This was a phase III randomised trial looking at relacorilant, which is a first in class glucocorticoid receptor antagonist, in combination with nab-paclitaxel versus nab-paclitaxel to see if the addition of relacorilant could help improve both progression free survival and to see what the initial responses are for overall survival. The rationale for doing the study was based on promising phase II data which showed preliminary activity of this drug, relacorilant, in women with ovarian cancer.
What was the methodology?
This was a randomised phase III trial looking at the addition of relacorilant with nab-paclitaxel versus nab-paclitaxel alone. There was a 1:1 randomisation. The primary endpoints were both progression free survival by BICR, or blinded central review radiology, and in addition overall survival was an additional primary endpoint. It was unblinded, patients were unrandomized.
What were the findings?
It’s compelling and interesting and really helping us to fill an unmet need. The bottom line: it met its primary endpoint for progression free survival. There was a significant improvement in progression free survival with a 30% decreased risk of recurrence or death in those patients treated in the relacorilant arm, the hazard ratio was 0.7. The difference in median survivals was 6.5 versus 5.5 months, however, we were really impressed and satisfied with the hazard ratio that we saw.
In addition, there was a clinically meaningful benefit for overall survival in those patients treated with the experimental arm with a hazard ratio of 0.69 and a five month improvement in overall survival in those patients treated with the agent. Again, this was done at the interim analysis, the data was approximately 50% mature at the time, but really suggesting that we’ll meet both primary endpoints of the study.
What are the clinical implications of these findings?
The treatment of ovarian cancer for those patients that are platinum resistant is truly an unmet need. We need to come up with better treatment options. Now, we have known that nab-paclitaxel is active in this disease but the addition of the relacorilant with the progression free survival advantage and with the clinically meaningful overall survival advantage at this time, really we feel that it will fill an unmet need and it should become a standard in patients with platinum resistant ovarian cancer.
We didn’t see any different safety signals, the safety signals were as expected. Overall it’s well tolerated. Personally I’ve had patients that enrolled in the trial and received the experimental arm and in my experience it’s very well tolerated. Really, if it gets regulatory approval, for me, I’ll incorporate this into my practice.
Is there anything else you would like to add?
We’re excited about it, OK. We’re excited for the data to be presented here at ASCO, we’re excited for the publication. We’re really excited about getting it into the clinic for our patients and then we’re excited for future directions. We don’t know what they exactly are yet but we know that, given the activity in the platinum resistant setting, we’re looking forward to further investigations to see what other populations of patients we could explore the use of this agent in.
