- Updated data to be presented today at
the 60th annual ASH meeting
- REACH1 study formed the basis of sNDA,
now under Priority Review by the FDA
Incyte Corporation (Nasdaq:INCY) announces updated results from
its pivotal Phase 2 REACH1 study evaluating ruxolitinib (Jakafi®)
in combination with corticosteroids as a treatment for patients
with acute graft-versus-host disease (GVHD) who have had an
inadequate response to corticosteroids. As previously announced,
the study met its primary endpoint, demonstrating an overall
response rate (ORR) of 55 percent (n=39/71) at Day 28, along with a
best overall response rate (BORR) – patients achieving a response
at any time point during the study – of 73 percent (n=52/71).
Many of the patients (68 percent) had Grade III or Grade IV
disease at baseline, illustrative of an at-risk patient population,
and responses were observed irrespective of grade or steroid
refractory (SR) criteria. Responses to ruxolitinib were rapid and
durable; the median time to response was seven days and the median
duration of response (DOR) for patients who had a minimum of six
months of follow-up was 345 days. Adverse events reported were
consistent with the safety profile established in prior ruxolitinib
studies, and in patients with SR acute GVHD.
These results are being presented at the American Society of
Hematology (ASH) Annual Meeting 2018 in San Diego, California, in
an oral session today, Monday, December 3, from 7:00 a.m. PT to
8:30 a.m. PT (Location: Manchester Grand Hyatt, Grand Hall A; Oral
Session 722, Abstract #601).
“There are known limitations to currently available treatment
approaches for patients with high-risk or relapsed hematologic
malignancies who develop acute GVHD after an allogeneic stem cell
transplant. Nearly half of acute GVHD patients do not achieve
sustained responses with corticosteroid therapy, and there are no
approved treatments for these patients,” said Madan Jagasia, M.D.,
M.B.B.S., M.S., Professor of Medicine, Vanderbilt University
Medical Center, Department of Medicine, Division of
Hematology-Oncology and Chief Medical Officer, Vanderbilt-Ingram
Cancer Center. “The REACH1 results being presented at ASH
demonstrate the potential of ruxolitinib to deliver meaningful and
sustained benefits to patients with this serious condition who,
without an approved second-line treatment option, have few
treatment options.”
GVHD is a condition that can occur after an allogeneic
transplant (the transfer of genetically dissimilar blood stem
cells) where the donated bone marrow or peripheral blood stem cells
view the recipient’s body as foreign and attack the body, leading
to significant morbidity and mortality in transplant recipients.
There are two forms of GVHD, acute and chronic, which can affect
multiple organ systems including the skin, gastrointestinal
(digestive) tract and liver. Acute GVHD typically occurs within the
first 100 days following an allogeneic transplant and is classified
based on clinical and histological features. With acute GVHD, up to
40 percent of patients have severe disease, resulting in a 12-month
survival of 50 percent or less.1
“The updated results of the REACH1 study being presented at ASH
further illustrate the potential of JAK inhibition as a therapeutic
option in GVHD, and specifically reinforce the durability of
responses seen in acute GVHD patients treated with ruxolitinib,”
said Steven Stein, M.D., Chief Medical Officer, Incyte. “We are
currently working with the FDA to facilitate the expedited review
of the sNDA for ruxolitinib in steroid refractory acute GVHD, and,
if approved, we believe ruxolitinib will provide an innovative
treatment option for U.S. patients with this deadly disease.”
Key Findings from REACH1
The primary endpoint of the REACH1 study was overall response
rate (ORR) at Day 28, defined as the proportion of patients having
complete response (CR), very good partial response (VGPR) or
partial response (PR). The key secondary endpoint was six-month
duration of response (DOR, the time from first response to GVHD
progression or death). At the six-month data cutoff (July 2, 2018),
71 patients had received at least one dose of ruxolitinib, and
treatment was ongoing in 11 patients (16 percent).
Results from the primary analysis being presented at ASH show
that in patients with steroid refractory (SR) acute GVHD who are
treated with ruxolitinib in combination with corticosteroids, the
primary endpoint of ORR was 55 percent (n=39/71), with responses
observed irrespective of grade or SR criteria. This included 19 (27
percent) patients with CR, seven (10 percent) patients with VGPR
and 13 (18 percent) patients with PR.
The median DOR among Day 28 responders who had a minimum of six
months follow-up was 345 days (lower limit, 159 days), the key
secondary endpoint. Event-free probability estimates for Day 28
responders at three and six months were 82 percent and 65 percent,
respectively. The median time to first response was rapid (seven
days). Additionally, most patients had sustained reductions in
corticosteroid use over time, with more than half of patients on
ruxolitinib at Day 28 (56 percent; n=24/43) demonstrating a ≥50
percent reduction from baseline in corticosteroid dose.
Additional secondary endpoints of the REACH1 study include
non-relapse mortality, overall survival (OS) and the incidence and
severity of adverse events (AE). Non-relapse mortality rates at
six, nine and twelve months were 44 percent, 48 percent and 53
percent, respectively. Among all patients, median OS was 232
days.
The ruxolitinib AE profile was consistent with expectations for
ruxolitinib and for patients with SR acute GVHD. The most common
treatment-emergent adverse events (TEAEs) of any grade were anemia
(65 percent), hypokalemia (49 percent), decreased platelet count
(45 percent), peripheral edema (45 percent) and decreased
neutrophil count (39 percent). A total of 14 patients had a
cytomegalovirus (CMV) event (n=10, infection; n=4, viremia), and
all patients who had a CMV event had a positive CMV donor or
recipient serostatus or both at baseline. Fatal treatment-related
TEAEs were sepsis and pulmonary hemorrhage (one patient each) and
were attributed to both ruxolitinib and corticosteroids. No deaths
were attributed to CMV events.
