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STOP-BOS: Phase I trial of pirfenidone for BOS related to cGvHD
Bronchiolitis obliterans syndrome (BOS) is a progressive form of chronic graft-versus-host disease (cGvHD) associated with high morbidity. Results from the 56-week phase I STOP-BOS trial (NCT03315741), with a 56-month extension evaluating the efficacy and safety of pirfenidone in patients with BOS related to cGvHD (primary; n = 25; extension; n = 10), were published by Sharifi et al. in Blood Advances. Quantitative computer tomography (qCT) scans were performed in 23 patients.
Key data: Pirfenidone was well tolerated in 63.3% of patients at the recommended dose, improved percent predicted forced expiratory volume in 1 second (ppFEV1; p < 0.003), and showed a trend toward improved pulmonary function test (PFT) in 41.3% of responders. qCT analysis showed healthier lungs (p = 0.002), lower air trapping (p = 0.005), greater lung volume change (p = 0.012), and greater heterogeneity of lung volume change (p = 0.004) in pirfenidone responders vs non-responders. Pirfenidone was associated with decreased liver enzymes and improved physical functioning and skin cGvHD symptoms at 12 months.
Key learning: Pirfenidone demonstrated acceptable tolerability and potential to decrease the progression of BOS. The findings support further investigation of pirfenidone in randomized trials.
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