The modelled data on overall survival of the statistical evaluation of the impact of crossover on the ADMYRE study were presented.
Of the 84 patients treated in the comparator arm (dexamethasone as a single agent), 44% received the combination with plitidepsin after progression.
After analyzing the impact of crossover, the registered overall survival with plitidepsin was 11.6 months against the 6.4 months of dexamethasone alone.
Madrid, 5th June, 2018. - PharmaMar (MSE:PHM) has presented today how crossover has had an influence on the overall survival of the ADMYRE trial. The impact on overall survival of those patients that relapsed after receiving dexamethasone as a single agent and who were subsequently treated with plitidepsin in combination with dexamethasone was analyzed. Of the 84 patients treated from the comparator arm -dexamethasone as a single agent- 44%, 37 patients were treated with the combination with plitidepsin thereafter.
This data has been presented as a poster discussion session during the American Society of Clinical Oncology (ASCO) that is being held from the 1st to the 5th of June in Chicago (USA).
The ADMYRE study is a pivotal, randomized, open label, international, multicenter, phase III study, which included 255 multiple myeloma patients who had relapsed after having previously received at least 3, but no more than 6 prior lines and that compared both the safety and efficacy of plitidepsin plus dexamethasone against dexamethasone alone.
The primary endpoint of this study was Progression Free Survival -which resulted to be positive- was to demonstrate a statistically significant reduction in the risk of disease progression or death of 35% against the comparator.
During the presentation, the 2 statistical models used (RPSFT and the two stage method) to correct and measure the impact of crossover on overall survival were discussed, emphasizing the two stage model (Latimer et al.), that was considered the most adequate in the context of the Admyre study.
Accordingly, and taking into account the effect of crossover using the two stage method, a statistically significant increase in overall survival in the plitidepsin plus dexamethasone arm (11.6 months) against the comparator (6.4 months) was observed.
The studies presented at this meeting are available at http://abstracts.asco.org