US-based pharmaceutical company AbbVie has reported the final analysis from the Phase III MIRASOL trial, which assessed its antibody-drug conjugate (ADC) Elahere against chemotherapy for treating platinum-resistant ovarian cancer (PROC).
The randomised trial assessed the therapy’s safety and efficacy when given to women with folate receptor alpha (FRα) positive PROC.
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Its primary endpoint was progression-free survival (PFS), with its secondary endpoints being objective response rate (ORR) and overall survival (OS).
The study enrolled 453 subjects who had received up to three previous therapies and exhibited high-grade serous epithelial PROC expressing high FRα levels.
The median follow-up of 30.5 months showed that ADC treatment led to a median PFS of 5.59 months compared to 3.98 months for investigator’s choice (IC) chemotherapy, decreasing the tumour progression or mortality risk by 37%.
In addition, it achieved an ORR of 41.9%, significantly higher than the 15.9% achieved with chemotherapy.
Subjects treated with Elahere also experienced a superior median OS of 16.85 months against 13.34 months for those receiving IC chemotherapy, marking a 32% decrease in mortality risk.
The drug’s safety profile and duration of response were consistent with the primary data analysis at a median follow-up of 13.1 months.
AbbVie oncology medical affairs vice-president Svetlana Kobina said: “Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey.
“The data presented today reinforce the importance of Elahere as a transformative therapy for patients with limited options.”
Elahere received full approval from the US Food and Drug Administration in March 2024 and from the European Commission last November.
Several other nations are currently reviewing applications for marketing authorisation submitted by AbbVie for the drug.
Last June, AbbVie released positive topline data from the Phase II PICCOLO trial, which investigated Elahere as a single agent in heavily pre-treated platinum-sensitive ovarian cancer subjects.
