Corcept Therapeutics’ oral antiglucocorticoid plus chemotherapy slashed risk of ovarian cancer progression by 30% compared to chemotherapy alone. The biopharma intends to take the phase 3 data to regulators in hopes of delivering a new standard of care for patients with platinum-resistant cancer.
The California-based company’s stock has skyrocketed 85% since Friday’s market close, climbing from $54.60 per share to $101 as of 10:30 a.m. ET today.
The top-line results come from Corcept’s pivotal late-stage trial, dubbed Rosella, which recruited 381 patients with platinum-resistant ovarian cancer. Participants were randomized to receive either Corcept’s antiglucocorticoid relacorilant alongside nab-paclitaxel (sold as Abraxane), or nab-paclitaxel alone.
The trial measured two primary endpoints—progression-free survival, as evaluated by a blinded independent central review (PFS-BICR), and overall survival (OS)—with a win achieved if either were met, according to Corcept.
It was on progression-free survival where Corcept claimed a win, with patients treated with relacorilant and chemotherapy experiencing a median PFS-BICR of 6.5 months compared to 5.5 months for patients who received nab-paclitaxel alone, representing a statistically significant 30% reduction.
An interim evaluation found a significant improvement for OS in patients receiving the investigational combo, with a median OS of 16 months compared to 11.5 months for patients receiving only nab-paclitaxel. The full data set was not shared, with complete findings expected to be presented at a medical conference later this year, according to the biopharma.
No new safety signals related to relacorilant were reported, and the therapy was well tolerated, according to Corcept.
The company plans to use the full data set to request market approval from U.S. regulators in the third quarter of this year, with a European ask to follow, Corcept Chief Development Officer Bill Guyer said in a March 31 release.
Relacorilant, an oral therapy, is a selective glucocorticoid receptor antagonist designed to modulate cortisol activity by binding to the receptor while avoiding other hormone receptors.
“Patients with advanced ovarian cancer have few good treatment options and, unfortunately, patients with recurrent disease eventually develop resistance to available therapies,” Alexander Olawaiye, M.D., director of gynecological cancer research at Magee-Womens Hospital of the University of Pittsburgh and principal investigator for Rosella, said in the release. “The Rosella results represent an important advancement in the development of a treatment for patients with platinum-resistant ovarian cancer.”
Corcept is studying relacorilant in multiple indications, including endogenous hypercortisolism, a hormonal disorder also known as Cushing’s syndrome in which the drug has snagged FDA orphan drug designation.
In May 2024, the biopharma reported a phase 3 win for the antiglucocorticoid in Cushing’s, with a new drug application submitted to the FDA in the indication earlier this month. A decision is expected by or before Dec. 30 of this year.