Dados do Trabalho

Título

SUSTAINED BENEFIT WITH SERALUTINIB TREATMENT: A POST-HOC ANALYSIS OF THE TORREY OPEN-LABEL EXTENSION

Introdução

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/ß, CSF1R, and c-KIT kinase inhibitor, significantly reduced PVR at Week (W) 24 in the phase 2 TORREY study (NCT04456998). Most patients were WHO functional class (FC) II, receiving 3 PAH medications at randomization (baseline, BL), including prostacyclin.

Objetivo

To characterize the longer-term hemodynamic benefits of seralutinib, we identified patients in the open-label extension (OLE; NCT04816604) with a > 15% reduction in PVR from BL to W72.

Método

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.

Resultados

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/cm5, 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/cm5 (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.

Conclusão

In 49% of patients with W72 right heart catheterization data, longer-term seralutinib treatment resulted in sustained hemodynamic and 6MWD improvement.