Relacorilant

The 'Cushing Syndrome - Pipeline Insight, 2024' report by ResearchAndMarkets.com details 4+ companies and 4+ pipeline drugs for Cushing Syndrome, including profiles of clinical and nonclinical stage products, therapeutic assessments, and pipeline development activities. Key players include Corcept Therapeutics, Sparrow Pharmaceuticals, and Crinetics Pharmaceuticals, with notable drugs like Relacorilant, SPI 62, and CRN-04894.

Recap of November 2024 episodes of OncLive On Air, featuring discussions on toripalimab in nasopharyngeal carcinoma, emerging breast cancer treatments, relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, zolbetuximab approval for CLDN18.2+ HER2-negative gastric/GEJ adenocarcinoma, HPV16-targeted immunotherapy in HNSCC, trastuzumab deruxtecan in HER2+ gynecologic cancer, long-term zanubrutinib data in R/R CLL, and obe-cel approval for B-cell precursor ALL.

In today’s OncLive On Air, host Ashling Wahner interviews Premal Thaker, MD, MS, about relacorilant (CORT125134) in ovarian cancer, discussing its combination with nab-paclitaxel (Abraxane) for platinum-resistant cases, phase 2 data, and the upcoming phase 3 ROSELLA trial.

Corcept Therapeutics' Phase III GRADIENT trial for relacorilant in Cushing’s syndrome missed its primary endpoint of systolic blood pressure improvement. However, the trial met secondary endpoints for hyperglycemia, weight, and body composition, with relacorilant showing significant improvements over placebo. The drug was well-tolerated, with no reported adverse effects like hypokalemia or adrenal insufficiency. The trial results will support the NDA submission this quarter, alongside data from the GRACE trial.

Platinum-resistant ovarian cancer's treatment challenge is addressed by the development of the oral, selective GR modulator relacorilant, which aims to block cortisol's antiapoptotic effects in GR-overexpressing solid tumors. The phase 3 ROSELLA study is underway to confirm relacorilant's efficacy with nab-paclitaxel in platinum-resistant ovarian cancer, based on promising phase 2 data showing improved progression-free survival and duration of response.

Corcept Therapeutics reports Q3 2024 revenue of $182.5M, up 48% YoY, and increases 2024 revenue guidance to $675-$700M. Net income per share is $0.41 (diluted), with cash and investments at $547.6M. The company plans to submit an NDA for relacorilant this quarter, supported by Phase 3 GRADIENT trial results.

Domenica Lorusso discusses phase 2 trial findings on relacorilant + nab-paclitaxel in platinum-resistant ovarian cancer, noting intermittent dosing's efficacy over continuous, guiding phase 3 ROSELLA trial design. Prophylactic measures for hematologic toxicities are more flexible in phase 3, showing manageable toxicities without routine use of granulocyte colony–stimulating factor. The cortisol pathway's role in chemoresistance offers a novel strategy to reduce it, enhancing patient outcomes.

Domenica Lorusso discusses findings from a phase 2 trial evaluating relacorilant plus nab-paclitaxel in recurrent, platinum-resistant ovarian cancer, showing significant improvements in PFS, overall survival, response rate, and DOR. The results led to the ongoing phase 3 ROSELLA trial comparing nab-paclitaxel alone with the combination in eligible patients.

Relacorilant, a selective glucocorticoid receptor modulator, enhances nab-paclitaxel efficacy in platinum-resistant ovarian cancer. Phase 2 trial results showed improved progression-free survival and duration of response with the combination. The ongoing phase 3 ROSELLA trial aims to confirm these benefits in a larger patient population.

Glucocorticoid-induced hypercoagulopathy in endogenous Cushing syndrome (CS) increases thromboembolic risk, with CS patients having an 18-fold higher risk of venous thromboembolism (VTE) compared to the general population. VTE risk is highest postoperatively, with up to 5.6% incidence. Hypercoagulopathy persists post-surgery and improves within 6 months. Relacorilant, a selective glucocorticoid receptor modulator, showed improvements in coagulation markers without undesirable effects, suggesting potential benefits for CS patients, particularly those at high VTE risk.