IMS 2023 | Final survival outcomes from the Phase III OPTIMISMM trial: PVd versus Vd in R/R myeloma
Meral Beksac, MD, Istinye University Ankara Liv Hospital, Ankara, Turkey, discusses the overall survival (OS) results from the Phase III OPTIMISMM trial (NCT01734928), which compared the combination of pomalidomide, bortezomib, and dexamethasone (PVd) versus Vd in patients with relapsed/refractory (R/R) multiple myeloma. Results demonstrated an OS advantage in favor of PVd, with no additional safety concerns observed with the use of this regimen. This interview took place at the 20th International Myeloma Society (IMS) Annual Meeting, held in Athens, Greece.
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Transcript (edited for clarity)
Today I am presenting at IMS 2023 for the first time, the overall survival (OS) results of the OPTIMISMM study. The OPTIMISMM study was initiated in 2012, and the data cut-off and overall survival was done in 2022, after 10 years. We now have a follow-up of 64 months. With this follow-up, we are presenting for the first time, the overall survival results. This study compares pomalidomide, bortezomib, and dexamethasone combination versus bortezomib and dexamethasone, in the setting of relapsed/refractory myeloma patients who have received one to three prior lines of therapy, all exposed to lenalidomide, and around 70% being refractory, but not bortezomib refractory...
Today I am presenting at IMS 2023 for the first time, the overall survival (OS) results of the OPTIMISMM study. The OPTIMISMM study was initiated in 2012, and the data cut-off and overall survival was done in 2022, after 10 years. We now have a follow-up of 64 months. With this follow-up, we are presenting for the first time, the overall survival results. This study compares pomalidomide, bortezomib, and dexamethasone combination versus bortezomib and dexamethasone, in the setting of relapsed/refractory myeloma patients who have received one to three prior lines of therapy, all exposed to lenalidomide, and around 70% being refractory, but not bortezomib refractory. This typical study constitutes a majority of patients who have received lenalidomide in the frontline. This is a good study to compare the impact of adding an IMiD to the bortezomib-dexamethasone backbone.
Initial results, that were published earlier, show PFS advantage and today we are presenting the overall survival results. Initially, at first look, the overall survival is similar, but a pre-planned, time-dependent, covariate analysis, including the subsequent treatment arms, showed that patients in the control arm received more pomalidomide (58% compared to 19% in the experimental arm), which results in an overall survival advantage in favor of PVd. This is an unofficial crossover study, patients who received pom in the first part of the study and after relapse, in the control arm more than 50% of patients received pomalidomide, making the overall survival analysis look similar but when you analyze deeper with the Cox proportional hazards model, it’s possible to show the overall survival advantage.
Here we also show for the first time the PFS2, which is also in favor of the PVd arm. The PFS was reanalyzed, validating the first results. The safety is also as reported earlier, with no concerns regarding myelosuppression or neurotoxicity, as well as secondary primary malignancies. I can say that PVd is an alternative regimen. Today we have seen, earlier this year, there were two publications comparing CAR-T versus standard of care, where PVd was included in the standard of care arm, so PVd still keeps this position as the second-line, or third-line of therapy.
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