Corcept Therapeutics Reports Statistically Significant Overall Survival Benefit for Lifyorli in Platinum-Resistant Ovarian Cancer at ASCO 2026
Corcept Therapeutics Incorporated, a commercial-stage biopharmaceutical company focused on discovering and developing therapies that modulate the effects of cortisol, has announced compelling new overall survival results from its pivotal Phase 3 ROSELLA trial evaluating Lifyorli™ (relacorilant) in combination with nab-paclitaxel in patients with platinum-resistant ovarian cancer.
The findings were presented in an oral session at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting and reinforce Lifyorli’s potential as a new standard-of-care treatment option in a patient population with historically limited therapeutic choices and poor outcomes.
Significant Improvement in Overall Survival
The ROSELLA trial demonstrated that treatment with Lifyorli plus nab-paclitaxel led to a statistically significant and clinically meaningful improvement in overall survival compared with nab-paclitaxel alone.
Patients receiving the combination therapy experienced a 35% reduction in the risk of death, corresponding to a hazard ratio (HR) of 0.65 and a highly statistically significant p-value of 0.0004. Median overall survival was 16.0 months for patients treated with Lifyorli plus nab-paclitaxel, compared to 11.9 months for those receiving nab-paclitaxel monotherapy.
These results are particularly notable in platinum-resistant ovarian cancer, a difficult-to-treat disease setting where survival improvements have historically been modest and treatment options remain limited after standard platinum-based therapies fail.
Importantly, the survival benefit was observed without the need for biomarker selection, suggesting that Lifyorli may provide broad clinical benefit across a wide range of patients.
Consistent Benefit Across Key Patient Subgroups
The overall survival advantage of Lifyorli was consistent across all prespecified subgroups evaluated in the ROSELLA trial, reinforcing the robustness of the treatment effect.
Patients with a taxane-free interval of six months or less demonstrated a 40% reduction in the risk of death (HR: 0.60), while those who had received a taxane in their most recent prior regimen experienced a 33% reduction in the risk of death (HR: 0.67).
These subgroup analyses are clinically important because they reflect real-world treatment heterogeneity, where patients often receive multiple lines of therapy and may have varying degrees of chemotherapy sensitivity or resistance.
The consistency of benefit across these diverse groups supports the potential applicability of Lifyorli across a broad platinum-resistant ovarian cancer population.
Expert Perspective on Clinical Impact
Clinical investigators involved in the study highlighted the potential significance of these findings for treatment practice in ovarian cancer.
Dr. Lucy Gilbert, Director of Gynecologic Oncology at McGill University Health Centre and Chair of Oncology at McGill University in Montreal, emphasized that the ROSELLA results suggest Lifyorli could become a new standard-of-care option for patients with platinum-resistant ovarian cancer.
She noted that the observed overall survival benefit was consistent across all patient subgroups, including those with poor prognostic characteristics and those previously exposed to taxane-based therapies. Importantly, she highlighted that the benefit was achieved without requiring biomarker-based patient selection, which may simplify clinical decision-making and broaden patient eligibility.
Mechanism of Action: Targeting Cortisol Signaling in Cancer
Lifyorli (relacorilant) is a selective glucocorticoid receptor (GR) antagonist designed to block the effects of cortisol, a hormone that plays a key role in stress response but has also been implicated in tumor progression and chemotherapy resistance.
Corcept Therapeutics’ scientific rationale is based on the hypothesis that excessive cortisol signaling through the glucocorticoid receptor can promote cancer cell survival, reduce chemotherapy sensitivity, and contribute to disease progression in certain tumor types.
By antagonizing this pathway, relacorilant is intended to enhance the efficacy of chemotherapy while simultaneously reducing tumor-supportive signaling mechanisms.
The ROSELLA trial results provide clinical validation for this mechanism, demonstrating that targeting cortisol signaling can translate into meaningful survival benefits in patients with advanced ovarian cancer.
