AbbVie has announced that it has received marketing authorisation from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for ELAHERE (mirvetuximab soravtansine) as monotherapy for the treatment of eligible adult patients with folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens.
Ovarian cancer is one of the leading causes of death from gynaecological cancer worldwide. In the UK, there are around 7,500 new diagnoses of the disease each year, making it the sixth most common cancer in women. Unfortunately, two thirds of women with ovarian cancer are diagnosed late, when the cancer is harder to treat. Women newly diagnosed with ovarian cancer typically receive surgery and platinum-based chemotherapy, but sadly, 80% of people with advanced disease relapse and the majority eventually develop resistance to this treatment, resulting in poor prognosis.
Mirvetuximab soravtansine is the first new treatment in 10 years to be licensed for the treatment of women in the UK with platinum-resistant ovarian cancer and is administered once every 3 weeks. This authorisation is supported by data from MIRASOL; a global, Phase 3, open-label, randomised, controlled trial. In MIRASOL, the median progression free survival (PFS, the primary endpoint of the trial) for patients who received mirvetuximab soravtansine (n=227) was 5.62 months compared with 3.98 months for those who received chemotherapy (n=226) [HR 0.65, 95% CI 0.521-0.808, p<0.001]. This means that mirvetuximab soravtansine reduced the chance of the cancer progressing or the patient dying by 35% compared with those who received chemotherapy. The median PFS for patients who received mirvetuximab soravtansine was 5.62 months compared with 3.98 months with those who received chemotherapy. Overall survival (a secondary endpoint) was significantly longer for those patients who received mirvetuximab soravtansine than those who received chemotherapy (median, 16.46 months vs. 12.75 months; HR 0.67; 95% CI, 0.50-0.89; P=0.005).1,7 ><0.001]. This means that mirvetuximab soravtansine reduced the chance of the cancer progressing or the patient dying by 35% compared with those who received chemotherapy. The median PFS for patients who received mirvetuximab soravtansine was 5.62 months compared with 3.98 months with those who received chemotherapy. Overall survival (a secondary endpoint) was significantly longer for those patients who received mirvetuximab soravtansine than those who received chemotherapy (median, 16.46 months vs. 12.75 months; HR 0.67; 95% CI, 0.50-0.89; P=0.005).
The most common adverse reactions with mirvetuximab soravtansine were blurred vision, nausea, diarrhoea, fatigue, abdominal pain, keratopathy, dry eye, constipation, vomiting, decreased appetite, peripheral neuropathy, headache, asthenia, increased aspartate aminotransferase, and arthralgia. The most commonly reported serious adverse reactions were pneumonitis, small intestinal obstruction, intestinal obstruction, pleural effusion, abdominal pain, dehydration, constipation, nausea, ascites and thrombocytopenia.
“It is fantastic news that the MHRA has granted authorisation for mirvetuximab soravtansine – this is a milestone for the treatment of eligible adult women with folate-receptor high platinum-resistant ovarian cancer in the UK. Treatment advances with novel mechanisms of action, like mirvetuximab soravtansine, are crucial for helping eligible women with this type of cancer,” said Professor Susana Banerjee, consultant medical oncologist, research lead Gynaecology Unit, The Royal Marsden NHS Foundation Trust, London and Professor in Women’s Cancers, the Institute of Cancer Research, London.
As an antibody-drug conjugate therapy, mirvetuximab soravtansine is designed to target and kill tumour cells that express high levels of FRα while reducing impact on healthy tissue. In approximately one third of people living with ovarian cancer, the FRα biomarker is highly expressed (≥75% of tumour cells with ≥2+ membrane staining intensity). To determine if people are eligible for mirvetuximab soravtansine, the Roche VENTANA FOLR1 (FOLR1-2.1) RxDx Assay can be used to test FRα biomarker status. The newly certified immunohistochemistry companion diagnostic test identifies patients who may be eligible for mirvetuximab soravtansine.
“AbbVie has an established portfolio of licensed therapies across blood cancers and today’s announcement marks our broader commitment to support treatment outcomes for patients with solid tumours,” said Rachael Millward, medical director, AbbVie UK. “This is an important development for women with advanced ovarian cancer, and in particular the underserved platinum-resistant patient population. Following marketing authorisation, our priority now is to work with NICE to provide all the necessary information for their appraisal of mirvetuximab soravtansine.”
