Latest news with #AlexanderB.Olawaiye
Business Wire
02-06-2025
- 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
01-04-2025
- Health
- Yahoo
Experimental women's cancer drug boosts survival rates in notable study
A new drug is showing promise in tackling treatment-resistant ovarian cancer. Relacorilant, the drug tested in a phase 3 ROSELLA trial with Corcept Therapeutics in California, was found to improve overall survival and progression of the disease when matched with a chemotherapy drug called nab-paclitaxel. The ROSELLA trial, conducted in collaboration with The GOG Foundation, analyzed 381 patients around the world, including the U.S., Europe, South Korea, Brazil, Argentina, Canada and Australia, according to a press release. Ai Detects Ovarian Cancer Better Than Human Experts In New Study The large, randomized phase 3 study revealed a 30% reduction in risk of disease progression in patients with platinum-resistant ovarian cancer, compared to those just treated with nab-paclitaxel. (Some types of chemotherapy contain the element platinum.) The researchers also noted "significant improvement" in overall survival with this combination of drugs. Read On The Fox News App Relacorilant, which is administered as an oral pill, was reportedly "well-tolerated" by patients without increased side effects. The drug is administered by mouth one day before, the day of and one day after nab-paclitaxel therapy, which is given via infusion every week. The findings will be presented at a medical conference later this year, researchers say. Results from the Phase 2 were published in the Journal of Clinical Oncology in 2023. Ovarian Cancer Treatment On Fast Track For Fda Approval As Chemo Alternatives Emerge: 'We're Making Progress' Ovarian cancer is the fifth most common cause of cancer death in women and is the deadliest of gynecologic cancers, according to the Ovarian Cancer Research Alliance. Alexander B. Olawaiye, MD, director of gynecological cancer research at Magee-Women's Hospital at the University of Pittsburgh and principal investigator in the ROSELLA trial, discussed the results with Fox News Digital. Olawaiye echoed that this new agent is the "first of its kind" in the battle against cancers that don't have many treatment options. "That's what makes the findings of this study really exciting, because it did show a very significant improvement in both progression-free survival and overall survival," he said. Ovarian Cancer Signs, Symptoms, Diagnosis And Treatment Options The expert shared his gratitude to his research team, mentioning that they "never stopped trying" for women undergoing treatment. "I want to congratulate the women that are being treated for ovarian cancer — first, for helping us to do this trial and second, for the potential that we may now have another option on the block." Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida, also commented on these findings in an interview with Fox News Digital. "We know ovarian cancer is very, very difficult to treat, particularly in those patients who have a disease that's resistant to the standard chemotherapies," he said. "For a long time, we've been trying to find treatments that can help patients not only keep the disease away longer, but also live longer. And most of the trials, unfortunately, have been negative." Click Here To Sign Up For Our Health Newsletter Slomovitz, a member of The GOG Foundation, said he considers the ROSELLA trial an "opportunity to use a unique drug" that has shown "positive, encouraging results." "A 30% decrease in risk of recurrence and a 31% decreased risk of death is promising," he stated. "To see data like this is refreshing, and it represents something that's exciting for our patients who suffer from ovarian cancer." Olawaiye shared his hope for the treatment to receive clinical approval "pretty soon." For more Health articles, visit As research and technology advance, various cancer treatments have surfaced in the last several years. Olawaiye commented that the past two decades have been a "very exciting time," as there's been an "explosion of approvals" for cancer therapies. "Today's news about Relacorilant is just another addition," he article source: Experimental women's cancer drug boosts survival rates in notable study
Fox News
01-04-2025
- Health
- Fox News
Experimental women's cancer drug boosts survival rates in notable study
A new drug is showing promise in tackling treatment-resistant ovarian cancer. Relacorilant, the drug tested in a phase 3 ROSELLA trial with Corcept Therapeutics in California, was found to improve overall survival and progression of the disease when matched with a chemotherapy drug called nab-paclitaxel. The ROSELLA trial, conducted in collaboration with The GOG Foundation, analyzed 381 patients around the world, including the U.S., Europe, South Korea, Brazil, Argentina, Canada and Australia, according to a press release. The large, randomized phase 3 study revealed a 30% reduction in risk of disease progression in patients with platinum-resistant ovarian cancer, compared to those just treated with nab-paclitaxel. (Some types of chemotherapy contain the element platinum.) The researchers also noted "significant improvement" in overall survival with this combination of drugs. Relacorilant, which is administered as an oral pill, was reportedly "well-tolerated" by patients without increased side effects. "A 30% decrease in risk of recurrence and a 31% decreased risk of death is promising." The drug is administered by mouth one day before, the day of and one day after nab-paclitaxel therapy, which is given via infusion every week. The findings will be presented at a medical conference later this year, researchers say. Results from the Phase 2 were published in the Journal of Clinical Oncology in 2023. Ovarian cancer is the fifth most common cause of cancer death in women and is the deadliest of gynecologic cancers, according to the Ovarian Cancer Research Alliance. Alexander B. Olawaiye, MD, director of gynecological cancer research at Magee-Women's Hospital at the University of Pittsburgh and principal investigator in the ROSELLA trial, discussed the results with Fox News Digital. Olawaiye echoed that this new agent is the "first of its kind" in the battle against cancers that don't have many treatment options. "That's what makes the findings of this study really exciting, because it did show a very significant improvement in both progression-free survival and overall survival," he said. The expert shared his gratitude to his research team, mentioning that they "never stopped trying" for women undergoing treatment. "I want to congratulate the women that are being treated for ovarian cancer — first, for helping us to do this trial and second, for the potential that we may now have another option on the block." Dr. Brian Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida, also commented on these findings in an interview with Fox News Digital. "We know ovarian cancer is very, very difficult to treat, particularly in those patients who have a disease that's resistant to the standard chemotherapies," he said. "For a long time, we've been trying to find treatments that can help patients not only keep the disease away longer, but also live longer. And most of the trials, unfortunately, have been negative." Slomovitz, a member of The GOG Foundation, said he considers the ROSELLA trial an "opportunity to use a unique drug" that has shown "positive, encouraging results." "A 30% decrease in risk of recurrence and a 31% decreased risk of death is promising," he stated. "To see data like this is refreshing, and it represents something that's exciting for our patients who suffer from ovarian cancer." Olawaiye shared his hope for the treatment to receive clinical approval "pretty soon." For more Health articles, visit As research and technology advance, various cancer treatments have surfaced in the last several years. Olawaiye commented that the past two decades have been a "very exciting time," as there's been an "explosion of approvals" for cancer therapies. "Today's news about Relacorilant is just another addition," he said.
