The European Commission (EC) has granted marketing authorization to AbbVie's Elahere (mirvetuximab soravtansine) for the treatment of folate receptor-alpha (FRα) positive, platinum-resistant high-grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancers in adult patients who have undergone one to three prior systemic treatment regimens. This approval marks a significant advancement in the treatment landscape, addressing a critical unmet need for patients with this aggressive form of ovarian cancer.
Clinical Efficacy and Safety
The approval of Elahere is supported by data from the Phase III MIRASOL trial (NCT04209855), a randomized study that enrolled 453 patients with FRα-positive platinum-resistant ovarian cancer. The trial demonstrated a statistically significant and clinically meaningful 35% reduction in the risk of disease progression or death compared to standard chemotherapy. Patients treated with Elahere experienced a median progression-free survival (PFS) of 5.6 months, compared to 4 months in the chemotherapy arm. Furthermore, the Elahere arm showed a median overall survival (OS) of 16.5 months, while the chemotherapy arm had a median OS of 12.8 months.
Toon Van Gorp, professor of gynaecological oncology at the University of Leuven, noted, "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."
Mechanism of Action and Target Population
Elahere is an antibody-drug conjugate (ADC) that targets the FRα protein, which is expressed in approximately 35%-40% of ovarian cancers. By selectively delivering the cytotoxic agent DM4 directly to cancer cells, Elahere aims to minimize off-target effects and reduce toxicity compared to traditional chemotherapy. This targeted approach is particularly beneficial for patients with platinum-resistant disease, where treatment options are limited and often associated with significant side effects.
Market Impact and Future Development
GlobalData market analysts predict that Elahere could generate up to $1.98 billion in revenue for AbbVie by 2030. AbbVie inherited Elahere as part of its $10.1 billion acquisition of ImmunoGen. The drug received accelerated approval by the US Food and Drug Administration (FDA) in November 2022 and was granted full FDA approval in the US in March 2024.
Elahere is also being investigated in three other ovarian cancer trials: in combination with Roche’s Avastin (bevacizumab) in the Phase III GLORIOSA study (NCT05445778), as a monotherapy in the Phase II PICCOLO study (NCT05041257), and with carboplatin in another Phase II trial (NCT05456685).
