Pomalidomide in Combination with Low-Dose Dexamethasone Demonstrates a Significant Progression Free Survival and Overall Survival Advantage, in Relapsed/Refractory MM A Phase 3, Multicenter, Randomized, Open-Label Study

SUMMARY: Pomalidomide (POM) is a novel, oral, immunomodulatory drug which is far more potent than Thalidomide (THALOMID® and Lenalidomide (REVLIMID®) and has been shown to be active in REVLIMID® and Bortezomib (VELCADE®) refractory patients. In this phase III trial, the efficacy and safety of POM given along with low-dose dexamethasone (LoDEX) (n=302) was compared with high-dose dexamethasone (HiDEX) (n=153) in patients who were refractory to both REVLIMID® and VELCADE®. The primary endpoint was Progression Free Survival (PFS). The Overall Survival (OS) was only evaluated if PFS was statistically significant. With a median follow up of 18 weeks, the PFS was significantly longer in the POM + LoDEX group compared to the HiDEX group (15.7 vs 8.0 weeks; hazard ratio [HR], 0.45; P < .001). Following interim analysis, the OS was significantly longer in the POM + LoDEX group compared to HiDEX group (median not reached vs 34 weeks; HR, 0.53; P< .001). The authors concluded that this oral treatment regimen should be the new standard of care for patients who have disease refractory to REVLIMID® and VELCADE®. Carfilzomib (KYPROLIS®), a new parenteral proteasome inhibitor is another option for patients with resistant and refractory multiple myeloma. Dimopoulos MA, Lacy MQ, Moreau P, et al. 54th ASH Annual Meeting and Exposition 2012, LBA-6