Publication in The Lancet Oncology: Cancer Diagnostic Company Canhelp Genomics' Canhelp-Origin Test Guides Precise Treatment for Cancer of Unknown Primary

HANGZHOU, China, July 31, 2024 /PRNewswire/ -- A team of clinicians and scientists from Fudan University Shanghai Cancer Center and Canhelp Genomics, a cancer diagnostic company in Hangzhou, China have discovered that site-specific treatment guided by a 90-gene expression assay (Canhelp-Origin test) for tumor origin classification significantly improves therapeutic outcomes in patients with cancer of unknown primary. On July 25^th, the results of the study, FUDAN-CUP001, were published in The Lancet Oncology. Article link: www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00313-9/abstract 

Cancer of unknown primary (CUP) is defined as pathologically diagnosed metastatic cancer without identification of the primary tumour after a comprehensive diagnostic approach. CUP accounts for 2–5% of all malignancies and has a high mortality rate. CUP poses significant diagnostic and therapeutic challenges due to its biological heterogeneity and poor response to standard chemotherapy.

The FUDAN-CUP001 prospective study aimed to evaluate the efficacy of site-specific therapy guided by Canhelp Genomics' China and EU approved 90-gene expression assay, Canhelp Origin test, compared to empirical chemotherapy in CUP patients. Prior to this study, the clinical benefit of predicted primary site of CUP patients has not been clearly defined. Published in The Lancet Oncology, the FUDAN-CUP001 trial is the first randomized study in the world showing that site-specific treatment guided by the 90-gene expression assay significantly improves progression-free survival time (PFS) and reduces the risk of disease progression by 32% compared to empirical chemotherapy.

The clinical trial enrolled 182 patients, who were randomly assigned in a 1:1 ratio to receive either site-specific therapy or empirical chemotherapy. The results showed that PFS for patients receiving site-specific therapy (9.6 months) was significantly better than for those receiving empirical chemotherapy (6.6 months), reaching the primary study endpoint.

"This clinical study provides high-level clinical evidence for using gene expression profiling to guide site-specific therapy in CUP patients." said Dr. Xichun Hu, the principal investigator from Fudan University Shanghai Cancer Center. "We anticipate that FUDAN-CUP001 will pave the way for a new approach to CUP diagnosis and treatment, offering renewed hope for patients."

"As mentioned by the end of the publication, the findings of FUDAN-CUP001 study suggest that identifying the tissue of origin as a guide for sites specific therapy has the potential to be the new standard of care in patients with CUP in the era of precision medicine." said Dr. Qinghua Xu, CEO of Canhelp Genomics, "based on this study as high-level evidence of clinical benefit, Canhelp Genomics' core product, Canhelp-Origin Test, stands out as a distinctive and clinically validated tool, empowering pathologists and oncologists to diagnose and treat CUP patients with enhanced precision."

In The Lancet Oncology journal, oncology experts from the Sarah Cannon Research Institute and Cancer Center, Harvard Medical School and Dana-Farber Cancer Institute in the U.S., and the Gustave Roussy Institute in France also addressed the clinical significance of FUDAN-CUP001 study in a commentary titled "Molecular Diagnosis and Site-Specific Therapy in Cancer of Unknown Primary: An Important Milestone."

Article link: www.thelancet.com/journals/lanonc/article/PIIS1470-2045(24)00344-9/abstract

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SOURCE Canhelp Genomics