Relacorilant plus chemotherapy met its main finish aim of progression-free survival and total survival.
The first finish aim was met in a part 3 trial of relacorilant plus nab-paclitaxel chemotherapy in sufferers with platinum resistant ovarian most cancers, which improved progression-free survival, in accordance with the drug’s producer, Corcept Therapeutics Inc.
Latest findings that supported this resolution come from the part 3 trial ROSELLA.
“Sufferers with superior ovarian most cancers have few good therapy choices and, sadly, sufferers with recurrent illness finally develop resistance to obtainable therapies,” Dr. Alexander B. Olawaiye mentioned within the information launch. “The ROSELLA outcomes characterize an necessary development within the growth of a therapy for sufferers with platinum-resistant ovarian most cancers.”
Olawaiye is the Director of gynecological most cancers analysis at Magee-Ladies’s Hospital of the College of Pittsburgh and Principal Investigator within the ROSELLA trial.
Within the ROSELLA trial, sufferers handled with relacorilant plus nab-paclitaxel had a 30% decrease danger of illness development than these receiving nab-paclitaxel alone. Median progression-free survival by blinded unbiased central assessment was 6.5 months versus 5.5 months, respectively. An interim total survival evaluation confirmed a major enchancment with relacorilant, with a median of 16 months in contrast with 11.5 months for nab-paclitaxel alone.
Glossary:
Total survival: the time from therapy initiation till loss of life from any trigger.
Development-free survival: the time at which half of the sufferers in a scientific trial expertise illness development or loss of life.
Orphan drug designation: a standing granted by regulatory businesses to medicine developed for uncommon illnesses, offering advantages like market exclusivity and tax credit.
Concerning security, relacorilant was nicely tolerated, with no new security alerts. Security and tolerability had been constant between teams, as seen within the firm’s part 2 trial.
Full outcomes might be introduced at a medical convention this 12 months. Findings from Corcept’s part 2 trial in platinum-resistant ovarian most cancers had been revealed within the Journal of Medical Oncology in June 2023.
“Platinum-resistant ovarian most cancers poses a major therapy problem. The ROSELLA outcomes exhibit that relacorilant together with nab-paclitaxel has the potential to develop into a key technique to assist enhance affected person outcomes,” Dr. Domenica Lorusso, Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas College, Rozzano and investigator within the ROSELLA trial, mentioned within the information launch.
The ROSELLA trial enrolled 381 sufferers with platinum-resistant ovarian most cancers at websites in america, Europe, South Korea, Brazil, Argentina, Canada and Australia. Biomarker choice was not required. Sufferers had been randomly assigned to obtain both relacorilant plus nab-paclitaxel or nab-paclitaxel alone.
The trial has twin main finish targets: progression-free survival by blinded unbiased central assessment and total survival. A optimistic final result is achieved if both finish aim is met.
Relacorilant is an oral remedy and a selective glucocorticoid receptor antagonist that modulates cortisol exercise by binding to the glucocorticoid receptor with out affecting different hormone receptors, as per the discharge. Corcept is learning relacorilant for ovarian most cancers and different critical situations, together with endogenous hypercortisolism, also referred to as Cushing’s syndrome, and prostate most cancers.
Relacorilant has been designated an orphan drug by the Meals and Drug Administration and the European Fee for the therapy of hypercortisolism and by the European Fee for ovarian most cancers.
“The development in survival seen in ROSELLA, with out an elevated security burden, brings us nearer to delivering a brand new standard-of-care therapy for sufferers with platinum-resistant ovarian most cancers,” Invoice Guyer, Corcept’s Chief Improvement Officer, mentioned within the information launch. “We deeply recognize the sufferers and investigators who participated within the trial, and we look ahead to presenting the trial’s full ends in the approaching months. We anticipate to submit our [new drug application] within the third quarter and our [Marketing Authorization Application] shortly thereafter.”
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