FDA Approval of Elahere Represents a ‘Step Forward’ for Platinum-Resistant Ovarian Cancer Subset

The Food and Drug Administration (FDA) approval of Elahere (mirvetuximab soravtansine-gynx) is a significant step forward for the treatment of patients with platinum-resistant ovarian cancer, especially since it is the first approval for this patient population since 2014, an expert said.

In particular, the FDA recently approved the antibody-drug conjugate Elahere for the treatment of patients with folate receptor alpha-positive, platinum-resistant gynecological cancers who have undergone one to three prior systemic treatment regimens. These cancers include epithelial ovarian, fallopian tube and primary peritoneal cancer.

“The fact that Elahere has received accelerated approval is huge,” Dr. Ursula A. Matulonis, chief of the division of gynecologic oncology and the Brock Wilson Family Chair at Dana-Farber Cancer Institute in Boston, told CURE®. “It’s definitely a step forward for our patients.”

Quick Response to Therapy

The approval was based on findings from the SORAYA trial, of which Matulonis was the co-principal investigator. Patients with folate receptor alpha-positive, platinum-resistant ovarian cancer who were treated with Elahere had an overall response rate (the percentage of patients with a partial or complete response to treatment within a certain period of time) of 32.4%, of whom five patients had a complete response (the disappearance of all signs of cancer from treatment) to the treatment.

Matulonis said that two-thirds of patients responded to treatment at their first cancer response assessment at six weeks, and that statistic shows that the drug has the ability to work quickly.

“Platinum-resistant ovarian cancer (is) a cancer where the patient can have significant tumor burden which causes symptoms or imminently may lead to symptoms if the cancer is not treated,” she said. “These symptoms include abdominal bloating and distension, gastrointestinal distress, early satiety, bowel changes such as constipation or diarrhea, and these could eventually lead to symptoms of a partial small bowel obstruction.”

Since 2014, PARP inhibitors were primarily used to treat patients with recurrent BRCA-mutated ovarian cancer and as maintenance for those with newly diagnosed as well as recurrent platinum-sensitive disease post-receipt of platinum. Most recently, the approvals of these PARP inhibitors have changed, Matulonis said. In 2022, three PARP inhibitors that were approved by the FDA for the treatment of recurrent BRCA-mutated ovarian cancer were voluntarily removed by the companies for efficacy issues, specifically Lynparza (olaparib), Rubraca (rucaparib) and Zejula (niraparib).

Matulonis noted that the FDA approval of Elahere represents a changing tide in treating patients with platinum-resistant ovarian cancer, but that does not mean that PARP inhibitors will no longer be of use.

“PARP inhibitors have been really important, and their importance is I think really exemplified in the upfront setting where patients have not received much treatment; they have received an initial platinum- and taxane-based regimen,” she explained.

Eye and Gastrointestinal Side Effects

Matulonis mentioned that most side effects associated with Elahere are low grade and predominately involve the eyes and gastrointestinal system. Patients may experience blurred vision with Elahere, which is due to microcysts that form in the cornea of the eye.

“The turnaround time for the regeneration of new corneal cells is around seven to 10 days,” Matulonis said. “That’s when we see improvement of side effects. If the blurred vision is bothersome to the patient, we can either dose delay or drop the dose from 6 milligrams per kilogram to 5 milligrams per kilogram, which typically takes care of the problem. … Patients should feel assured that if they have to dose reduce, that the dose reduction will not negatively impact treatment efficacy.”

The gastrointestinal side effects with Elahere were also low grade and included nausea and diarrhea, both of which are manageable.

Even with the progress made with this FDA approval, more treatment options are needed for platinum-resistant ovarian cancer.

“Survival is increasing (in women with ovarian cancer), so we’re really able to manage folks who have recurrent ovarian cancer well,” Matulonis said. “We need to keep identifying targets that are exploitable, developing novel therapeutics and continuing the research effort.”

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