Miricorilant

Lifyorli (relacorilant) in combination with nab-paclitaxel and bevacizumab demonstrated clinically meaningful progression-free survival (PFS), objective response rate (ORR) and overall survival (OS), with the more pronounced results being in patients who had no prior treatment with bevacizumab. 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 announced positive results from Part A of the company’s Phase 2 BELLA trial, which evaluated Lifyorli in combination with nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer. In the study, patients treated with Lifyorli plus nab-paclitaxel and bevacizumab demonstrated a median PFS by investigator of 7.2 months compared to a median PFS of 5.4 months for Lifyorli plus nab-paclitaxel and 3.9 months for nab-paclitaxel alone in the pivotal Phase 3 ROSELLA study. ORR in BELLA was 59%, compared to 37% for Lifyorli plus nab-paclitaxel and 30% for nab-paclitaxel monotherapy in ROSELLA. Median OS had not been reached at the time of the primary analysis. In BELLA, 88% of patients were alive at the 6-month OS timepoint, compared to 82% for Lifyorli plus nab-paclitaxel and 77% for nab-paclitaxel alone in ROSELLA. In BELLA, responses were more pronounced in patients who were bevacizumab-naive. Approximately half the patients enrolled in BELLA had not previously received bevacizumab. In these patients, median PFS was 8.1 months and ORR was 66%, with an OS at the 6-month mark of 91%. The safety events were consistent with the known profiles of each individual agent in the combination and with Lifyorli combined with nab-paclitaxel, with no new safety signals identified. In BELLA Part A, the most common (≥25% of patients) adverse events were neutropenia, anemia, nausea, asthenia, nail disorder, peripheral neuropathy, fatigue, and leukopenia. Lifyorli is not approved for use in combination with bevacizumab. See full indication and important safety information below. “Following ROSELLA’s outstanding results, these BELLA data provide valuable insight into adding bevacizumab to the Lifyorli/nab-paclitaxel treatment backbone,” said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano. “These findings help advance our understanding of both the efficacy and safety pro this triplet combination as we work to expand treatment options for patients.” Lifyorli is the first FDA-approved selective glucocorticoid receptor (GR) antagonist. In oncology, GR antagonism is a novel mechanism that counters cortisol-mediated immunosuppression and enhances chemotherapy sensitivity. Corcept expects that the findings from BELLA Part A will augment Lifyorli’s preferred status in the National Comprehensive Cancer Network ® Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a treatment for women with platinum-resistant ovarian cancer. Complete results from BELLA Part A will be presented at a medical conference next year. BELLA Part A is a single-arm, open-label trial that enrolled 95 women with recurrent, platinum-resistant ovarian cancer at approximately 45 sites in North America, Europe and Asia-Pacific. Corcept is conducting clinical studies of its proprietary GR antagonists in platinum-sensitive ovarian, endometrial, cervical, pancreatic, prostate and other cancers in combination with various anti-cancer agents. Further information is available at Corcept.com/Pipeline-and-Clinical-Trials . “Our goal is to demonstrate our proprietary selective GR antagonists’ ability to benefit patients with a wide array of solid tumors, in combination with many different anti-cancer agents,” said Bill Guyer, Pharm.D., Corcept’s Chief Development Officer. “These results provide more evidence of GR antagonism’s versatility – in this case, of Lifyroli’s potential to benefit patients when combined with nab-paclitaxel and bevacizumab, whether or not bevacizumab had been included in a patient’s prior treatment regimen. We look forward to presenting the full BELLA Part A data next year.” About Ovarian Cancer Ovarian cancer is the fifth most common cause of cancer death in women. Patients whose tumors return or resume growing less than six months after receiving platinum-containing therapy have "platinum-resistant" disease. There are few treatment options for these women. In the United States, approximately 20,000 women with platinum-resistant disease are candidates to start a new therapy each year. In Europe, the annual figure is the same or higher. About Cortisol's Role in Oncology Cortisol plays a role in tumor growth through several mechanisms. Cortisol suppresses the body's immune response, which weakens its ability to fight all diseases, including cancer. Cortisol also helps solid tumors resist chemotherapy by inhibiting 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. Corcept is developing relacorilant in ovarian, endometrial, cervical, pancreatic and prostate cancers. Lifyorli (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 received a positive opinion for its Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for relacorilant to treat patients with platinum-resistant ovarian cancer. About Lifyorli ® Lifyorli (relacorilant) is an oral medication taken the day before, the day of and the day after treatment with nab-paclitaxel in patients with platinum-resistant ovarian cancer. There is no biomarker requirement to receive Lifyorli. Lifyorli competitively binds to the glucocorticoid receptor (GR), where it mediates cortisol’s immunosuppressive effects and enhances chemotherapy sensitivity. Lifyorli does not have any effect at the body’s other steroid receptors. It the first U.S. Food and Drug Administration (FDA)-approved selective glucocorticoid receptor antagonist. 