KEY TAKEAWAYS
- This Phase III study analyzed PFS and OS statistics based on the number of previous treatments received by PROC patients.
- The primary endpoint was PFS. The key secondary endpoints were ORR, OS, and PROs.
- MIRV extended OS and PFS vs IC, irrespective of the number of PLOT.
Mirvetuximab soravtansine (MIRV), which targets folate receptor alpha (FRα), showed better outcomes in terms of both progression-free survival (PFS) and overall survival (OS) in patients (pts) with platinum-resistant ovarian cancer (PROC) when compared to chemotherapy chosen by investigators (IC). In this study, researchers detailed PFS and OS statistics based on the number of previous treatments received by the patient pool intended for treatment.
The study included 453 pts with PROC who also had high levels of FRα as determined by the Roche FOLR1 Assay. These pts, who had received between 1 and 3 prior lines of therapy (PLOT), were randomly assigned in a 1:1 ratio to receive either Mirvetuximab soravtansine (MIRV), or investigator choice (IC) chemotherapy, which could be paclitaxel, pegylated liposomal doxorubicin, or topotecan. The study’s primary endpoint was to assess PFS, while secondary key objectives included evaluating the ORR, OS, and patient-reported outcomes (PRO) in that particular sequence of importance.
Of the total, 227 pts were allocated to the MIRV group, while 226 were in the IC chemotherapy group. Among the pts, 14% had received one PLOT, 39% had two, and 47% had been through three. For those with either 1 or 2 PLOT (n=245), the PFS hazard ratio (HR) with a 95% confidence interval was 0.61 (0.45, 0.81). For pts with 3 PLOT (n=208), the PFS HR was 0.71 (0.52, 0.98). Regarding OS, the HR for those with 1 or 2 PLOTs was 0.66 (0.45, 0.98), and for those with 3 PLOTs, it was 0.65 (0.43, 0.96). When compared to the IC arm, the MIRV arm had fewer instances of grade 3 or higher treatment-emergent adverse events (TEAEs) (42% vs. 54%), serious adverse events (24% vs. 33%), and treatment discontinuations due to TEAEs (9% vs. 16%). The results for the key secondary patient-reported outcome (PRO) measure, which is the EORTC QLQ-OV28 focusing on abdominal/GI symptoms, will be shared later.
The study showed that MIRV outperformed IC in OS and PFS, irrespective of the number of PLOTs. This makes MIRV the first treatment to show benefits in both OS and PFS in a phase III clinical trial in PROC. Given its efficacy and a well-defined safety profile, MIRV emerged as a new benchmark treatment for pts with FRα-positive PROC.
Source: https://www.emma.events/site/programme/?sessiondetail=4534533&trackid=0&a=esgo2023#!
Clinical Trial: https://classic.clinicaltrials.gov/ct2/show/NCT04209855
Gorp, T.V., Sabatier, R., Konecny, G.E., Gordon, J., Pignata, S., Colombo, N., Moroney, J., Martin, L.P., Lee, J-Y., Roszak, A., Breuer, S., Boere, I., Tredan, O., Provencher, D., Farrelly, L., Leath, T., Wang, Y., Method, M., Lorusso, D., Moore, K.N. MIRASOL Trial: Efficacy Of Mirvetuximab Soravtansine In Folate Receptor Alpha High, Platinum Resistant Ovarian Cancer By Type And Number Of Prior Treatment Regimes: An Exploratory Analysis.
