FDA approves ImmunoGen’s Elahere for platinum-resistant ovarian cancer

The US Food and Drug Administration (FDA) has granted accelerated approval for ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) for the treatment of adult patients with folate receptor alpha (FRα)-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have received one to three prior systemic treatment regimens.

Ovarian cancer is the leading cause of death from gynaecological cancers in the US, with approximately 20,000 patients diagnosed each year and accounting for 13,000 deaths.

Most patients present with late-stage disease and will typically undergo surgery followed by platinum-based chemotherapy, but the majority of patients eventually develop platinum-resistant disease, which is difficult to treat. In this setting, standard of care single-agent chemotherapies are associated with low response rates, short durations of response and significant toxicities.

The FDA’s decision was based on positive results from the pivotal SORAYA trial, a single-arm study in 106 patients with platinum-resistant ovarian cancer whose tumours expressed high levels of FRα and who had been treated with one to three prior systemic treatment regimens – at least one of which included Avastin (bevacizumab).

Elahere demonstrated an overall response rate – the primary endpoint of the study – of 31.7%, including five complete responses. The median duration of response – the key secondary endpoint – was 6.9 months.

The company outlined that the safety of Elahere has been evaluated in a pooled analysis from three studies among a total of 464 patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who received at least one dose of Elahere.

In terms of safety, the prescribing information for Elahere includes a boxed warning for ocular toxicity, including visual impairment, keratopathy, dry eye, photophobia, eye pain, and uveitis.

"The approval of Elahere is significant for patients with FRα-positive platinum-resistant ovarian cancer, which is characterised by limited treatment options and poor outcomes," said Ursula Matulonis, chief of the division of gynaecological oncology at the Dana-Farber Cancer Institute, professor of medicine at the Harvard Medical School, and SORAYA co-principal investigator.

She continued: “Elahere’s impressive anti-tumour activity, durability of response, and overall tolerability observed in SORAYA demonstrates the benefit of this new therapeutic option, and I look forward to treating patients with Elahere."

The company said MIRASOL, the confirmatory randomised trial designed to convert the accelerated approval of Elahere to full approval, is fully enrolled and top-line data is expected in early 2023.