Data from the REACH1 study supported the submission of a
supplemental New Drug Application (sNDA) by Incyte which was
accepted for Priority Review by the U.S. Food and Drug
Administration and assigned a Prescription Drug User Fee Act
(PDUFA) date of February 24, 2019. The FDA grants Priority Review
to medicines that have the potential to provide significant
improvements in the treatment of a serious disease.
About REACH
The REACH clinical trial program for Jakafi in patients with
GVHD who have had an inadequate response to corticosteroids
includes the Incyte-sponsored REACH1 study—a single-cohort, pivotal
Phase 2 study (NCT02953678) evaluating Jakafi in combination with
corticosteroids in patients with acute GVHD who have had an
inadequate response to corticosteroids. For more information about
the REACH1 study, please visit
https://clinicaltrials.gov/show/NCT02953678.
The REACH clinical program also includes the collaborative
Novartis-sponsored randomized pivotal Phase 3 studies in acute GVHD
(REACH2) and chronic GVHD (REACH3), which are both underway; data
are expected in 2019.
About Jakafi®(ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. Food and Drug Administration for treatment of people with
polycythemia vera (PV) who have had an inadequate response to or
are intolerant of hydroxyurea.
Jakafi is also indicated for treatment of people with
intermediate or high-risk myelofibrosis (MF), including primary MF,
post–polycythemia vera MF and post–essential thrombocythemia
MF.
Jakafi is marketed by Incyte in the U.S. and by Novartis as
Jakavi® (ruxolitinib) outside the U.S. Jakafi is a registered
trademark of Incyte Corporation. Jakavi is a registered trademark
of Novartis AG in countries outside the U.S.
Important Safety Information
Jakafi can cause serious side effects, including:
Low blood counts: Jakafi® (ruxolitinib) may cause your
platelet, red blood cell, or white blood cell counts to be lowered.
If you develop bleeding, stop taking Jakafi and call your
healthcare provider. Your healthcare provider will perform blood
tests to check your blood counts before you start Jakafi and
regularly during your treatment. Your healthcare provider may
change your dose of Jakafi or stop your treatment based on the
results of your blood tests. Tell your healthcare provider right
away if you develop or have worsening symptoms such as unusual
bleeding, bruising, tiredness, shortness of breath, or a fever.
Infection: You may be at risk for developing a serious
infection during treatment with Jakafi. Tell your healthcare
provider if you develop any of the following symptoms of infection:
chills, nausea, vomiting, aches, weakness, fever, painful skin rash
or blisters.
Skin cancers: Some people who take Jakafi have developed
certain types of non-melanoma skin cancers. Tell your healthcare
provider if you develop any new or changing skin lesions.
Increases in Cholesterol: You may have changes in your
blood cholesterol levels. Your healthcare provider will do blood
tests to check your cholesterol levels during your treatment with
Jakafi.
The most common side effects of Jakafi include: low
platelet count, low red blood cell counts, bruising, dizziness,
headache.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider for more information. Tell your
healthcare provider about any side effect that bothers you or that
does not go away.
Before taking Jakafi, tell your healthcare provider
about: all the medications, vitamins, and herbal supplements
you are taking and all your medical conditions, including if you
have an infection, have or had tuberculosis (TB), or have been in
close contact with someone who has TB, have or had hepatitis B,
have or had liver or kidney problems, are on dialysis, had skin
cancer or have any other medical condition. Take Jakafi exactly as
your healthcare provider tells you. Do not change or stop taking
Jakafi without first talking to your healthcare provider. Do not
drink grapefruit juice while on Jakafi.
Women should not take Jakafi while pregnant or planning to
become pregnant, or if breast-feeding.
Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at
www.jakafi.com.
About Incyte
Incyte Corporation is a Wilmington, Delaware-based
biopharmaceutical company focused on the discovery, development and
commercialization of proprietary therapeutics. For additional
information on Incyte, please visit the Company’s website at
www.incyte.com.
Follow @Incyte on Twitter at https://twitter.com/Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this release contain predictions, estimates
and other forward-looking statements, including statements
regarding the potential of ruxolitinib to benefit patients who
develop acute GVHD, the durability of responses seen in acute GVHD
patients treated with ruxolitinib, whether and when the Company’s
sNDA for the approval of ruxolitinib for the treatment of steroid
refractory acute GVHD will be approved by the FDA, and whether
ruxolitinib will become an accepted treatment option for such
patients.
These forward-looking statements are based on the Company’s
current expectations and subject to risks and uncertainties that
may cause actual results to differ materially, including
unanticipated developments in and risks related to: unanticipated
delays; further research and development and the results of
clinical trials possibly being unsuccessful or insufficient to meet
applicable regulatory standards or warrant continued development;
determinations made by the FDA; the Company’s dependence on its
relationships with its collaboration partners; the efficacy or
safety of the Company’s products and the products of the Company’s
collaboration partners; and other risks detailed from time to time
in the Company’s reports filed with the Securities and Exchange
Commission, including its Form 10-Q for the quarter ended September
30, 2018. The Company disclaims any intent or obligation to update
these forward-looking statements.
1 MacMillan et al. Biology of Blood and Marrow Transplantation.
(2002). 8:387-394
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