InterMune, which is in the process of being acquired by Roche for $8.3 billion, says that data over 72 weeks provides further evidence of a durable pirfenidone treatment benefit on multiple measures of idiopathic pulmonary fibrosis including reducing the risk of mortality.
Speaking at the European Respiratory Society meeting in Munich, Giacomo di Nepi, head of InterMune Europe, also said that previously published data from the ASCEND study on Esbriet (pirfenidone) was submitted to the European Medicines Agency in July and the revised Summary of Product Characteristics should be effective by year-end.
A raft of pirfenidone long-term safety and tolerability data was presented at the ERS, including real-world data from an ongoing patient registry, confirming safety to be consistent with clinical trials. The analysis of data from the ASCEND and CAPACITY studies showed a durable pirfenidone treatment benefit on multiple measures of disease status in IPF patients up to 72 weeks of treatment.
Paul Noble at Cedars-Sinai Medical Center in Los Angeles, said the “spectacular” ASCEND results had exceeded all expectations and that the pooled data showed a 52% reduction in risk of a greater than or equal to 10% decline predicted for forced vital capacity (FVC) or death, plus a 34% reduction in the risk of a 50 metre decline in six-minute walk distance or death. The progression-free survival analysis showed the risk of progression was reduced by 38% for pirfenidone compared with placebo.
Additionally, the risk of all-cause mortality was reduced by 37% and the risk of treatment emergent IPF-related mortality was reduced by 60% in the pirfenidone group. “This analysis provides compelling evidence to support the long-term efficacy benefits associated with pirfenidone,” said Prof Noble.
A separate study presented by Ulrich Costabel from Essen University Hospital in Germany examined the long-term safety of pirfenidone in patients with IPF enrolled in RECAP – a long-term, open-label extension study. Interim analysis showed pirfenidone to have a favourable safety profile and to be generally well tolerated for up to 4.9 years.
The safety of pirfenidone was also evaluated in an interim analysis of data from 530 patients enrolled in PASSPORT, a post-authorisation surveillance study assessing the long-term safety of patients receiving pirfenidone in the clinical setting in Europe. Interim results, presented by Dirk Koschel of Fachkrankenhaus Coswig in Germany, showed that the safety of pirfenidone in the real world setting appears to be consistent with that observed in clinical trials.
Mr di Nepi said that the new ASCEND data was filed with the US Food and Drug Administration as part of a resubmission in May. In July 2014, pirfenidone, which in all likelihood will compete with Boehringer Ingelheim’s nintedanib, received breakthrough therapy designation and has an action date of November 23.