FCS Contributes to Phase 1 Study Demonstrating Antitumor Activity with First-in-Class KRAS-Targeted Therapy for Treatment of Lung and Pancreatic Cancers

Setidegrasib results published in New England Journal of Medicine

Fort Myers, Fla., April 2, 2026 – Results of a Phase 1 clinical study conducted with participation from Florida Cancer Specialists & Research Institute, LLC (FCS) have provided significant insights into the safety and efficacy of setidegrasib in patients with advanced non-small-cell lung cancer and pancreatic cancer with KRAS G12D mutations.  Setidegrasib is a first-in-class therapy that targets and breaks down KRAS G12D, a genetic mutation that can drive the growth of certain cancers. FCS Associate Director of Drug Development Judy Wang, MD is a co-author of the study, recently published in the New England Journal of Medicine.

“These results signify a major milestone in oncology and first proof of concept for targeted KRAS G12D, a genetic mutation long considered difficult to treat,” notes Cesar Augusto Perez, MD, director of the Drug Development Unit at the Sarah Cannon Research Institute at FCS in Lake Nona, Florida.

The authors note that while the “KRAS G12D variant occurs in 5% of patients with non–small-cell lung cancer (NSCLC), it is the most common substitution variant in pancreatic ductal adenocarcinoma, occurring in 40% of patients,” and no targeted therapies directed against this variant are currently approved for clinical use.

The primary objectives of the Phase 1 study were to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of setidegrasib in patients with previously treated advanced solid tumors harboring KRAS G12D variants. The authors concluded, “Setidegrasib was associated with antitumor activity and a low incidence of treatment discontinuation due to adverse events in patients with previously treated advanced KRAS p.G12D–mutated NSCLC or pancreatic ductal adenocarcinoma.” The study results have served to determine dosing for the Phase 2 study.

FCS Medical Director of Drug Development Manish R. Patel, MD said, “Meaningful achievements such as this reinforce that FCS continues to lead at the forefront of breakthroughs in cancer treatment drugs and therapies.”  Early-phase clinical studies are conducted at FCS Drug Development Units in Sarasota and Central Florida. In partnership with Sarah Cannon Research Institute, one of the world’s leading oncology research organizations conducting community-based clinical trials, FCS is part of a network that reaches more clinical trial patients than any single cancer center in Florida. At any point in time, more than 180 active clinical trials are underway at FCS.

View the abstract:  Setidegrasib in Advanced Non–Small-Cell Lung Cancer and Pancreatic Cancer