Phase 3 Trial Update of Esbriet for Idiopathic Pulmonary Fibrosis
InterMune announced new analyses of data from the RECAP extension study of Esbriet (pirfenidone), being studied for the treatment of idiopathic pulmonary fibrosis (IPF).
RECAP is an open-label extension study for patients who participated in the Phase 3 program for Esbriet, known as CAPACITY. The CAPACITY program (Studies 004 and 006) was designed to evaluate the safety and efficacy of Esbriet in IPF patients with mild to moderate impairment in lung function. In the CAPACITY studies, 779 patients were randomized to treatment with Esbriet or placebo and 626 patients completed the study. Of these, 603 (96%) were enrolled in RECAP.
New analyses of Forced Vital Capacity (FVC) and survival in patients who received placebo in CAPACITY and were newly treated with Esbriet in RECAP were released. The new analyses are based on the patients who received placebo in the CAPACITY studies and therefore first received Esbriet in RECAP. To facilitate comparison to outcomes in the CAPACITY trials, the analyses focused on the patients who at the time of entry into RECAP had baseline FVC and DLco values that would have met the original eligibility criteria for CAPACITY. Of the 274 newly treated patients in RECAP, 178 met the CAPACITY FVC and DLco criteria and were included in the analyses.
The first analysis examined the proportion of patients at Week 60 with a Forced Vital Capacity (FVC) decrement of ≥10%, an outcome that is highly clinically relevant and predictive of mortality. Analysis of pooled data from CAPACITY demonstrated that treatment with Esbriet resulted in a 32% reduction in the percentage of patients who experienced an FVC decrement of at least 10% at Week 60 (P=0.011). A comparison of outcomes in patients newly treated with Esbriet in RECAP showed similar results: the proportion of patients who experienced a ≥10% decline in FVC at Week 60 was 16.3% among patients newly treated with Esbriet in RECAP, compared with 16.8% in the Esbriet group in CAPACITY. The proportion of placebo-treated patients meeting this criterion in CAPACITY was 24.8%.
The second analysis was based on the mean change from baseline in percent predicted FVC in the entire population of patients. The analysis of data at Week 60 showed that the mean change in percent predicted FVC in patients newly treated with Esbriet in RECAP was -5.8%; the mean change over the corresponding interval during CAPACITY was -7% in patients treated with Esbriet and -9.4% in patients treated with placebo. Analysis of data at earlier time points also showed very similar results between patients newly treated with Esbriet in RECAP and those originally treated with Esbriet in CAPACITY.
The last analysis examined overall survival from baseline to Week 60 in patients newly treated with Esbriet during RECAP. While neither RECAP nor CAPACITY was powered to evaluate the effect of treatment on survival, analyses showed that overall survival at 60 weeks post initiation of therapy was similar in patients newly treated with Esbriet in RECAP and CAPACITY, and greater than that of patients who were treated with placebo in CAPACITY.
Pirfenidone is an orally active antifibrotic and anti-inflammatory drug that inhibits the synthesis of TGF-beta, a chemical mediator that plays a key role in fibrosis. It also inhibits the synthesis of TNF-alpha, a cytokine that plays an active role in inflammation.
For more information call (415) 466-2200 or visit www.intermune.com/Pirfenidone.