- Results of REACH3 trial also demonstrate significant
improvements in failure-free survival (FFS) and patient-reported
symptoms1
- Findings from the study are being presented at ASH 2020, and
complement previously-reported positive results for Jakafi in
steroid-refractory acute graft-versus-host disease (GVHD)2
- Chronic GVHD is a life-threatening complication of stem cell
transplants and half of patients become steroid
refractory/dependent3,4
- Investor conference call and webcast scheduled for Monday,
December 7, 2020 at 10:00 a.m. ET (7:00 a.m. PT)
Incyte (Nasdaq:INCY) today announced that detailed results from
the pivotal Phase 3 REACH3 study demonstrate Jakafi® (ruxolitinib)
significantly improved outcomes across a range of efficacy measures
in patients with steroid-refractory or steroid-dependent chronic
graft-versus-host disease (GVHD) compared to best available therapy
(BAT)1. The results of REACH3, the first successful, randomized
Phase 3 trial in chronic GVHD, were highlighted in a press briefing
today and will be presented during the 62nd American Society of
Hematology Annual Meeting & Exposition (ASH 2020). REACH3 is
jointly sponsored by Incyte and Novartis.
“The results from this large, randomized study further emphasize
the role Jakafi can play as a meaningful option for patients with
chronic GVHD, for whom new treatments are urgently needed,” said
Peter Langmuir, M.D., Group Vice President, Oncology Targeted
Therapies, Incyte. “These data are important for patients living
with GVHD and their physicians as they represent the continued
success of Jakafi in the chronic form of the disease, a
historically difficult-to-treat condition.”
In REACH3, patients treated with Jakafi achieved significantly
greater overall response rate (ORR) compared to BAT (49.7% vs.
25.6%; p<0.00015) at Week 24, the primary endpoint of the
study6. Jakafi also demonstrated statistically significant and
clinically meaningful improvements in key secondary endpoints:
- Patients receiving Jakafi had a significant improvement in
failure-free survival (FFS; defined as time to the earliest
recurrence of the underlying disease, the start of new systemic
treatment for chronic GVHD, or death) versus patients receiving BAT
(median FFS not yet reached vs. 5.7 months; hazard ratio, 0.37, 95%
CI, 0.27-0.51; p<0.0001)1.
- Patients treated with Jakafi also had greater improvements in
patient-reported symptoms than those treated with BAT (24.2% vs.
11.0%; p=0.0011), as measured by the rate of responders who
achieved a reduction of ≥ 7 points of total symptom score (TSS)
from baseline of the modified Lee Symptom Score (mLSS)1.
- Additionally, best overall response (BOR) rate, defined as any
response up to week 24, was achieved in 76.4% of patients in the
Jakafi arm compared to 60.4% in the BAT arm (odds ratio [OR], 2.17;
95% CI, 1.34-3.52). The median duration of response was 6.2 months
in the BAT arm, but was not yet reached in the Jakafi arm1.
No new safety signals were observed in REACH3, and adverse
events (AEs) attributable to treatment were consistent with the
known safety profile of Jakafi. The most common AEs in the Jakafi
vs. BAT arms were anemia (29.1% vs. 12.7%), hypertension (15.8% vs.
12.7%) and pyrexia (15.8% vs. 9.5%). While 37.6% and 16.5% of
patients required Jakafi and BAT dose modifications, respectively,
the number of patients who discontinued treatment due to AEs was
low (16.4% and 7%, respectively). Mortality rates were similar
across treatment arms (19% vs. 16% BAT)1. Deaths reported as
primarily due to chronic GVHD were slightly higher for Jakafi.
“The damaging and sometimes deadly effects of chronic GVHD
following stem cell transplant present significant treatment
challenges, particularly for the nearly half of patients who do not
adequately respond to steroid treatment,” said Dr. Robert Zeiser,
University Hospital Freiburg, Department of Haematology, Oncology
and Stem Cell Transplantation, Freiburg, Germany. “Based on the
compelling REACH3 results, we now have a potential new standard of
care for these patients.”
GVHD is a condition that can occur after an allogeneic stem cell
transplant (the transfer of stem cells from a donor) where the
donated cells initiate an immune response and attack the transplant
recipient’s organs, leading to significant morbidity and mortality.
There are two major forms of GVHD: acute, which occurs within 100
days of transplant, and chronic, which occurs after 100 days of
transplant3. GVHD can affect multiple organ systems including the
skin, gastrointestinal (digestive) tract and liver.
In 2019, Jakafi® (ruxolitinib) was approved by the U.S. Food and
Drug Administration for the treatment of steroid-refractory acute
GVHD in adult and pediatric patients 12 years and older, based on
the positive results of the Phase 2 REACH1 trial6. Jakafi is
marketed by Incyte in the U.S.; ruxolitinib (Jakavi®) is licensed
to Novartis ex-U.S.
About REACH3
REACH3 (NCT03112603), a randomized, open-label, multicenter
Phase 3 study sponsored by Novartis and conducted in collaboration
with and co-funded by Incyte, is evaluating the safety and efficacy
of ruxolitinib compared with best available therapy in patients
with steroid-refractory chronic GVHD.
The primary endpoint is overall response rate (ORR) at Day 1 of
the Cycle 7 (Day 168) visit, defined as the percentage of
participants demonstrating a complete or partial response.
