OU Health Stephenson Cancer Center Phase 1 Clinical Trial Drug Approved by the FDA

A drug tested at OU Health Stephenson Cancer Center at the University of Oklahoma Health Sciences was recently approved by the FDA, providing new and improved treatment options for patients with platinum-resistant ovarian cancer for the first time in nearly a decade.

Mirvetuximab soravtansine (Elahere) received accelerated FDA approval in November 2022, for patients with ovarian cancer whose tumors are resistant to certain chemotherapies. Most ovarian cancer tumors develop resistance to chemotherapy, making them difficult to treat. The FDA has not approved any new therapies to treat this disease since 2014.

OU Health Stephenson Cancer Center, through the TSET Phase 1 Drug Development Unit, led development of mirvetuximab soravtansine globally. The first human to ever receive the medication was treated at OU Health Stephenson Cancer Center, where more patients have had access to this agent through clinical trials than anywhere else in the world.

Kathleen Moore, M.D., M.S., associate director of clinical research and director of the TSET Phase 1 Drug Development Unit, served as principal investigator on the original Phase 1 trial and recently presented the positive, practice-changing Phase 3 results at the 2023 American Society of Clinical Oncology annual meeting.

The Phase 3 trial demonstrated an overall survival benefit for patients with platinum resistant high grade serous ovarian cancer that expresses high levels of folate receptors.

According to the American Cancer Society, ovarian cancer is the leading cause of death from gynecological cancers in the U.S., with approximately 20,000 patients diagnosed and 13,000 dying from the disease each year. Newly diagnosed patients can be tested at diagnosis to determine whether this agent will be an option for them at the time of progression to platinum resistance, and new studies are ongoing at OU Health Stephenson Cancer Center testing mirvetuximab soravtansine earlier in the ovarian cancer treatment course.

More than 100 patients participated in the Phase 1 clinical trial at OU Health Stephenson Cancer Center, which led to understanding the dose, treatment interval and efficacy of mirvetuximab soravtansine. Phase 1 trials are performed to evaluate the dose and schedule of new medications, including those that treat a variety of cancers. They are often used also to demonstrate early signs of efficacy and are opportunities for patients with cancer to access cutting-edge therapies.

“Clinical trials are imperative for discovering new treatments for diseases,” said Robert Mannel, M.D., director of OU Health Stephenson Cancer Center. “Treatments that are discovered through clinical trials advance the field by helping diagnose patients earlier and helping them live longer. Stephenson Cancer Center provides more options than anyone else in Oklahoma due to the deep clinical trial portfolio. We currently have approximately 300 active clinical trials available for a range of cancers in different stages. That is more than any other center in Oklahoma and offers hope to many Oklahomans who otherwise have no options. I am proud of the work that Dr. Moore and team do here at Stephenson Cancer Center with clinical trials — we have world-class physicians right here in Oklahoma.”

“Clinical trials are incredibly important and they give patients options outside the standard of care,” said Moore. “This is especially important for patients where there are typically modest to low outcome rates, such as epithelial ovarian cancer, which was the focus of this trial. Now that mirvetuximab has received FDA approval, it will offer women with epithelial ovarian, fallopian tube or primary peritoneal cancer, a better outcome.”

To find out if you qualify to participate in a Phase I clinical trial at OU Health Stephenson Cancer Center, you can talk with your oncologist about a referral, or call the clinical trials office directly at (405) 271-8778.

For more information, go to: Clinical Cancer Trials in Oklahoma | Stephenson Cancer Center (ouhealth.com)