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Business Wire
7 days ago
- Business
- Business Wire
Corcept Presents Pivotal Clinical Data in ASCO Late-Breaker with Simultaneous Publication in The Lancet: Relacorilant Improves Progression-Free and Overall Survival in Patients with Platinum-Resistant Ovarian Cancer
REDWOOD CITY, Calif.--(BUSINESS WIRE)--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, today shared data from its pivotal Phase 3 ROSELLA trial of relacorilant plus nab-paclitaxel in patients with platinum-resistant ovarian cancer in a late-breaking oral presentation at the ASCO 2025 (American Society of Clinical Oncology) Annual Meeting. The presentation abstract can be found here and the presentation slides here. The data have been simultaneously published in The Lancet, titled ' Relacorilant and nab-paclitaxel in patients with platinum-resistant ovarian cancer (ROSELLA): an open-label, randomised, controlled, phase 3 trial.' ROSELLA met its primary endpoint of improved progression-free survival as assessed by blinded independent central review (PFS-BICR). Patients who received relacorilant in addition to nab-paclitaxel chemotherapy experienced a 30 percent reduction in risk of disease progression compared to patients who received nab-paclitaxel monotherapy (hazard ratio: 0.70; p-value: 0.0076). Median PFS-BICR was extended to 6.5 months, compared to 5.5 months in patients who received nab-paclitaxel alone. In addition, PFS assessed by investigators was consistent with PFS-BICR, with a hazard ratio of 0.71 (p-value: 0.0030). An interim analysis of overall survival (OS), showed that the addition of relacorilant reduced the risk of death by 31 percent, substantially lengthening patients' lives. Median OS for patients who received relacorilant was 16.0 months, compared to 11.5 months for patients who received nab-paclitaxel alone (hazard ratio: 0.69; p-value: 0.0121). These benefits were seen in all clinically relevant subgroups, including those with poor prognoses. Relacorilant plus nab-paclitaxel was well-tolerated, with a comparable safety profile between treatment arms. The addition of relacorilant did not increase patients' safety burden. In addition, patients treated with relacorilant plus nab-paclitaxel had a lower incidence of ascites (5.3 percent), than did patients who received nab-paclitaxel alone (10.5 percent). The occurrence of abdominal paracenteses during treatment was also lower for patients treated with relacorilant plus nab-paclitaxel (7.4 percent), compared to nab-paclitaxel alone (13.2 percent). 'For many patients with advanced, recurrent ovarian cancer, the tumor eventually becomes resistant to chemotherapy, and oncologists have few good treatment options. Relacorilant plus nab-paclitaxel may provide a powerful tool for improving progression-free and overall survival in patients with this disease,' said Alexander B. Olawaiye, M.D., Director of gynecological cancer research at Magee-Women's Hospital of the University of Pittsburgh and Principal Investigator in the ROSELLA trial. 'The data presented at ASCO 2025 and published in The Lancet support this regimen becoming a new standard-of-care treatment.' 'These data show that treatment with relacorilant can help patients with platinum-resistant ovarian cancer live longer, without adding to their safety burden. We plan to bring this treatment option to patients as quickly as possible and are working on our regulatory applications in the U.S. and Europe. We want to thank all the patients and investigators who participated in this trial,' said Bill Guyer, PharmD, Corcept's Chief Development Officer. 'These data also illustrate the benefits of modulating cortisol activity in patients whose tumors express the glucocorticoid receptor. We have initiated a trial evaluating the benefit of adding relacorilant to a regimen of nab-paclitaxel and bevacizumab (BELLA Trial), and are considering additional clinical trials.' ROSELLA enrolled 381 patients with platinum-resistant ovarian cancer at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia; biomarker selection was not required. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone. ROSELLA has dual primary endpoints — PFS-BICR and OS. A positive outcome is achieved if either endpoint is met. 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 Relacorilant 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 studying relacorilant in a variety of serious disorders in addition to ovarian cancer, including endogenous hypercortisolism (Cushing's syndrome) and prostate cancer. 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 FDA and the European Commission (EC) for the treatment of hypercortisolism and by the EC for the treatment of ovarian cancer. About Platinum-Resistant 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. 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, 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 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. About Corcept Therapeutics For over 25 years, Corcept has focused on cortisol modulation and its potential to treat patients with a wide variety of serious disorders, leading to the discovery of more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor antagonists. Corcept is conducting advanced clinical trials in patients with hypercortisolism, solid tumors, ALS and liver disease. In February 2012, the company introduced Korlym ®, the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous hypercortisolism. Corcept is headquartered in Redwood City, California. For more information, visit Forward-Looking Statements Statements in this press release, other than statements of historical fact, are forward-looking statements based on our current plans and expectations and are subject to risks and uncertainties that might cause our actual results to differ materially from those such statements express or imply. These risks and uncertainties are set forth in our SEC filings, which are available at our website and the SEC's website. In this press release, forward-looking statements include statements concerning: the results of our ROSELLA and BELLA trials; relacorilant's efficacy, safety and other clinical attributes and its potential to receive regulatory approval and become a standard-of-care treatment for patients with platinum-resistant ovarian cancer; regulatory oversight of relacorilant and the scope, pace and outcome of potential NDA and MAA submissions; relacorilant's acceptance and use by physicians and patients and its commercial prospects; the likelihood of Corcept undertaking or completing other clinical trials and their outcomes; and the scope and protective power of relacorilant's orphan drug designation and our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release.
