Mirvetuximab soravtansine-Gynx (MIRV) for treating platinum-resistant recurrent ovarian cancer.
Mirvetuximab soravtansine (MIRV), an anti-folate receptor 1/alpha (FRα, FOLR1) antibody-drug conjugate (ADC) with a companion diagnostic immunohistochemical (IHC) biomarker using VENTANA FOLR1 assay represents a precisely targeted chemotherapy for treating platinum-resistant recurrent epithelial ovarian cancer (PR-rEOC) patients with overexpression of FRα and possibly for platinum-sensitive rEOC (PS-rEOC) patients, regardless of status of FRα expression. The global phase III randomized clinical trial (RCT, MIRASOL) enrolling 453 highly FRα expressed PR-rEOC patients demonstrated that MIRV treatment provided statistically significant improvements in clinical outcomes compared to investigator's choice of chemotherapy (ICC), which included not only the progression free-survival (median PFS 5.6 months vs. 4.0 months, hazard ratio [HR] 0.65) but also the overall survival (median OS 16.5 months vs. 12.8 months, HR 0.67). Additionally, overall response rate (ORR) was significantly higher in MIRV treatment (42.3 % vs. 15.9 %). Moreover, the severe adverse events (AEs) and treatment-related AEs (TRAEs)-associated discontinuation in MIRV group were dramatically fewer (41.7 % vs. 54.1 %) and lower (9.2 % vs. 15.9 %), respectively compared to ICC group. These findings suggest that the treatment of choice may be the utilizing MIRV as the front-line for treating PR-rEOC patients if FRα expression of Pr-rEOC patients is high. Finally, any-grade ocular adverse events (OAEs) are particularly common in patients during MIRV treatment, arising in 125 (57 %); grade ≥3 in 34 (16 %), most frequently, blurred vision (18 [8 %]), keratopathy (21 [10 %]), cataract (11 [5 %]), and dry eye (8 [4 %]); however, fortunately, over 90 % with OAEs had either full resolution or documented final grade 1 or better. The current review also discusses OAE, based on its high incidence, frequent cause responsible to dose reduction and delaying therapy with impacting 11-35 % of patients and of the most importance, relative unfamiliarity to most gynecological oncologists in the routine clinical practice.