Ursula A. Matulonis, MD, on the Approval of 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, spoke about the phase 3 SORAYA trial and how it helped lead to the approval of mirvetuximab soravtansine in folate receptor-α–positive platinum-resistant ovarian cancer.

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 a professor of medicine at Harvard Medical School in Boston, Massachusetts, about the recent approval of mirvetuximab soravtansine-gynx (Elahere) 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.1 The accelerated approval was based on the results of the phase 3 SORAYA trial (NCT04296890), where patients were treated with mirvetuximab monotherapy.2

In the trial, patients had an overall response rate of 32.4% in the overall patient population, with a complete response rate of 4.8%, a partial response rate of 27.6%, and 45.7% had stable disease. Additionally, the median duration of response was 6.9 months, and the disease control rate was 51.4%, with a reduction in tumor size by 71.4%.

Transcript:

The accelerated FDA approval of mirvetuximab soravtansine, which is an antibody-drug conjugate [ADC], is the first ADC approved for ovarian cancer. The ADC targets FR-α, and it’s linked to DM4, which is an anti-tubulin drug. The approval is for patients who have FR-α–positive, high-grade serous ovarian cancer who have received up to 3 prior lines of treatment. The FR-α positivity is defined by the companion diagnostic approved by the FDA, showing that 75% or higher of cancer cells have to be at least 2-plus or higher staining, positive for FR-α.

The tissue we found through other studies, does not have to be a fresh biopsy, but it can be archival tissue from the patient’s original surgery; FR-α staining does not significantly change between new diagnosis and then recurrent disease.

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.