ROSELLA Trial: Beyond Biomarkers
Trial results suggest a new standard in platinum-resistant ovarian cancer (PROC) therapy.
Platinum-resistant ovarian cancer (PROC) is one of the more severe forms of ovarian cancer, often recurring within six months of completion of platinum-based chemotherapy and with a high mortality rate. Current treatment options are limited, but the results of the phase 3 ROSELLA trial show promise for a potential new standard therapy for patients with this condition.
Today’s late-breaking abstract presentation, “Final overall survival (OS) results from the phase 3 ROSELLA trial: Relacorilant plus nab-paclitaxel vs. nab-paclitaxel monotherapy in patients with platinum-resistant ovarian cancer” highlighted those results and how they could impact the future of PROC treatment and care.
“This trial is the third trial ever to meet the overall survival endpoint in PROC, which is the most impactful efficacy endpoint in this patient population with high unmet need,” said lead study author Alexander Olawaiye, MD, a leader in clinical trials at Magee-Women’s Hospital of the University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania. “This study provides a robust analysis that is mature, has ample follow-up, and is based on a very complete dataset.”
Patients in the study were randomized 1:1 to relacorilant plus nab-paclitaxel or nab-paclitaxel alone. Progression-free survival (PFS), assessed by blinded independent central review, and overall survival were the dual primary endpoints. The final OS analysis was performed after 288 deaths had been reported.
At the median follow-up of 24.8 months, the addition of relacorilant to nab-paclitaxel resulted in a statistically and clinically significant 35% reduction in the risk of death from any cause. Median OS in the relacorilant combination arm was extended by 4.1 months, compared with the nab-paclitaxel monotherapy arm (16 months vs. 11.9 months). At 18 months, the probability of being alive was 45% in the relacorilant combination arm compared to 27% in the nab-paclitaxel monotherapy arm.
One of the key benefits of this therapy, according to Dr. Olawaiye, is a lot of new therapies in this space are “biomarker select,” meaning they would only benefit certain groups of patients with those biomarkers. Relacorilant, on the other hand, does not require biomarker selection.
“This study is the first positive clinical trial conducted with registrational intent for a selective glucocorticoid receptor antagonist in patients with cancer, offering a new and unique mechanism of action to improve survival outcomes in [a larger group of] patients with advanced ovarian cancer,” he said.
The other highlight of this trial was the safety profile of relacorilant. In addition to meeting both dual primary endpoints, relacorilant plus nab-paclitaxel demonstrated safety results similar to those previous reported, with no new safety signals identified with additional follow-up. The most frequently reported adverse events were known toxicities of nab-paclitaxel including anemia, neutropenia, fatigue, and nausea.
“Most of the toxicities seen on the trial were due to nab-paclitaxel, not relacorilant,” Dr. Olawaiye said. “Overall, the addition of relacorilant to nab-paclitaxel demonstrated progression-free and overall survival benefits in patients with PROC. With a 35% reduction in the risk of death from any cause and a median overall survival improvement of 4.1 months, relacorilant plus nab-paclitaxel is well-positioned to be a new standard treatment option for patients with PROC, without the need for biomarker selection.”
Although he said that he would like his patients to have access to relacorilant in the clinic as soon as possible, Dr. Olawaiye said more research is always a good idea.
“I recommend further research into how else we can leverage the efficacy of relacorilant in treating cancer patients,” he said. “The data supports the ongoing evaluation of relacorilant in other solid tumor indications and in combination with other classes of anti-cancer agents.”
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