AbbVie has officially published its final analysis of the confirmatory Phase 3 MIRASOL trial, which evaluated the efficacy and safety of ELAHERE® (mirvetuximab soravtansine-gynx) in women suffering from folate receptor alpha (FRα)-positive platinum-resistant ovarian cancer (PROC), as compared to chemotherapy.
According to certain reports, at 30.5 months median follow-up, treatment with ELAHERE would show significant improvements in progression-free survival (PFS) and overall survival (OS), as compared to investigator’s choice (IC) chemotherapy.
To understand the significance of these results, we must take into account how ovarian cancer patients are often diagnosed at a late stage. Furthermore, they are usually first treated with platinum-based chemotherapy, which they may become resistant to and require another therapy, such as ELAHERE.
Making the given development even more critical is a fact that, in US, ovarian cancer happens to be the leading cause of death; as far as gynecological cancers are concerned. You see, every single year, approximately 20,000 women are diagnosed with the given condition.
We briefly touched upon how most patients also go on to develop platinum-resistant disease, adding to the difficulty during treatment, but what we haven’t mentioned yet is that this is a because single-agent chemotherapies have long been associated with minimal survival benefit, all while causing significant toxicity burden.
“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 at AbbVie. “We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers.”
In response to that, ELAHERE (mirvetuximab soravtansine-gynx) brings to the fore a first-in-class antibody-drug conjugate (ADC) made up with a folate receptor alpha-binding antibody, cleavable linker, as well as maytansinoid payload DM4, which would be a potent tubulin inhibitor designed to kill the targeted cancer cells
Anyway, talk about AbbVie’s Phase 3 MIRASOL study, it recruited a total 453 patients with high-grade serous epithelial PROC, patients whose tumors express high levels of FRα and have been treated with up to three prior therapies.
As for the results, they begin by revealing that ELAHERE treatment achieved superior efficacy versus IC chemotherapy, with a median PFS of 5.59 months versus 3.98 months. This marks a a 37% reduction in the risk of tumor progression or death (HR 0.63; [95% CI: 0.51, 0.79]), and a higher objective response rate of 41.9% versus 15.9%.
Next up, the results dig into how the patients, who were administered ELAHERE, experienced superior and clinically meaningful overall survival for patients receiving ELAHERE (median 16.85 months), compared to IC chemotherapy (median 13.34 months), representing a 32% reduction in the risk of death (HR 0.68 [95% CI: 0.54, 0.84]).
Some of the other endpoints in play here happen to include safety and duration of response (DOR), which were consistent with the primary data analysis at 13.1-months median follow-up.
Turning our attention towards most common treatment-emergent adverse events (TEAEs), they were observed across at least 20% of patients in the ELAHERE contingent. These TEAEs included blurred vision, keratopathy, abdominal pain, fatigue, diarrhea, dry eye, constipation, nausea, and peripheral neuropathy.
Having said so, as compared with IC chemotherapy, treatment done using ELAHERE, from an overall standpoint, exhibited lower rates of grade ≥3 TEAEs, serious AEs and discontinuations due to AEs.
“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, investigator and presenter, MD, PhD, Professor of Gynecologic Oncology at 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.”
