Ursula A. Matulonis, MD, Reviews Additional Trials Investigating Mirvetuximab Soravtansine in FR-α–Positive Platinum-Resistant Ovarian Cancer

Approval Alert | <b>Mirvetuximab Soravtansine Folate Receptor-α-Positive Platinum-Resistant Ovarian Cancer</b>

Ursula A. Matulonis, MD, discussued studies are being conducted assessing the use of mirvetuximab soravtansine in patients with folate receptor-α–positive platinum-resistant ovarian cancer.

Mirvetuximab soravtansine-gynx (Elahere) was recently approved by the FDA for patients with folate receptor-α (FR-α)–positive platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with 1 to 3 lines of prior therapy.1Following this regulatory decision, 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, regarding other indications mirvetuximab may be efficacious in, including for platinum-sensitive recurrent disease, as a single-agent, and in combination regimens. Moreover, she discussed the ongoing confirmatory phase 3 trial that may further build upon the phase 3 SORAYA trial (NCT04296890) for which the agent was granted approval.2

Transcript:

There are multiple trials of mirvetuximab ongoing currently. The phase 3 MIRASOL trial [NCT04209855] is an important one in order to inform the accelerated approval of mirvetuximab [by building on] the SORAYA study. The accelerated approval needs a confirmatory phase 3 study in order for us to get full approval for mirvetuximab in the platinum-resistant setting. MIRASOL is a phase 3 confirmatory trial, and the accrual has been completed; the results are currently being evaluated. Sometime in 2023, [we should] expect some preliminary results. This trial is a randomized study of single-agent mirvetuximab vs physician’s choice chemotherapy in patients with platinum-resistant ovarian cancer. The cancers have to have evidence of high FR-α expression through the companion diagnostic [assay] available for the accelerated approval.

There are other trials ongoing as well looking mirvetuximab and platinum-sensitive recurrence, as a single agent through the phase 2 PICCOLO study [NCT05041257], and then there’s the phase 3 GLORIOSA study [NCT02631876], which is testing mirvetuximab vs mirvetuximab plus bevacizumab [Avastin] as maintenance treatment post platinum doublet. Mirvetuximab is also being studied up front as part of a neoadjuvant regimen for newly diagnosed patients. Then there’s another trial from Gottfried E. Konecny, MD, that is testing carboplatin /mirvetuximab in patients whose cancers have high levels of FR-α expression, but also in lower expression levels too. [Essentially, the study is] looking at [outcomes by] different levels of FR-α expression [following] carboplatin plus mirvetuximab. There’s a lot going on.

References

  1. ImmunoGen announces FDA accelerated approval of ELAHERE™ (mirvetuximab soravtansine-gynx) for the treatment of platinum-resistant ovarian cancer. News release. ImmunoGen. November 14, 2022. Accessed November 14, 2022. https://bwnews.pr/3AayMyH
  2. Coleman RL, Lorusso D, Oaknin A, 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.