Yahoo
02-04-2025
- Business
- Yahoo
CORT Shares Rise as Relacorilant Combo Meets Ovarian Cancer Study Goal
Shares of Corcept Therapeutics Incorporated CORT were up a staggering 109.1% on March 31 after the company announced data from the phase III ROSELLA study, which evaluated its pipeline candidate, relacorilant, in combination with nab-paclitaxel for treating patients with platinum-resistant ovarian cancer. The ROSELLA study met its primary endpoint of improved progression-free survival, as assessed by blinded independent central review (PFS-BICR). Per management, data from the ROSELLA study suggested that the combo of relacorilant plus nab-paclitaxel has the potential to become a new standard of care for patients with platinum-resistant ovarian cancer. Year to date, shares of Corcept have skyrocketed 126.7% against the industry's decline of 1.9%. Image Source: Zacks Investment Research The phase III ROSELLA study evaluated relacorilant in combination with nab-paclitaxel for treating patients with recurrent, platinum-resistant ovarian cancer. Data from the same showed that treatment with relacorilant plus nab-paclitaxel reduced the risk of disease progression by 30% compared to patients treated with nab-paclitaxel alone. Patients who were treated with relacorilant plus nab-paclitaxel achieved a median PFS-BICR of 6.5 months compared to 5.5 months in patients who received nab-paclitaxel alone. Patients treated with the combo of relacorilant plus nab-paclitaxel had a significant improvement in overall survival (OS), with the median OS being 16 months versus 11.5 months for patients receiving nab-paclitaxel alone, at an interim analysis of OS. The combo of relacorilant plus nab-paclitaxel improved progression-free and overall survival without increasing the side effect burden. The company plans to submit a new drug application in the United States in the third quarter of 2025, while a marketing authorization application in Europe is likely to be filed shortly thereafter. Relacorilant is Corcept's lead candidate, which is being developed for treating patients with Cushing's syndrome. In December 2024, CORT submitted a new drug application (NDA) for relacorilant to the FDA for the same. Last month, the FDA accepted the NDA and assigned a Prescription Drug User Fee Act (PDUFA) target action date of Dec. 30, 2025. The NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT, as well as long-term extension studies and a phase II study in hypercortisolism. Another study is evaluating relacorilant in combination with Keytruda (pembrolizumab) for treating patients with adrenal cancer along with cortisol excess. The successful development and commercialization of relacorilant for additional indications will be a big boost to the company. Corcept currently carries a Zacks Rank #2 (Buy). Some top-ranked stocks in the biotech sector are Amicus Therapeutics, Inc. FOLD, CytomX Therapeutics, Inc. CTMX and ANI Pharmaceuticals, Inc. ANIP, each carrying a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today's Zacks #1 Rank stocks here. In the past 60 days, estimates for Amicus' earnings per share have increased from 43 cents to 52 cents for 2025. During the same time, earnings per share estimates for 2026 have increased from 72 cents to 78 cents. Year to date, shares of FOLD have declined 13.4%. FOLD's earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 45.42% In the past 60 days, estimates for CytomX Therapeutics have improved from a loss of 31 cents per share to earnings of 25 cents per share. During the same time, loss per share estimates for 2026 have narrowed from 65 cents to 31 cents. Year to date, shares of CTMX have plunged 38.2%. CTMX's earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 180.70%. In the past 60 days, estimates for ANI Pharmaceuticals' earnings per share have increased from $5.54 to $6.35 for 2025. During the same time, earnings per share estimates for 2026 have increased from $6.75 to $7.21. Year to date, shares of ANIP have rallied 21.2%. ANIP's earnings beat estimates in each of the trailing four quarters, the average surprise being 17.32%. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Amicus Therapeutics, Inc. (FOLD) : Free Stock Analysis Report Corcept Therapeutics Incorporated (CORT) : Free Stock Analysis Report ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report CytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report This article originally published on Zacks Investment Research ( Zacks Investment Research
