Corcept Therapeutics Incorporated (NASDAQ: CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, announced that the U.S. Food and Drug Administration (FDA) has approved Lifyorli™ (relacorilant) 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 treatment regimens, at least one of which included bevacizumab. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist (SGRA).

Approval was based on the positive outcomes of Lifyorli’s pivotal ROSELLA trial, which enrolled 381 patients with platinum-resistant ovarian cancer who had received one to three prior lines of therapy, at least one of which included bevacizumab. Patients were randomized 1:1 to receive either Lifyorli plus nab-paclitaxel or nab-paclitaxel monotherapy. No biomarker selection was required.

ROSELLA met its dual primary endpoints of progression-free and overall survival. Patients treated with Lifyorli in addition to nab-paclitaxel experienced a 35 percent reduction in the risk of death compared to patients treated with nab-paclitaxel alone (hazard ratio: 0.65; p-value: 0.0004), with a median overall survival (OS) of 16.0 months, compared to 11.9 months for patients receiving nab-paclitaxel alone, a difference of 4.1 months. Patients who received Lifyorli in addition to nab-paclitaxel also experienced a 30 percent reduction in the risk of disease progression (hazard ratio: 0.70; p-value: 0.008), as assessed by blinded independent central review (PFS-BICR), compared to patients treated with nab-paclitaxel alone.

The combination of Lifyorli with nab-paclitaxel was well-tolerated and manageable. The safety of Lifyorli was assessed in a pooled analysis of patients from ROSELLA and Lifyorli’s Phase 2 trial. The prescribing information for Lifyorli includes warnings and precautions for neutropenia and severe infections, adrenal insufficiency, exacerbation of conditions treated with glucocorticoids and embryo-fetal toxicity. The most common adverse reactions experienced by more than 20 percent of patients (including laboratory abnormalities) were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash and decreased appetite.

Data from ROSELLA were first presented at ASCO 2025 (American Society of Clinical Oncology) with simultaneous publication in The Lancet. Complete results from ROSELLA will be presented at the Society of Gynecologic Oncology (SGO) meeting in April.

“Data demonstrate that Lifyorli plus nab-paclitaxel provides a clinically meaningful benefit in overall survival for patients with platinum-resistant ovarian cancer and is well tolerated. Lifyorli is positioned to become a new standard-of-care treatment,” said Rob Coleman, M.D., Texas Oncology and special advisor to the president of the GOG Foundation. "Having a new treatment for this advanced, recurrent disease will provide clinicians with a compelling option to help patients with this extremely difficult-to-treat cancer."

“The FDA’s approval of Lifyorli in combination with nab-paclitaxel is welcome news to all of us in the ovarian cancer community,” said Sarah DeFeo, Chief Program Officer at Ovarian Cancer Research Alliance (OCRA). “We are grateful to everyone who participated in the clinical trials, their families and the physicians who helped advance this urgently needed treatment option for patients with platinum-resistant ovarian cancer.”

“It is a privilege to bring forward a new treatment for patients who historically have had few options,” said Joseph Belanoff, M.D., Corcept’s Chief Executive Officer. “We have worked for years to demonstrate the potential of cortisol modulation in oncology. Today’s approval of Lifyorli is an important first step, but there is much more to explore with this new mode of treatment. We extend our deep appreciation to the patients and healthcare providers who participated in the clinical trials that made this approval possible.”

ROSELLA enrolled patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia, and was conducted in collaboration with The GOG Foundation, Inc. (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).