Inova instrumental in new IPF study findings

TETON pivotal studies meet primary end point

In two landmark phase 3 trials, nebulized Tyvaso® (treprostinil) Inhalation Solution demonstrated superiority over placebo for the primary endpoint of change in absolute forced vital capacity at 52 weeks in patients with idiopathic pulmonary fibrosis (IPF). In addition, the treatment arm demonstrated a reduction in the risk of clinical worsening, with positive results observed across all subgroups. Together, these studies provide a compelling case for a fourth approved drug for IPF, for which existing treatments provide only modest benefit.   

Inova’s Advanced Lung Disease team, which enrolled the highest number of patients in TETON-1, has been integral to this work. Positive results from the TETON-2 study, which included 14 countries outside North America, were released  in March, followed by TETON-1 results in May.  Results of both trials were published in the July 9 issue of the New England Journal of Medicine (NEJM), with an accompanying editorial. Steven Nathan, MD, Medical Director and Schar Chair, Advanced Lung Disease and Lung Transplant, chaired the steering committee for the global TETON program and was first author of both NEJM articles. Christopher King, MD, Associate Medical Director of Inova’s program, was a contributing author to both papers as well.  

Integrated analyses of TETON-1 and TETON-2 showed statistically significant treatment effects across the primary endpoint and most secondary efficacy endpoints, reinforcing the robustness of the clinically meaningful results observed in each individual study. 

“IPF is a progressive, life-limiting disease for which existing treatments provide only modest benefit and are often accompanied by significant side effects,” said Dr. Nathan, who has been deeply involved in both the study’s design and execution. “TETON-1 reinforces what was shown in TETON-2, with both studies demonstrating clinically meaningful treatment outcomes in IPF patients with or without background anti-fibrotic therapy. Together, the studies demonstrated better preservation of lung function and quality of life, as well as reduced disease worsening and reduced acute IPF exacerbations. These findings have the potential to fundamentally shift our approach to IPF management and could be a game changer.”  

Connect with Dr. Nathan and Dr. King on Doximity.