Setidegrasib results published in New England Journal of Medicine

FORT MYERS, Fla., April 2, 2026 /PRNewswire/ -- 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

About Florida Cancer Specialists & Research Institute, LLC: (FLCancer.com)
For more than 40 years, Florida Cancer Specialists & Research Institute (FCS) has embraced innovation to deliver world-class care and drive the dramatic transformation of oncology care through its robust clinical research program.

FCS provides patients with access to a wide range of clinical trials, positioning it as a leader in research among private oncology practices in Florida and across the country. Through its robust clinical research program with Sarah Cannon Research Institute (SCRI) and a suite of independent site management programs, with advanced clinical trial matching technology, FCS offers patients innovative therapies close to home. Each year, FCS conducts more than 180 active clinical trials that directly elevate patient care and accelerate progress in oncology. Many of the cancer drugs approved by the FDA in the U.S over the past decade were accessible to patients at FCS through clinical trial participation before receiving approval.

Our outstanding team of highly trained and dedicated physicians is committed to delivering tailored treatment plans that make the best use of cutting-edge precision oncology advancements to enhance patient outcomes.

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SOURCE Florida Cancer Specialists & Research Institute