WASHINGTON (dpa-AFX) - AbbVie (ABBV) announced that final data analysis from Phase 3 MIRASOL trial after 30.5-month median follow-up demonstrated 32% reduction in risk of death with ELAHERE or mirvetuximab soravtansine-gynx compared to chemotherapy in folate receptor alpha (FR?)-positive platinum-resistant ovarian cancer (PROC).
The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial platinum-resistant ovarian cancer or PROC whose tumors express high levels of FR? and had been treated with up to three prior therapies. Key findings from the 30.5-month median follow-up include: ELAHERE treatment achieved superior efficacy versus IC chemotherapy, with a median PFS of 5.59 months versus 3.98 months, representing a 37% reduction in the risk of tumor progression or death and a higher objective response rate of 41.9% versus 15.9%; Other endpoints included safety and duration of response (DOR), which were consistent with the primary data analysis at 13.1-months median follow-up.
The company noted that a separate analysis from the Phase 3 MIRASOL study evaluating the impact of [ELAHERE] treatment-emergent ocular events on patient-reported health-related quality of life (HRQoL), will be shared during an oral presentation March 17 at the SGO Annual Meeting scientific plenary session.
ELAHERE was granted full approval by the U.S. Food and Drug Administration in March 2024 and was approved by the European Commission in November 2024. Marketing Authorization Applications for ELAHERE are also under review in multiple other countries.
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