Tumor Test Predicts Response to First-Line Ovarian Cancer Treatment with 89 Percent Accuracy

Assay Based on 3D Spheroid Culture Would Direct Chemotherapy-resistant Women to Second-line Treatment Faster

FAIRFAX, Virginia – A prospective, multi-center pilot study indicates that Ex Vivo 3D Cell Culture (EV3D) can accurately predict at diagnosis whether a patient’s ovarian cancer will respond to standard of care first-line treatment. Inova collaborated with KIYATEC, Inc., of Greenville, South Carolina, in developing this technology.

The study results, published in Scientific Reports, indicate that with further validation a diagnostic test based on the technology could provide clinically valid evidence to support immediate initiation of second-line therapy in the 20-30 percent of women who will not respond to first-line chemotherapy. The results also provide support for application of the EV3D platform to other cancer types.

“Women with ovarian cancer typically have to wait months to find out whether their cancer is chemotherapy-sensitive or chemotherapy-resistant,” said G. Larry Maxwell, MD, Chairman of Obstetrics and Gynecology at Inova Fairfax Hospital and co-director of the Inova Women’s Health Integrated Research Center (WHIRC). “A diagnostic test administered at the outset of treatment could direct non-responders to a potentially more effective treatment right away and eliminate periods of ineffective treatment.”

The EV3D technology assesses the response of patient-derived tumor cells grown in a three-dimensional culture to a panel of guideline-recommended drug options for the treatment of ovarian cancer, including platinum chemotherapy. The test is being further evaluated by investigators within the Inova WHIRC and Inova Schar Cancer Institute and is being commercialized by KIYATEC, which has received investment from the Inova Personalized Health Accelerator.

A total of 154 women diagnosed with ovarian cancer were enrolled in the study. Of those, 92 were eligible for analysis, and by publication time a total of 44 had sufficient clinical follow-up to sufficiently categorize their disease status six months following completion of chemotherapy. All were treated with standard of care adjuvant (35 patients) or neoadjuvant (nine patients) chemotherapy.

Within the larger adjuvant therapy group, the EV3D test predicted 26 responders and nine non-responders, correctly anticipating the outcome for 31 of the 35 cases. Four of the nine women who were predicted to be non-responders did show response to chemotherapy. The overall results produced an accuracy rate of 89 percent (p < 0.001), with an overall test sensitivity of 86 percent and test specificity of 100 percent.

“For ovarian cancer patients and their physicians, this study represents an important step in demonstrating our ability to deliver a robust predictive assay with the potential to positively support therapeutic decision-making and improve patient outcomes,” said Matthew Gevaert, CEO of KIYATEC. “Our mission is to optimize and leverage our EV3D cell culture technology to develop response-predictive clinical assays across a range of solid tumor types and make a difference in the future of cancer care.”

Importantly, the test indicated that the five test-predicted chemotherapy non-responders who received primary debulking surgery followed by chemotherapy would be sensitive to other drugs in the panel, including doxorubicin and, in some cases, topotecan. This result suggests that a deviation from the standard of care might have benefited these patients.

KIYATEC has opened a larger, 500-patient clinical study, 3D-PREDICT (NCT03561207), to further validate EV3D testing in newly diagnosed and recurrent ovarian cancer, as well as glioblastoma. The study is currently open to enrollment.

Media Contact: Kelly Schlageter, Kelly.schlageter@inova.org, 571-241-6342

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About Inova

Inova is Northern Virginia’s leading nonprofit healthcare provider, employing more than 18,000 team members and serving more than 2 million individuals annually through an integrated network of hospitals, primary and specialty care practices, emergency and urgent care centers, outpatient services and destination institutes such as the Inova Heart and Vascular Institute, Inova Schar Cancer Institute and Inova Neuroscience and Spine Institute. Our mission is to provide world-class healthcare – every time, every touch – to each person in every community we have the privilege to serve. Founded in 1956 as the Fairfax Hospital Association, Inova has grown with its surrounding community and the region to provide a full spectrum of health services, including Northern Virginia’s only Level 1 Trauma Center and Level 4 Neonatal Intensive Care Unit. Its hospitals have a total of 1,800 licensed beds.

 Four of Inova’s five hospitals have received five-star rankings from the Centers for Medicare and Medicaid Services; they are the only hospitals in the Washington, DC region to have earned the highest rating from the federal agency. Inova Fairfax Medical Campus (IFMC) was named the #1 hospital in the Washington, DC, Metropolitan Area for the 5th time, according to U.S. News & World Report 2019-20 Best Hospitals rankings. Inova’s Gynecology department is the highest ranked in the region and #13 in the country. Of Inova Health System’s five hospitals, three ranked in the top ten in the DC region.  To achieve its mission of providing world-class healthcare to a diverse community, Inova is home to prominent clinicians and scientists who drive innovation to improve patient care, prevent disease and promote wellness. More information and statistics about Inova can be found at www.inova.org.