Safety Profile and Tolerability
The combination of Lifyorli and nab-paclitaxel was generally well tolerated, with a safety profile consistent with that of nab-paclitaxel monotherapy.
The most commonly observed adverse reactions (including laboratory abnormalities) occurring in more than 20% of patients included decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelet counts, rash, and decreased appetite.
The prescribing information for Lifyorli includes warnings and precautions related to neutropenia and severe infections, adrenal insufficiency, potential exacerbation of conditions treated with glucocorticoids, and embryo-fetal toxicity. These risks are consistent with the drug’s mechanism of action as a glucocorticoid receptor antagonist and are being monitored closely in clinical use.
Overall, the safety data suggest that the addition of Lifyorli does not significantly increase toxicity beyond that expected with chemotherapy alone, supporting its feasibility in combination treatment settings.
Trial Design and Global Collaboration
The ROSELLA study enrolled 381 patients with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer. Participants were randomized in a 1:1 ratio to receive either Lifyorli in combination with nab-paclitaxel or nab-paclitaxel alone.
Patients were recruited across a broad international network spanning the United States, Europe, South Korea, Brazil, Argentina, Canada, and Australia, reflecting the global relevance of the study population and the collaborative nature of the trial.
The study was conducted in partnership with several major oncology cooperative groups, including The GOG Foundation (GOG-F), 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 extensive collaboration provided a diverse patient population and strengthened the generalizability of the trial findings across different healthcare systems and geographic regions.
Regulatory Status and Clinical Adoption
Lifyorli has already achieved a major regulatory milestone. In March 2026, the U.S. Food and Drug Administration approved Lifyorli in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received one to three prior systemic regimens, at least one of which included bevacizumab.
This approval is particularly significant as Lifyorli is the first selective glucocorticoid receptor antagonist to receive FDA approval. The therapy has also been incorporated into the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology as a preferred treatment regimen for platinum-resistant ovarian cancer.
The new overall survival data from ROSELLA further strengthen its clinical profile and may support broader adoption in clinical practice as clinicians gain confidence in its long-term benefits.
Broader Implications for Cortisol Modulation in Oncology
Beyond ovarian cancer, Corcept Therapeutics has signaled its intention to expand research into other tumor types where glucocorticoid signaling may contribute to disease progression or treatment resistance.
The company is actively exploring the role of cortisol modulation in additional cancers, including endometrial, cervical, pancreatic, and prostate cancers, as well as in other difficult-to-treat solid tumors.
The positive results from ROSELLA may therefore represent not only a milestone for ovarian cancer treatment but also a validation of a broader therapeutic platform targeting hormone-driven tumor biology.
Company Outlook and Future Development
According to Corcept Therapeutics, the ROSELLA findings support continued advancement of glucocorticoid receptor antagonism as a promising therapeutic strategy in oncology. The company views these results as a strong foundation for expanding clinical development across multiple cancer indications.
The combination of statistically significant survival benefit, broad subgroup consistency, manageable safety profile, and regulatory approval positions Lifyorli as an important new treatment option in platinum-resistant ovarian cancer.
As further post-marketing and long-term data emerge, Lifyorli’s role in treatment guidelines and real-world clinical practice is expected to evolve, potentially establishing it as a key component of therapy for patients facing this challenging disease.
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 Therapeutics 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.
About Lifyorli™
Lifyorli (relacorilant), approved in combination with nab-paclitaxel, is the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist for adults with platinum-resistant ovarian cancer. Lifyorli is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel. There is no biomarker requirement to receive Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it enhances chemotherapy sensitivity by inhibiting cortisol’s suppression of apoptosis – the programmed cell death that chemotherapies such as nab-paclitaxel are meant to cause. Lifyorli does not have any effect at the body’s other steroid receptors.
It is included in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines®) as a preferred regimen for patients with platinum-resistant ovarian cancer.
