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Susan Marie Lang, MD, discusses the incidence of real-world ocular toxicity during treatment with mirvetuximab soravtansine in pretreated ovarian cancer.
Susan Marie Lang, MD, affiliate, Dean's Office Operations, Dean, Fellow in Medicine, Stanford Medicine, Stanford University, discusses the evaluation of real-world incidence of ocular toxicity due to treatment with mirvetuximab soravtansine-gynx (Elahere) in patients with pretreated ovarian cancer.
The rationale for this investigation was based on unmet needs in platinum-resistant ovarian cancer. This disease is characterized by the recurrence of ovarian cancer within 6 months from patients’ last platinum-based chemotherapy, and patients with platinum-resistant disease face relatively shorter survival times, Lang begins. Notably, the antibody-drug conjugate (ADC) mirvetuximab soravtansine was granted FDA approval in November 2022 for patients with folate receptor α–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1 to 3 prior systemic treatment regimens. This regulatory decision positioned mirvetuximab soravtansine as the first approved ADC for patients with platinum-resistant recurrent ovarian cancer, she elucidates.
However, mirvetuximab soravtansine is associated with a notable adverse effect (AE)––ocular toxicity, for which the agent has a black box warning, Lang emphasizes. According to published data from the pivotal phase 3 SORAYA trial (NCT04296890), the reported overall rate of ocular toxicity was 61% in the population of patients who received mirvetuximab soravtansine, she states. Given that findings from clinical trials are often derived in a controlled environment, this real-world evaluation assessed how patient factors may contribute to mirvetuximab soravtansine–associated ocular toxicity outside of a clinical trial setting.
A total of 26 patients, all diagnosed with high-grade serous platinum-resistant recurrent ovarian cancer, were examined, Lang expands. This investigation revealed that the incidence of mirvetuximab soravtansine–related ocular toxicity in the real-world setting closely aligned with that in SORAYA, she elucidates. The most prevalent ocular AE observed in this real-world study was keratopathy, or corneal changes, a finding which aligned with the most common ocular toxicity reported in SORAYA, Lang notes.
One aspect of particular interest in this research was the rate of decreased visual acuity among the patients studied, Lang continues. Literature often aggregates various visual changes reported by patients, including decreased acuity, visual blurriness, and other alterations, according to Lang. In this investigation, a focused examination on the rate of decreased visual acuity uncovered that 24% of patients experienced these visual changes when undergoing treatment with mirvetuximab soravtansine, Lang explains. These nuanced insights contribute to a more comprehensive understanding of the real-world implications of and challenges associated with this novel therapeutic approach, she concludes.