Corcept's Relacorilant Shows Promise in Ovarian Cancer Treatment, Paving Way for FDA Filing

Corcept Therapeutics has announced groundbreaking results from its phase 3 Rosella trial, demonstrating significant efficacy of its investigational oral therapy relacorilant in combination with chemotherapy for platinum-resistant ovarian cancer. The positive outcome has set the stage for a potential new standard of care and an imminent FDA filing.

Impressive Clinical Results

The pivotal late-stage trial involved 381 patients with platinum-resistant ovarian cancer, randomized to receive either relacorilant alongside nab-paclitaxel (Abraxane) or nab-paclitaxel alone. The combination therapy showed a statistically significant 30% reduction in the risk of disease progression compared to chemotherapy alone.

Key findings from the trial include:

• Median progression-free survival (PFS) of 6.5 months for the combination therapy versus 5.5 months for nab-paclitaxel alone
• Interim analysis revealed a median overall survival (OS) of 16 months for the combination therapy compared to 11.5 months for chemotherapy alone
• No new safety signals were reported, and the therapy was well-tolerated

Dr. Alexander Olawaiye, director of gynecological cancer research at Magee-Womens Hospital of the University of Pittsburgh and principal investigator for Rosella, stated, "The Rosella results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer."

Regulatory Strategy and Market Impact

Corcept Therapeutics plans to leverage these compelling results to advance its regulatory strategy:

• The company intends to submit a market approval request to U.S. regulators in the third quarter of 2025
• A European application is set to follow
• The full data set is expected to be presented at an upcoming medical conference later this year

The announcement has had a significant impact on Corcept's market position, with the company's stock price surging 85% since the news broke, climbing from $54.60 to $101 per share.

Relacorilant: A Versatile Therapy

Relacorilant, an oral selective glucocorticoid receptor antagonist, is designed to modulate cortisol activity without affecting other hormone receptors. Its potential extends beyond ovarian cancer:

• The drug has received FDA orphan drug designation for endogenous hypercortisolism (Cushing's syndrome)
• A phase 3 trial for Cushing's syndrome yielded positive results in May 2024
• A new drug application for Cushing's syndrome was submitted to the FDA earlier this month, with a decision expected by December 30, 2025

As Corcept Therapeutics continues to explore relacorilant's potential across multiple indications, the pharmaceutical industry eagerly anticipates the therapy's impact on treatment paradigms for both rare endocrine disorders and challenging oncology indications.