Corcept racks up phase 3 cancer win to bounce back from FDA Cushing's rejection

 Corcept Therapeutics’ relacorilant has improved overall survival (OS) in a phase 3 ovarian cancer study, building on interim data published last year and giving the biotech momentum as it heads into an FDA approval ruling.

The study assessed the effect of adding relacorilant, an oral selective glucocorticoid receptor antagonist, to chemotherapy in patients with platinum-resistant ovarian cancer. In March, Corcept reported that the combination improved progression-free survival. Interim data showed patients on the combination were living longer, with the 16-month median OS on relacorilant beating the 11.5 months on the control. 

Corcept confirmed Thursday that the OS advantage held up in the final analysis. In today's readout, a median OS of 16 months in the relacorilant arm played off against 11.9 months in the control arm. The difference, which amounted to a 35% reduction in the risk of death, was statistically significant. 

Having secured the OS win, Corcept can point to hits on both dual primary endpoints as it tries to win approval for relacorilant in the U.S. and the EU. The FDA is set to rule on the biotech’s filing by July 11.

Alexander Olawaiye, M.D., a University of Pittsburgh physician and the trial’s principal investigator, said in a statement that relacorilant “is positioned to become a new standard-of-care treatment for patients with platinum-resistant ovarian cancer.” Olawaiye based the prediction on the OS benefit, well-tolerated side effect profile and oral administration.

Corcept’s share price rose 19% to $43.15 in premarket trading, going a little way to reverse the losses the stock suffered at the turn of the year. Investors halved the biotech’s share price after it revealed the FDA had rejected a filing for approval of relacorilant in Cushing’s syndrome. At the time, Truist Securities analysts said in a note to investors that their ovarian cancer outlook was unaffected by the setback.

Cancer could become an increasingly important part of Corcept’s activities, with the biotech responding to the success of the phase 3 trial by advancing plans to study relacorilant in a range of tumor types. The company’s road map includes phase 2 studies in endometrial, cervical, pancreatic and prostate cancers. Corcept is also working to generate more data in ovarian cancer. 

https://www.fiercebiotech.com/biotech/corcept-racks-phase-3-cancer-win-bounce-back-fda-rejection