FILGOTINIB DEMONSTRATES DURABLE EFFICACY AND CONSISTENT SAFETY
PROFILE AT 52 WEEKS IN FINCH 1 AND 3 STUDIES IN RHEUMATOID
ARTHRITIS
-- Integrated
Safety Analysis from the Phase 3 FINCH and Phase 2 DARWIN Programs
Informs Long-Term Safety Profile of Filgotinib in RA
--
-- Data Presented at The European League
Against Rheumatism, EULAR, European E-Congress of Rheumatology
2020 --
Foster City, Calif., & Mechelen,
Belgium, 4 June, 2020, 07.00 CET – Gilead Sciences, Inc.
(Nasdaq: GILD) and Galapagos NV (Euronext & Nasdaq: GLPG) today
announced Week 52 results from the Phase 3 FINCH 1 and FINCH 3
studies of filgotinib, an investigational, oral, selective JAK1
inhibitor, in adults with moderately to severely active rheumatoid
arthritis (RA). The data demonstrate sustained efficacy and a
consistent safety profile with up to 52 weeks of filgotinib
treatment across RA patient populations. The new data are among 15
abstracts on filgotinib in RA that will be presented at the
European League Against Rheumatism, EULAR, European E-Congress of
Rheumatology 2020.
“Many people with RA struggle with uncontrolled
symptoms that affect their daily lives. We are working to develop
effective and well-tolerated treatment options that will make a
difference in the lives of patients,” said Mark Genovese, MD,
Senior Vice President, Inflammation, Gilead Sciences. “These data
add to the body of evidence supporting filgotinib as a potential
treatment option for a range of RA patients.”
“After more than 4,544 patient years’ exposure
thus far, the FINCH and DARWIN programs continue to show that
filgotinib has a consistent efficacy and safety profile and has the
potential to help more people living with RA achieve symptom
control,” said Walid Abi-Saab, MD, Chief Medical Officer at
Galapagos.
FINCH 1 – 52-Week Data from Phase 3 Study in
Patients with Inadequate Response to Methotrexate (Poster
#0198)1The FINCH 1 program evaluated filgotinib versus placebo or
adalimumab, on a stable background dose of methotrexate in patients
with moderately to severely active RA who had prior inadequate
response to methotrexate (MTX-IR). Patients were randomized to
receive filgotinib 200 mg once daily (n=475), filgotinib 100 mg
once daily (n=480), adalimumab 40 mg bi-weekly (n=325) or matching
placebo (n=475). As previously reported, the filgotinib 200 mg
group met the primary study endpoint evaluating the proportion of
patients who achieved American College of Rheumatology Criteria of
at least a 20 percent improvement in the number of tender and
swollen joints (ACR20) at Week 12 versus placebo. Filgotinib was
superior to placebo in all secondary endpoints pertaining to signs
and symptoms of RA, physical function and structural damage.
The majority of patients in FINCH 1 (80.7
percent, n=1,417/1755) completed 52 weeks of treatment with study
drug. Both doses of filgotinib showed sustained efficacy in primary
and secondary outcome measures at Week 52. In addition, a greater
proportion of patients treated with filgotinib 200 mg achieved low
disease activity (DAS28(CRP) ≤3.2) and clinical remission
(DAS28(CRP) <2.6) compared with adalimumab-treated patients at
Week 52 (nominal p<0.05). Rates of remission based on CDAI ≤2.8
and Boolean remission criteria were also nominally significantly
higher in patients receiving filgotinib 200 mg versus adalimumab at
Week 52 (nominal p<0.05). Reductions in Heath Assessment
Questionnaire-Disability Index from baseline to Week 52 were
greater in patients receiving filgotinib 200 mg versus those
receiving adalimumab (nominal p<0.05). Response rates were
numerically similar between patients treated with filgotinib 100 mg
versus adalimumab for these endpoints.
Filgotinib 200 mg and 100 mg demonstrated a
consistent safety profile in this study of MTX-IR patients, and no
new safety signals were detected through Week 52. There were five
deaths reported prior to Week 24; two patients were in the placebo
group, two were in the filgotinib 200 mg group and one was in the
filgotinib 100 mg group. Four deaths were reported between Weeks 24
and 52; two treated with filgotinib 200 mg, one in the adalimumab
group, and one in the placebo group. Adverse events of interest
including serious infections, herpes zoster, venous thromboembolism
(VTE) and major adverse cardiovascular events (MACE) were
infrequent and balanced across treatment groups. Herpes zoster was
observed in all treatment groups, with a numeric increase in the
filgotinib 200 mg group compared with the filgotinib 100 mg
group.
