Data from KIYATEC clinical study shows test accurately predicts response in brain cancer patients
KIYATEC, Inc. today announced the publication of new peer-reviewed data that establishes a clinically meaningful prediction of patient-specific responses to standard treatment, before treatment, in newly diagnosed glioblastoma (GBM) and other gliomas high-grade (HGG) patients. The results, the interim analysis of data from the company’s 3D-PREDICT clinical study, were published on June 16, 2021 in Advances in neuro-oncology, an open access clinical journal.
One goal of the study, which continues to enroll, was for the prediction of the prospective and patient-specific response of the test to achieve statistical significance for predictive accuracy. The 3D-PREDICT study achieved this goal very early on, during its interim data analysis, an achievement that is rare for innovations in oncology. For clinicians and payers, the publication establishes successful analytical validation and early clinical validation of KIYATEC’s 3D Predict ™ Glioma Assay.
The recent bipartisan resolution passed by the US Senate designating July 21, 2021 as Glioblastoma Awareness Day highlights the seriousness of this aggressive brain cancer. Less than 10% of patients survive more than five years. Pharmaceutical and clinical efforts have resulted in only modest increases in overall survival since the disease was first described in the 1920s. Today, most newly diagnosed patients receive the same treatment regimen. (radiotherapy and temozolomide), which represents an opportunity to improve care by shifting the paradigm towards individualized medicine for the treatment of HGG.
KIYATEC test results accurately identified patients as future temozolomide responders or non-responders prior to the start of drug therapy. The group of future responders showed a statistically significant comparative increase at 6 months in overall survival. Since test results are only available seven days after surgery, this creates an opportunity to improve outcomes for each predicted non-responder by providing the possibility of patient-specific treatment strategies. In the future, the results of KIYATEC may also prove useful in improving the results for each predicted responder through patient-specific combination strategies.
The prediction of successful response for newly diagnosed patients follows the company’s previous success with predicting response to treatment in patients with recurrent high-grade glioma. In December 2020, KIYATEC announced a clinical case series demonstrating that the use of their test doubled the median time to progress of these patients compared to what would be expected without the use of the test. In addition, the previous announcement demonstrated the successful clinical use of the targeted agent dabrafenib in two patients who were not identified by genetic sequencing. By identifying a successful response to drugs that would have been missed by today’s tests, KIYATEC’s findings have broadened the successful treatment options for these patients.
“Decision making in our setting is based on patient-specific evidence, embodying truly personalized medicine. Evidence of response before the first dose is given creates options that were not previously available in treatment. “said Matthew Gevaert, PhD, CEO of KIYATEC.
Compared to other approaches, assays developed using KIYATEC’s 3D ex vivo cell culture platform demonstrate increased biological fidelity, which was first reported in 2019 in ovarian cancer. In patients with newly diagnosed ovarian cancer, the KIYATEC test prospectively and accurately predicted response to first-line chemotherapy with 89% accuracy. The new GBM results now establish comparable predictive accuracy in two solid tumors, with eight additional cancers in the company’s pipeline.
KIYATEC leverages its proprietary ex vivo 3D cell culture platforms to accurately model and predict response to approved and experimental cancer drugs targeting a spectrum of solid tumors. The platforms are positioned to address the critical limitations of the current selection of cancer drugs. The Company’s Clinical Services activity is currently engaged in the validation of clinical trials as well as studies initiated by researchers in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its laboratory. CLIA certified. The Company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates in the majority of solid tumor types.
Lauren Arnold, 781-235-3060
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