Dr Myers on HRQOL Outcomes With Mirvetuximab Soravtansine in Ovarian Cancer

“I’m happy to say that what we found is there was no implication on QOL scores in patients who exhibited ocular [adverse] effects [AEs]. That’s a big important feature for patients, as this was a unique AE of the drug and made patients hesitant, either for the acute effect of the ocular AE, or whether it would affect their QOL.”

Tashanna K. Myers, MD, a professor of obstetrics and gynecology at the UMass Chan Medical School—Baystate, discusses findings from an analysis of the phase 3 MIRASOL trial (NCT04209855) evaluating the effects of treatment-emergent ocular adverse effects (AEs) on health-related quality of life (HRQOL) in patients with folate receptor alpha–positive platinum-resistant ovarian cancer who received mirvetuximab soravtansine-gynx (Elahere).

This analysis used patient-reported outcome (PRO) data from MIRASOL to compare HRQOL outcomes between patients treated with mirvetuximab soravtansine who experienced treatment-emergent blurred vision or keratopathy (cohort 1) vs those who did not experience treatment-emergent ocular (cohort 2). PROs were collected at screening and at every 3-week cycle for up to 21 weeks. The select HRQOL measures included in this analysis included the EORTC Quality of Life Questionnaire Core Questionnaire (EORTC-QLQ-C30) Global Health Scale (GHS)/Quality of Life (QOL) and physical functioning subscales, as well as the EuroQol (EQ) 5D-5L measures for mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The primary PRO analysis from MIRASOL showed no statistically significant differences in HRQOL measures between cohorts 1 and 2 at 9, 15, and 21 weeks following treatment initiation. The mean EORTC QLQ-C30 GHS/QOL least squares (LS) scores in cohorts 1 and 2, respectively, were 64.92 (standard error [SE], 2.35) vs 67.14 (SE, 2.45) at week 9, 65.23 (SE, 2.58) vs 66.18 (SE, 2.79) at week 15, and 65.46 (SE, 2.62) vs 64.48 (SE, 3.12) at week 21. The mean EORTC QLQ-C30 physical functioning LS scores in these respective cohorts were 78.44 (SE, 1.99) vs 75.14 (SE, 2.07) at week 9, 80.39 (SE, 2.32) vs 76.31 (SE, 2.47) at week 15, and 78.99 (SE, 2.15) vs 77.41 (SE, 2.55) at week 21. The mean EQ-5D-5L utility scores in these respective cohorts were 0.76 (SE, 0.03) vs 0.70 (SE, 0.03) at week 9, 0.75 (SE, 0.03) vs 0.73 (SE, 0.03) at week 15, and 0.73 (SE, 0.03) vs 0.71 (SE, 0.03) at week 21.

A sensitivity analysis that used a broader definition of treatment-emergent ocular AEs demonstrated consistent select HRQOL results between the population of patients with any treatment-emergent ocular effects and those with no treatment-emergent ocular effects.