treated with MPT (HR 0.72; 95% CI, 0.61 to 0.85; P<0.001) and a 30% reduction compared with Rd18 (HR 0.70; 95% CI, 0.60 to 0.82; P<0.001) in the study.
The company noted that the pre-planned interim analysis of overall survival demonstrated a 22% reduction in risk of death for continuous Rd vs. MPT (HR 0.78; 95% CI, 0.64 to 0.96; P=0.02), although the difference did not cross the pre-specified superiority boundary (P<0.0096). As of the time of the analysis (May 24, 2013), 121 of 535 (23%) patients in the continuous Rd arm were still on therapy.
Additional secondary endpoints showed response rates were also significantly better with continuous Rd (75%) and with Rd18 (73%) than with MPT (62%; P<0.001 for both comparisons). More patients achieved a very good partial response or better in the continuous Rd (44%) or Rd18 arms (43%) compared with MPT (28%). Complete response rates were 15%, 14% and 9% for continuous Rd, Rd18 and MPT, respectively.
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