Inka Health Partners with OneMedNet to Develop AI-Powered External Control Arms for Cancer Drug Development
Key Insights
Inka Health (search) has been selected by OneMedNet (search) to lead a data analytics initiative using real-world data to develop external control arms as a faster, more cost-effective alternative to traditional clinical trials.
The project will deploy Inka Health (search)'s proprietary SynoGraph platform to build and validate an external control arm for the Keynote-189 trial of pembrolizumab in non-small cell lung cancer (search).
This collaboration aims to accelerate market entry for new cancer therapies by offering a more efficient path to generate evidence needed for regulatory and reimbursement approvals.
Inka Health (search) Corp., a wholly owned subsidiary of Onco-Innovations Limited (search), has been selected by OneMedNet (search) Corporation to lead a high-impact data analytics initiative focused on improving how cancer therapies are brought to market. The project leverages OneMedNet's regulatory-grade patient data, including radiology imaging data, to develop external control arms (ECAs) as a potentially faster, more cost-effective alternative to traditional clinical trials.
The strategic collaboration reflects growing momentum behind real-world data as a critical component of next-generation evidence generation for cancer therapeutics. OneMedNet (search)'s iRWD™ Real-World Data platform and federated provider network offers regulatory-grade, diverse, and longitudinal datasets, making it uniquely suited to drive Real-World Evidence studies and accelerate healthcare innovation.
Targeting Non-Small Cell Lung Cancer
The multi-phase project is designed to showcase how OneMedNet (search)'s oncology dataset can replicate the results of traditional clinical trials without the same time, cost, and complexity. Inka Health (search) plans to deploy its proprietary SynoGraph platform, which combines machine learning with causal inference methods, to build and validate an ECA for the Keynote-189 trial of pembrolizumab in non-small cell lung cancer (search).
The validation will align with regulatory and Health Technology Assessment best practices, including those from the FDA, European Medicines Agency (search), and National Institute for Health and Care Excellence (search). The initial focus on non-small cell lung cancer (search) represents a prevalent and clinically significant cancer type where real-world insights can meaningfully improve both patient access to therapies and regulatory confidence.
Market Opportunity and Strategic Vision
The initiative provides both organizations with exposure to the rapidly expanding Real-World Evidence market, projected to exceed $4.6 billion globally by 2030. By offering a faster and more efficient path to generate evidence needed for regulatory and reimbursement approvals, this initiative can potentially help accelerate market entry for new cancer therapies, particularly in areas of high unmet needs like colorectal cancer (search).
"We selected Inka Health (search) for this initiative because their methodological approach aligns perfectly with our vision for high-quality evidence generation," said Aaron Green, President & CEO of OneMedNet (search). "Their ability to apply rigorous, AI-driven analytics to our regulatory-grade, diverse datasets makes them the ideal partner to showcase how OneMedNet's Real-World Data can be used as a trusted external control arm in oncology research."
Advanced AI Technology Platform
Inka Health (search)'s SynoGraph platform leverages AI-powered causal inference to identify which cancer patients are most likely to respond to specific treatments, advancing precision medicine. The platform integrates diverse multimodal medical data, including genomics, transcriptomics, and proteomics, to uncover hidden insights that can optimize treatment decisions and clinical trial design.
"This collaboration is about more than applying advanced analytics to oncology data. It's about reshaping how we generate credible evidence for regulatory and reimbursement decisions using real-world patients, not just trial participants," said Paul Arora, Co-Founder of Inka Health (search). "With SynoGraph, we're aiming to set a new bar for how external control arms can be built and trusted."
Scientific Validation and Future Impact
The collaboration is expected to result in a scientific abstract for submission to ISPOR Europe 2025, reinforcing Inka Health (search)'s leadership in applying artificial intelligence and real-world data to oncology research. As ECAs become increasingly prominent in global drug development strategies, this project positions Onco-Innovations and its subsidiary at the forefront of how the industry brings new therapies to patients.
OneMedNet (search)'s network spans over 1,750 healthcare sites, providing access to de-identified medical imaging and electronic health records that fuel breakthroughs for drugmakers, medical device pioneers, and AI visionaries. The platform's reach extends across rare diseases, oncology, cardiology, and beyond, delivering precision insights that redefine patient care and power healthcare innovation.