Treatment with Elahere (mirvetuximab soravtansine-gynx) showed consistent survival benefits in a long-term analysis from the phase 3 trial MIRASOL evaluating patients with folate receptor alpha-positive platinum-resistant ovarian cancer, according to a news release from drug’s manufacturer, AbbVie.
After a median follow-up of 30.5 months, Elahere demonstrated superior efficacy over the investigator’s choice of treatment with chemotherapy. The median progression-free survival was 5.59 months with Elahere versus 3.98 months with chemotherapy, and it reduced the risk of tumor progression or death by 37%. The objective response rate was higher with Elahere at 41.9% versus 15.9% and the median overall survival was 16.85 months and 13.34 months with Elahere versus chemotherapy, respectively, a 32% reduction in the risk of death. Safety and duration of response remained consistent with the primary analysis at a median follow-up of 13.1 months.
Glossary:
Progression-free survival: the length of time during and after treatment that a patient lives without disease progression.
Objective response rate: the percentage of patients whose cancer shrinks or disappears after treatment.
Overall survival: the length of time from diagnosis or treatment start that patients are still alive.
Folate receptor alpha: a protein found in high amounts on some ovarian cancer cells that can be targeted by certain treatments.
PARP inhibitor: a type of drug that prevents cancer cells from repairing DNA damage, making them more likely to die.
Keratopathy: damage to the cornea, the clear outer layer of the eye, which can cause vision problems.
Peripheral neuropathy: nerve damage that can cause numbness, tingling or pain, usually in the hands and feet.
"Ovarian cancer can be devastating, and when cancer cells stop responding to chemotherapy patients may feel hopeless about their journey. The data presented reinforce the importance of Elahere as a transformative therapy for patients with limited options," Dr. Svetlana Kobina, vice president of oncology medical affairs at AbbVie, said in the news release. "We remain steadfast in our commitment to bring forward innovative therapies that improve the lives of patients with difficult-to-treat cancers."
Delving Into the Phase 3 MIRASOL Study
Elahere is a unique targeted cancer treatment which combines an antibody with a cancer-killing drug. Notably, the agent specifically targets cancer cells with high levels of a protein called folate receptor alpha, delivering a powerful medication to destroy them.
"The final data showcase the significant improvement in overall survival benefit of treatment with Elahere compared to standard of care chemotherapy," trial investigator, Dr. Toon Van Gorp, a professor of Gynecologic Oncology at University of Leuven, said in the release. "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."
The phase 3 MIRASOL study enrolled 453 patients with high-grade serous epithelial platinum-resistant ovarian cancer whose tumors had high levels of folate receptor alpha and had received up to three prior treatments. Patients were stratified by the number of prior therapy lines, with 14% having one, 39% having two and 47% having three. They were also stratified by investigator’s choice chemotherapy, with paclitaxel most common (41%), followed by PLD (36%) and topotecan (23%). Prior treatment included bevacizumab in 62% of patients and a PARP inhibitor.
For the primary end goal of the study, investigators evaluated progression-free survival; secondary end goals included objective response rate and overall survival.
Regarding side effects, the most common treatment-emergent side effects which occurred in at least 20% of patients treated with Elahere included blurred vision, keratopathy, abdominal pain, fatigue, diarrhea, dry eye, constipation, nausea and peripheral neuropathy. Compared with investigator’s choice chemotherapy, Elahere was associated with lower rates of severe side effects, serious side effects and treatment discontinuations due to side effects.
A separate analysis from the phase 3 MIRASOL study on the impact of Elahere treatment-emergent ocular events and patient-reported health-related quality of life will be presented March 17 during an oral session at the Society of Gynecologic Oncology Annual Meeting on Women’s Cancer in Seattle.
Elahere received full Food and Drug Administration approval in March 2024 and European Commission approval in November 2024.
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