Galapagos and Bayer/Orion will both report phase III data this quarter – the former with filgotinib in arthritis and the latter with darolutamide in prostate cancer.
Welcome to your weekly digest of upcoming events. Safety will be the key to determining whether Galapgos’s filgotinib can make headway in an already crowded rheumatoid arthritis market.
The Gilead-partnered drug is expected to yield results in the third quarter from the phase III Finch 2 trial, which pits filgotinib against placebo in patients on conventional disease-modifying anti-rheumatic drugs who have failed on a biological RA treatment.
Most analysts expect filgotinib to show efficacy roughly in line with other Jak inhibitors in RA but, crucially, with a cleaner safety profile; Stifel cited a lack of safety issues in the long-term Darwin 3 study.
This will matter as analysts have recently delayed the expected launch of the product from 2020 to 2021, as they expect Gilead to need time to collect sufficient safety data. This would make filgotinib the fourth Jak inhibitor to reach the market.
Consensus outlook for JAK inhibitor market Annual sales ($m)CompanyProductMechanismStatusUS launch20172024ePfizerXeljanzJak 3 inhibitorMarketed20121,3453,154AbbvieUpadacitinibJak 1 inhibitorPhase III2019-2,184LillyOlumiantJak 1&2 inhibitorMarketed2018461,339GileadFilgotinibJak 1 inhibitorPhase III2021-1,279AstellasASP015K OralJak inhibitorFiled--40Source: EvaluatePharma.
Xeljanz’s first-mover advantage is reflected in the drug’s 2024 forecast sales, despite a black box warning over serious infections and malignancies. Meanwhile, Lilly’s Olumiant got the go-ahead from the FDA in June but only for the lower, 2mg dose, after concerns about thrombotic events.
Abbvie’s upadacitinib, due to launch next year, has also been linked with thrombosis, although recent trial results appear to have assuaged some of these worries. As if this competition were not enough, filgotinib might not have long on the market before it goes up against generics, too: Xeljanz’s patent is set to expire by the end of 2025.
Success in Finch 2 would bode well for the remaining Finch 1 and 3 RA trials, due to read out in 2019. Investors might also become more optimistic about filgotinib’s success in other indications including chronic dermatitis, ulcerative colitis and ankylosing spondylitis; results from the phase II Tortuga study in the last indication are due this quarter.
Study
Setting
Trial ID
Finch 2
Rheumatoid arthritis
NCT02873936
Finch 1
Rheumatoid arthritis
NCT02889796
Finch 3
Rheumatoid arthritis
NCT02886728
Tortuga
Ankylosing spondylitis
NCT03117270