Corcept Highlights New ROSELLA Data at ASCO 2026 Demonstrating Broad Survival Benefits of Lifyorli in Platinum-Resistant Ovarian Cancer
Corcept Therapeutics has unveiled new findings from its pivotal Phase 3 ROSELLA clinical trial at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting, further strengthening the case for Lifyorli™ (relacorilant) as a significant advancement in the treatment of platinum-resistant ovarian cancer. The newly presented data demonstrate that the therapy delivers meaningful overall survival benefits across all major patient subgroups, including those with recent exposure to taxane chemotherapy and those with particularly challenging disease characteristics.
The oral presentation showcased updated survival analyses from the global ROSELLA trial, which evaluated Lifyorli in combination with nab-paclitaxel compared with nab-paclitaxel alone. Results revealed a substantial reduction in mortality risk among patients receiving the combination therapy, highlighting its potential to redefine treatment standards for a disease area that has historically faced limited therapeutic progress.
Significant Improvement in Overall Survival
The ROSELLA study demonstrated that patients treated with Lifyorli plus nab-paclitaxel experienced a 35% reduction in the risk of death compared with patients receiving nab-paclitaxel alone. The treatment combination achieved a hazard ratio of 0.65 with strong statistical significance, underscoring the robustness of the findings.
Patients receiving the combination therapy achieved a median overall survival of 16.0 months, compared with 11.9 months among patients treated with chemotherapy alone. This survival advantage is particularly noteworthy in platinum-resistant ovarian cancer, where treatment options are limited and long-term outcomes remain poor for many patients.
Importantly, the observed survival benefit did not require biomarker testing or patient selection based on specific molecular characteristics. This broad applicability may simplify treatment decisions and expand access to therapy for a wider patient population.
Consistent Benefits Across Patient Subgroups
One of the key highlights of the data presented at ASCO 2026 was the consistency of survival improvements across all predefined patient subgroups examined in the study.
Researchers specifically analyzed patients who had a taxane-free interval of six months or less, a population generally considered more difficult to treat due to recent exposure to taxane-based therapies. In this subgroup, treatment with Lifyorli plus nab-paclitaxel resulted in a hazard ratio of 0.60, indicating a substantial reduction in the risk of death.
Similarly, patients whose most recent treatment regimen included a taxane also experienced meaningful clinical benefit. In this subgroup, the combination therapy achieved a hazard ratio of 0.67, further demonstrating the durability and consistency of the treatment effect.
The subgroup analyses reinforce the overall study findings and suggest that relacorilant’s mechanism of action may provide meaningful benefits regardless of prior taxane exposure or other prognostic factors.
Expert Perspective on the Findings
According to leading ovarian cancer specialists, the consistency of the survival data across diverse patient populations could position relacorilant as a new treatment standard in platinum-resistant ovarian cancer.
Lucy Gilbert, M.D., Director of Gynecologic Oncology at McGill University Health Centre and Chair of Oncology at McGill University in Montreal, emphasized the significance of the findings. She noted that the consistent survival improvements observed across all patient groups, including those with unfavorable prognostic features and varying histories of taxane exposure, support the therapy’s potential role as a standard-of-care option.
Dr. Gilbert also highlighted the practical advantage of not requiring biomarker testing, which can often limit access to targeted therapies and complicate treatment selection.
Advancing Glucocorticoid Receptor Research
Corcept executives believe the ROSELLA results validate years of research focused on targeting the glucocorticoid receptor (GR) pathway in cancer treatment.
Bill Guyer, PharmD, Corcept’s Chief Development Officer, stated that the study clearly demonstrates how blocking cortisol activity at the glucocorticoid receptor can improve outcomes for patients facing difficult-to-treat cancers. The findings support the company’s broader strategy of developing selective glucocorticoid receptor antagonists as novel cancer therapies.
Beyond ovarian cancer, Corcept is actively investigating GR antagonists across multiple tumor types and treatment settings. Ongoing research programs include studies in platinum-sensitive ovarian cancer, endometrial cancer, cervical cancer, pancreatic cancer and prostate cancer.
