AbbVie Receives European Marketing Approval for Elahere

AbbVie receives European marketing approval for Elahere for the treatment of platinum-resistant ovarian cancer

Overview

AbbVie announced the European Commission (EC) granted marketing authorization for Elahere (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha (FRa) positive, platinum-resistant high grade serous epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic treatment regimens. Elahere is the first and only folate receptor alpha (FR?)-directed antibody drug conjugate (ADC) medicine approved in the European Union (EU), as well as Iceland, Liechtenstein, Norway, and Northern Ireland.

Words from the Professor: University of Leuven

It's been 10 years since a new treatment for platinum-resistant ovarian cancer was approved in the EU, and now oncologists have an effective, new, targeted treatment option for these patients,"" said Toon Van Gorp, Professor of Gynaecological Oncology at the University of Leuven.

About the Ovarian Cancer

• Ovarian cancer is one of the leading causes of death from gynecological cancers worldwide. 
• Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy. 
• Unfortunately, most patients eventually develop platinum-resistant disease. 
• Historically, treatment options for patients with platinum-resistant ovarian cancer (PROC) have been limited, and those available often result in adverse events which can negatively impact quality of life.

From the CEO: World Ovarian Cancer Coalition

• Ovarian cancer can be devastating, taking women away from precious moments with their family, disrupting careers and the many other important contributions that women make to society,"" said Clara Mackay, CEO, World Ovarian Cancer Coalition. 
• In Europe, ovarian cancer is three times more deadly than breast cancer, and having new innovative options allows us to work toward a world where everyone living with ovarian cancer has the best chance of survival and the best quality of life possible, no matter where they live.

The Folate-Receptor Alpha (FRa) Biomarker in Cancer

• In approximately one third of people living with ovarian cancer, the folate-receptor alpha (FRa) biomarker is highly expressed (=75% of tumour cells with =2+ membrane staining intensity). 
• To determine biomarker status, patients can be tested with Roche's Ventana FOLR1 (FOLR1-2.1) RxDx Assay at diagnosis or at the first sign of resistance to platinum-based chemotherapy. 
• AbbVie collaborated with Roche Diagnostics on the newly approved immunohistochemistry (IHC) companion diagnostic test to identify patients who may be eligible for Elahere.

Statement from the CSO: AbbVie

The approval of Elahere by the European Commission provides a much needed clinically meaningful option for patients who receive the heartbreaking news their ovarian cancer has returned, fearing what's next in their treatment journey after they've developed platinum-resistance,"" said Roopal Thakkar, M.D., executive vice president, research and development, chief scientific officer, AbbVie.

Marketing authorization: - The marketing authorization of Elahere is supported by data from MIRASOL: a global, phase 3 open-label, randomized, controlled trial.

About the Trial

• Trial participants were 18 years of age or older with disease that had progressed while on or after one to three lines of previous therapy. 
• Patient tumours had to express high levels of FR? (=75% of tumour cells with =2+ membrane intensity), assessed using the Ventana FOLR1 (FOLR1-2.1) RxDx Assay. 
• The primary endpoint was investigator-assessed progression-free survival (PFS). 
• Key secondary endpoints included objective response rate (ORR) and overall survival (OS).
• Results presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting demonstrated a 35% reduction in the risk of tumour progression or death in patients treated in the Elahere arm compared with the investigator's choice (IC) chemotherapy arm, which represented an improvement in PFS [HR 0.65 (95% CI: 0.52, 0.81; p<0.0001)].

For Overall Surviva

Elahere also demonstrated improvement in OS compared with IC chemotherapy, representing a 33% reduction in the risk of death in the Elahere arm in comparison to the IC chemotherapy arm [HR 0.67 (95% CI: 0.50, 0.89; p=0.0046)].

Adverse Event

• The most common adverse reactions with Elahere 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 reaction was pneumonitis.

Data from the phase 3 MIRASOL Trial were also published in the New England Journal of Medicine (NEJM).

The MIRASOL Trials

• MIRASOL is a global phase 3 open-label, randomized, controlled trial that enrolled 453 patients to compare the efficacy and safety of mirvetuximab soravtansine 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 ovarian cancer whose tumours express high levels of FRa (=75% of cells with =2+ staining intensity), confirmed with a validated test. 
• Participants had previously received one to three lines of prior therapy. 
• The primary endpoint was investigator-assessed progression-free survival (PFS). 
• Key secondary endpoints included objective response rate (ORR) and overall survival (OS).

About the Antibody: Elahere

• Elahere is a first-in-class 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 (approved under the brand name Elahere) was granted approval by the European Commission in November 2024, and was granted full FDA approval in the United States in March 2024.
• Marketing authorization submissions for mirvetuximab soravtansine are under review in multiple other countries.

About the Company: AbbVie

• AbbVie is committed to transforming standards of care for patients living with difficult-to-treat cancers. 
• The company is advancing a dynamic pipeline of investigational therapies across a range of cancer types in both blood cancers and solid tumours.
• 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.

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