-- Integrated Safety Analysis from the Phase
3 FINCH and Phase 2 DARWIN Programs Informs the Long-Term Safety
Profile of Filgotinib in RA --
-- Data Presented at the European League
Against Rheumatism, EULAR, European E-Congress of Rheumatology 2020
--
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.
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“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 meaningful 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)1
The 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=1,417/1,755) 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)2
The 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 improvement 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)3
Despite 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)4
An 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
Collaboration5
Gilead 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 ulcerative 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 Galapagos
Galapagos (Euronext & NASDAQ: GLPG) 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
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 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
Statement
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’ 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.
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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Gilead Douglas Maffei, PhD, Investors +1 (650)
522-2739
Sonia Choi, Media +1 (650) 425-5483
Galapagos Elizabeth Goodwin, Investors +1 (781)
460-1784
Carmen Vroonen, Media +32 473 824 874
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