I’m presenting a subgroup analysis of the ROSELLA study and my subgroup analysis is related to prior taxane exposure. The ROSELLA study is a large phase III randomised controlled open-label trial in which nab-paclitaxel, which is the best standard of care treatment for platinum-resistant ovarian cancer, was compared with a new drug called relacorilant. So in one arm we had relacorilant with nab-paclitaxel compared to nab-paclitaxel alone. This trial was conducted in 117 sites across 14 countries and it showed a substantial, 35%, reduction in death associated with the use of relacorilant and a median overall survival increase of 4.1 months.
So this is the ROSELLA trial. Within the ROSELLA trial my subgroup analysis looked at whether prior taxane use, whether it was less than six months or more than six months, or whether the last treatment included taxane, whether this materially reduced the effect of relacorilant and it did not. It did not show that, regardless of whether a taxane was used more than six months or less than six months, did not affect the advantage that relacoriland had for these patients.
The other important point is that the use of relacorilant does not need a biomarker, it’s not dependent on biomarker analysis. This was a very difficult group of patients because about 44% of patients had three lines of platinum-based therapy and all the patients, 100%, had anti-angiogenic bevacizumab already used. A large proportion of them had a PARP inhibitor used. So, regardless of that, relacorilant provided a substantial survival advantage.
What impact could these findings have?
It gives an important treatment for patients who have failed platinum. This is a difficult group, as I said, and the fact that even three prior lines, patients who have had three prior lines, benefitted makes this a very important addition for platinum-resistant patients.