Gilead and Galapagos’ filgotinib meets primary and all key secondary endpoints in first phase 3 study
Gilead and Galapagos announced that FINCH 2, a global, randomized, placebo-controlled, Phase 3 study of filgotinib, an investigational, selective JAK1 inhibitor, in adults with moderately-to-severely active rheumatoid arthritis and prior inadequate response/intolerance to biologic agents, achieved its primary endpoint in the proportion of patients achieving an American College of Rheumatology 20 percent response (ACR20) at Week 12. Also at Weeks 12 and 24, the proportion of patients achieving ACR50 and ACR70, low disease activity (LDA, DAS28(CRP) ≤ 3.2), and clinical remission (DAS28(CRP) < 2.6) were significantly higher for patients receiving once-daily filgotinib 100 mg or 200 mg compared to patients receiving placebo.
Filgotinib was generally well-tolerated in the FINCH 2 trial, with no new safety signals compared to those reported in previous trials of filgotinib. Treatment-emergent adverse events and serious adverse events were mostly mild or moderate in severity. Serious adverse events occurred in 3.4, 5.2 and 4.1 percent of the patients in the placebo, 100mg and 200mg groups, respectively. The proportion of patients who discontinued study drug due to treatment-emergent adverse events was also similar across groups. Two cases of uncomplicated herpes zoster were reported in each filgotinib group. Two major adverse cardiovascular events (MACE) were identified, one subarachnoid hemorrhage in the placebo group and one myocardial ischemia in the filgotinib 100 mg group. There was one case of non-serious retinal vein occlusion in the filgotinib 200 mg group and no reports of deep venous thrombosis (DVT) or pulmonary embolism (PE). There were no deaths, malignancies, gastrointestinal perforations, or opportunistic infections, including active tuberculosis.
Detailed findings from the FINCH 2 study will be submitted for presentation at a future scientific conference.
“Gilead is committed to the development of new therapies that offer meaningful benefit for people living with rheumatoid arthritis and other serious inflammatory diseases,” said John McHutchison, MD, Chief Scientific Officer, Head of Research and Development, Gilead Sciences. “These initial Phase 3 data support the potential of filgotinib, in combination with select disease modifying drugs, to help patients with active rheumatoid arthritis who do not adequately respond to current biologic disease modifying agents. These data are particularly encouraging as we look ahead to Phase 3 results from the ongoing FINCH 1 and 3 trials, which are exploring filgotinib in other populations of patients with rheumatoid arthritis.”
“We are pleased that filgotinib has demonstrated significantly improved clinical responses in this difficult to treat population,” said Dr. Walid Abi-Saab, Chief Medical Officer at Galapagos. “The good tolerability in this study is also very encouraging.”
Filgotinib is investigational and not approved anywhere globally. Its efficacy and safety have not been established. For information about the clinical trials with filgotinib: www.clinicaltrials.gov