ESMO Gynae 2025 | PICCOLO: final analysis of mirvetuximab soravtansine in ovarian cancer

Yes, absolutely. I’m happy to. I was really excited about this study for several reasons. One being that we know that the landscape of care has changed for patients who have platinum-sensitive disease in this new era where many patients are exposed to a PARP inhibitor. And it was very important to find novel therapies that may be effective in patients who have heavily pretreated platinum-sensitive disease. So we wanted to evaluate mirvetuximab (soravtansine), which is a first-in-class antibody drug conjugate targeting folate receptor alpha. This is an agent that has a payload that’s called maytansinoid DM4, so it’s a potent tubulin targeting agent. This drug is already approved for patients who have platinum-resistant recurrent FR-alpha positive disease. In our primary analysis, we demonstrated that patients who had platinum-sensitive recurrence with high FR-alpha expression and were treated with mirvetuximab had a very high level of response, 51.9%, and that was consistent in all the groups, including a high response rate in patients who had been previously treated with a PARP inhibitor. And the median duration of response was 8.25 months with a median progression-free survival of 6.93 months. In the initial presentation, we had a follow-up of 16.36 months, and the overall survival was not yet mature. So we really were excited to present this overall final analysis to present the overall survival data. In the interim, there was a really interesting study that was a metadata pooled clinical trial analysis of patients with third-line greater platinum-sensitive ovarian cancer, and 96.9% of these patients had progressed on a PARP inhibitor. And in that study that included 130 patients, the median overall survival was 19.35 months with an objective response rate of 16.9% and a median progression-free survival of 6.11 months. And this study was really important because it provided a benchmark of what to expect in patients who had progressed on a PARP inhibitor. So yeah, so let me just share a little bit. The PICCOLO study design was a single arm open label Phase II trial of mirvetuximab . And the primary endpoint here is objective response rate. And key secondary endpoints included that progression-free survival and overall survival. In terms of the final analysis, the baseline demographics and characteristics of the patient population were very similar to previously reported. 81% of these patients have been previously treated with a PARP inhibitor and 75% of patients progressed. And our final analysis study showed that with a median follow-up of 26.55 months, the median overall survival was 27.17 months. I also want to share that about 77% of these patients received subsequent therapy and 47% of them received a platinum-based regimen. The overall efficacy summary in terms of objective response rate was very similar to the initial presentation. It was 51.9% objective response rate in the overall population. Patients who were PARP naive, it was 75%. And patients who progressed on a PARP, it was 45.8%. And the median overall survival was similar in all these groups, ranging in the 27-month timeframe. The safety profile was very similar. There’s no new safety events. So in terms of our overall conclusions, we were very pleased to find that the overall survival data of 27.17 months, the consistent median overall survival across all of these patient subgroups, as well as the objective response rate that was preserved in the final analysis, compared very favorably to the metadata pooled clinical trial analysis that I mentioned. And the safety profile showed that mirv is really well tolerated with no new safety events. So I’m very excited because I think that the overall final analysis is consistent with our initial results. And the overall survival findings of 27 months is very promising given the other data regarding the pooled analysis. So mirv appears to be an efficacious treatment option for patients with heavily pretreated platinum-sensitive disease.

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