Expert Interview
Analyzing the Phase 3 TETON-2 Study Results for Tyvaso (Inhaled Treprostinil) in Idiopathic Pulmonary Fibrosis from United Therapeutics
Ticker(s): UTHRInstitution: National Jewish Health
- Associate Professor in the Department of Medicine and Clinic Director of the Interstitial lung disease(ILD) Program at National Jewish Health.
- Manages over 50+ patients with IPF. Sub-investigator for the Phase II study for PLN 74809 as well as numerous other ILD/IPF studies being conducted at National Jewish Health.
- Research focuses on biomarkers in ILD and exercise limitation in post-COVID syndrome, with past research focused on investigating the role of angiogenesis in resolving lung injury and fibrosis.
The TETON-2 study met its primary endpoint, showing a 95.6 mL benefit in absolute FVC over placebo at week 52 (p<0.0001). How meaningful is this improvement in slowing IPF progression, given the chronic and degenerative nature of the disease?
Added By: slingshot_insightsPositive efficacy signals were observed across all prespecified subgroups, including patients on antifibrotic background therapy, those not receiving treatment, and patients using supplemental oxygen. How important is this consistency for broad clinical adoption of Tyvaso?
Added By: slingshot_insightsSeveral secondary endpoints, including time to clinical worsening, percent predicted FVC, DLCO, and K-BILD quality-of-life scores, showed statistically significant benefits. Which of these findings do you find most clinically compelling, and why?
Added By: slingshot_insightsPatients receiving Tyvaso demonstrated improvements in K-BILD scores, which measure health-related quality of life in IPF. How valuable are these improvements when evaluating new therapies, especially for patients already on standard antifibrotic treatments?
Added By: slingshot_insightsCurrently approved antifibrotics, such as nintedanib and pirfenidone, often offer modest benefits and can be limited by tolerability issues. Where does inhaled Tyvaso potentially fit within the evolving IPF treatment paradigm, particularly as an add-on or alternative therapy?
Added By: slingshot_insightsThe TETON-2 trial reported no new safety signals, with adverse events consistent with prior Tyvaso studies and prostacyclin-related effects. How do these safety outcomes influence your comfort level with long-term use of inhaled Tyvaso in IPF patients?
Added By: slingshot_insightsUnited Therapeutics plans to use TETON-2 data alongside the ongoing TETON-1 trial to support a supplemental NDA for Tyvaso in IPF. What are your expectations for regulatory review, and how might an approval reshape treatment options for this underserved patient population?
Added By: slingshot_insightsGiven Tyvaso’s success in pulmonary hypertension associated with interstitial lung disease and now IPF, do you anticipate its role expanding further across other fibrotic lung conditions? What additional studies would you like to see to validate its broader utility?
Added By: slingshot_insightsAre You Interested In These Questions?
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