Background

Patients with platinum-resistant ovarian cancer have limited therapeutic options available to them. Treatment is largely comprised of chemotherapy, which is known to have limited efficacy where just 4% and 13% will benefit and substantial toxicity.

No biomarker-driven approaches have been indicated for this population.

Clinically meaningful antitumor activity and an acceptable safety profile were seen with the use of Mirvetuximab Soravtansine in patients with platinum-resistant ovarian cancer harboring high folate receptor–alpha (FRα) expression, according to the results of the phase 3 SORAYA trial (NCT04296890) presented during the The Society of Gynecologic Oncology (SGO) 2022 Annual Meeting on Women’s Cancer.

About the Study in ovarian cancer

The global, single-arm, phase 3 SORAYA trial enrolled patients with platinum-resistant ovarian cancer who were treated with 1 to 3 prior regimens and experienced recurrence within 6 months after the last platinum dose they had received.

To be eligible for enrollment, patients needed to have high-grade serous histology and have received prior Avastin.

Patients needed to have tumors that demonstrated FRα-high with immunohistochemistry PS2+ scoring.

Study Results – Patients with Platinum-Resistant Ovarian Cancer Harboring High Folate Receptor–Alpha (FRα) Expression

This antibody-drug conjugate (ADC) elicited a response rate (percentage of patients whose tumors decreased) of 32.4% in the patient population (n = 105).

• Among the 34 responders, 5 patients achieved a complete remission
• 29 patients experienced a partial response (percentage of patients whose tumors decreased between 30-50%)
• 7% of patients achieved stable disease
• 0% experienced disease progression
• The median duration of response was 6.9 months with the drug
• Moreover, the median progression-free survival (The time it took until the disease progressed under the treatment) with Mirvetuximab Soravtansine was 4.3 months.

What is Mirvetuximab Soravtansine?

Mirvetuximab Soravtansine is an antibody-drug conjugate (ADC) comprised of an FRα-binding antibody, a cleavable linker, and maytansinoid DM4.

Findings from a pooled analysis of prior studies that examined the ADC in 70 patients with FRα-high, platinum-resistant ovarian cancer who previously received 1 to 3 therapies, which included Avastin showed:

• Response Rate of 31.4%
• Median Duration of Response of 7.8 months
• Median Time Until Disease Progression of 4.4 months

Side Effects

Most side effects were low-grade, reversible ocular and gastrointestinal events.

Serious treatment-related side effects were experienced by 8% of patients.

A total of 7 patients discontinued treatment with the ADC because of toxicity.

Takeaway Message for ovarian cancer patients

Phase 3 SOROYA trial revealed promising response rates with Mirvetuximab Soravtansine in patients with platinum-resistant ovarian cancer and high folate receptor–alpha (FRα) expression.

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