Dr Graham on the Significance of the FDA Approval of Mirvetuximab Soravtansine in Ovarian Cancer

“Antibody-drug conjugates [ADCs] are here to stay [in ovarian cancer]. In other tumor types such as breast cancer, we’ve learned that it’s not just about the target; an ADC is made up of the linker, the payload, and the target. There are always ways to manipulate those 3 [elements]. Those of us who [treat] patients with ovarian cancer need to understand more about these tumors [in order to create] more targeted therapies.”

Deena M. Atieh Graham, MD, medical oncologist at John Theurer Cancer Center at Hackensack Meridian Health, discussed the FDA approval of mirvetuximab soravtansine-gynx (Elahere) following World Ovarian Cancer Day.

In March 2024, the FDA granted regular approval to mirvetuximab soravtansine for the treatment of patients with folate receptor α (FRα)–positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have previously received 1 to 3 systemic therapy regimens. The approval was supported by data from the phase 3 MIRASOL trial (NCT04209855). Patients who received mirvetuximab soravtansine (n = 227) experienced a median overall survival of 16.5 months (95% CI, 14.5-24.6) vs 12.7 months (95% CI, 10.9-14.4) for patients who received investigator’s choice of chemotherapy (n = 226; HR, 0.67; 95% CI, 0.50-0.88; P = .0046).

The development and approval of mirvetuximab soravtansine underscores the shift towards targeted therapies in ovarian cancer, which now also include HER2-directed agents, Graham said. In the past, most patients with ovarian cancer were treated in a similar manner, but now with the emergence of more targeted agents, oncologists can use personalized medicine to a greater degree, she continued. There is also interest among investigators in moving targeted treatments into the maintenance setting of ovarian cancer, Graham noted.

Mirvetuximab soravtansine is currently being evaluated in combination with bevacizumab (Avastin) in the maintenance setting in the phase 3 GLORIOSA study (NCT05445778). GLORIOSA is enrolling patients with FRα-high ovarian cancer who did not experience disease progression after second-line treatment with platinum-based doublet chemotherapy and bevacizumab. Patients will be randomly assigned 1:1 to receive mirvetuximab soravtansine plus bevacizumab or bevacizumab monotherapy.