▎WuXiEdited by Kant Content Team

AbbVie announced today that the U.S. FDA has fully approved its "first-in-class" antibody-drug conjugate (ADC) Elahere (mirvetuximab soravtansine) for the treatment of patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian cancer, fallopian tube cancer, or primary peritoneal cancer who have previously received up to three systemic treatment regimens. According to the press release,Elahere is the first therapy to demonstrate an improvement in overall survival (OS) in patients with platinum-resistant ovarian cancer.

This approval is mainly based on the positive results of the Phase 3 MIRASOL clinical verification trial. Analysis showed that, compared with investigator's choice (IC) chemotherapy, Elahere demonstrated a statistically and clinically significant improvement in OS. As of the data cutoff,The median OS for patients in the Elahere group was 16.46 months, with a hazard ratio (HR) of 0.67 compared to 12.75 months in the IC chemotherapy group, p=0.0046.This means that, compared with the IC chemotherapy group, the risk of death in the Elahere group was reduced by 33%.

According to the investigator's assessment,Compared with IC chemotherapy, Elahere demonstrated a statistically and clinically significant improvement in PFS, with a hazard ratio of 0.65 (p<0.0001).This means that, compared with the IC chemotherapy group, the risk of tumor progression or death was reduced by 35% in the Elahere group. The median PFS was 5.62 months in the Elahere group and 3.98 months in the IC chemotherapy group. In addition, according to the investigator assessment,The ORR in the Elahere group was 42.3%, including 12 complete responses (CR), compared to 15.9% in the IC chemotherapy group, with no CR.

Elahere's safety profile mainly includes low-grade ocular and gastrointestinal events. No new safety signals were identified.

Elahere is a "first-in-class" antibody-drug conjugate (ADC) that links a humanized monoclonal antibody targeting FRα with the cytotoxic DM4 molecule via a disulfide bond.After the ADC binds to FRα, FRα is able to transfer the ADC into the cell, where the cytotoxic molecules carried by the ADC inhibit the mitosis of tumor cells. In November 2022, the U.S. FDAAccelerated ApprovalElahere Launches as Monotherapy for Heavily Pretreated, Platinum-Resistant, Advanced Ovarian Cancer Patients with High FRα Expression.

It is worth mentioning that Elahere was originally developed by ImmunoGen. In November 2023, AbbVie reached an agreement with ImmunoGen for $10.1 billion.AcquisitionThe company has also obtained Elahere. Prior to this, in October 2020, Huadong Medicine acquired the exclusive development and commercialization rights for the drug in Greater China for over $300 million.

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References:

[1] U.S. Food and Drug Administration (FDA) Grants Full Approval for ELAHERE® (mirvetuximab soravtansine-gynx) for Certain Ovarian Cancer Patients. Retrieved March 22, 2024 from https://news.abbvie.com/2024-03-22-U-S-Food-and-Drug-Administration-FDA-Grants-Full-Approval-for-ELAHERE-R-mirvetuximab-soravtansine-gynx-for-Certain-Ovarian-Cancer-Patients

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