Takeda - mobocertinib/Exkivity benchmark analysis, from Flatiron Health's RWE case studies (ResearchX Episode 5)

Takeda used Flatiron's Spotlight database to support regulatory and HTA submissions for mobocertinib (Exkivity), targeting the rare EGFR Exon20 insertion NSCLC subtype. The team ran benchmark and inverse probability treatment weighting (IPTW) comparisons, finding real-world response rates of about 14% and median overall survival of 11 months, versus mobocertinib's trial results of 28-35% response rate and 24-month OS. The FDA approved mobocertinib in September 2022, followed by UK approval in March 2023.

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.