New analyses from Esbriet RECAP study in IPF patients presented at ERS 2012

InterMune, Inc. (NASDAQ: ITMN) announced that new analyses of data from the RECAP extension study of Esbriet® (pirfenidone) were presented today at the 2012 Annual Congress of the European Respiratory Society (ERS) in Vienna, Austria by Dr. Ulrich Costabel of the Ruhrlandklinik, Essen, Germany.    

The RECAP study is an ongoing open-label extension study evaluating the long-term administration of Esbriet in patients who completed InterMune's Phase 3 CAPACITY program.  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.

Dr. Costabel presented new analyses of Forced Vital Capacity (FVC) and survival in patients who received placebo in CAPACITY and were newly treated with Esbriet in RECAP.  These analyses show that patients with mild-to-moderate IPF newly-treated with Esbriet in RECAP for 60 weeks had similar FVC and survival outcomes when compared to those treated with Esbriet for the same duration in CAPACITY.  

Dr. Costabel commented, "The population in this RECAP analysis represents the fourth large, well-defined cohort of IPF patients to be treated with pirfenidone and followed prospectively for more than one year.  FVC and survival outcomes in the RECAP patients treated with pirfenidone were highly consistent with those in pirfenidone-treated patients in three previous randomized, controlled Phase 3 studies. While these data should be interpreted with due regard to the limitations inherent to the open-label study design of RECAP, the results provide further support for the role of Esbriet in the treatment of patients with this devastating disease.

Methods of the Analyses

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. 

Results of the Analyses

The first analysis examined the proportion of patients at Week 60 with an FVC decrement of 10% or greater, 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>

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 -7.0% 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.  Additionally, fewer treatment emergent deaths, defined as deaths occurring within 28 days of the last dose of study drug, were observed among Esbriet-treated patients in both RECAP and CAPACITY compared with patients who were treated with placebo during CAPACITY.  Treatment-emergent death occurred in 3.4% and 2.9% of Esbriet-treated patients in RECAP and CAPACITY, respectively, compared with 5.8% of patients treated with placebo in CAPACITY.

These results, coupled with new results to be presented at ERS during a poster discussion session on Tuesday, September 4 on the long-term safety data in IPF patients treated with Esbriet for up to 7.7 years, provide further evidence to support the clinical efficacy and safety of Esbriet in patients with IPF.