Ursula A. Matulonis, MD, Discusses the Toxicity Profile of Mirvetuximab Soravtansine in Advanced Ovarian Cancer With High FR- α Expression

CancerNetwork^® spoke with Ursula A. Matulonis, MD, chief of the Division of Gynecologic Oncology, Brock-Wilson Family Chair, and institute physician at Dana-Farber Cancer Institute as well as professor of medicine at Harvard Medical School in Boston, Massachusetts, at the 2022 Annual Global Meeting of the International Gynecologic Cancer Society about the toxicity profile from the phase 3 SORAYA trial (NCT04296890) of mirvetuximab soravtansine monotherapy in patients with folate receptor α–high platinum-resistant ovarian cancer.

In 9% of patients, grade 3 or higher treatment-related adverse effects (TRAEs) occurred. Dose delays occurred in 33% of patients and reduction occurred in 20%. The most common grade 3 TRAEs were keratopathy (8%) and blurred vision (6%). There was 1 instance of grade 4 keratopathy.

Transcript:

Mirvetuximab is very well-tolerated drug, and it’s important to remember that each antibody-drug conjugate has its own unique adverse effects. They’re not interchangeable whatsoever. Mirvetuximab has predominantly low-grade eye toxicities that are reversible and low-grade gastrointestinal toxicities. The remainder of toxicities [occurred in] small amounts. About a third of the patients do develop some type of keratopathy, and it is what the ophthalmologists will see on the eye examination. Only 8% of [the AEs in the trial were] grade 3. The keratopathy was mostly grade 1 and grade 2 in severity. Blurred vision happened in about 41% of patients, only 6% were grade 3 events, the vast majority of blurred vision AEs were grade 1 or 2. The most common gastrointestinal AE was nausea; that happened in about 30% of patients, and none were grade 3 or higher.

What’s important is the level of peripheral neuropathy which happened in 13% of all patients, none of which were grade 3 or 4. Serious grade 3 or higher TRAEs happened in 9% of patients. TRAEs lead to dose delays in a third of the patients, dose reductions in 20% of the patients, and 9% of patients stopped treatment due to treatment-related adverse events. One patient discontinued because of ocular toxicity. Once they stopped the drug, the ocular toxicity fully resolved. One death was possibly related to the study, which was a lung toxicity. Upon autopsy, that patient was found to have lung metastases but no evidence of lung toxicity associated with mirvetuximab. In essence, that was not a lung toxicity. Overall, it’s a very well-tolerated drug.

Reference

Coleman RL, Matulonis U, Lorusso D, et al. Clinical benefit of mirvetuximab soravtansine in ovarian cancer patients with high folate receptor alpha expression: results from the SORAYA study. Presented at: 2022 Annual Global Meeting of the International Gynecologic Cancer Society; New York, NY; September 29-October 1, 2022. Abstract O028.