The first and only treatment to show superior efficacy vs standard single-agent chemotherapy in FRα-positive* PROC^1-3

MIRASOL: The first, only, and largest positive phase 3 study specifically for patients with FRα-positive PROC VS STANDARD CHEMOTHERAPY^1-3,5*

MIRASOL was a confirmatory, global, multicenter, randomized, open-label study evaluating the efficacy and safety of ELAHERE vs investigator's choice chemotherapy in FRα-positive, platinum-resistant ovarian cancer^1,2†

*Versus single-agent chemotherapy.

^†Includes epithelial ovarian, fallopian tube, or primary peritoneal cancer.¹

^‡Paclitaxel was administered intravenously on days 1, 8, 15, and 22 of a 4-week cycle (80 mg/m² of BSA); PLD was administered intravenously on day 1 of a 4-week cycle (40 mg/m²); and topotecan was administered intravenously on days 1, 8, and 15 of a 4-week cycle (4 mg/m²) or was administered intravenously on days 1 to 5 of a 3-week cycle (1.25 mg/m²).²

^§Since the primary endpoint was statistically significant, a hierarchical testing procedure was used to control the study-wise error rate for key secondary endpoints of ORR and OS, in that order.²

^¶Due to there being no procedure in place to control the type I error on other secondary efficacy endpoints, all P values for treatment comparison on other secondary efficacy endpoints will be for information only and will be considered as nominal.^2,6

Key eligibility criteria for MIRASOL

• Patients received 1 to 3 lines of prior systemic therapy; prior bevacizumab and PARPi therapy were allowed²
• Patients with BRCA mutations were allowed in the study²
• Patients with primary platinum-refractory disease, defined as PFI of <3 months, were excluded^2,7
• Patients were excluded if they had corneal disorders, ocular conditions requiring ongoing treatment, Grade >1 peripheral neuropathy, or noninfectious interstitial lung disease¹

AIBW=adjusted ideal body weight; BRCA=breast cancer gene; BSA=body surface area; ORR=overall response rate; OS=overall survival; PARPi=poly(ADP-ribose) polymerase inhibitor; PFI=platinum-free interval; PFS=progression-free survival; PLD=pegylated liposomal doxorubicin; q3w=every 3 weeks.

453 PARTICIPANTS REPRESENTING A RANGE OF DEMOGRAPHICS^1,2

In the overall MIRASOL patient population, 14% of patients had received 1 prior line of systemic therapy, 39% had received 2 prior lines, and 47% had received 3 prior lines. Additionally, 37% of patients had received prior systemic therapy for platinum-resistant disease, 62% had received prior bevacizumab, and 55% had received a prior PARPi.¹

ECOG PS=Eastern Cooperative Oncology Group performance status.