Amgen - Lumakras/KRAS G12C natural history study, from Flatiron Health's RWE case studies (ResearchX Episode 5)

Amgen partnered with Flatiron and Foundation Medicine on a natural-history study of 743 KRAS G12C-positive patients (drawn from 7,069 advanced NSCLC patients) using Flatiron's Clinical Genomics Database, covering data from January 2011 through September 2019. The study documented poor real-world outcomes -- median overall survival of 12 months from first-line therapy -- to contextualize single-arm trial data supporting Lumakras. Lumakras received FDA accelerated approval in May 2020 and was subsequently approved in 36+ additional countries, with this real-world evidence included in the FDA's multidisciplinary review.

Flatiron Health is a Roche-owned company supplying EHR-derived oncology real-world data, captured at the source through its own OncoEMR software.

This sits in the Data Providers stage of the AI use-case lifecycle: Named examples from the real-world-data, claims and competitive-intelligence providers pharma AI systems are trained on, benchmarked against, or run inside of.