Secondary endpoints include change in the modified Lee chronic GVHD
symptom scale score at Day 1 of Cycle 7, rate of failure-free
survival (FFS) up to 36 months, best overall response (BOR),
duration of response (DoR), overall survival (OS), among others.
For more information about the study, please visit
https://clinicaltrials.gov/ct2/show/NCT03112603.
About REACH
The REACH clinical trial program evaluating ruxolitinib in
patients with steroid-refractory GVHD includes the randomized
pivotal Phase 3 REACH2 and REACH3 trials, conducted in
collaboration with Novartis.
The REACH program was initiated with the Incyte-sponsored REACH1
trial, a prospective, open-label, single-cohort, multicenter,
pivotal Phase 2 trial (NCT02953678) evaluating Jakafi in
combination with corticosteroids in patients with
steroid-refractory grade II-IV acute GVHD. For more information
about the study, including trial results, please visit
https://clinicaltrials.gov/show/NCT02953678.
About Jakafi® (ruxolitinib)
Jakafi is a first-in-class JAK1/JAK2 inhibitor approved by the
U.S. FDA for the treatment of polycythemia vera (PV) in adults who
have had an inadequate response to or are intolerant of
hydroxyurea, in adults with intermediate or high-risk myelofibrosis
(MF), including primary MF, post-polycythemia vera MF and
post-essential thrombocythemia MF and for the treatment of
steroid-refractory acute GVHD in adult and pediatric patients 12
years and older.
Jakafi is marketed by Incyte in the United States and by
Novartis as Jakavi® (ruxolitinib) outside the United States. Jakafi
is a registered trademark of Incyte Corporation. Jakavi is a
registered trademark of Novartis AG in countries outside the United
States.
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: for
certain types of MF and PV - low platelet or low red blood cell
counts, bruising, dizziness, headache, and diarrhea; and for acute
GVHD – low platelet, red or white blood cell counts, infections,
and fluid retention.
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, have a high
level of fat in your blood (high blood cholesterol or
triglycerides), 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.
Women should not take Jakafi while pregnant or planning to
become pregnant. Do not breast-feed during treatment with Jakafi
and for 2 weeks after the final dose.
Full Prescribing Information, which includes a more complete
discussion of the risks associated with Jakafi, is available at
www.jakafi.com.
Conference Call Information
Incyte will host an investor conference call and webcast at
10:00 a.m. ET (7:00 a.m. PT) on Monday, December 7, 2020—the call
and webcast can be accessed via the Events and Presentations tab of
the Investor section of Incyte.com and it will be available for
replay for 90 days.
To access the conference call, please dial 877-407-3042 for
domestic callers or +1 201-389-0864 for international callers. When
prompted, provide the conference identification number,
13713399.
About Incyte
Incyte is a Wilmington, Delaware-based, global biopharmaceutical
company focused on finding solutions for serious unmet medical
needs through the discovery, development and commercialization of
proprietary therapeutics. For additional information on Incyte,
please visit Incyte.com and follow @Incyte.
Forward-Looking Statements
Except for the historical information set forth herein, the
matters set forth in this press release, including statements about
the REACH3 data, the effect of the REACH3 results on patients with
GVHD, and the overall REACH program, contain predictions, estimates
and other forward-looking statements.
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;
the ability to enroll sufficient numbers of subjects in clinical
trials; 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; the acceptance of the Company’s products
and the products of the Company’s collaboration partners in the
marketplace; market competition; sales, marketing, manufacturing
and distribution requirements; greater than expected expenses;
expenses relating to litigation or strategic activities; and other
risks detailed from time to time in the Company’s reports filed
with the Securities and Exchange Commission, including its
quarterly report on Form 10-Q for the quarter ended September 30,
2020. The Company disclaims any intent or obligation to update
these forward-looking statements.
1 Zeiser R, M.D., et al. Ruxolitinib (RUX) vs Best Available
Therapy (BAT) in Patients with Steroid-Refractory/Steroid-Dependent
Chronic Graft-vs-Host Disease (cGVHD): Primary Findings from the
Phase 3, Randomized REACH3 Study. 62nd American Society of
Hematology Annual Meeting & Exposition (ASH). Abstract #77. 2
Zeiser R, M.D., et al. Ruxolitinib for Glucocorticoid-Refractory
Acute Graft-versus-Host Disease. New England Journal of Medicine.
2020;382:1800-1810. 3 Ferrara JL., et al. Graft-versus-host
disease. Lancet. 2009;373(9674):1550-1561. 4 Jaglowski SM, et al.
Graft-versus-Host Disease: Why Haven’t We Made More Progress? Curr
Opin Hematol. 2014;21(2):141-147. 5 Descriptive P value given for
ORR at the primary analysis as the efficacy boundary was crossed at
the interim analysis (ORR, P = 0.0003). 6 Jakafi (ruxolitinib)
tablets: Prescribing Information. U.S. Food and Drug
Administration; May 2019.
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Incyte Media Catalina
Loveman +1 302 498 6171 cloveman@incyte.com Jenifer Antonacci +1
302 498 7036 jantonacci@incyte.com
Investors Michael Booth, DPhil +1 302 498 5914
mbooth@incyte.com Christine Chiou +1 302 274 4773
cchiou@incyte.com
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