Celgene has results from Phase 3 myeloma study: ASCO

Celgene announced results from the OPTIMISMM study, a phase III, randomized, open-label, international clinical study of the investigational combination regimen of Pomalyst, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma, or RRMM, who had received at least one prior treatment including lenalidomide. The results were presented at the 54th Annual American Society of Clinical Oncology Scientific Sessions, or ASCO. OPTIMISMM evaluated the efficacy and safety of Pomalyst/Imnovid plus bortezomib and low-dose dexamethasone, or PVd, versus bortezomib and low-dose dexamethasone, or Vd, in patients with early RRMM. It is the only phase III trial to report results with a triplet combination in patients who have all received prior lenalidomide therapy. With lenalidomide becoming a standard of care, this represents a patient population for which there is a growing unmet medical need. An analysis of the results found that the treatment with PVd resulted in significantly improved progression-free survival, or PFS, and an earlier, deeper, more durable response in these patients compared to Vd treatment. The study, which included a high percentage of patients refractory to lenalidomide, met its primary endpoint of PFS. Those receiving PVd achieved a statistically significant longer PFS than those in the Vd treatment arm, reducing the risk of disease progression or death by 39% in the PVd arm. The PFS benefit was observed in the following subgroups of patients: LEN-refractory, LEN-nonrefractory, prior PI exposure or high-risk cytogenetics. Overall response rate, or ORR, one of the study’s secondary endpoints, was also significantly higher in the PVd treatment arm, compared to those receiving Vd. Additionally, time to treatment response was longer in the PVd arm, complete response was higher in the PVd arm and those receiving PVd experienced a longer duration of response than those in the Vd arm. In an exploratory sub-group analysis, patients who had received one prior line of therapy reported longer PFS and ORR with a 46% reduction in the risk of disease progression or death in the PVd treatment arm compared with Vd. Other secondary endpoints included overall survival and safety. Pomalyst plus dexamethasone in combination with bortezomib is not approved in any country for any use.

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