So, ROSELLA trial was the first randomized trial exploring the combination of a new HIFET, which is the glucocorticoid receptor inhibitor relacorilant in combination with the nab-paclitaxel. Preclinical and also clinical data suggest that hyperexpression of glucocorticoid receptor is a marker of poor prognosis in ovarian cancer because glucocorticoid receptor is involved in reduced chemosensitivity and epithelial-mesenchymal transition...
So, ROSELLA trial was the first randomized trial exploring the combination of a new HIFET, which is the glucocorticoid receptor inhibitor relacorilant in combination with the nab-paclitaxel. Preclinical and also clinical data suggest that hyperexpression of glucocorticoid receptor is a marker of poor prognosis in ovarian cancer because glucocorticoid receptor is involved in reduced chemosensitivity and epithelial-mesenchymal transition. And we have some data suggesting that when we combine nab-paclitaxel with relacorilant, we increase progression-free survival in ovarian cancer, data coming from a randomized phase two. Why nab-paclitaxel? Because nab-paclitaxel does not require corticosteroid premedication. The drug is active in ovarian cancer, but in particular, the absence of corticosteroid premedication makes nab-paclitaxel a perfect companion for relacorilant. Some questions? Okay. So in this randomized phase 3 trial, we compare relacorilant plus nab-paclitaxel versus nab-paclitaxel alone in patients with platinum-resistant ovarian cancer who have received no more than three prior lines of therapy. And the trial reported a significant increase in progression-free survival with a hazard ratio of 0.70 and a median increase from 5.5 to 6.5 in median PFS. But also even more important in this interim analysis, there was a trend that showed an increase in overall survival with a hazard ratio of 0.69 and the median overall survival increasing from 11.5 to 15.9 months. And also the toxicity profile was really manageable, particularly what we saw, it was a slight increase in neutropenia and anemia, but when we adjust for the duration of treatment, it was very comparable between the two treatment arms. So this is a new standard of care for platinum-resistant ovarian cancer.
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