University Hospital of Southern Denmark has had the positive IndiTreat® trial results published in the highly recognized “Journal of Experimental & Clinical Cancer Research”. The IndiTreat® test was used to identify personalized treatment options for metastatic colorectal cancer patients.
The patients were enrolled in the trial (ClinicalTrials.gov, register NCT03251612,) between 2017 and 2020 and the positive trial results were originally presented at the American Society of Clinical Oncology (ASCO) 2021 Annual meeting.
The enrolled patients suffered from end stage metastatic colorectal cancer (mCRC) and had exhausted all standard therapies. The aim of the trial was to investigate if 3D-microtumor-based (IndiTreat) testing could improve the Progression-Free-Survival (PFS) after two months of IndiTreat-guided treatment.
The trial was initiated and run by the University Hospital of Southern Denmark as a phase 2, prospective, interventional study. According to the authors, the trial is the largest of its kind so far and demonstrated that patient-derived tumoroids for drug sensitivity testing can identify effective treatments for patients who have exhausted standard therapies.
The primary endpoint, progression-free survival at two months, was achieved in 50% of the treated patients, surpassing the pre-defined success rate (endpoint) of 31%. Historical data for two months of Standard-of-Care treatment show a progression-free survival of 20%. These results highlight the benefits of using patient-derived tumoroids for in-vitro sensitivity testing in metastatic colorectal cancer.
Ole Thastrup, CSO and Founder of 2cureX, commented: "When we presented the results of this first interventional clinical trial where cancer treatment was guided by a functional 3D microtumor test, it stirred a lot of interest. It is therefore very rewarding to see that the data now has been published by such high-impact journal. Since this early clinical application of functional precision oncology, we have developed three CE-IVD IndiTreat® tests for mCRC patients that are distributed in 20 European countries”.
2cureX's Medical Director, Raphael Gruber, added: "This study showcases the power of leveraging patient-derived tumoroids to develop individualized treatment strategies, bringing hope to patients with limited therapeutic options. Publications like this one in “Journal of Experimental & Clinical Cancer Research” are important to support the active discussions we are having with oncology hospitals throughout Europe."
The publication can be found here.
Additional information on the portfolio of IndiTreat® products for colorectal cancer can be found on our website here.