US biotech major Celgene (Nasdaq: CELG) yesterday announced promising results from the OPTIMISMM study, a Phase III, randomized, open-label, international clinical trial of the investigational combination regimen of pomalidomide, bortezomib and dexamethasone in patients with relapsed or refractory multiple myeloma (RRMM) who had received at least one prior treatment including lenalidomide, which the company markets at Revlimid.
OPTIMISMM evaluated the efficacy and safety of pomalidomide plus bortezomib and low-dose dexamethasone (PVd) versus bortezomib and low-dose dexamethasone (Vd) in patients with early RRMM (1-3 prior lines of therapy). It is the only Phase III trial to report results with a triplet combination in patients who have all received prior Revlimid (lenalidomide) therapy. In the UK, over 16,000 patients have been treated with lenalidomide since 2009; thisrepresents a patient population for which there is a growing unmet medical need.
“Results from OPTIMISMM are promising and show the potential of pomalidomide in combination with other therapies, earlier in the myeloma treatment pathway. For patients with myeloma, there is real concern about relapse and a range of effective treatments that can delay relapse and potentially be available in the future is of the utmost importance,” said Dr Neil Rabin, Consultant Hematologist at University College London Hospitals. “There is a growing unmet need for those patients who have been treated previously with lenalidomide, and combination therapies are key to meet that need. These data are therefore very encouraging.”
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