GSK and Innoviva report positive headline results from IMPACT study showing single inhaler triple therapy Trelegy Ellipta reduced COPD exacerbations

GlaxoSmithKline plc (LSE/NYSE: GSK) and Innoviva, Inc. today announced positive headline results from the landmark phase III IMPACT study of Trelegy Ellipta, the first and only FDA approved once-daily single inhaler triple therapy comprising an inhaled corticosteroid (ICS), long-acting muscarinic antagonist (LAMA) and long-acting beta agonist (LABA). Trelegy Ellipta is approved for the long-term, once-daily, maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) who are receiving Breo and require additional bronchodilation or who are receiving Breo and Incruse.

The IMPACT study, which involved 10,355 patients, met its primary endpoint demonstrating statistically significant reductions in the annual rate of on-treatment moderate/severe exacerbations for FF/UMEC/VI (100/62.5/25mcg) when compared with two, once-daily dual COPD therapies from GSK’s existing portfolio. The study showed a:

• 15% reduction for FF/UMEC/VI compared with Relvar/Breo Ellipta (FF/VI,100/25mcg); 0.91 vs 1.07 per year; p<0.001
• 25% reduction for FF/UMEC/VI compared with Anoro Ellipta (UMEC/VI, 62.5/25mcg); 0.91 vs 1.21 per year; p<0.001

In addition, statistically significant improvements were observed across all pre-specified key secondary endpoints and associated treatment comparisons:

• Change from baseline trough FEV1 at week 52 for FF/UMEC/VI compared with FF/VI was 97mL; p<0.001 and for FF/UMEC/VI compared with UMEC/VI was 54mL; p<0.001
• Change from baseline St George’s Respiratory Questionnaire at week 52 for FF/UMEC/VI compared with FF/VI was -1.8 units; p<0.001 and for FF/UMEC/VI compared with UMEC/VI was 1.8 units; p<0.001
• Analysis of time to first on-treatment moderate/severe COPD exacerbation demonstrated a 14.8% reduction in risk for FF/UMEC/VI compared with FF/VI; p<0.001, and a 16.0% reduction in risk for FF/UMEC/VI compared with UMEC/VI; p<0.001

Based on review of the headline data, the safety profile of FF/UMEC/VI was consistent with the known profile of the individual medicines and their dual combinations. The most common adverse events across the treatment groups were viral upper respiratory tract infection, worsening of COPD, upper respiratory tract infection, pneumonia and headache. The incidences of the most frequent serious adverse events were worsening of COPD: 11%, 11% and 13% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively; and pneumonia: 4%, 4% and 3% for FF/UMEC/VI, FF/VI and UMEC/VI, respectively.

Patrick Vallance, President R&D, GSK, said: “We are delighted with the positive results achieved in the IMPACT study. This is the first study to report a comparison of a single inhaler triple therapy with two dual therapies, providing much needed clinical evidence about the ability of a single inhaler triple therapy to reduce exacerbations. It is important to note that all treatments were comprised of different combinations of the same component molecules administered in the same Ellipta inhaler, in a single dose, once a day to allow direct treatment comparisons. We hope these results will inform global guidelines and look forward to sharing the results with regulatory authorities. We will continue to analyse the wealth of data generated to further the understanding of the treatment of COPD.”

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