Highlights

  • Corcept reports median progression-free survival of 7.2 months in BELLA Part A.
  • The 95-patient study records an objective response rate of 59%.
  • Bevacizumab-naive patients show 8.1-month median progression-free survival.
  • The three-drug combination identifies no new safety signals.

Corcept Therapeutics Incorporated (NASDAQ:CORT) has announced positive results from Part A of its Phase 2 BELLA study evaluating Lifyorli, or relacorilant, alongside nab-paclitaxel and bevacizumab in women with platinum-resistant ovarian cancer. The open-label, single-arm study enrolled 95 patients and reported progression-free survival, response and early overall survival measurements.

Progression-Free Survival and Response Rates

Median investigator-assessed progression-free survival reached 7.2 months in BELLA Part A, and the objective response rate was 59%. For context, Corcept reported median progression-free survival of 5.4 months for Lifyorli plus nab-paclitaxel and 3.9 months for nab-paclitaxel alone in its separate pivotal Phase 3 ROSELLA trial. Corresponding ROSELLA response rates were 37% and 30%. These figures come from different studies, rather than a randomized comparison within BELLA.

Prior Bevacizumab Treatment Matters

Approximately half of BELLA participants had not previously received bevacizumab. In this subgroup, median progression-free survival was 8.1 months and the objective response rate was 66%. At six months, 91% were alive, compared with 88% of the overall BELLA population. Six-month overall survival in the separate ROSELLA groups was 82% for Lifyorli plus nab-paclitaxel and 77% for nab-paclitaxel alone. Median overall survival in BELLA had not been reached at primary analysis.

Safety and Current Treatment Status

The safety events were consistent with the known profiles of the individual medicines and the existing Lifyorli and nab-paclitaxel combination, with no new safety signals. Common events affecting at least one-quarter of patients included neutropenia, anemia, nausea, asthenia, nail disorders, peripheral neuropathy, fatigue and leukopenia. Lifyorli is approved in combination with nab-paclitaxel for specified adults with platinum-resistant ovarian, fallopian tube or primary peritoneal cancer, but it is not approved for use with bevacizumab.

Further Data and Development Plans

BELLA Part A enrolled patients at approximately 45 locations across North America, Europe and Asia-Pacific. Corcept plans to present the complete findings at a medical conference next year. It is also studying proprietary glucocorticoid receptor antagonists in several other cancers and combinations. The latest BELLA announcement establishes a new set of Phase 2 observations while further clinical development and regulatory considerations remain ahead.