FINCH 3 - Week 52 Data from Phase 3 Study in
Methotrexate-Naïve Patients (Poster #0158)2The FINCH 3 program
evaluated filgotinib in patients naïve to methotrexate. Patients
were randomized to receive filgotinib 200 mg plus methotrexate
(n=416), filgotinib 100 mg plus methotrexate (n=207), filgotinib
200 mg monotherapy (n=210) and methotrexate monotherapy (n=416). As
previously reported, the filgotinib 200 mg plus methotrexate group
met the primary study endpoint evaluating the proportion of
patients who achieved ACR20 at Week 24 versus methotrexate
monotherapy (p<0.001).
The majority of patients in FINCH 3 (78.1
percent, n=975/1,249) received study drug through Week 52. In this
analysis, all treatment groups demonstrated sustained efficacy
through Week 52 based on clinical response, physical function and
radiographic progression. Higher proportions of patients in the
filgotinib 200 mg plus methotrexate, 100 mg plus methotrexate and
filgotinib 200 mg monotherapy achieved ACR20 (nominal p <0.001,
p<0.01 and p<0.001), ACR50 (nominal p<0.001, p<0.01 and
p<0.01), ACR70 response (nominal p<0.001, p<0.05,
p<0.01) and disease remission (nominal p<0.001 for all three
arms) compared with patients receiving methotrexate monotherapy at
Week 52. Patients treated with filgotinib 200 mg plus methotrexate
(nominal p<0.001) or filgotinib monotherapy (nominal p<0.05)
experienced a significantly greater reduction in physical function
(measured by reductions in Heath Assessment
Questionnaire-Disability Index from baseline) compared with those
receiving methotrexate alone at Week 52. Patients in the filgotinib
treatment groups demonstrated less progression of structural damage
at Week 52 with filgotinib 200 mg plus methotrexate (nominal
p<0.001); filgotinib 100 mg plus methotrexate and filgotinib 200
mg monotherapy (nominal p<0.05) versus patients receiving
methotrexate monotherapy.
Treatment with filgotinib either in combination
with methotrexate or as monotherapy demonstrated a consistent
safety profile in this study of methotrexate-naive patients, and no
new safety signals were detected. Three deaths were reported in the
filgotinib 200 mg plus methotrexate group and one death was
reported in the filgotinib 100 mg plus methotrexate group. Adverse
events of interest, including rates of infections, serious
infections and herpes zoster occurred at similar rates with
filgotinib as methotrexate monotherapy. There were no VTEs reported
in the filgotinib treatment groups.
In addition to the 52-week FINCH 1 and FINCH 3
study results, new analyses on the safety and efficacy of
filgotinib for the treatment of RA will also be presented at the
congress.
FINCH 2 - Subgroup Analysis in Patients with
Inadequate Response to Biologic DMARDs (Poster #0204)3Despite
currently available treatments, many people living with RA have
inadequate responses to biologic disease modifying antirheumatic
drugs (bDMARD-IR). In this subgroup analysis of clinical response
to filgotinib in bDMARD-IR patients at Week 24, filgotinib
demonstrated consistently higher rates of low disease activity and
remission versus placebo that were independent of the number of
prior bDMARDs or prior exposure to IL-6 or TNF inhibition. The
differences in rates of low disease activity were statistically
significant overall for filgotinib 200 mg versus placebo (nominal
p<0.001).
Adverse events across subgroups were consistent
with the overall study population.
Integrated Safety Analysis from Phase 3 FINCH
and Phase 2 DARWIN Programs (Poster #0202)4An integrated safety
analysis of pooled data from seven clinical trials of filgotinib in
the FINCH Phase 3 and DARWIN Phase 2 programs reinforced the
consistent safety profile of filgotinib in the treatment of RA,
with no new safety concerns identified. Across the trials, 3,827
patients with RA received more than one dose of treatment for a
total of 4,544.5 total patient years of exposure.
Exposure-adjusted incidence rates (EAIRs) of
serious adverse events or treatment-emergent adverse events leading
to death in patients who received filgotinib were comparable with
EAIRs in patients treated with placebo, adalimumab or methotrexate;
no dose-dependent effects were noted. With filgotinib, EAIR of
serious infections and herpes zoster were generally similar to
adalimumab and methotrexate. Most cases of herpes zoster were mild
to moderate and not serious. The frequency of MACE and VTE were
numerically lower for filgotinib relative to placebo. In this
integrated analysis, filgotinib was well-tolerated, and no new
safety concerns were identified.
Filgotinib is an investigational drug whose
efficacy and safety have not been demonstrated. It is not approved
for use by any regulatory authority.
