AbbVie’s First in Class Therapy ELAHERE® ▼ (mirvetuximab soravtansine) Licensed by the Medicines and Healthcare products Regulatory Agency for the Treatment of Eligible Adult Patients with Platinum-Resistant Ovarian Cancer

• Mirvetuximab soravtansine is the first folate receptor-alpha (FRα) targeted antibody-drug conjugate (ADC) licensed in the UK for the treatment of adults with platinum-resistant high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic treatment regimens, and who test positive for high levels of FRα.[1]

• Mirvetuximab soravtansine demonstrated progression free survival and overall survival benefit in a Phase 3 trial in platinum-resistant ovarian cancer compared with chemotherapy (paclitaxel, pegylated liposomal doxorubicin, or topotecan).¹

• 80% of people living with advanced ovarian cancer relapse during or after first-line treatment and the majority eventually develop resistance to platinum-based chemotherapy,[2]^,[3] highlighting the unmet clinical need for these patients.

MAIDENHEAD, UK, 24^th July 2025 – AbbVie (NYSE: ABBV) today 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.¹

Ovarian cancer is one of the leading causes of death from gynaecological cancer worldwide.[4] In the UK, there are around 7,500 new diagnoses of the disease each year, making it the sixth most common cancer in women.[5]  Unfortunately, two thirds of women with ovarian cancer are diagnosed late, when the cancer is harder to treat.[6] 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.^2,3

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]

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.^1,7

“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).[8] 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”.

-Ends-

UK media contact:

Olivia Bailey

AbbVie UK

T: +44 7974 352660

E: olivia.bailey@abbvie.com

NOTES TO EDITORS:

About Ovarian Cancer

Ovarian cancer is caused by cells in the ovaries dividing uncontrollably, forming a tumour and potentially spreading to surrounding tissues or other parts of the body.[9] There are different types of ovarian cancer, depending on the type of cell it starts in these include, but are not limited to: epithelial ovarian cancers, germ cell ovarian cancer and sex cord stromal cancers.⁹ Around 7,500 women are diagnosed with ovarian cancer in the UK each year, making it the 6th most common cancer among women.⁵

About ELAHERE^® (mirvetuximab soravtansine)
ELAHERE^® is a first-in-class antibody-drug conjugate (ADC) composed of a folate receptor alpha binding antibody, cleavable linker, and the maytansinoid payload DM4, a potent tubulin inhibitor designed to kill the targeted cancer cells.

Mirvetuximab soravtansine (under the brand name ELAHERE^®) was licensed by the European Commission and authorised by the National Medical Products Administration (NMPA) in China in November 2024 and also granted full FDA approval in the United States in March 2024.

Marketing authorisation submissions for mirvetuximab soravtansine are under review in multiple other countries.

About the Phase 3 MIRASOL Trial
MIRASOL is a global Phase 3 open-label, randomised, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine, administered once every 3 weeks as an intravenous infusion, with the investigator's choice of single-agent chemotherapy (weekly paclitaxel, pegylated liposomal doxorubicin, or topotecan) in the treatment of platinum-resistant, high-grade serous epithelial ovarian cancer whose tumours express high levels of FRα (≥75% of cells with ≥2+ staining intensity), confirmed with a validated test. Participants had previously received one to three lines of prior systemic therapy. The primary endpoint was investigator-assessed progression-free survival (PFS). Key secondary endpoints included objective response rate (ORR) and overall survival (OS).

More information can be found on www.clinicaltrials.gov (NCT 04209855).

About AbbVie in Oncology

At AbbVie, we are committed to transforming standards of care for multiple blood cancers, while advancing a dynamic pipeline of investigational therapies across a range of cancer types. Our dedicated and experienced team joins forces with innovative partners to accelerate the delivery of potentially breakthrough medicines. We are evaluating more than 35 investigational medicines in over 300 clinical trials across some of the world’s most widespread and debilitating cancers. As we work to have a remarkable impact on people’s lives, we are committed to exploring solutions to help patients obtain access to our cancer medicines. For more information, please visit www.abbvie.co.uk

About AbbVie

AbbVie’s mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas – immunology, oncology, neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at abbvie.co.uk. Follow @abbvieuk on X, formally known as Twitter, and YouTube (@abbvieuk6755).

References

Clicking the links below will take you to external websites that are not managed or owned by AbbVie.

[1] ELAHERE. UK Summary of Product Characteristics.

[2] Berg T, Nøttrup TJ, Roed H. Gemcitabine for recurrent ovarian cancer - a systematic review and meta-analysis. Gynecol Oncol. 2019; 155(3): 530-537.

[3] Havasi A, Cainap SS, Havasi AT, Cainap C. Ovarian Cancer-Insights into Platinum Resistance and Overcoming It. Medicina (Kaunas). 2023 Mar 10;59(3):544.

[4] WHO International Agency for Research on Cancer. GLOBOCAN 2022. Cancer Today. Absolute numbers, Mortality, Females, age [0-74], in 2022. Available from: https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf [Last accessed: July 2025].

[5] Cancer Research UK. Ovarian cancer statistics. Available from: https://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/ovarian-cancer. [Last accessed: July 2025].

[6] Target Ovarian Cancer. Key facts and figures. Available from: https://targetovariancancer.org.uk/about-us/media-centre/key-facts-and-figures. [Last accessed: July 2025].

[7] Moore K, Angelergues, A, Konecny, G et al. Mirvetuximab Soravtansine in FRα-Positive, Platinum-Resistant Ovarian Cancer. N Engl J Med 2023; 389: 2162-2174.

[8] Markert S, Lassmann S, Gabriel B, et al. Alpha-folate receptor expression in epithelial ovarian carcinoma and non-neoplastic ovarian tissue. Anticancer Res. 2008;28(6A):3567–3572.

[9] Cancer Research UK. What is ovarian cancer? Available from: https://www.cancerresearchuk.org/about-cancer/ovarian-cancer/what-is-ovarian-cancer [Last accessed: July 2025].