AbbVie announced today that ELAHERE® (mirvetuximab soravtansine-gynx) continues to demonstrate significant survival benefits in women with folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC) according to the final analysis of the Phase 3 MIRASOL trial. The data, presented at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women's Cancer in Seattle, showed a 32% reduction in the risk of death compared to standard chemotherapy.
The final analysis, with a median follow-up of 30.5 months, reinforces ELAHERE's potential as a transformative therapy for patients with limited treatment options. The antibody-drug conjugate (ADC) received full approval from the U.S. Food and Drug Administration in March 2024 and European Commission approval in November 2024.
Significant Survival Improvements in Difficult-to-Treat Patient Population
The Phase 3 MIRASOL study included 453 patients with high-grade serous epithelial PROC whose tumors express high levels of FRα and who had received up to three prior therapies. Key findings from the extended follow-up include:
- Median progression-free survival (PFS) of 5.59 months with ELAHERE versus 3.98 months with investigator's choice chemotherapy, representing a 37% reduction in the risk of tumor progression or death (HR 0.63; [95% CI: 0.51, 0.79])
- Median overall survival of 16.85 months with ELAHERE compared to 13.34 months with chemotherapy, representing a 32% reduction in the risk of death (HR 0.68 [95% CI: 0.54, 0.84])
- Objective response rate of 41.9% with ELAHERE versus 15.9% with chemotherapy
"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," said Svetlana Kobina, MD, PhD, vice president, oncology medical affairs, AbbVie.
Addressing a Critical Unmet Need
Ovarian cancer is the leading cause of death from gynecological cancers in the United States, with approximately 20,000 women diagnosed each year. Most patients eventually develop platinum-resistant disease, which is difficult to treat and has historically had poor outcomes with conventional chemotherapy.
"The final data showcase the significant improvement in overall survival benefit of treatment with ELAHERE compared to standard of care chemotherapy," said investigator and presenter, Toon Van Gorp, MD, PhD, Professor of Gynecologic Oncology, University of Leuven. "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."
Favorable Safety Profile
The most common treatment-emergent adverse events (TEAEs) occurring in at least 20% of patients in the ELAHERE arm were blurred vision, keratopathy, abdominal pain, fatigue, diarrhea, dry eye, constipation, nausea, and peripheral neuropathy.
Importantly, compared with investigator's choice chemotherapy, treatment with ELAHERE was associated with lower rates of grade ≥3 TEAEs, serious adverse events, and discontinuations due to adverse events. This favorable safety profile is particularly significant for this patient population, as conventional chemotherapies often add substantial toxicity burden with minimal survival benefit.
A separate analysis from the MIRASOL study evaluating the impact of ELAHERE treatment-emergent ocular events on patient-reported health-related quality of life will be shared during an oral presentation on March 17 at the SGO Annual Meeting scientific plenary session.
About ELAHERE
ELAHERE is a first-in-class antibody-drug conjugate comprising a folate receptor alpha-binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill targeted cancer cells. The drug is indicated for adults with folate receptor-alpha positive ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have not responded to or are no longer responding to platinum-based chemotherapy and have received 1 to 3 prior types of chemotherapy.
The MIRASOL trial was a randomized Phase 3 study comparing ELAHERE to investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan). Patients were stratified by number of prior lines of therapy, with 14% having one prior line, 39% having two prior lines, and 47% having three prior lines. Sixty-two percent of patients had received prior bevacizumab, and 55% had received a prior PARP inhibitor.
These results represent an important advancement in the treatment landscape for platinum-resistant ovarian cancer, offering new hope for patients with this challenging disease.
