Q3 2020 Sales Performance slide image

Q3 2020 Sales Performance

GSK'165 (GM-CSF antagonist): phase III programme in rheumatoid arthritis started in July 2019 Encouraging Ph II data presented at ACR October 2018 demonstrating marked clinical response CDAI response using the phase II EOW dosing regimen Three pivotal studies ongoing Study 201790: Innovative design including JAKI active comparator Placebo + MTX gsk L5 mean (SE) change from baseline in CDM -10 -15 1-4.95 -6.59 -Placebo MTX-IR →GSK3196165 22.5 mg GSK3196165 150mg weekly + MTX GSK3196165 90mg weekly +MTX Tofacitinib 5mg BID + MTX GSK3196165 45 mg Screening -GSK3196165 90 mg -20 -17.14*** GSK3196165 135 mg -25 -23.23*** GSK3196165 180 mg W-6 -30 ***p<0.001 vs placebo Significant unmet need remains in RA - Around 50% of patients do not achieve low disease activity criteria within 12 months of aTNF treatment¹ 45% of patients report daily pain and pain is the key driver in 25% of switches to biological and oral therapies² WO W 12 W 24 Primary Endpoint: ACR20 vs placebo W 12 endpoint visit & re-randomise all Placebo to active W 24 X-ray W 52 End of study treatment and X-ray Primary endpoint ACR20 vs placebo at W 12 Key secondaries include Target population Pain and CDAI vs active comparator Administration Post first line targeted therapy Weekly via a subcutaneous injection with a choice of autoinjector or prefilled syringe 210791 52 week duration with tofacitinib active comparator Two further pivotal studies of similar design will include biologic-IR patients 202018 24 week duration with sarilumab active comparator Sources: 1. Gerd R Burmester and Janet E Pope. Novel treatment strategies in rheumatoid arthritis. Lancet 2017; 389: 2338-48; 2. Targeted treatments for rheumatoid arthritis, Adelphi RA DSP 2016 MTX = methotrexate, IR = inadequate response, CDAI = clinical disease activity index, EOW = every other week 61
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