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. Corcept is committed to timely patient access for Lifyorli. For questions regarding product availability, please contact Lifyorli Support™ at 1-85-LIFYORLI (1-855-439-6754). LIFYORLI Indication & Usage LIFYORLI is indicated in combination with nab-paclitaxel for the treatment of adults with platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received 1-3 prior systemic treatment regimens, at least one of which included bevacizumab. IMPORTANT SAFETY INFORMATION Contraindications: LIFYORLI is contraindicated in patients receiving systemic glucocorticoids for lifesaving purposes (e.g., immunosuppression after organ transplantation) because LIFYORLI antagonizes the effect of glucocorticoids. Warnings and Precautions: Neutropenia and Severe Infections LIFYORLI in combination with nab-paclitaxel can cause neutropenia, including febrile neutropenia and severe infections. There was one fatal event of septic shock with febrile neutropenia. Thirty-eight percent of patients initiated granulocyte colony-stimulating factor (G-CSF) during the first or second cycle of therapy. Monitor complete blood counts prior to each weekly treatment with LIFYORLI in combination with nab-paclitaxel and as clinically indicated. Based on the severity of neutropenia, delay dose, reduce dose or permanently discontinue LIFYORLI in combination with nab-paclitaxel. Consider short-acting G-CSF administration as applicable. Consider the possibility of concurrent adrenal insufficiency, particularly in the setting of serious infection. Adrenal Insufficiency LIFYORLI is a reversible glucocorticoid receptor antagonist and can cause adrenal insufficiency. Adrenal insufficiency can occur at any time during treatment with LIFYORLI. The risk of adrenal insufficiency is increased in situations of stress, such as acute illness, infection, or surgery. Consider whether supplemental glucocorticoids are required in the perioperative period in patients who have received LIFYORLI within 30 days of surgery. Monitor patients receiving LIFYORLI for signs and symptoms of adrenal insufficiency. Withhold LIFYORLI and administer glucocorticoid therapy if adrenal insufficiency is suspected. High doses of supplemental glucocorticoids may be needed to overcome the glucocorticoid receptor antagonism produced by LIFYORLI. After resolution of adrenal insufficiency, resume previous dose, reduce dose or permanently discontinue LIFYORLI based on severity. Exacerbation of Conditions Treated with Glucocorticoids Use of LIFYORLI in patients taking systemic glucocorticoids for other conditions (e.g., autoimmune disorders) may exacerbate these conditions. LIFYORLI is a glucocorticoid receptor antagonist that may make systemic glucocorticoids less effective. Similarly, coadministration of systemic glucocorticoids may make LIFYORLI less effective. Monitor patients for reduced effectiveness of LIFYORLI and glucocorticoids in patients receiving both. Embryo-Fetal Toxicity LIFYORLI can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Verify pregnancy status of females of reproductive potential prior to initiating LIFYORLI treatment. Advise females of reproductive potential, including male patients with female partners of reproductive potential, to use effective contraception during treatment with LIFYORLI and for 1 week after the last dose. Adverse Reactions: Serious adverse reactions occurred in 35% of patients who received LIFYORLI in combination with nab-paclitaxel. Serious adverse reactions (≥2%) in patients were neutropenia (4%), pneumonia (3.2%), pleural effusion (3.2%), febrile neutropenia (2.1%), and fatigue (2.1%). Fatal adverse reactions (2.1%) in patients were septic shock (0.5%), cardiac arrest (0.5%), ischemic stroke (0.5%), and intestinal perforation (0.5%). Permanent discontinuation of LIFYORLI in combination with nab-paclitaxel due to adverse reactions occurred in 9% of patients. The adverse reaction (>2%) that resulted in permanent discontinuation of LIFYORLI in patients was intestinal obstruction (2.6%). Dosage interruptions of LIFYORLI due to an adverse reaction occurred in 72% of patients. Adverse reactions (≥5%) that required dosage interruptions of LIFYORLI in combination with nab-paclitaxel in patients included neutropenia (44%), anemia (12%), and fatigue (7%). Adverse reactions requiring dose reductions of LIFYORLI included fatigue (1.6%), decreased appetite (1.2%), abdominal pain (0.5%), neutropenia (0.5%), edema (0.5%), and sciatica (0.5%). LIFYORLI should be interrupted or discontinued when nab-paclitaxel is interrupted or discontinued. The most common adverse reactions (>20%) of patients treated with LIFYORLI plus nab-paclitaxel, including laboratory abnormalities, were decreased hemoglobin, decreased neutrophils, fatigue, nausea, diarrhea, decreased platelets, rash, and decreased appetite. Drug Interactions: Strong CYP3A Inducers: Avoid coadministration of LIFYORLI plus nab-paclitaxel with strong CYP3A inducers. Both relacorilant and paclitaxel are CYP3A substrates. Coadministration of strong CYP3A inducers can decrease concentrations of relacorilant and paclitaxel, which may reduce their effectiveness. CYP2C8 and Moderate CYP3A Inducers: Monitor for reduced effectiveness of LIFYORLI plus nab-paclitaxel with CYP2C8 inducers and moderate CYP3A inducers. Paclitaxel is a substrate of CYP2C8 and CYP3A, and relacorilant is a CYP3A substrate. Coadministration of CYP2C8 and moderate CYP3A inducers can decrease concentrations of paclitaxel and relacorilant, which may reduce their effectiveness. CYP2C8 Inhibitors: Monitor for increased adverse reactions and modify the dosage for adverse reactions as recommended. Paclitaxel is a substrate of CYP2C8. Coadministration of CYP2C8 inhibitors may increase concentrations of paclitaxel, which may increase the risk of adverse reactions. CYP3A Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP3A substrates. Relacorilant is a strong CYP3A inhibitor. Relacorilant increases exposure of CYP3A substrates which may increase the risk for adverse reactions related to these substrates. Certain CYP2C8 Substrates: Avoid concomitant use unless otherwise recommended in the Prescribing Information for CYP2C8 substrates where minimal concentration changes may lead to reduced effectiveness. Relacorilant is a weak CYP2C8 inducer. Relacorilant decreases exposure of CYP2C8 substrates which may decrease the effectiveness related to these substrates. Use in Specific Populations: Lactation: Advise women not to breastfeed during treatment with LIFYORLI and for 1 week after the last dose. Geriatric Use: A higher incidence of grade 3-4 adverse events and dosage modification occurred in patients aged ≥65 years compared to younger adult patients. Hepatic Impairment: Avoid LIFYORLI in combination with nab-paclitaxel in patients with moderate or severe hepatic impairment (total bilirubin >1.5 to 10x ULN and any AST). Please see the full Prescribing Information for additional Important Safety Information. 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. We have discovered more than 1,000 proprietary selective glucocorticoid receptor antagonists. Our development activities include advanced clinical trials in patients with hypercortisolism, a variety of solid tumors, ALS and liver disease. In 2012, we introduced Korlym ® , the first medication approved by the U.S. Food and Drug Administration for the treatment of patients with endogenous Cushing’s syndrome. In March 2026, we introduced Lifyorli ® as a treatment for patients with platinum-resistant ovarian cancer. Lifyorli is the first FDA-approved selective glucocorticoid receptor antagonist. We are headquartered in Redwood City, California. For more information, visit Corcept.com . 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 any future results expressed or implied by such forward-looking statements. In this press release, forward-looking statements include those concerning: Lifyorli's efficacy, safety and other clinical attributes, including when administered in combination with nab-paclitaxel and bevacizumab; the ability of BELLA Part A to demonstrate a clinically meaningful overall survival benefit; our efforts to expand treatment options for patients with solid tumors and the outcome of such efforts; the ability of GR antagonism to meaningfully counter cortisol-mediated immunosuppression and enhance chemotherapy sensitivity; our plan to present the full results of BELLA Part A and the substance of those results; our ability to complete our ongoing and planned studies of GR antagonists in platinum-sensitive ovarian, endometrial, cervical, pancreatic, prostate and other cancers in combination with various anti-cancer agents and the results of those studies; and our ability to prove that GR antagonism can benefit patients with a wide array of solid tumors. A further description of risks and uncertainties can be found in our SEC filings, which are available at our website and the SEC’s website. These risks and uncertainties include, but are not limited to, those related to our ability to: operate our business; study and develop Korlym, relacorilant, miricorilant, dazucorilant, nenocorilant and our other product candidates; those molecules’ clinical attributes, regulatory approvals, mandates, oversight and other requirements; and the scope and protective power of our intellectual property. We disclaim any intention or duty to update forward-looking statements made in this press release. Contacts Investor inquiries: ir@corcept.com Media inquiries: communications@corcept.com