Sustained benefit with seralutinib treatment: Lessons from the open-label extension (OLE) of the TORREY study

<bold>Objective:</bold> A reduction in pulmonary vascular resistance (PVR) of 15-50% in patients with pulmonary arterial hypertension (PAH) has been observed in studies of combination therapy. Seralutinib, a novel inhaled PDGFRα/β, CSF1R, and c-KIT kinase inhibitor, significantly reduced PVR at Week (W) 24 in the phase 2 TORREY study (<ext-link>NCT04456998</ext-link>). Most patients were WHO functional class (FC) II, receiving 3 PAH medications at randomization (baseline, BL), including prostacyclin. To characterize the longer-term hemodynamic benefits of seralutinib, we identified patients in the OLE (<ext-link>NCT04816604</ext-link>) with a > 15% reduction in PVR from BL to W72. <bold>Methods:</bold> 74 patients enrolled in the OLE. Hemodynamic data were available for 53 patients at W72; patients demonstrating a > 15% PVR reduction from BL to W72 were identified. Results are descriptive. <bold>Results:</bold> Seralutinib treatment for up to 72 weeks resulted in a > 15% PVR decrease in 26 (49%) patients. The mean BL PVR was 643 dynes*s/cm<sup>5</sup>, six-minute walk distance (6MWD) was 413 m, and 17 patients were WHO FC II. 13 patients were receiving 3 PAH medications, including prostacyclin. The mean PVR reduction was 234 dynes*s/cm<sup>5</sup> (36%) at W72. Furthermore, mean pulmonary artery pressure decreased by 6.5 mmHg (13%), cardiac output increased by 0.9 L/min (20%), and 6MWD increased from BL by 40 m. Seralutinib was well tolerated. <bold>Conclusions:</bold> In 49% of patients with W72 right heart catheterization data, longer-term seralutinib treatment resulted in sustained hemodynamic and 6MWD improvement.

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Published
2024-09-14
DOI
https://doi.org/10.1183/13993003.congress-2024.oa1871
Primary Topic
Lung Cancer Treatments and Mutations
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article
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article

Sustained benefit with seralutinib treatment: Lessons from the open-label extension (OLE) of the TORREY study

Luke Howard, J.F. Kingrey, Ed Parsley, R.F. Roscigno et al.
Lung Cancer Treatments and Mutations
article

Sustained benefit with seralutinib treatment: Lessons from the open-label extension (OLE) of the TORREY study

Luke Howard, J.F. Kingrey, Ed Parsley, R.F. Roscigno, Robin Osterhout, Lawrence S. Zisman, Roham T. Zamanian, Anna R. Hemnes, Matt Cravets, Vallerie V. McLaughlin, Irina Sobol, Sandeep Sahay, Pilar Escribano Subías, Kelly Chin, Robert P. Frantz, Namita Sood, Ronald Zolty, Hossein Ardeschir Ghofrani, Sidra Hoffman, Olivier Sitbon, Richard Aranda, Benjamin G. Penn, Richard N. Channick, Raymond L. Benza, Vachiéry Jean-Luc
article en

Abstract

<bold>Objective:</bold> A reduction in pulmonary vascular resistance (PVR) of 15-50% in patients with pulmonary arterial hypertension (PAH) has been observed in studies of combination therapy. Seralutinib, a novel inhaled PDGFRα/β, CSF1R, and c-KIT kinase inhibitor, significantly reduced PVR at Week (W) 24 in the phase 2 TORREY study (<ext-link>NCT04456998</ext-link>). Most patients were WHO functional class (FC) II, receiving 3 PAH medications at randomization (baseline, BL), including prostacyclin. To characterize the longer-term hemodynamic benefits of seralutinib, we identified patients in the OLE (<ext-link>NCT04816604</ext-link>) with a > 15% reduction in PVR from BL to W72. <bold>Methods:</bold> 74 patients enrolled in the OLE. Hemodynamic data were available for 53 patients at W72; patients demonstrating a > 15% PVR reduction from BL to W72 were identified. Results are descriptive. <bold>Results:</bold> Seralutinib treatment for up to 72 weeks resulted in a > 15% PVR decrease in 26 (49%) patients. The mean BL PVR was 643 dynes*s/cm<sup>5</sup>, six-minute walk distance (6MWD) was 413 m, and 17 patients were WHO FC II. 13 patients were receiving 3 PAH medications, including prostacyclin. The mean PVR reduction was 234 dynes*s/cm<sup>5</sup> (36%) at W72. Furthermore, mean pulmonary artery pressure decreased by 6.5 mmHg (13%), cardiac output increased by 0.9 L/min (20%), and 6MWD increased from BL by 40 m. Seralutinib was well tolerated. <bold>Conclusions:</bold> In 49% of patients with W72 right heart catheterization data, longer-term seralutinib treatment resulted in sustained hemodynamic and 6MWD improvement.

Universidad Complutense de Madrid (ES), Nebraska Medical Center (US), Université Libre de Bruxelles (BE), Imperial College Healthcare NHS Trust (GB), University of California, Los Angeles (US), Cornell University (US), Université Paris-Saclay (FR), University of Michigan (US), UCLA Medical Center (US), Erasmus Hospital (BE), Research Institute Hospital 12 de Octubre (ES), Presbyterian Hospital (US), Southwestern Medical Center (US), Los Angeles Medical Center (US), Assistance Publique – Hôpitaux de Paris (FR), Mount Sinai Hospital (US), Mount Sinai Hospital (US), Methodist Hospital (US), Gossamer Bio (United States) (US), Utah Department of Health (US), Mayo Clinic in Arizona (US), Universities of Giessen and Marburg Lung Center (DE), Stanford Medicine (US), Cardio-Pulmonary Institute (DE), University of California Davis Medical Center (US), Bicêtre Hospital (FR), University of Oklahoma Health Sciences Center (US), The University of Texas Southwestern Medical Center (US), Vanderbilt University Medical Center (US), Stanford University (US)
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