Comparing Immunomodulatory Agents in Myeloma at First Relapse: OPTIMISMM Trial
Posted: Wednesday, November 18, 2020
Patients with relapsed or refractory multiple myeloma may benefit from the recently approved therapeutic combination of immunomodulatory agents pomalidomide, bortezomib, and dexamethasone (PVd). In particular, the PVd triplet regimen improved overall response rate and progression-free survival at first relapse, including immediately after lenalidomide treatment failure. The findings from the international, open-label, controlled, phase III OPTIMISMM trial were published in Leukemia.
“The improvements in outcomes with PVd treatment across all subgroups of patients, including those with and without prior bortezomib exposure or stem cell transplant, demonstrate that pomalidomide-based regimens at first relapse confer benefits irrespective of previous exposure to these common front-line treatments,” stated principal investigator Paul Richardson, MD, of Harvard Medical School, Boston, and colleagues.
A total of 226 patients with progressive multiple myeloma were enrolled at first relapse and were required to have previously undergone between 1 and 3 treatment regimens, including at least 2 cycles of lenalidomide. Patients who had received lenalidomide but were nonresponsive to treatment or developed disease progression within 60 days of the last dose were considered to have refractory disease. Patients were randomly assigned to groups that either received PVd or a combination of bortezomib and dexamethasone (Vd). Treatment was administered in 21-day cycles until disease progression or unacceptable toxicity was observed.
Second-line PVd treatment nearly doubled the progression-free survival compared with Vd treatment in groups with both lenalidomide-refractory (P = .027) and nonrefractory (P = .049); the median progression-free survival with PVd was 11.2 months, compared with 7.1 months with Vd. The PVd regimen also increased progression-free survival in patients who had received prior bortezomib treatment as well as in patients who had or did not have a stem cell transplant. Overall response rates were significantly increased after PVd treatment in both lenalidomide-refractory and -nonrefractory patients (P < .001), and similar results were observed regardless of bortezomib or stem cell transplant history.
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