Dr Graham on Notable Ongoing Studies in Ovarian Cancer

"The future [of ovarian cancer treatment] is an individualized approach to [treating] each patient. This will be the key to identifying the treatments that work and minimizing toxicities or exposure to medications that may not work.”

Deena M. Atieh Graham, MD, medical oncologist at John Theurer Cancer Center at Hackensack Meridian Health, discussed ongoing studies of note in patients with ovarian cancer following World Ovarian Cancer Day.

During the 2025 SGO Annual Meeting on Women’s Cancer, investigators presented data from part 1b of the ongoing phase 2 DENALI trial (NCT05128825) which is examining the WEE1 inhibitor azenosertib in patients with platinum-resistant ovarian cancer, Graham explained. At the January 13, 2025, data cutoff, response-evaluable patients with cyclin E1–positive disease (n = 43) achieved an objective response rate (ORR) of 34.9% (95% CI, 21.0%-50.9%). Patients in the intention-to-treat population with cyclin E1–positive disease (n = 48) experienced an ORR of 31.3% (95% CI, 18.7%- 46.3%) and a median duration of response of 6.3 months (95% CI, 2.7-not estimable).

Graham also noted that investigators are anticipating the results of the ongoing phase 3 GLORIOSA study (NCT05445778). GLORIOSA is examining the antibody-drug conjugate (ADC) mirvetuximab soravtansine-gynx (Elahere) in combination with bevacizumab (Avastin) vs bevacizumab monotherapy as maintenance therapy in patients with folate receptor α (FRα)–high ovarian cancer who did not experience disease progression following second-line treatment withplatinum-based doublet chemotherapy plus bevacizumab, she added. The primary end point of the study is investigator-assessed progression-free survival (PFS).

In March 2024, the FDA granted full approval to mirvetuximab soravtansine for the treatment of patients with FRα-positive, platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have previously received 1 to 3 systemic therapy regimens. The regulatory decision was supported by findings from the phase 3 MIRASOL trial (NCT04209855), which demonstrated that patients who received the ADC (n = 227) achieved a median overall survival of 16.5 months (95% CI, 14.5-24.6) compared with 12.7 months (95% CI, 10.9-14.4) among patients treated with investigator’s choice of chemotherapy (n = 226; HR, 0.67; 95% CI, 0.50-0.88; P = .0046). The median PFS was 5.6 months (95% CI, 4.3-5.9) vs 4.0 months (95% CI, 2.9-4.5), respectively (HR, 0.65; 95% CI, 0.52-0.81; P < .0001).