ESMO Gynae 2025 | MIRASOL: PROs of mirvetuximab soravtansine in FRα-positive ovarian cancer

This is a trial which was performed in platinum-resistant ovarian cancer, which is really a special situation for our patients and for us physicians also. Why is that? Because they usually have a large cancer burden, they have symptoms, they have psychological issues like anxiety or insomnia, and especially things like appetite loss or abdominal pain. And those patients are in a strong palliative setting and they know they will die. So that’s the tension when you treat a patient with platinum-resistant ovarian cancer. And we have only limited therapeutic choices. Some years ago, the bevacizumab and anti-angiogenic antibodies found into this indication was really effective to a small amount of those patients. However, the MIRASOL trial we published or where I worked with the team on the quality of life data is a trial which compared an antibody drug conjugate. It’s called mirvetuximab soravtansine against physician choice or investigator choice chemotherapy. And there we could see that the response, that the shrinkage of the tumor was definitely better in the experimental MIRV group and that PFS and especially very important that overall survival was significantly prolonged by mirvetuximab in comparison to investigator choice chemotherapy. And it’s one of the really, it’s these findings we hadn’t before in this way without other drugs. So the incorporation of mirvetuximab into the treatment of platinum-resistant ovarian cancer patients will come and it will be standard of care in patients. That’s one limitation we have high folate receptor alpha expression. However, our task was to analyze the quality of life data and they collected it in a correct manner for the study and they have a plan how they wanted to analyze quality of life and they have had pre-specified quality of life endpoints. So it was really well done. And we analyzed this and we found very important findings. There was one thing that makes it complicated. So the primary endpoint for the quality of life analysis was the improvement of abdominal pain after eight to nine weeks of treatment. So and the threshold we selected or the primary endpoint was we wanted to see a 15-point improvement on a 100-point scale. And when you know that a 10-point improvement is the minimal clinically significant change, we even put more, we wanted to see more. And when we take a look with a 15-point improvement, we see that there’s an important percentage of more improvement. However, it was not significant. But when we take the pre-specified sensitivity analysis with a 10-point improvement, there we see clearly significant improvement of abdominal pain, the primary endpoint in the MIRASOL trial. But that’s the problem when you, you know we wanted too much at least with the 15-point improvement where we didn’t see significance but we saw with the pre-specified sensitivity analysis so it’s it’s in the middle but for sure we can say there’s strong evidence that patients go better with the most important symptom they have with platinum-resistant ovarian cancer when you compare MIRV against chemotherapy. But there were some other interesting findings that some functional scales did improve in the MIRV arm versus worsened in the chemotherapy arm, like physical functioning or the global health status, quality of life. And very interesting also that fatigue, which is also a very important symptom for our patient, improved in the MIRV arm and worsened in the chemotherapy arm.

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