MIRASOL: Elahere extends survival in hard-to-treat ovarian cancer
Treatment reduced mortality risk by 32% over chemotherapy
Treatment with AbbVie’s Elahere (mirvetuximab soravtansine) reduced the risk of death by 32% in women with difficult-to-treat epithelial ovarian cancer over standard chemotherapy.
That’s according to final data from the confirmatory Phase 3 MIRASOL (NCT04209855) trial, which supported the therapy’s full approval in the U.S. and the E.U. last year.
The therapy is indicated for adults with hard-to-treat epithelial ovarian, fallopian tube, or primary peritoneal cancer whose tumors express high amounts of the protein folate receptor-alpha, or FR-alpha. These patients have also failed to respond to or become resistant to platinum-based chemotherapy and their disease has progressed while on, or after, one to three lines of previous treatment regimens.
The findings from MIRASOL were presented during the Society of Gynecologic Oncology’s (SGO) Annual Meeting on Women’s Cancer in Seattle, March 14-17.
“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,” Svetlana Kobina, MD, PhD, vice president, oncology medical affairs of AbbVie, said in a company press release. “We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult to treat cancers.”
Most patients with advanced ovarian cancer initially have surgery followed by platinum-based chemotherapy. However, many eventually develop resistance to treatment. Therapeutic options for those with platinum-resistant ovarian cancer have historically been limited and often come with significant side effects that impact daily living and overall well-being.
Results from MIRASOL study
MIRASOL enrolled 453 adults with platinum-resistant FR-alpha positive epithelial ovarian cancer — the most common type of ovarian cancer — who were randomly assigned to a standard chemotherapy or to Elahere, given as an infusion into a vein, or intravenously, every three weeks.
After a median follow-up of 30.5 months, or about two and a half years, treatment with Elahere led to a significant increase in progression-free survival, that is, the median time patients lived without their cancer progressing, over standard chemotherapy (median, 5.59 vs. 3.98 months). This difference translated into a 37% reduction in the risk of tumor progression or death.
The objective response rate — the proportion of patients who saw a predefined reduction in tumor size over a set period of time — was also markedly higher in Elahere-treated patients (41.9% vs. 15.9%).
Elahere was also associated with a superior and clinically meaningful overall survival (median, 16.85 vs. 13.34 months), representing a 32% reduced risk of death. Treated patients also had a lower rate of severe or serious treatment-emergent adverse events (TEAEs), or the need to discontinue treatment. The most common TEAEs, detected in at least 20% in the Elahere group, included blurred vision, problems affecting the cornea (the clear surface that covers the eye), dry eye, abdominal pain, fatigue, diarrhea, constipation, nausea and damage to peripheral nerves.
“The final data showcase the significant improvement in overall survival benefit of treatment with Elahere compared to standard of care chemotherapy,” said Toon Van Gorp, MD, PhD, a professor of gynecological oncology at the University of Leuven in Belgium. “The significant improvements in survival, along with the well-characterized safety profile, reinforce Elahere as an emerging standard of care for difficult to treat ovarian cancer and warrants further study of this medicine in earlier treatment settings.”
Elahere is an antibody-drug conjugate administered into the bloodstream. It consists of an antibody that’s designed to recognize and bind to the FR-alpha receptor on the surface of ovarian cancer cells. This antibody is chemically linked to DM4, a potent toxic agent.
The connection between DM4 and the antibody is made using a breakable linker. Once the antibody attaches to the FR-alpha receptor, Elahere is taken in by tumor cells. Inside the cell, the linker breaks down, releasing DM4 which then disrupts the cells’ microtubule structure, which are essential components that maintain the cell shape and help transport molecules, ultimately leading to the cancer cells’ death.
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