Relacorilant Combo Sustains Ovarian Cancer Benefit Post Platinum Break

Survival gains were observed with relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer and a platinum-free interval of 1 to 6 months.

Adding relacorilant to nab-paclitaxel (Abraxane) was linked with better survival in patients with platinum-resistant ovarian cancer in poor-prognosis subgroups, including those with an interval of 1 to 6 months without platinum-based treatment, per data from an analysis of the phase 3 ROSELLA trial (NCT05257408).

Findings presented at the 2025 ESMO Gynecological Cancers Congress demonstrated among patients who had a primary platinum-free interval of 1 to 6 months, relacorilant plus nab-paclitaxel (n = 54) generated a median progression-free survival (PFS) of 5.82 months (95% CI, 5.29-7.89) compared with 3.94 months (95% CI, 2.73-5.78) for nab-paclitaxel alone (n = 58; HR, 0.50; 95% CI, 0.30-0.84; nominal P = .0081).

Additionally, patients in this subgroup treated with the relacorilant regimen experienced a median overall survival (OS) that was not reached (NR; 95% CI, 8.44-NR) compared with 9.56 months (95% CI, 6.05-11.50) for those given nab-paclitaxel alone (HR, 0. 52; 95% CI, 0.31-0.89; nominal P = .0140).

“In this subgroup analysis of patients with primary platinum-refractory and -resistant populations, the combination [still showed] a significant benefit in PFS,” lead study author Domenica Lorusso, MD, PhD, said in a presentation of the data. Lorusso is director of the Gynecological Oncology Unit at Humanitas Hospital San Pio X in Milan, Italy, and a full professor of obstetrics and gynecology at Humanitas University in Rozzano.

Prior Data From ROSELLA

Data previously reported at the 2025 ASCO Annual Meeting and shared again at the ESMO Gynecological Cancers Congress showed that in the overall population, relacorilant plus nab-paclitaxel (n = 188) produced a median PFS of 6.54 months (95% CI, 5.55-7.43) compared with 5.52 months (95% CI, 3.94-5.88) for nab-paclitaxel alone (n = 193; HR, 0.70; 95% CI, 0.54-0.91; P = .0076). The 6- and 12-months PFS rates were 52% and 25% for relacorilant plus nab-paclitaxel, respectively. These respective rates were 42% and 13% in the control arm.

Additionally, the median OS was 15.97 months (95% CI, 13.47-NR) in the relacorilant arm vs 11.50 months (95% CI, 10.02-13.57) in the control arm (HR, 0.69; 95% CI, 0.52-0.92; P = .0121). The 12-month OS rates were 60% and 49%, respectively.

The overall response rate (ORR) per RECIST 1.1 criteria was 36.9% in the relacorilant arm vs 30.1% in the nab-paclitaxel alone arm. The respective clinical benefit rates (CBR) were 51.1% and 38.9%, respectively. CA-125 responses were observed in 43.4% of patients in the experimental arm vs 37.4% of patients in the control arm.

Investigator Alexander Olawaiye, MD, shared with Oncology Nursing News in an interview that the treatment will be more convenient for patients.

"It’s also very dose-convenient because it’s [in the form of] a pill," said Olawaiye. "The patient can use the pill in the comfort of their own home and only come into the hospital for infusion."

ROSELLA Background

The phase 3 study evaluated the addition of the novel, selective GR antagonist relacorilant to nab-paclitaxel in patients with epithelial ovarian, primary peritoneal, or fallopian tube cancer who experienced disease progression less than 6 months after the last dose of platinum-based chemotherapy. The study excluded patients who had no response to platinum or experienced progression less than 1 month of receiving primary platinum. Notably, 29.4% of patients (n = 112/381) had a primary platinum-free interval of 1 to 6 months.

One to 3 prior lines of therapy, including prior bevacizumab (Avastin), were required for all patients. They also needed to have an ECOG performance status of 0 or 1.

Patients were randomly assigned 1:1 to receive open-label relacorilant plus nab-paclitaxel or nab-paclitaxel alone. Patients were stratified by prior lines of therapy (1 vs >1) and region (North America vs Europe vs Korea, Australia, and Latin America).

Blinded independent central review–assessed PFS per RECIST 1.1 criteria and OS served as the trial’s primary end points. Secondary end points included investigator-assessed PFS, ORR, duration of response, CBR, CA-125 response, PFS and OS by subgroups, and safety.

Subgroup Baseline Characteristics

The baseline demographics for the trial’s overall population, which were also previously reported, were well balanced between the two arms.

In the subgroup of patients with a platinum-free interval of 1 to 6 months, the median age was 63 years (range, 43-85) in the relacorilant arm vs 63 years (range, 33-85) in the control arm. The majority of patients in both groups were White (relacorilant arm, 75.9%; control arm, 63.8%), from Europe (51.9%; 48.3%), did not harbor BRCA mutations (75.9%; 70.7%), and received 2 prior lines of therapy (46.3%; 48.3%).

Additionally, 24.1% of patients in the relacorilant arm had primary platinum-refractory disease compared with 22.4% of patients in the nab-paclitaxel arm. Prior taxanes in the platinum-resistant setting were given to 5.6% and 6.9% of patients, respectively. Other prior therapies comprised pegylated liposomal doxorubicin (48.1%; 60.3%) and a PARP inhibitor (35.2%; 39.7%).

Safety Data

The mean duration of nab-paclitaxel was 23.2 weeks (range, 0.1-90.3) in the relacorilant arm vs 18.6 weeks (range, 0.1-68.1) in the control arm. Any-grade treatment-emergent adverse effects (TEAEs) occurred in all patients in the relacorilant arm vs 99.5% percent of patients in the control arm. The rates of grade 3 or higher TEAEs were 74.5% and 59.5%, respectively. Serious AEs were reported at respective rates of 35.1% and 23.7%.

In the experimental arm, TEAEs led to dose reductions of relacorilant in 6.9% of patients, dose reductions of nab-paclitaxel in 48.4% of patients, treatment interruptions of either agent in 72.9% of patients, and discontinuations of both agents in 9.0% of patients. In the control arm, TEAEs led to dose reduction, dose interruption, and treatment discontinuation in 31.6%, 54.7%, and 7.9% of patients, respectively.

The most common any-grade TEAEs included neutropenia (relacorilant arm, 64%; nab-paclitaxel arm, 49%), anemia (61%; 55%), nausea (44%; 35%), diarrhea (39%; 27%), constipation (32%; 27%), abdominal pain (29%; 28%), vomiting (26%; 23%), decreased appetite (22%; 12%), fatigue (53%; 45%), and alopecia (38%; 31%).

Reference

Lorusso D, Gladieff L, Gilbert L, et al. Phase III results of relacorilant + nab-paclitaxel vs nab-paclitaxel in platinum-resistant ovarian cancer (PROC) (ROSELLA, GOG-3073, ENGOT-ov72): Secondary endpoints. Presented at: 2025 ESMO Gynecological Cancer Congress; June 19-21, 2025; Vienna, Austria. Abstract 70O.