AbbVie’s Elahere secures EU approval for platinum-resistant ovarian cancer

USA – The European Commission (EC) has granted marketing authorisation to AbbVie’s Elahere (mirvetuximab soravtansine), marking a significant advancement in the treatment of folate receptor-alpha (FRα) positive, platinum-resistant ovarian cancer.

This approval comes a decade after the last breakthrough in therapies for this challenging condition.

Elahere, an antibody-drug conjugate (ADC), is now authorised in Europe for adult patients with high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers expressing FRα.

Eligible patients include those who have undergone one to three prior systemic treatments.

Approximately 35%-40% of ovarian cancer patients express the FRα biomarker, which Elahere specifically targets.

The ADC delivers the cytotoxic agent DM4 directly to cancer cells, sparing healthy tissue and reducing side effects compared to traditional chemotherapy.

“It’s been ten 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 Professor Toon Van Gorp, gynaecological oncology expert at the University of Leuven.

Promising clinical trial results

Elahere’s approval is based on data from the Phase III MIRASOL trial (NCT04209855), which evaluated 453 patients with FRα-positive platinum-resistant ovarian cancer. The results demonstrated:

• 35% reduction in the risk of disease progression or death compared to standard chemotherapy.
• Median progression-free survival (PFS) of 5.6 months versus 4 months in the chemotherapy arm.
• Median overall survival (OS) of 16.5 months compared to 12.8 months with standard treatment.

These outcomes address an unmet need for effective therapies in platinum-resistant ovarian cancer, providing a new hope for patients.

Global impact and future potential

Elahere is the first FRα-targeted ADC approved in the EU, enhancing AbbVie’s position in the ovarian cancer treatment landscape.

Analysts forecast the therapy could generate US $1.98 billion in revenue by 2030. Its first-to-market advantage positions it ahead of competitors like Bristol Myers Squibb and Eisai’s ADC farletuzumab ecteribulin, currently in Phase II trials.

The drug is also under investigation in three additional trials:

• GLORIOSA (Phase III): In combination with Roche’s Avastin.
• PICCOLO (Phase II): As a monotherapy.
• Another Phase II trial with carboplatin.

A strategic win amid challenges for AbbVie

AbbVie acquired Elahere through its US $10.1 billion purchase of ImmunoGen, marking a strategic success in diversifying its portfolio as revenue from Humira (adalimumab) declines due to biosimilar competition.

However, not all acquisitions have met expectations. Recently, disappointing Phase II results for emraclidine, a selective M4 muscarinic modulator, caused AbbVie shares to drop 13%.