Experimental Women’s Cancer Drug Boosts Survival Rates
Experimental Women’s Cancer Drug Boosts Survival Rates
A promising new drug may offer hope for women around the world who are battling ovarian cancer, a disease that is resistant to treatment.
Relacorilant, the experimental drug used in Phase 3 of the ROSELLA trial, improved overall survival and reduced disease progression when used along with the chemotherapy drug nab-paclitaxel.
The ROSELLA trial investigated whether the combined treatment of relacorilant and nab-paclitaxel is more effective in improving progression-free and overall survival than using nab-paclitaxel as a single treatment for cancer.
Relacorilant is the “first of its kind” in the fight against cancers that have limited treatment options, according to Dr. Alexander B. Olawaiye, director of gynecological cancer research at Magee-Women’s Hospital at the University of Pittsburgh and principal investigator in the ROSELLA trial.
“That’s what makes the findings of this study really exciting, because it did show a very significant improvement in both progression-free survival and overall survival,” Dr. Olawaiye told Fox News Digital.
Ovarian cancer is the fifth most common cause of cancer death in women and is the deadliest of gynecologic cancers, according to the Ovarian Cancer Research Alliance.
Ovarian cancer is typically treated with platinum-based drugs, especially in advanced stages or when the cancer recurs. It is often referred to as a “platinum-resistant disease” because it usually progresses or returns within six months after completing platinum-based chemotherapy.
“For many patients with advanced, recurrent ovarian cancer, the tumor eventually becomes resistant to chemotherapy, and oncologists have few good treatment options,” Dr. Olawaiye explained in a press release.
Platinum-resistant ovarian cancer “poses a significant treatment challenge,” Dr. Domenica Lorusso, an investigator in the ROSELLA trial and the director of the Gynaecological Oncology Unit at Humanitas Hospital San Pio X, Milan, Italy, said in a press release. “The ROSELLA results demonstrate that relacorilant in combination with nab-paclitaxel has the potential to become a key strategy to help improve patient outcomes.”
The overall survival rate of women following recurrence is approximately 12 months when using only one chemotherapy drug to treat the cancer, according to Corcept Therapeutics, the California-based company that manufactures relacorilant. Besides ovarian cancer, the company stated in a press release that it was studying the use of relacorilant with other severe disorders, such as prostate cancer and endogenous hypercortisolism (Cushing’s syndrome).
Dr. Olawaiye told Fox News Digital that he was grateful for his research team members because they “never stopped trying” for women undergoing treatment.
“I want to congratulate the women that are being treated for ovarian cancer—first, for helping us to do this trial and second, for the potential that we may now have another option on the block,” Dr. Olawaiye said.
The ROSELLA Trial
The ROSELLA trial enrolled 381 patients in 14 countries, including Argentina, Australia, Brazil, Canada, Europe, South Korea, and the United States. The women had to be 18 years old or older and have a confirmed diagnosis of platinum-resistant ovarian cancer. The patients were randomly assigned either relacorilant plus nab-paclitaxel or nab-paclitaxel alone.
The investigators observed a 30% reduction in the risk of disease progression in patients treated with relacorilant and nab-paclitaxel compared to those treated with nab-paclitaxel alone. Not only that, but the analysis of overall survival showed that the addition of relacorilant lowered the risk of death by 31 percent, substantially lengthening patients’ lives. The study found that the median overall survival for women who received relacorilant was 16 months, compared to 11.5 months for patients who received nab-paclitaxel only.
“These data show that treatment with relacorilant can help patients with platinum-resistant ovarian cancer live longer, without adding to their safety burden,” Dr. Bill Guyer, Corcept’s Chief Development Officer, said in a press release. “We plan to bring this treatment option to patients as quickly as possible and are working on our regulatory applications in the U.S. and Europe.”
In addition to seeing “significant improvement” in overall survival with relacorilant and nab-paclitaxel, the investigators noted that relacorilant was “well-tolerated” by patients without increased side effects.
The drug is taken by mouth one day before, on the day of, and one day after nab-paclitaxel therapy, which is administered via infusion each week.
The researchers presented the complete results at a medical conference in June.
Doctors Optimistic About Experimental Drug
Dr. Brian Slomovitz, a member of The GOG Foundation, said he views the ROSELLA trial as an “opportunity to use a unique drug” that has shown “positive, encouraging results.” The GOG Foundation, a non-profit organization dedicated to advancing research in gynecologic oncology, collaborated in the ROSELLA trial.
“We know ovarian cancer is very, very difficult to treat, particularly in those patients who have a disease that’s resistant to the standard chemotherapies,” Dr. Slomovitz, director of gynecologic oncology and co-chair of the Cancer Research Committee at Mount Sinai Medical Center in Miami Beach, Florida, told Fox News Digital. “For a long time, we’ve been trying to find treatments that can help patients not only keep the disease away longer, but also live longer. And most of the trials, unfortunately, have been negative.”
Dr. Olawaiye hopes the treatment will receive clinical approval “pretty soon.” He also told Fox News Digital that the past two decades have been a “very exciting time,” as there has been an “explosion of approvals” for cancer therapies.
“Today’s news about Relacorilant is just another addition,” he said.
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