Corcept Therapeutics Incorporated (NASDAQ:CORT), a commercial-stage company engaged in the discovery and development of medications to treat severe endocrinologic, oncologic, metabolic and neurologic disorders by modulating the effects of the hormone cortisol, today announced positive results from Part A of the company’s Phase 2 BELLA trial, which evaluated Lifyorli in combination with nab-paclitaxel and bevacizumab in 95 patients with platinum-resistant ovarian cancer.
In the study, patients treated with Lifyorli plus nab-paclitaxel and bevacizumab demonstrated a median PFS by investigator of 7.2 months compared to a median PFS of 5.4 months for Lifyorli plus nab-paclitaxel and 3.9 months for nab-paclitaxel alone in the pivotal Phase 3 ROSELLA study. ORR in BELLA was 59%, compared to 37% for Lifyorli plus nab-paclitaxel and 30% for nab-paclitaxel monotherapy in ROSELLA. Median OS had not been reached at the time of the primary analysis. In BELLA, 88% of patients were alive at the 6-month OS timepoint, compared to 82% for Lifyorli plus nab-paclitaxel and 77% for nab-paclitaxel alone in ROSELLA.
In BELLA, responses were more pronounced in patients who were bevacizumab-naive. Approximately half the patients enrolled in BELLA had not previously received bevacizumab. In these patients, median PFS was 8.1 months and ORR was 66%, with an OS at the 6-month mark of 91%.
The safety events were consistent with the known profiles of each individual agent in the combination and with Lifyorli combined with nab-paclitaxel, with no new safety signals identified. In BELLA Part A, the most common (≥25% of patients) adverse events were neutropenia, anemia, nausea, asthenia, nail disorder, peripheral neuropathy, fatigue, and leukopenia. Lifyorli is not approved for use in combination with bevacizumab. See full indication and important safety information below.
"Following ROSELLA’s outstanding results, these BELLA data provide valuable insight into adding bevacizumab to the Lifyorli/nab-paclitaxel treatment backbone," said Domenica Lorusso, M.D., Ph.D., Director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, and Full Professor of Obstetrics and Gynaecology, Humanitas University, Rozzano. "These findings help advance our understanding of both the efficacy and safety profile of this triplet combination as we work to expand treatment options for patients."
Lifyorli is the first FDA-approved selective glucocorticoid receptor (GR) antagonist. In oncology, GR antagonism is a novel mechanism that counters cortisol-mediated immunosuppression and enhances chemotherapy sensitivity. Corcept expects that the findings from BELLA Part A will augment Lifyorli’s preferred status in the National Comprehensive Cancer Network® Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a treatment for women with platinum-resistant ovarian cancer. Complete results from BELLA Part A will be presented at a medical conference next year.
BELLA Part A is a single-arm, open-label trial that enrolled 95 women with recurrent, platinum-resistant ovarian cancer at approximately 45 sites in North America, Europe and Asia-Pacific. Corcept is conducting clinical studies of its proprietary GR antagonists in platinum-sensitive ovarian, endometrial, cervical, pancreatic, prostate and other cancers in combination with various anti-cancer agents. Further information is available at Corcept.com/Pipeline-and-Clinical-Trials.