Roche says Esbriet shown to extend lives of IPF patients
pharmafile | September 30, 2015 | News story | Medical Communications, Research and Development, Sales and Marketing | Esbriet, Roche, idiopathic pulmonary fibrosis
Roche has presented new clinical data and abstracts on Esbriet (pirfenidone) in the treatment of idiopathic pulmonary fibrosis (IPF), showing a significant reduction in risk of death for patients who stayed on the treatment up to two years.
The company presented the findings on the oral medication at the European Respiratory Society (ERS) congress in Amsterdam.
A pooled analysis from the Ascend and Capacity phase III studies showed a 38% reduction in risk of death (p=0.0515) in IPF patients who stayed on Esbriet treatment up to two years (120 weeks) compared with placebo.
IPF is a fatal disease caused by irreversible, progressive scarring (fibrosis) of the lungs, which makes breathing difficult and prevents the heart, muscles and vital organs from receiving enough oxygen to function properly.
The disease can advance quickly or slowly, (making treatment complex) but inevitably the lungs will eventually harden and stop working altogether. The outlook for patients post-diagnosis is poor- in fact worse than that of most cancers. In a recent study, only patients with lung and pancreatic cancer were shown to have a worse survival.
Half of IPF patients die within three years of diagnosis, and the five-year survival rate is approximately 20-40%. IPF is much more common in people over the age of 45, and tends to affect slightly more men than women.
Approximately 100,000 people in the US and 110,000 people in Europe have IPF. The cause is currently unknown, and there is no cure. A limited number of patients with IPF undergo lung transplantation.
But Roche representatives were positive that Esbriet was demonstrated to improve this outlook.
“These new data demonstrate Esbriet’s ability to reduce the risk of death for patients with this severe, progressive lung disease,” says Sandra Horning, Roche’s chief medical officer and head of global product development. As the first long-term mortality data in IPF patients treated with Esbriet, these results provide valuable information to help physicians and patients make decisions about their treatment.”
Previously-reported data at one year showed the risk of mortality was reduced by 48% after treatment with Esbriet, a statistically significant result. The new data at 120 weeks show a strong trend in a reduced risk of death with long-term Esbriet treatment in IPF.
Also presented at the ERS, an ad-hoc analysis of the pooled Ascend and Capacity data showed patients who are hospitalised within the first six months of treatment saw their risk of disease progression (≥10% decline in lung function) or death reduced by more than two-thirds (relative difference = 72.2%) at one year by remaining on Esbriet treatment, compared with placebo.
“These additional data show that continuing treatment with Esbriet after early hospitalisation may help slow disease progression,” adds Horning.
Both analyses reinforced the well-established safety profile of Esbriet and were consistent with previous trial results. Esbriet has been available to physicians and IPF patients in Europe for four years and was approved last year in the United States.
More than 20,000 IPF patients worldwide have been treated with Esbriet for the equivalent of a year. The medication’s mechanism of action is not fully understood, although it is believed to interfere with the production of transforming growth factor (TGF)-beta, a small protein in the body involved in how cells grow and produce scars (fibrosis), and tumour necrosis factor (TNF)-alpha, a small protein that is involved in inflammation.
Joel Levy
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