Date: 2013-05-15
Type of information:
phase:
Announcement: results
Company: Epigenomics (Germany - USA)
Product: Epi proColon® (colorectal cancer blood test)
Action mechanism:
Disease: colorectal cancer detection
Therapeutic area: Cancer - Oncology
Country: USA
Trial details: The double blind study was performed at 70 clinical trial sites across the US and comprised two arms. The first arm included a total of 103 asymptomatic, average risk individuals without family history or previous incidences of CRC, who were diagnosed and confirmed as having colorectal cancer during a screening colonoscopy. Matched blood and stool samples from these patients were collected at least 10 days after colonoscopy but before surgical intervention. The second arm of the study included 198 individuals selected according to the same criteria, but whose blood and stool samples were collected before the colonoscopy. This study arm included three cancer cases as well as advanced adenomas, polyps and individuals with no evidence of disease.
Latest
news: * On May 15, 2013, Epigenomics, a German-American cancer molecular diagnostics company, has announced that results of the head-to-head comparative study between its blood-based colorectal cancer (CRC) detection test Epi proColon® and fecal immunochemical testing (FIT) will be presented at a workshop of the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee during this year’s DDW (Digestive Disease Week) Conference in Orlando, FL, U.S.A., on May 17, 2013. In the final analysis of the study results, it was demonstrated that Epi proColon® was able to detect 74% of all evaluable CRC cases in this large multi-centric clinical study, in comparison to 67% of CRC cases detected by FIT. These results indicate that sensitivity of the plasma-based methylated Septin9 test is statistically non-inferior to a widely recommended stool-based screening test (FIT). Further analysis of the data shows that Epi proColon® was able to demonstrate 61% sensitivity for 23 cases in stages 0 and 1 (FIT 61% sensitivity), 75% for 16 cases in stage 2 (FIT 75% sensitivity), 70% for 20 cases in stage 3 (FIT 85% sensitivity) and 92% in 12 stage 4 cases (FIT 64% sensitivity). In the 32 cases of unknown clinical staging, the sensitivity was 69% (57% sensitivity for FIT). The correspondence of the blood and stool based test methods was 62%, whereby Epi proColon® was able to identify 20 cases that could not be identified by FIT, while FIT identified 17 CRC cases, which were not found through Epi proColon®.
The presentation titled “Use of FIT versus Septin 9: Trial results” presented by Nicholas T. Potter will be held at the WEO (World Endoscopy Organization) Colorectal Cancer Screening Committee Meeting, DDW 2013 Workshop, in Orlando, FL, U.S.A. on Friday, May 17, 2013 during the session “Updates on Screening Methods/ New Tests” which is scheduled for 3.30 pm to 5.10 pm.
* On December 19, 2012, Epigenomics has provided detailed results from a head-to-head comparative study between its blood-based colorectal cancer (CRC) detection test Epi proColon® and fecal immunochemical testing (FIT) for which it recently reported top-line results. This trial was designed to evaluate non-inferiority of the blood based Epi proColon® assay performance in comparison to FIT. The subjects included in the first arm of the study were average risk, asymptomatic screening patients with no history (own or familial) of CRC. These patients were identified as CRC patients in the context of screening colonoscopies performed from April-November 2012 across 70 sites in the US. As previously reported, in this study, Epi proColon® was able to detect 73 out of 103 cancer cases, demonstrating an overall sensitivity of 71%. Clinical staging information of the disease was available for 71 of the 103 cases.
The second arm of the study comprised 198 average risk individuals, which were prospectively enrolled (i.e. before colonoscopy). Among these, 3 CRC cases were identified by colonoscopy. Both, Epi proColon® and FIT were able to find 2 out of these three CRC cases. At the same time, of the 24 advanced adenomas included in the second arm, neither method detected a significant number of these. The adenoma detection for Epi proColon®, as shown in previous studies, was low. Surprisingly, the finding was the same for FIT, although it was previously believed to be a distinct advantage of this method. Overall reported specificities for Epi proColon® and FIT were at 81% and 98% respectively. While the point estimate of 81% specificity for Epi proColon® was still above the pre-defined non-inferiority margin, this result was statistically non-significant. The difference in specificity is less vital in the Company’s opinion, as patients will undergo a colonoscopy – the currently recommended screening procedure – as a result of a positive test result. In addition to this it is noteworthy that the Company’s CE marked version of the product, optimized for specificity and launched in Europe earlier this year, has a specificity for CRC detection of 99%. This could open additional possibilities to address the US market in the future.
* On December 4, 2012, Epigenomics has announced top-line results from a head-to-head comparative study between its blood-based colorectal cancer (CRC) detection test Epi proColon® and fecal immunochemical testing (FIT) to demonstrate the non-inferiority of Epi proColon® in detection of CRC. In the reported trial, Epi proColon® detected 73 in a total of 103 evaluable samples from patients with colorectal cancer, which represents a sensitivity of 71%. The FIT comparator used in the study, one of the most commonly used FIT products in the US market, detected 66 out of 98 cancer cases for which stool samples were provided, translating into a sensitivity of 67%. Based on Epigenomics’ analysis of the data, which was confirmed by an external party, the Company met the critically important endpoint of non-inferiority with respect to sensitivity of Epi proColon® to FIT. These results will be part of the final module of the Premarket Approval (PMA) submission expected to be filed with the FDA before the end of this year. Based on all non-CRC samples from the second arm, specificity for Epi proColon® was determined at 81% and for FIT at 98%. These findings are in line both with previous studies on Epi proColon® and published data for FIT.
Epigenomics met the critically important sensitivity endpoint, which provides the potential to discover more CRC patients. The difference in specificity was anticipated and in the Company’s opinion is less vital, since patients will undergo a colonoscopy –the currently recommended screening procedure– as a result of a positive test result. Testing of all samples was performed strictly according to the instructions for use by the respective manufacturers of both tests at an independent third party testing laboratory in the US, which was blinded to the samples analyzed. The company expects to be able to complete its PMA filing before the end of the year. The company plans to submit detailed study results for presentation at a medical meeting and for peer-reviewed publications in the near future.
* On April 11, 2012, Epigenomics has announced the start of the head-to-head comparative study of Epi proColon® with fecal immunochemical testing (FIT) for colorectal cancer detection. Meanwhile the first study subject has been enrolled. As previously announced, the FDA has requested Epigenomics to perform a head-to-head comparative study for colorectal cancer detection through comparison with FIT for the purpose of demonstrating non-inferiority of Epi proColon® to FIT. The study will compare FIT and Epi proColon® analyses for 100 subjects with confirmed cancer (post colonoscopy) and 200 asymptomatic average risk individuals (pre-colonoscopy). Epigenomics plans to complete this study in the second half of 2012 and the results will be an integral part of the company’s Modular Premarket Approval (PMA) submission to the FDA. The Company already submitted the first two PMA modules and is on track to file its third and fourth modules in the second quarter and second half of 2012, respectively.
