It’s a promising day for advanced ovarian cancer research as two biopharma companies achieved positive results. Here’s what you need to know about research.
Two research for advanced ovarian cancer treatment show promising results.
One bright spot in a week otherwise dominated by negative clinical trial news has been the field of advanced ovarian cancer research where two biopharma companies achieved positive results in mid and late-stage trials.
Data from Corcept Therapeutics’ Phase II trial on a candidate drug for advanced ovarian cancer demonstrated a 33% reduction in risk of death compared to the current standard of care.
Researchers in the Phase II randomized and controlled trial of relacorilant plus nab-paclitaxel found the drug to be effective in people diagnosed with recurrent, platinum-resistant advanced ovarian cancer. The study had 178 participants who were already very sick and experiencing disease progression even after having an average of three prior therapies.
Patients who were treated with relacorilant the day before, the day of and the day after their regular nab-paclitaxel infusions demonstrated a 33% drop in risk of death compared to those who received only nab-paclitaxel. The median overall survival was 13.9 months in this clinical group versus 12.2 months in those under monotherapy.
Participants who had already undergone at least four lines of therapy before or were in the primary platinum-refractory disease stage were assigned to another group that received relacorilant intermittently. This group demonstrated a 48% reduction in risk of death compared to those who received nab-paclitaxel alone. The median overall survival for this arm was 13.9 months versus 12.2 in those who received just nab-paclitaxel.
The Results of Advanced Ovarian Cancer Therapy
The add-on therapy’s safety and tolerability results were consistent with those observed in monotherapy. By the time of the database cutoff, 128 of the 178 participants had died, giving researchers significant numbers to support their findings.
The next step is to move the study forward to Phase III.
“If our Phase 3 trial replicates the results in progression-free survival, duration of response and overall survival that we’ve seen in Phase 2, it will be an unprecedented success for patients with ovarian cancer. No approved therapy has been shown to significantly extend survival compared to standard chemotherapy in women with platinum-resistant ovarian cancer. We plan to meet with the FDA as soon as possible to define the best path forward and to open our Phase 3 trial in the second quarter of 2022,” said Corcept Chief Development Officer Bill Guyer, PharmD.
Advanced ovarian cancer is the fifth leading cause of cancer death in females. Patients whose disease returns in less than six months after platinum-containing treatment are labeled as having “platinum-resistant” disease. Around 20,000 women in the U.S. start new therapy every year for this type of ovarian cancer. To date, there are no approved therapies that can significantly extend overall survival.
“Corcept has introduced a novel oncologic therapeutic platform, cortisol modulation. These results constitute a potentially important medical advance,” noted Thomas Herzog, M.D., the deputy director at the University of Cincinnati Cancer Center, member of the Board of Directors of the Gynecologic Oncology Group Foundation and associate director for GOG Partners.
More details about this study and other items in Corcept’s pipeline will be discussed Thursday at the company’s investors and analysts’ advanced ovarian cancer update. These will also be shared at an upcoming national oncology conference.
In related news, the week scored another win in the fight against advanced ovarian cancer after Clovis Oncology announced that its experimental therapy achieved the primary endpoint in its Phase III ATHENA trial.
Topline data demonstrated that Rubraca (rucaparib) achieved the primary endpoint of significantly improved investigator-assessed progression-free survival compared to those who received a placebo. After receiving platinum-based chemotherapy, this benefit was observed in the primary analyses of the drug’s efficacy in newly-diagnosed patients with advanced ovarian cancer. The benefit of PFS was also observed in the trial’s subgroup of participants who have HRD-negative and BRCA mutant tumors.
Rubraca is being considered as a first-line maintenance treatment for women in the late stage of the disease and who have responded to first-line platinum-based chemo. The Phase III ATHENA trial involved 538 women with high-grade ovarian, fallopian tube or primary peritoneal cancer.
The next step for Clovis is to submit a supplemental New Drug Application (sNDA) to the FDA by the second quarter of 2022. It will then submit a Type II Variation to the European Medicines Agency by the third quarter.
