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2014 Post-ERS Report
September 29, 2014
The European Respiratory Society (ERS) conference was held in Munich, Germany from September 6-10, 2014. Important combination data in pulmonary arterial hypertension and Phase III asthma data from the novel anti-cytokine antibodies were presented.
Highlights from this year’s meeting include:
Pulmonary Arterial Hypertension (PAH)
- The first major combination trial for endothelin receptor antagonist ambrisentan (GILD, GSK), given with PDE-5 inhibitor tadalafil (UTHR, LLY), showed positive results on its morbidity/mortality endpoint. On the negative side, the combination did appear to increase peripheral edema compared to the monotherapies, and did not improve WHO functional class or numerically lower mortality, as macitentan (Actelion) did in its combination trial. The ambrisentan/tadalafil study was novel as the combination was given first-line, and the sponsors are hoping to position the combination as a new treatment paradigm to replace stepwise therapy.
- Positive details were released for two Phase III trials of the anti-IL5 antibody mepolizumab (GSK) given every 4 weeks, showing a reduction in exacerbations and oral steroid use versus placebo. The placebo group in the exacerbation trial also had a substantial reduction in exacerbations from baseline, leading an editorialist to question whether a number of patients may just need to have their current treatments optimized first, rather than simply starting such new therapies.
- Another anti-IL5 antibody, reslizumab (TEVA), similarly showed strong reductions in exacerbations in first Phase III data released just before the conference, but unlike mepolizumab, dosing was exclusively IV. Shorter term data presented at the conference showed improvements in lung function, but at this point it is difficult to say whether there is any difference on this versus mepolizumab.
- First results from the large Phase III TOnado studies of Boehringer's tiotropium/olodaterol FDC were not quite as strong as the initial trial presented at this year's ATS meeting, but overall the FEV1 results appear within the range of Anoro Ellipta, launched earlier this year. The difference in trough FEV1 versus the components was not large; nevertheless we expect it should pass FDA standards.
- The WISDOM trial of ICS (inhaled corticosteroid) withdrawal in patients with severe COPD on tiotropium (a LAMA), salmeterol (a LABA), and an ICS showed non- inferiority on exacerbations compared with continued ICS treatment. However, patients in the withdrawal arm developed slightly worse FEV1, the implications of which are unclear. We hesitate to conclude physicians who routinely use ICS now will be comfortable using LAMA/LABAs without an ICS in severe patients just based on the study.
- Phase IIb data for nebulized TD-4208 (THRX), released concurrently with the conference, were generally consistent with prior cross-over data. There could still be questions about the best dose for registration trials however.
- Additional details from nintedanib's INPULSIS trials (Boehringer) encouragingly showed its benefit was similar across various baseline levels of FVC (forced vital capacity) severity. It would have been useful to see lower FVC cutoffs however.
| Disease Group Covered: |
Cardiovascular
Respiratory |
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