For a bit of background, we initially presented the primary endpoint, the efficacy findings of LenCabo at ESMO last year and published it where we showed that lenvatinib plus everolimus was associated with a significant improvement in time to disease progression compared to Cabozantinib. And so this is a secondary analysis of that trial where we’re looking to evaluate the tolerability and compare tolerability between lenvatinib plus everolimus versus Cabozantinib...
For a bit of background, we initially presented the primary endpoint, the efficacy findings of LenCabo at ESMO last year and published it where we showed that lenvatinib plus everolimus was associated with a significant improvement in time to disease progression compared to Cabozantinib. And so this is a secondary analysis of that trial where we’re looking to evaluate the tolerability and compare tolerability between lenvatinib plus everolimus versus Cabozantinib. And we did this in two different ways. The first was we measured quality of life with the FKSI-DRS assessment score. For that measurement, unfortunately, we had a limited number of patients that completed both endpoints. When we looked at the adjusted mean values after 60 days of treatment, we saw that there was inconclusive, there was no significant difference between the two treatment arms for quality of life, where there was a little bit of a trend favoring Cabozantinib, but nothing significant. Then we moved on to the second way of evaluating tolerability, which is we measured body composition objectively with CT scans starting at baseline and then four months thereafter. We used the adjusted mean value at four months for different body composition metrics, including skeletal muscle mass, subcutaneous fat, and total adiposity levels. And what we saw was that the use of lenvatinib plus everolimus was associated with a lower odds of having higher skeletal muscle mass or higher subcutaneous fat at four months. Or said another way, Cabozantinib had more favorable changes on body composition at four months compared to lenvatinib plus everolimus. And so we saw overall a bit of alignment, suggesting that tolerability was better with Cabozantinib, significantly so in evaluating body composition after four months of therapy, and then not significantly, but a similar trend for quality of life measures.
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