PARSIPPANY, N.J.--(BUSINESS WIRE)--Diaceutics, the medtech company enabling better patient testing globally, today announces research results that indicate controlled clinical trials may overestimate the percentage of oncology patients eligible for targeted therapies. In its real-world data analysis of patients with acute myeloid leukemia (AML), Diaceutics found that in some cases, the percentage of patients testing positive for the key biomarkers involved in 25 targeted therapies in development was half the percentage quoted by controlled epidemiological studies. Diaceutics believes its findings, published by ASCO, are not isolated to AML.
Until now, the prevalence of AML and other oncology biomarkers was assumed to be in line with published data from epidemiological and clinical trial studies. That data is used by payors, pharmaceutical companies and guideline developers to forecast the clinical and financial benefit of new test-dependent targeted therapies. However, Diaceutics’ research, using real-world patient testing data from its global network of lab partners, has found a discrepancy between its data and the data gathered in the clinical trial setting.
Diaceutics’ research relates to 24 biomarkers involved in the launch of 25 targeted therapies before 2020. Amongst its findings were that, of the 20,000 people diagnosed with AML every year in the US, only 3,900 are likely to test positive for FLT3 or IDH2. However, published clinical trial data suggests 8,000 should test positive for those biomarkers. This indicates that a significant number of patients are potentially being missed when real-world testing dynamics are applied.
This research highlights the importance of data gathered from real-world clinical settings in decision-making on testing and treatment guidelines, access and reimbursement policies and predicting disease outcomes. The close relationship between laboratories and clinicians is therefore vital, as it allows pharmaceutical companies to base their judgements on real-world testing data and allows laboratories to advise and support clinicians in interpreting test results.
Dr. Jordan Clark, Managing Director, Diaceutics, said: “Every time a new test-dependent drug is launched, there is always a lengthy clinical discussion afterwards as to whether or not the actual prevalence of the related biomarker is as high as is indicated in clinical trials. With support of real-time data from leading laboratories, we can lead this discussion and adjust decisions based on the clinical reality – not the highly controlled clinical trial setting.
“FLT3, IDH1 and IDH2 represent some of the most significant biomarkers being investigated with regards to targeted AML drugs. Currently, 15 FLT3-dependent drugs from 14 companies are in phase two and three of clinical trials, while 10 IDH1 and IDH2-dependent drugs from 10 companies are at the same stage. It is therefore critical to understand the real-world prevalence of these biomarkers.
“This case in AML is not unusual; our broader data sets indicate that this discrepancy befalls almost all targeted drugs, hindering pharmaceutical teams that rely solely on clinical trials to establish financial forecasts. Many of our partner labs tell us that doctors will have been told to expect that a certain percentage of their patients will test positive for a new biomarker, and when that testing rate is less than half, they start to wonder about the quality of the testing. We believe that with real-world data, pharmaceutical companies can plan and invest smarter in better testing for their patients, as well as adjust internal management and external investor expectations on revenues.”
Diaceutics’ AML research has been accepted for publication by ASCO1 as part of its annual meeting in Illinois, starting June 2. Diaceutics gathers its data through partnerships with more than 230 laboratories around the world that conduct diagnostic tests. Through its work, Diaceutics has so far helped with the planning and launch of more than 200 drugs worldwide.
1 Real world patient numbers for AML targeted therapies. J Clin Oncol 35, 2017 (suppl; abstr e18510) http://abstracts.asco.org/199/AbstView_199_192127.html
Notes to the editor
From its patient testing data, Diaceutics’ research found the following:
FLT3 Diaceutics data shows 13.5% of patients tested positive, clinical trials indicate 24-28% should test positive
IDH1 Diaceutics data shows 3.4% of patients tested positive, clinical trials indicate 9% should test positive
IDH2 Diaceutics data shows 7% of patients tested positive, clinical trials indicate 8-9% should test positive
Diaceutics is transforming an industry model by enabling pharmaceutical companies to accelerate their market penetration and achieve a better return on new drugs by helping them to radically improve their patient testing. It does this by allowing them access to real-time testing data from its worldwide laboratory network, which helps them understand and leverage the diagnostic landscape and segment physicians by their testing behavior. The company leads the top 10 global markets in its cancer-related therapy area, with a 60% market share and experience of more than 200 drug launches. Eight out of the world’s top 10 pharmaceutical companies are clients and it currently analyses 80% of testing data in the US in its selected cancer related therapy areas. The company employs the leading global group of experts from the laboratory, diagnostic and pharmaceutical industries. www.diaceutics.com