CHMP Backs Corcept's Lifyorli Plus Nab-Paclitaxel for Platinum-Resistant Ovarian Cancer
核心洞察
The EMA's CHMP has recommended EU approval of relacorilant combined with nab-paclitaxel for patients with platinum-resistant ovarian cancer (搜索).
The opinion rests on Phase 2 and pivotal Phase 3 ROSELLA data showing improved progression-free and overall survival versus nab-paclitaxel alone.
ROSELLA randomized 381 patients 1:1 across sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia.
The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended that the European Commission approve relacorilant, in combination with nab-paclitaxel, for the treatment of patients with platinum-resistant ovarian cancer (搜索), Corcept Therapeutics announced.
The recommendation is based on positive data from Corcept's Phase 2 and pivotal Phase 3 ROSELLA trials, in which patients receiving relacorilant plus nab-paclitaxel experienced improved progression-free survival and overall survival compared with patients who received nab-paclitaxel alone. The safety profile of the combination in these trials was consistent with the known safety profile of nab-paclitaxel monotherapy.
"The CHMP's positive opinion takes us a big step closer to making the benefits of glucocorticoid receptor (搜索) antagonism available to patients in the EU. We look forward to the European Commission's final decision," said Joseph K. Belanoff, M.D., Corcept's Chief Executive Officer. He thanked the CHMP for what he described as an efficient and timely review, and thanked the healthcare providers and patients who participated in relacorilant's clinical trials.
The European Commission will now review the CHMP's opinion and is expected to issue a final decision on marketing authorization in the fourth quarter of 2026.
ROSELLA Trial Design
ROSELLA was relacorilant's pivotal Phase 3 trial. It enrolled 381 patients with platinum-resistant ovarian cancer (搜索) at sites in the United States, Europe, South Korea, Brazil, Argentina, Canada and Australia. Patients were randomized 1:1 to receive either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.
The trial is being conducted in collaboration with the GOG Foundation, Inc., the European Network of Gynaecological Oncological Trial groups, the Asia-Pacific Gynecologic Oncology Trials Group, the Latin American Cooperative Oncology Group and the Australia New Zealand Gynaecological Oncology Group.
Mechanism and Regulatory Status
Relacorilant is a selective glucocorticoid receptor (搜索) modulator that binds to the glucocorticoid receptor without binding to the body's other hormone receptors. According to Corcept, it is the only selective glucocorticoid receptor modulator approved by the U.S. Food and Drug Administration for any indication, and it is marketed in the United States under the trade name Lifyorli (搜索) for the treatment of patients with platinum-resistant ovarian cancer (搜索). The molecule is proprietary to Corcept and is protected by composition of matter, method of use, formulation, manufacturing and other patents.
Disease Burden and Unmet Need
Ovarian cancer (搜索) is the fifth most common cause of cancer death in women. Patients whose disease progresses less than six months after commencing platinum-based chemotherapy are considered to have platinum-resistant disease, and there are few treatment options for these women. 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.
Rationale for Glucocorticoid Receptor Antagonism
Corcept states that 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 oncogenic signaling in the cells to which it binds. Cortisol also suppresses the body's immune response, which weakens its ability to fight disease, including cancer.
Corcept has focused on cortisol modulation for over 25 years and has discovered more than 1,000 proprietary selective cortisol modulators and glucocorticoid receptor (搜索) antagonists. The company is conducting advanced development programs in patients with hypercortisolism, a variety of solid tumors, ALS and liver disease.