Pre-ESMO insights: Corcept on platinum-resistant ovarian cancer
Earlier this year at the American Society of Clinical Oncology (ASCO) Congress, pharmaphorum spoke with Redwood City, California-headquartered Corcept Therapeutics about its presentation of data in platinum-resistant ovarian cancer.
Now, ahead of the European Society of Medical Oncology (ESMO) Congress in Berlin, 17th-21st October, Corcept shared that the company will be presenting new late-breaking data from its pivotal Phase 3 ROSELLA trial focused on participants who were previously treated with a PARP inhibitor.
Addressing unmet needs in gynaecological cancers
Back in June, Roberto Vieira, president of oncology at Corcept – 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 – set the scene of unmet need within this gynaecological cancer space: 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 and there are few treatment options for these women. Median overall survival following recurrence is approximately 12 months with single-agent chemotherapy.
Approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year in the United States alone, with at least an equal number in Europe. And progress in developing an effective treatment in those who have become platinum-resistant has been frustratingly slow in the past 15 years.
For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders. Cortisol plays a role in tumour growth through several mechanisms. It helps solid tumours resist chemotherapy by inhibiting cellular apoptosis – the tumour-killing effect chemotherapy is meant to stimulate. In some cancers, cortisol promotes tumour growth by activating oncogenes 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.
To this end, relacorilant, an oral therapy, is a selective glucocorticoid receptor (GR) antagonist that modulates cortisol activity by binding to the GR, but not to the body's other hormone receptors. Corcept is developing relacorilant in ovarian cancer and a variety of other serious disorders, including endogenous hypercortisolism and prostate cancer. It has been designated an orphan drug by the European Commission (EC) for the treatment of ovarian cancer and the FDA assigned a Prescription Drug User Fee Act (PDUFA) date of 11th July 2026 for relacorilant as a treatment for patients with platinum-resistant ovarian cancer.
At ASCO 2025, Corcept shared data from the ROSELLA phase 3 trial, which demonstrated that relacorilant in combination with nab-paclitaxel showed statistically significant improvements in progression-free and overall survival in this patient population, with the dual primary endpoint of progression-free survival being met and a favourable safety burden. It was the first time a selective glucocorticoid receptor antagonist had been introduced to the market.
Providing healthspan, not just lifespan
Also spoken with was Adrian Jubb, head of oncology and neurology clinical development at Corcept, who added that there have only been, in the last 10 years, two new drugs in this space. What's really important about the ROSELLA trial is that it's for everybody who's platinum-resistant, regardless of any biomarker selection.
Asked if there was one major problem in oncology that they could solve for in the next decade, what it would be, Vieira stated: “I think the challenge in oncology remains twofold. Number one, our priority should remain in overall survival and, as much as we can, to maintain quality of life for those patients. Really, healthspan, not just lifespan. I think that a combination of those two things are super important for patients, so they can truly enjoy their life”
He continued: “Now, beyond that, I think that in cancer, we have made tremendous progress in the last several decades, but the truth is that there are several populations that are still unserved, and there are gaps in several areas. We need to be looking at those populations that are actually 'left behind'. We have an opportunity to innovate medicines for patients that have not been served by recent innovation. Ultimately, I think it comes back to giving patients hope, the hope that they can continue to live their lives and achieve those milestones in a moment where they are threatened by a devastating disease.”
For Jubb, it would be around earlier lines of therapy.
“Within ovarian cancer, from the first diagnosis, 70% of those patients will recur, and once they recur they can get many more lines of treatment, but they will never be cured,” he said. “I think there's a lot of opportunity to bring relacorilant into earlier lines of therapy, benefit a broader population of patients. I'm excited to see if we can drive up that cure rate in the hardest-to-treat patients […] and also extend it beyond that into other gynaecological and other malignancies. I think we'd all feel really good if we could drive efficacy of chemotherapy to the point where we're getting cures, instead of recurrence and resistance.”
Speaking generally about ASCO 2025, Vieira commented that what was most evident in terms of oncological innovation and advancement were antibody-drug conjugates (ADCs). Jubb agreed, noting that they are “essentially targeted cytotoxic chemotherapy.”
He added: “One of the good things about relacorilant is that we believe it's going to be broadly combinable. When we see [this] data coming forward, and interesting efficacy in endometrial and other gynaecologic malignancies, we think actively, ‘Gosh, is that a place where we could add on relacorilant?’ We really believe this has the potential to be combined broadly in many different tumour types, with many different chemotherapies, including ADCs.”
As for looking ahead to ESMO 2025, Corcept will present a mini oral session in Gynaecological cancers on Sunday 19th October, 10:56am-11:01am CEST titled: LBA45 - ROSELLA (GOG3073, ENGOTov72, APGOT-OV10): Relacorilant + Nab-paclitaxel in the Subgroup of Patients With Platinum-Resistant Ovarian Cancer (PROC) Previously Exposed to a PARP Inhibitor.
The ROSELLA trial is being 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).
About the interviewees
Roberto Vieira joined Corcept as president of oncology in January 2024. He brings more than 20 years of sales, marketing, and oncology experience to his role. Vieira previously served as senior vice president of US commercial at Mirati Therapeutics, Inc, where he built the US commercial organisation and led the launch of the company’s first targeted cancer therapy for the treatment of advanced non-small cell lung cancer. Prior to that, Vieira spent 15 years at Bristol-Myers Squibb in positions of increasing seniority, including vice president of worldwide oncology strategy. He also served as general manager in Europe (The Netherlands) and was part of the leadership team that led the introduction of transformational medicines in the immuno-oncology space across a broad range of solid tumours. Prior to Bristol-Myers Squibb, Vieira spent 10 years at Eli Lilly and Company, where he worked across manufacturing, finance, and sales and marketing. Vieira holds an MBA in Business Administration and Management from the University of Pittsburgh. He also holds a diploma in Chemical Engineering from Universidade Estadual de Campinas (UNICAMP) in São Paulo, Brazil, and has completed the General Management Program at CEDEP, France.
Adrian Jubb serves as the vice president and head of clinical development for oncology and neurology at Corcept Therapeutics. His team led the design and execution of the Phase 3 ROSELLA trial and the filing of the relacorilant NDA for women with platinum-resistant ovarian cancer. Prior to that, Jubb worked in senior leadership roles across multiple biotech companies, including Zentalis Pharmaceuticals, Flare Therapeutics, 23andMe, Immune-Onc Therapeutics, and Achaogen. Jubb is a board-certified physician-scientist with 25 years of research and clinical development experience spanning oncology, infectious disease, and neuroscience. He received his medical degree (with honours) and PhD from the University of Leeds, and completed his residency and fellowship through joint academic and clinical training at the John Radcliffe Hospital and University of Oxford, before joining the faculty of the Nuffield Department of Clinical Laboratory Sciences. Throughout and following his training, Jubb interweaved a 13-year tenure across the research and development organisation at Genentech.
