US-based Immunogen recently announced positive top-line data from their Phase III MIRASOL trial evaluating Elahere (mirvetuximab) for the treatment of platinum-resistant ovarian cancer. The company plans to use the data to support their forthcoming supplemental Biologics Licensing Application for full FDA approval. Elahere’s sales are expected to reach $615 million by 2029, registering a 114% compound annual growth rate (CAGR), according to GlobalData, a leading data and analytics company.

Elahere, a folate receptor alpha (FR)-directed antibody-drug conjugate (ADC) was granted FDA accelerated approval in November 2022, becoming the first ADC approved for platinum-resistant ovarian cancer. The drug is approved for patients with FRα-positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior lines of systemic therapy. The trial evaluated Elahere against various single-agent chemotherapy drugs.

Israel Stern, Oncology & Hematology Analyst at GlobalData, comments: “The standard of care (SOC) for epithelial ovarian, fallopian, and primary peritoneal cancers has long been platinum therapies. Patients who become resistant to these therapies have been treated with nonplatinum cytotoxic agents, including liposomal doxorubicin, paclitaxel, and topotecan, alone or in combination with Avastin (bevacizumab). Immunogen believes Elahere will replace these therapies as a SOC.”

In the study, Elahere outperformed the investigator’s choice (IC) of chemotherapies in various clinical metrics, including median progression-free survival of 5.6 months in the Elahere arm vs. 4 months in the IC arm, in addition to an improvement in median overall survival of 16.5 months compared to 12.8 months and objective response rates of 42.3% vs. 15.9%. The drug’s safety profile primarily consists of low-grade ocular and gastrointestinal events and has lower rates of grade ≥3 adverse events.

Stern continues: “With the data from MIRASOL, Immunogen is poised to receive the full FDA nod as well as market access in Europe. A key to an expanded patient pool  is Elahere’s potential clinical benefit for patients who have platinum-sensitive ovarian disease.”

Immunogen currently has two ongoing trials for platinum-sensitive ovarian cancer: PICCOLO, a Phase ll study, and GLORIOSA, a Phase lll study where Elahere is administered in combination with Avastin.

Stern concludes: “The likely full approval of Elahere is great news for Immunogen and its investors. Data from the ongoing trials will go a long way toward forecasting the true revenue potential for the drug. One thing is for certain, Immunogen will continue to utilize their successful proprietary ADC technology to develop new agents across the cancer spectrum.”