On January 9, 2020 Molecular genetics company MiraDx reported it is opening patient enrollment in collaboration with UCLA for a first-ever non-tumor based microRNA biomarker-driven clinical trial for KRAS-variant positive HPV-positive head and neck cancer patients (HNSCC) (Press release, MiraDx, JAN 9, 2020, View Source [SID1234552941]). The trial will randomize 70 patients to current standard of care (radiation plus cisplatin) or radiation, cisplatin and ERBITUX (cetuximab), an epidermal growth factor receptor (EGFR) antagonist, to compare differences in overall survival.
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The trial is intended to further confirm findings from a previous Phase 3 randomized study for HNSCC patients, RTOG 0522 (NCT00265941), which MiraDx previously analyzed and showed that the subgroup of patients with the KRAS-variant who received ERBITUX in combination with radiation and cisplatin had significantly improved overall survival.
"This trial is groundbreaking in that it will further validate that there are powerful biomarkers in regions of DNA, previously considered ‘junk’ DNA, which can predict improved survival when certain targeted agents, such as cetuximab, are added to radiation," said Dr. Joanne Weidhaas, Chair of MiraDx and Head of Translational Research, Department of Radiation Oncology, David Geffen School of Medicine. "Our goal is to continue to prove that these types of microRNA mutations can enable clinicians to more accurately identify individuals who will benefit from specific therapeutic combinations, to truly individualize cancer therapies in meaningful ways to improve patient survival."
The trial is expected to begin enrolling patients with locally advanced HNSCC this month. It is expected to last approximately two years with an interim analysis after year one. Patients will be recruited from across the U.S. Enrollment will begin at UCLA and potentially expand to other sites. The primary investigator is Robert K. Chin, MD, PhD, a radiation oncologist affiliated with the Ronald Reagan UCLA Medical Center and UCLA Medical Center, Los Angeles. Dr. Weidhaas is a co-investigator.
The KRAS-variant is an inherited genetic marker that predicts cancer risk as well as unique response to cancer therapies. Numerous studies have already shown the KRAS-variant to be predictive across cancer types (rather than tumor-specific), functional (its presence or lack thereof has direct implications for how a patient will respond to specific therapies, stressors to the immune system, etc.), and actionable (a direct link between the presence of the KRAS-variant and the course of action for cancer treatment).