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-- Filgotinib 100 mg and 200 mg Plus Methotrexate (MTX) Demonstrated Significantly Higher ACR20/50/70 Responses Than Methotrexate Alone --
-- Filgotinib Safety Profile Consistent With Previously Reported Results --
The proportion of patients achieving ACR50, ACR70, and clinical remission (DAS28(CRP)
Top-line FINCH 3 efficacy† data are summarized in the table below:
Filgotinib 200 mg+ MTX(n=416)& | Filgotinib 100 mg+ MTX(n=207)& | Filgotinib 200 mgmonotherapy(n=210)& | MTX(n=416)& | |
ACR20 (%) | 81.0*** | 80.2* | 78.1 | 71.4 |
ACR50 (%) | 61.5*** | 57.0** | 58.1**# | 45.7 |
ACR70 (%) | 43.8*** | 40.1*** | 40.0***# | 26.0 |
DAS28(CRP) | 54.1*** | 42.5*** | 42.4***# | 29.1 |
HAQ-DI change | -0.94*** | -0.90** | -0.89*# | -0.79 |
mTSS change | 0.20 | 0.22 | -0.04**# | 0.52 |
†Efficacy assessed at Week 24 for all endpoints&Number
of patients randomized to each treatment group and who received at least
one dose of study drugACR20/50/70 represents
The safety profile of filgotinib in FINCH 3 is consistent with prior studies up to Week 24. Serious adverse events occurred in 4.1 percent, 2.4 percent, 4.8 percent, and 2.9 percent of patients receiving filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg monotherapy and MTX alone, respectively. There was one venous thrombotic event (in the MTX group), five cases of adjudicated major adverse cardiovascular events (two in the filgotinib 200 mg plus MTX group, one in the filgotinib 200 mg group and two in the MTX group) and one malignancy (in the MTX group). There was one death, reported in the filgotinib 200 mg plus MTX group. Serious infections occurred in 1.0 percent, 1.0 percent, 1.4 percent and 1.0 percent of the patients in the filgotinib 200 mg plus MTX, filgotinib 100 mg plus MTX, filgotinib 200 mg monotherapy and MTX groups, respectively. The proportion of patients reporting herpes zoster was 0.5 percent in each of the treatment groups.
“The FINCH 3 data clearly demonstrate improved efficacy when filgotinib
is compared with the use of MTX alone in rheumatoid arthritis patients
with earlier stages of disease,” said
“Additional effective and tolerable treatment options are still needed for people newly diagnosed with rheumatoid arthritis or in the early stages of the disease. This complements the FINCH 1 and FINCH 2 data, underlining the potential of filgotinib as a treatment option across a wide range of patient populations suffering from rheumatoid arthritis.” said Dr. Walid Abi-Saab, Chief Medical Officer, Galapagos.
Detailed findings from FINCH 3 will be submitted for presentation at a future scientific conference. Filgotinib is an investigational agent and not approved anywhere globally. Its efficacy and safety have not been established.
About FINCH 3
FINCH 3 is an ongoing 52-week randomized, double-blind and active-controlled study examining filgotinib alone and in combination with MTX, enrolling 1,252 adult patients with moderately to severely active RA who are naïve to MTX. Patients were randomized (2:1:1:2) to receive filgotinib 200 mg plus MTX (n=417), filgotinib 100 mg plus MTX (n=207), filgotinib 200 mg alone (n=210) or MTX (n=418). The primary endpoint is the proportion of patients who achieve an ACR20 response at Week 24.
More information about clinical trials with filgotinib can be accessed at: www.clinicaltrials.gov.
About the Galapagos – Gilead Collaboration
Galapagos and Gilead entered into a global collaboration for the development and commercialization of filgotinib in inflammatory indications. The FINCH studies are among several clinical trials of filgotinib in inflammatory diseases, including the EQUATOR Phase 2 program in psoriatic arthritis, the TORTUGA study in ankylosing spondylitis, the DIVERSITY Phase 3 trial in Crohn’s disease (also small bowel and fistulizing Crohn’s disease Phase 2 studies) and the Phase 3 SELECTION trial in ulcerative colitis.
About Galapagos
This press release contains inside information within the meaning of
Regulation (EU) No 596/2014 of the European Parliament and of the
Council of
About
Galapagos Forward-Looking Statements
This release may contain forward-looking statements with respect to
Galapagos, including statements regarding Galapagos’ strategic
ambitions, the mechanism of action and potential safety and efficacy of
filgotinib, the anticipated timing of clinical studies with filgotinib
and the progression and results of such studies. Galapagos cautions the
reader that forward-looking statements are not guarantees of future
performance. Forward-looking statements involve known and unknown risks,
uncertainties and other factors which might cause the actual results,
financial condition and liquidity, performance or achievements of
Galapagos, or industry results, to be materially different from any
historic or future results, financial conditions and liquidity,
performance or achievements expressed or implied by such forward-looking
statements. In addition, even if Galapagos’ results, performance,
financial condition and liquidity, and the development of the industry
in which it operates are consistent with such forward-looking
statements, they may not be predictive of results or developments in
future periods. Among the factors that may result in differences are the
inherent uncertainties associated with competitive developments,
clinical trial and product development activities and regulatory
approval requirements (including that data from the ongoing and planned
clinical research programs may not support registration or further
development of filgotinib due to safety, efficacy or other reasons),
Galapagos’ reliance on collaborations with third parties (including its
collaboration partner for filgotinib, Gilead), and estimating the
commercial potential of Galapagos’ product candidates. A further list
and description of these risks, uncertainties and other risks can be
found in Galapagos’
Gilead Forward-Looking Statement
This press release includes forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995 that are
subject to risks, uncertainties and other factors, including the
possibility of unfavorable results from ongoing and additional clinical
trials involving filgotinib. Further, it is possible that the parties
may make a strategic decision to discontinue development of filgotinib,
and as a result, filgotinib may never be successfully commercialized.
All statements other than statements of historical fact are statements
that could be deemed forward-looking statements. These risks,
uncertainties and other factors could cause actual results to differ
materially from those referred to in the forward-looking statements. The
reader is cautioned not to rely on these forward-looking statements.
These and other risks are described in detail in Gilead’s Annual Report
on Form 10-K for the year ended
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Source:
Galapagos ContactsInvestors:Elizabeth GoodwinVP IR+1-781-460-1784Sofie Van GijselDirector IR+32 485 19 14 15ir@glpg.comMedia:Carmen VroonenSenior Director Communications+32 473 824 874Evelyn FoxDirector Communications+31 6 53 591 999communications@glpg.comGilead ContactsInvestors:Sung Lee+1 650-524-7792Media:Nathan Kaiser+1 650-522-1853
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