NEW YORK – By linking real-world cancer patient data and liquid biopsy results to patient outcomes, Hedera Dx hopes to drive the in-house adoption of assays such as its own Hedera Profiling kit throughout hospital labs, particularly within Europe.
The Swiss company recently announced the launch of Hedera Frame, a real-world evidence (RWE) registry for non-small cell lung cancer (NSCLC) that will combine genomic data with clinical and other molecular data. Hedera is prospectively collecting data to be added to the registry through its EMPATHY NSCLC observational study, for which it recruited its first patients last week.
Hedera Dx aims to recruit up to 500 patients across 10 European sites in six countries into the study, although Tommi Lehtonen, Hedera Dx's CEO and cofounder, said this number may be expanded as the study progresses. To be included, patients need to be treatment-naïve but expected to be treated with an interleukin-targeted therapy, be over 18 years old, and have advanced or metastatic NSCLC with an ECOG score –– a measure of patients' level of functioning in terms of their ability to care for themselves, daily activity, and physical ability –– of at least two.
"In most clinical trials, you usually have a very narrow, well-defined, homogeneous patient population," Lehtonen said. The problem with this approach is that these are generally not very representative of the overall patient population.
"What we do with EMPATHY is exactly the opposite," he said. "We are looking at a representative, real-world population of essentially every possible advanced metastatic non-small cell lung cancer that's fit enough to be treated."
EMPATHY was designed to address questions of molecular tumor profiling, treatment choices, and patient outcomes. Its three primary endpoints are sensitivity of the company's 32-gene sequencing-based Hedera Profiling 2 ctDNA Test Panel as compared to tissue biopsy testing, the proportion of treatment decisions guided by actionable genetic variants found via liquid biopsy, and time to treatment failure.
Progression-free survival, overall survival, and treatment decisions based on molecular data will be assessed at six months and 12 months, along with patient-reported outcomes collected via the myHedera app.
Lehtonen expects the real-world evidence generated in the EMPATHY study and contained in the Hedera Frame registry, coupled with kits such as Hedera Profiling and its machine learning-assisted data analysis software package, Hedera Prime, will make it easier for hospital labs to adopt liquid biopsy testing in the future.
Hedera Dx mainly works with European university hospitals for the time being. Lehtonen said many of the labs in these institutions are interested in including liquid biopsies in their offerings but are reluctant to go ahead because of a lack of real-world evidence regarding patient outcomes.
Brandon Sheffield, an anatomical pathologist with the William Osler Health System in Brampton, Ontario, who has led research into point-of-care applications of liquid biopsies in cancer treatment, said via email that while liquid biopsy testing is becoming more widely adopted, implementation in healthcare settings remains challenging, and any evidence to support this will be useful for those looking to provide such a service.
"Real-world evidence is an important data source that can provide payors and decision-makers with a very realistic picture of the new technology, the cost savings, and the improved outcomes for patients," he said.
As a case in point, a lack of real-world evidence related to Guardant Health's Shield blood-based colon cancer screening test came up as a sticking point during a recent US Food and Drug Administration advisory committee meeting to discuss the test's safety and likely efficacy.
Sheffield further noted that while real-world evidence will play a significant role in the further adoption of liquid biopsies, other implementation challenges, such as the lack of in-house testing options and an unclear division of labor between oncology and laboratory medicine as to who should be interpreting liquid biopsy data must also be overcome.
Also, testing labs may already be overburdened with tissue-based assays with long turnaround times and may not be able to take on fast liquid biopsy testing on top, he said.
In addition to helping guide clinical liquid biopsy adoption, Hedera Dx sees its registry as a tool with which to contribute to future research, as all investigators involved in the study will have access to the data for future studies.
To help ensure transparency and accountability with respect to data usage, Lehtonen said that Hedera Dx has established a steering committee for the study that includes representatives of the patient advocacy group Women Against Lung Cancer in Europe (WALCE).
"We are helping not only patients but the community [by] advancing knowledge," Lehtonen said.
In launching EMPATHY NSCLC, Hedera Dx joins several other companies that have launched their own registry studies aimed at showing the utility of liquid biopsies through generating real-world evidence.
Earlier this year, for instance, Exact Sciences enrolled the first patient in its multi-cancer early detection Falcon Registry Real-World Evidence study. Outside of cancer, molecular diagnostics firm Natera incorporated real-world evidence into its RenaCARE study, which examined the impact of the firm's Renasight test in chronic kidney disease.
Although Hedera Frame will not immediately be leveraged as a revenue-generating tool, this might change going forward.
"In the future, we will be looking at commercial opportunities for real-world data and especially insights that are derived from [it]," Lehtonen said.
EMPATHY NSCLC is the first study to launch using Hedera Dx's real-world evidence database.
"EMPATHY Prostate is one [study] that is very likely to happen in the not-too-distant future," said Christian Meisel, the company's cofounder and chief medical officer. "EMPATHY Breast is another one, because there are so many new targeted drugs in breast cancer."
Keeping with breast cancer, Hedera Dx is planning to release Hedera Profiling 3, an expanded assay designed to better assess both breast and prostate cancer that will include the breast cancer risk genes BRCA1 and BRCA2.
"We don't have an exact date for this launch, but [it will be] this year," Lehtonen said.