sam patrick posted an articleStudy Shows Typical Cancer-Free Survival Doubled for Recurrent Brain Cancer Patients when KIYATEC’s Test Informed Therapy SelectionFirst release of 3D-PREDICT clinical study data fuels momentum of company’s glioblastoma program see more
GREENVILLE, SC – December 17, 2020 – KIYATEC, Inc. today announced the first clinical use of its response-prediction test to improve outcomes in relapsed brain cancer patients. Test results that measure the effect of cancer drugs on a patient’s live cancer cells are available in just seven days, thereby enabling oncologists to select drugs informed by patient-specific evidence of response before treatment begins.
Lindsay Lipinski, MD, Assistant Professor of Oncology and a neurosurgeon at Roswell Park Comprehensive Cancer Center (Buffalo, NY), presented her and her colleagues’ findings at the 2020 Society of Neuro-Oncology meeting in November. A case series of seven patients with recurrent high-grade gliomas – six with glioblastoma multiforme (GBM) and one with anaplastic astrocytoma – was detailed.
“In this early experience, tools that can predict a tumor cell’s responsivity to a variety of chemotherapy or other therapeutic agents have already been extremely valuable in guiding treatment decision-making for patients with recurrent high-grade gliomas at our center,” said Dr. Lipinski. “Our results show that we are far along in the paradigm shift toward individualized medicine.”
Today, when these cancers return following a patient’s initial treatment, oncologists do not have evidence-based guidelines to choose which drug therapy to use next. Across several drug options, the typical expectation for the time in which these recurrent patients will remain cancer-free (i.e., median progression free survival or PFS) is only 4 months. The use of KIYATEC’s test results to inform drug selection approximately doubled the typical expectation, achieving a group median PFS of 7.9 months, a significant improvement over expected PFS in these patients.
KIYATEC’s test results informed two of the seven patients’ successful treatment with dabrafenib, a targeted agent. Notably, neither had a typically associated genetic mutation, demonstrating that the test can uncover effective drug options that would have normally been missed.
“Our vision is to successfully translate these study findings into the GBM population at large, including newly diagnosed patients – a population that we’re also actively enrolling and testing in our study,” said Matthew Gevaert, PhD, CEO of KIYATEC. “Today’s positive results in relapsed patients, with a median age of 60 and some having had two or even three relapses, paves the way to do this.”
This first release of data from KIYATEC’s active 3D-PREDICT (ClinicalTrials.gov ID NCT03561207) clinical study coincides with the continued addition of new sites at which high-grade glioma patients can enroll, bringing this study to nine institutions across the United States.
About KIYATEC, Inc.
KIYATEC leverages its proprietary ex vivo 3D cell culture technology platforms to accurately model and predict response to approved and investigational cancer drugs targeting a spectrum of solid tumors. The company’s Clinical Services business is currently engaged in the validation of clinical assays as well as investigator-initiated studies in ovarian cancer, breast cancer, glioblastoma and rare tumors, in its CLIA-certified laboratory. The company’s Drug Development Services business works in partnership with leading biopharmaceutical companies to unlock response dynamics for their investigational drug candidates across the majority of solid tumor types.
Lindsay Lipinski, et al., INNV-16. Clinical applicability of individualized drug response profiling utilizing ex-vivo tissue-derived 3D cell culture assays in high-grade glioma: a single institution case series using 3D-PREDICT results, Neuro-Oncology, Volume 22, Issue Supplement_2, November 2020, Pages ii119–ii120, https://doi.org/10.1093/neuonc/noaa215.499.
sam patrick posted an articleKIYATEC Adds Oregon Health & Science University as Study Site for Landmark Clinical Validation TrialKIYATEC and OHSU initiate patient enrollment into key oncology clinical trial. see more
GREENVILLE, S.C.-- KIYATEC, Inc., today announced that Oregon Health & Science University (OHSU) Knight Cancer Institute has initiated patient enrollment into KIYATEC’s clinical study, 3D-PREDICT, to validate the company’s test as a patient-specific predictor of response to cancer therapies for solid tumors.
In this clinical study, the test analyzes a patient’s live cancer cells, grown in KIYATEC’s laboratory within a biologically-relevant 3D microenvironment, to determine whether or not those cells respond to guideline-recommended cancer drugs. Evidence from the company’s earlier pilot study established a correlation between patient-specific predicted tumor response and actual patient clinical response to cancer therapy. The 3D-PREDICT study is a fully prospective, multi-institutional effort to validate the predictive accuracy of the test and correlate response predictions to clinical outcomes among patients with newly diagnosed and relapsed ovarian cancer, glioblastoma and certain rare tumors.
At present, the OHSU Knight Cancer Institute is enrolling newly diagnosed and relapsed ovarian cancer patients into the 3D-PREDICT Study.
“As a pioneer in personalized cancer care, the OHSU Knight Cancer Institute is deeply committed to optimizing appropriate therapy for our patients as early as possible following diagnosis, when the disease is most treatable,” said Dr. Koen De Geest, lead investigator of the clinical trial at OHSU. “Five-year survival among high-grade ovarian cancer patients is 30%, and we believe this test has the potential to help improve outcomes in the clinic.”
“With cancer treatment, and especially ovarian cancer, time is of the essence and being able to measure patient-specific evidence of response and non-response before treatment begins can truly change the future of cancer care,” said Matthew Gevaert, CEO of KIYATEC. “We welcome OHSU to our clinical study and their participation will be integral as we work to deliver accurate predictions of patient response to cancer therapies, reducing the need for patients to undergo treatments that may not work.”
The 3D-PREDICT study is anticipated to continue through 2022. Details on the trial can be found on https://clinicaltrials.gov/ct2/show/NCT03561207.
About KIYATEC, Inc.
KIYATEC is changing the future of cancer care by accurately predicting patient-specific response and non-response to therapies before treatment begins. Wasted time is the enemy of cancer patients and there is currently no way to accurately predict which cancer patients will respond to standard oncology treatments. KIYATEC has developed a validated process to use a cancer patient’s own live cells to accurately predict treatment response prior to beginning treatment.