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Joyce F. Liu, MD, MPH
Joyce F. Liu, MD, MPH
Posted: Thursday, April 30, 2026
With final overall survival results presented at the 2026 Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer (Abstract LBA01) and published in The Lancet, the global phase III ROSELLA trial met its dual primary endpoints. In the primary analysis, the addition of the selective glucocorticoid receptor antagonist relacorilant to nab-paclitaxel demonstrated a significant improvement in progression-free survival, while the updated results confirmed an overall survival benefit in platinum-resistant ovarian cancer. According to Alexander B. Olawaiye, MD, of the University of Pittsburgh School of Medicine, and colleagues, the combination was also well tolerated, with a manageable safety profile.
“Combined with the evidence from previous studies, these positive overall survival data support relacorilant plus nab-paclitaxel as a potential new standard treatment option for patients with platinum-resistant ovarian cancer, without the need for biomarker selection,” the investigators remarked.
A total of 381 patients who had a history of one to three prior treatment lines were randomly assigned in a 1:1 ratio to receive nab-paclitaxel with or without relacorilant. With a median follow-up of 24.8 months, the addition of relacorilant was found to produce a statistically and clinically significant 35% decrease in the risk of all-cause mortality (hazard ratio = 0.65; P = .0004). Median overall survival was longer with relacorilant, with a 4.1-month improvement compared with nab-paclitaxel alone (16.0 vs 11.9 months). The 18-month overall survival rates were 46% and 27%, respectively. Overall survival analyses consistently showed a benefit with relacorilant across all subgroups.
Use of subsequent anticancer therapies appeared similar between the arms. The safety profile was found to be consistent with prior reports, and additional follow-up since the primary analysis did not reveal any new safety signals. Neutropenia (64%), anemia (61%), fatigue (54%), and nausea (44%) were among the most frequently reported adverse events with the combination, in line with the expected toxicities of nab-paclitaxel.
According to the investigators, “The data support the ongoing evaluation of relacorilant in other solid tumor indications and in combination with other classes of anticancer agents.”
Disclosure: For full disclosures of the study authors, visit thelancet.com.
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