About the Filgotinib
Collaboration5Gilead and Galapagos NV are collaborative
partners in the global development and commercialization of
filgotinib in RA, and other inflammatory indications. The
companies have multiple clinical study programs for filgotinib in
inflammatory diseases, including the FINCH Phase 3 program in
rheumatoid arthritis, the Phase 3 SELECTION trial in ulcerativ
colitis, the DIVERSITY Phase 3 trial in Crohn’s disease, the Phase
3 PENGUIN trials in psoriatic arthritis, as well as Phase 2 studies
in uveitis and in small bowel and fistulizing Crohn’s disease. More
information about clinical trials with filgotinib can be accessed
at: www.clinicaltrials.gov.
About Gilead
Sciences
Gilead Sciences, Inc. is a research-based
biopharmaceutical company that discovers, develops and
commercializes innovative medicines in areas of unmet medical need.
The company strives to transform and simplify care for people with
life-threatening illnesses around the world. Gilead has operations
in more than 35 countries worldwide, with headquarters
in Foster City, California. For more information on Gilead
Sciences, please visit the company’s website at www.gilead.com.
About GalapagosGalapagos NV
discovers and develops small molecule medicines with novel modes of
action, three of which show promising patient results and are
currently in late-stage development in multiple diseases. Our
pipeline comprises discovery through Phase 3 programs in
inflammation, fibrosis, osteoarthritis and other indications. Our
ambition is to become a leading global biopharmaceutical company
focused on the discovery, development and commercialization of
innovative medicines. More information at www.glpg.com.
Gilead Forward-Looking
StatementThis 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 and
the possibility that we are unable to complete one or more of such
trials on the currently anticipated timelines. 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 Form 10-Q for
the quarter ended March 31, 2020, as filed with the U.S. Securities
and Exchange Commission. All forward-looking statements are based
on information currently available to Gilead, and Gilead assumes no
obligation to update any such forward-looking statements.
Galapagos Forward-Looking
StatementThis press 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’ Securities and Exchange Commission (SEC)
filings and reports, including in Galapagos’ most recent annual
report on form 20-F filed with the SEC and subsequent filings and
reports filed by Galapagos with the SEC. Given these
uncertainties, the reader is advised not to place any undue
reliance on such forward-looking statements. These forward-looking
statements speak only as of the date of publication of this
document. Galapagos expressly disclaims any obligation to update
any such forward-looking statements in this document to reflect any
change in its expectations with regard thereto or any change in
events, conditions or circumstances on which any such statement is
based or that may affect the likelihood that actual results will
differ from those set forth in the forward-looking statements,
unless specifically required by law or regulation.
# # #Contacts Galapagos
Investors:
Media:Elizabeth
Goodwin
Carmen Vroonen VP
IR
Senior Director Communications+1 781 460
1784
+32 473 824
874
Sofie Van Gijsel
Evelyn FoxDirector IR
Director Communications+32 485 19 14
15
+31 6 53 591
999ir@glpg.com
communications@glpg.com
Contacts
GileadInvestors:
Media:Douglas Maffei,
PhD
Sonia Choi+1 650 522
2739
+1 650 425 5483
1Combe, B et al. Efficacy and Safety of Filgotinib for Patients
with Rheumatoid Arthritis with Inadequate Response to Methotrexate:
FINCH 1 52-Week Results. Abstract at the European League Against
Rheumatism, EULAR, European E-Congress of Rheumatology 2020.
2Westhovens, R et al. Efficacy and Safety of Filgotinib in
Methotrexate-Naïve Patients with Rheumatoid Arthritis: FINCH 3
52-Week Results. Abstract at the European League Against
Rheumatism, EULAR, European E-Congress of Rheumatology 2020.
3Gottenberg, J-E et al. A Subgroup Analysis of Low Disease
Activity and Remission from Phase 3 Study of Filgotinib in Patients
with Inadequate Response to Biologic DMARDs. Abstract at the
European League Against Rheumatism, EULAR, European E-Congress of
Rheumatology 2020.
4Genovese, M C et al. Integrated safety Analysis of Filgotinib
Treatment for Rheumatoid Arthritis from 7 Clinical Trials. Abstract
at the European League Against Rheumatism, EULAR, European
E-Congress of Rheumatology 2020.
5 Gilead & Galapagos Filgotinib Clinical Program Trial
Details: FINCH 1 (NCT02889796); FINCH 2 (NCT02873936); FINCH 3
(NCT02886728); SELECTION (NCT02914522); DIVERSITY (NCT02914561);
PENGUIN 1 (NCT04115748); PENGUIN 2 (NCT04115839)
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