On May 28, 2026 Onc.AI, a digital health company developing computational biomarkers and decision-support products in oncology using Deep Learning imaging AI, reported positive external validation results for Onclara IO, an imaging-based AI biomarker that stratifies survival outcomes in patients with PD-L1-High, mutation negative metastatic non-small cell lung cancer (mNSCLC) receiving first-line immune checkpoint inhibitor (ICI) monotherapy. The findings will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2026 Annual Meeting in Chicago. In an external blinded validation conducted on a Flatiron Health longitudinal imaging dataset, Onclara IO derived from a single pretreatment CT scan, the patients most likely to benefit from ICI monotherapy.
Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:
Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing
Schedule Your 30 min Free Demo!
In the retrospective validation cohort of 205 patients with PD-L1-High mNSCLC without actionable mutations, patients classified as Onclara IO High had a median overall survival of 484 days, compared to 155 days for Onclara IO Low patients. "These results position Onclara IO as a noninvasive imaging biomarker that complements PD-L1 testing, with the potential to inform first-line treatment selection and risk-adapted strategies in this population," said Ravi Parikh, MD, first author on this work and Medical Director of the Winship Data and Technology Applications Shared Resource at Winship Cancer Institute, Emory University.
"As longstanding partners of Onc.AI, we are pleased to see Flatiron’s high-quality, real-world data support the independent validation of Onclara IO in patients with PD-L1-high metastatic non-small cell lung cancer. These findings reinforce the value of combining curated real-world data with imaging AI to advance more precise, biomarker-informed treatment decisions, and we look forward to continuing this collaboration as Onc.AI achieves additional milestones together," said Jacqueline Law, Ph.D., VP, Scientific Engagement and Applied Research at Flatiron Health.
Onclara IO is not FDA cleared and is not available for commercial use. Onc.AI expects to submit Onclara IO for clearance as a software-as-medical-device in 2027.
(Press release, Onc AI, MAY 28, 2026, View Source [SID1234666172])