The company believes that cortisol signaling may contribute to tumor progression and treatment resistance in several cancer types, creating opportunities for relacorilant and future GR-targeting therapies to address significant unmet medical needs.
Regulatory Milestone and Clinical Adoption
The newly presented ASCO data build upon a major regulatory achievement for Corcept earlier this year. In March 2026, the U.S. Food and Drug Administration approved Lifyorli in combination with nab-paclitaxel for adults with platinum-resistant epithelial ovarian cancer, fallopian tube cancer or primary peritoneal cancer.
The approval covers patients who have received one to three prior systemic treatment regimens, including at least one regimen containing bevacizumab. The decision marked a historic milestone, making Lifyorli the first selective glucocorticoid receptor antagonist approved by the FDA.
The therapy has also gained recognition within clinical practice guidelines. It is now included as a preferred treatment regimen in the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for patients with platinum-resistant ovarian cancer, reflecting growing confidence among oncology experts regarding its clinical value.
Favorable Safety and Tolerability Profile
In addition to demonstrating efficacy, the ROSELLA trial showed that the Lifyorli and nab-paclitaxel combination was generally well tolerated.
Investigators reported that the overall safety profile was comparable to that observed in patients receiving nab-paclitaxel alone. This finding is particularly important because maintaining quality of life and minimizing treatment-related toxicity are major considerations in the management of recurrent ovarian cancer.
The prescribing information for Lifyorli includes warnings and precautions related to neutropenia and severe infections, adrenal insufficiency, worsening of conditions treated with glucocorticoids, and embryo-fetal toxicity.
Among adverse reactions occurring in more than 20% of patients, the most commonly reported events included decreased hemoglobin levels, reduced neutrophil counts, fatigue, nausea, diarrhea, thrombocytopenia, rash and decreased appetite. These side effects were generally consistent with expectations for patients undergoing cancer treatment and were manageable within established clinical practice.
Global Collaboration Behind ROSELLA
The ROSELLA trial represents one of the most extensive international research efforts conducted in platinum-resistant ovarian cancer.
A total of 381 patients were enrolled across multiple countries, including the United States, Canada, Australia, Brazil, Argentina, South Korea and several European nations. Participants were randomly assigned in a 1:1 ratio to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.
The study was carried out through a broad network of respected oncology research organizations. Collaborating groups included The GOG Foundation, the European Network of Gynaecological Oncological Trial Groups (ENGOT), the Asia-Pacific Gynecologic Oncology Trials Group (APGOT), the Latin American Cooperative Oncology Group (LACOG) and the Australia New Zealand Gynaecological Oncology Group (ANZGOG).
This international collaboration helped ensure a diverse patient population and strengthened the reliability and global relevance of the study findings.
The updated ROSELLA results presented at ASCO 2026 provide compelling evidence that Lifyorli can deliver meaningful and consistent survival benefits for patients with platinum-resistant ovarian cancer. The therapy’s ability to improve outcomes across multiple patient subgroups, including those with recent taxane exposure, reinforces its clinical value and supports its growing adoption in oncology practice.
As Corcept continues to expand research into glucocorticoid receptor antagonism across additional cancer types, the company believes the success of ROSELLA could represent the beginning of a broader transformation in how hormone-related pathways are targeted in cancer treatment. For patients facing one of the most difficult forms of ovarian cancer, the findings offer renewed optimism and a promising new therapeutic option capable of extending survival while maintaining a manageable safety profile.
About Ovarian Cancer
Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose disease returns less than six months after receiving platinum-containing therapy have “platinum-resistant” disease. There are few treatment options for these women. Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States, with at least an equal number in Europe.
About Cortisol’s Role in Oncology
Cortisol plays a role in tumor growth through several mechanisms. It helps solid tumors resist chemotherapy by inhibiting cellular apoptosis — the tumor-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumor growth by activating oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body’s immune response, which weakens its ability to fight all diseases, including cancer.
Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. Relacorilant is proprietary to Corcept and is protected by composition of matter, method of use and other patents. It has been designated an orphan drug by the European Commission (EC) for the treatment of ovarian cancer. Corcept has submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer.
