Clearance of Circulating Tumor HPV-DNA, Monitored Using HPV-SEQ, Predicts Improved Survival: A JAMA Oncology Publication

BALTIMORE, Aug. 27, 2024 /PRNewswire/ -- Sysmex Inostics Inc., a subsidiary of Japan's Sysmex Corporation and Baltimore-based biotechnology firm and CLIA-certified lab, in collaboration with the University of Chicago Medicine announces the publication of results from the OPTIMAII trial in JAMA Oncology. Circulating tumor HPV-DNA (ctHPV-DNA) clearance, monitored using HPV-SEQ assay, predicts improved survival in patients with HPV-associated oropharyngeal cancer following nivolumab-based neoadjuvant therapy.

"At Sysmex Inostics, we recognize the critical role of ctHPV-DNA monitoring in accelerating drug development and ultimately optimizing patient care and treatment management for HPV-driven cancers," said Shinichi Sato, President, and CEO of Sysmex Inostics. "We are excited about the latest findings using HPV-SEQ published in JAMA Oncology. These collaborative efforts with academia and pharma attest to our commitment in expediting the use of this novel biomarker in clinical settings," said Sato.

This is the first clinical trial to assess immunotherapy (nivolumab) in the neoadjuvant chemotherapy setting with response-adapted deintensification therapy.

Non-invasive biomarkers such as PDL-1 and ctHPV-DNA were assessed pre/post-treatment to understand their clinical utility in treatment monitoring and surveillance, especially as a future tool to guide treatment strategy for treatment de-intensification.

Key results from the study include:

• All (31, 100%) patients with paired samples at baseline and after 2-3 cycles of neoadjuvant therapy, had detectable and quantifiable ctHPV-DNA at baseline.
• All (31, 100%) patients showed quantitative reduction of ctHPV-DNA with neoadjuvant therapy along with clinical assessment of radiographic response.
• Majority of patients (26/31) had clearance of ctHPV-DNA during neoadjuvant therapy, while 5 patients had detectable and persistent ctHPV-DNA after 6-9 weeks of neoadjuvant therapy.
• 2-year PFS was significantly improved for patients with neoadjuvant clearance of ctHPV-DNA as compared with those with persistent ctHPV-DNA (p=0.0018).

Exciting about the findings from this paper, lead author Ari Rosenberg, MD, an oncologist at UChicago Medicine, said, "We are seeing mounting evidence that ctHPV-DNA is very useful in grading response to treatment and warrants investigation in guiding treatment decisions such as selecting patients for treatment de-intensification."

This study suggests that ctHPV-DNA clearance may be an improved surrogate biomarker to grade treatment response to neoadjuvant therapy and serve as a non-invasive tool to select patients for de-intensification. Importantly, ctHPV-DNA is a sensitive dynamic biomarker which along with deep response may offer advantages and complementary information compared with baseline, static biomarkers.

About HPV-SEQ

HPV-SEQ is an ultra-sensitive, CLIA-validated NGS-based assay for detection and quantification of cell-free HPV-DNA. It can detect as low as 2 copies of HPV 16 and HPV 18 DNA, offering high analytical and clinical sensitivity. It is currently being utilized in several clinical trials of HPV-associated cancers for monitoring of treatment response.

About Sysmex Inostics

Sysmex Inostics, Inc., a subsidiary of Japan's Sysmex Corporation, is a Baltimore-based biotechnology firm and CLIA-certified lab offering biomarker testing to accelerate the development of personalized medicine. Pioneering liquid biopsy technology with OncoBEAM™ in 2008, Sysmex Inostics now provides next generation sequencing Plasma-Safe-SeqS technology panels. The Plasma-Safe-SeqS panels empower more accurate detection of low-frequency biomarkers with ultra-sensitive 0.03% to 0.05% allele frequency from a simple blood draw to expedite studies and uncover deeper insights into therapy response. The company offers CLIA validated NGS testing services for HPV16/18 quantification, HNSCC, AML, breast cancer, and solid tumors impacted by RAS-RAF and PI3K signaling pathways.

SOURCE Sysmex Inostics