Final ROSELLA Data Show Relacorilant Extends Survival in Platinum-Resistant Ovarian Cancer

Adding Corcept Therapeutics' relacorilant to nab-paclitaxel cut the risk of death by 35% compared with nab-paclitaxel alone in women with platinum-resistant ovarian cancer, according to final overall survival results from the Phase 3 ROSELLA trial presented at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting, OncLive reported.

The results were presented by Alexander B. Olawaiye of the University of Pittsburgh Medical Center at the meeting, held April 10-13 in San Juan, Puerto Rico. The final analysis was published the same day in The Lancet, with Domenica Lorusso of Humanitas University in Italy as first author, according to the paper's Europe PMC record. The trial ran at 117 hospitals and community oncology centres in 14 countries, the paper says.

The survival results

ROSELLA (NCT05257408) randomized 381 patients with epithelial ovarian, primary peritoneal or fallopian tube cancer whose disease had progressed within six months of platinum therapy. All had received bevacizumab and one to three prior lines of therapy. Patients received relacorilant 150 mg plus nab-paclitaxel 80 mg/m2, or nab-paclitaxel 100 mg/m2 alone. Progression-free survival and overall survival were dual primary endpoints.

At a median follow-up of 24.8 months, median overall survival was 16.0 months with the combination and 11.9 months with nab-paclitaxel alone (hazard ratio 0.65; 95% CI, 0.51-0.83; P = .0004), according to OncLive. The 12-month survival rates were 60% and 50%, and the 18-month rates were 46% and 27%. Survival favored the combination across all prespecified subgroups, including prior lines of therapy, prior PARP inhibitor use and platinum-free interval length.

The investigators also reported that use of later anticancer therapies was similar in the two arms: 67.6% of patients in the relacorilant arm and 72.0% in the control arm went on to further systemic treatment.

"We are very delighted to present this regimen now as an option for treatment of patients with platinum-resistant ovarian cancer," Olawaiye said in the presentation, as quoted by OncLive. "It is now listed as a preferred option in the NCCN guidelines."

Safety

Grade 3 or higher adverse events occurred in 74.5% of patients given the combination and 59.5% of those given nab-paclitaxel alone, and serious adverse events in 35.1% and 23.7%. The most common grade 3 or higher events in the combination arm were neutropenia (44% vs 25%) and anemia (18% vs 9%). Discontinuations because of adverse events were similar between arms. Olawaiye said there were no fatal adverse events associated with relacorilant and no cases of adrenal insufficiency, and no new safety signals emerged with longer follow-up.

Regulatory status

Relacorilant is a glucocorticoid receptor antagonist. The FDA approved it under the brand name Lifyorli on March 25, 2026, in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian, fallopian tube or primary peritoneal cancer who have received one to three prior systemic regimens, at least one including bevacizumab. The agency's announcement cited ROSELLA's progression-free and overall survival results and said the approval came 3.5 months ahead of the FDA goal date.

The FDA said the prescribing information includes a contraindication for patients who require corticosteroids for a lifesaving indication, and warnings for neutropenia and severe infections, adrenal insufficiency, worsening of conditions treated with glucocorticoids, and embryo-fetal toxicity. Olawaiye noted at the start of his presentation that it might include data not in the approved prescribing information, OncLive reported.