- Long-term data reinforce Jakafi®
(ruxolitinib) as an effective long-term treatment option for
patients with polycythemia vera (PV) who have had an inadequate
response to or are intolerant of hydroxyurea
- Overall safety profile of Jakafi remained
consistent with previously-reported 80-week RESPONSE data
Incyte Corporation (Nasdaq:INCY) today announced new 208-week
(4-year) follow-up data from the ongoing, global, multi-center,
open-label Phase 3 RESPONSE study of Jakafi® (ruxolitinib)
comparing the efficacy and safety of Jakafi with best available
therapy (BAT) in patients with polycythemia vera (PV) who are
resistant to or intolerant of hydroxyurea (HU). The pre-planned
data analysis showed a durable primary response to Jakafi in
patients with PV who are resistant to or intolerant of HU and the
overall safety profile for Jakafi remained consistent with
previously reported 80-week RESPONSE data.1 The results were shared
in an oral presentation today at the 59th American Society of
Hematology (ASH) Annual Meeting 2017 in Atlanta, Georgia.
“With 30 months of additional follow-up, the four-year RESPONSE
data analysis presented today at ASH further reinforces the
potential of Jakafi as a long-term option for patients with PV,”
said Peg Squier, M.D., Ph.D., Head of U.S. Medical Affairs at
Incyte. “Given the few treatment options available to treat this
chronic and progressive blood cancer, these long-term safety and
efficacy data are meaningful to patients with uncontrolled PV.”
The 80-week follow-up results from RESPONSE confirmed that among
patients who initially responded to Jakafi treatment, the
probability of maintaining primary and hematocrit (Hct) responses
for ≥ 80 weeks was 92% and 89%, respectively, and hence Jakafi
could be an effective long-term treatment option for patients with
PV who are HU-resistant or intolerant.
At the week 208 analysis, the overall long-term safety profile
remained consistent with the 80-week data analysis and the response
was durable. In both the Jakafi arm and the crossover population,
around 30% of patients completed the study treatment and 37% of
patients were still receiving treatment.
“These are clinically relevant long-term safety and efficacy
results, and further support the use of Jakafi in PV patients who
have an inadequate response to or are intolerant of hydroxyurea,”
said Srdan Verstovsek, M.D., Ph.D., medical oncologist and
professor, Department of Leukemia at The University of Texas MD
Anderson Cancer Center, Houston, Texas.
About the RESPONSE Trial
RESPONSE is an ongoing, global, multi-center, open-label, Phase
3 trial comparing the efficacy and safety of Jakafi® (ruxolitinib)
with BAT in 222 patients (Jakafi, 110; BAT, 112) with PV who are
resistant to or intolerant of hydroxyurea (HU).2
The primary response was a composite endpoint of the proportion
of patients who achieved both hematocrit (Hct) control (defined as
no phlebotomy eligibility from week 8 through week 32, with no more
than 1 post-randomization phlebotomy eligibility up to week 8) and
a spleen volume reduction of at least 35% from baseline at week 32.
Phlebotomy eligibility was defined as an Hct >45% and at least 3
percentage points greater than baseline or an Hct >48%. Patients
randomized to BAT could crossover (CO) to ruxolitinib at week 32 if
they did not meet the primary endpoint, or after week 32 in case of
disease progression (PBT eligibility, splenomegaly progression, or
both).2
The primary endpoint of the RESPONSE study was achieved,
demonstrating that Jakafi was superior to BAT at controlling Hct
and reducing spleen volume at week 32.2 The 80-week follow-up
results from RESPONSE have been published previously and confirmed
that ruxolitinib could be an effective long-term therapy option for
HU-resistant/intolerant (R/I) patients with PV.3
Durability of the primary response, overall clinicohematologic
(CLHM) response (defined as Hct control, platelet count ≤ 400 ×
109/L, white blood cell count ≤ 10 × 109/L, and spleen volume
reduction ≥ 35% by imaging), as well as long-term safety were
updated at week 208.1
At week 208, the Kaplan-Meier (KM) estimate of duration of
primary response was 0.73 (95% CI: 0.49, 0.87), and the KM estimate
of duration of absence of PBT eligibility was 0.73 (95% CI: 0.60,
0.83). The KM estimate of duration of at least 35% reduction in
spleen volume was 0.86 (95% CI: 0.61, 0.95). Median duration of
primary and CLHM responses has not been reached.1
Out of the 70 patients (63.6%) in the Jakafi arm who achieved an
overall CLHM response at week 32, 21 had progressed by week 208.
The KM estimate of duration of complete hematological remission
(defined as Hct control, platelet count ≤ 400 × 109/L, and white
blood cell count ≤ 10 × 109/L) at 208-weeks was 0.54 (95% CI: 0.31,
0.72). RESPONSE data also demonstrated that the KM estimate for
overall survival at 5-years was 90.6% (95% CI: 80.1, 95.7) for
patients treated with Jakafi compared to 87.7% (95% CI: 74.8, 94.3)
for patients treated with BAT.1
At the week 208 analysis, 41 patients (37%) originally
randomized to the Jakafi arm were still receiving therapy (median
exposure, 225 weeks) versus no patients on BAT (median exposure, 34
weeks). Among patients in the Jakafi arm, 29% completed the
treatment as per protocol. Of the 98 patients who crossed over to
Jakafi after week 32, 38% remained on Jakafi (median exposure, 189
weeks) and 31% completed treatment. Other main reasons for the
study drug discontinuations (Jakafi + CO patients) were disease
progression (11% + 8%), patient decision (6% + 6%), and adverse
events (14% + 14%).1
The most common adverse events in the Jakafi randomized arm
(week 208 vs week 80) per 100 patient-years of exposure were anemia
(9.3 vs 13.2), pruritus (7.3 vs 9.7), diarrhea (7.1 vs 9.7),
headache (6.1 vs 10.5), arthralgia (5.9 vs 6.1), increased weight
(5.6 vs 7.5) and muscle spasms (5.4 vs 7.9).
The 208-week results (Abstract #322) were presented as a part of
an oral session (#634) on Sunday, December 10, 2017, 7:30-9:00 AM
Eastern Time (8:15 AM), Building C, Level 2, C208-C210.
About Polycythemia Vera (PV)
Polycythemia vera (PV) is a myeloproliferative neoplasm (MPN)
and is typically characterized by elevated hematocrit, the percent
volume of red blood cells in the blood, which can lead to a
thickening of the blood and an increased risk of blood clots. An
elevated white blood cell and/or platelet count may also be
present.4 Patients with PV who fail to consistently maintain
appropriate hematocrit levels have a four times higher risk of
major thrombosis (blood clots) or cardiovascular death.5 Patients
with PV can also suffer from an enlarged spleen and a significant
symptom burden which may be attributed to thickening of the blood
and lack of oxygen to parts of the body.6 Signs and symptoms of PV
commonly include fatigue, itching, night sweats, bone pain, fever,
and unexplained weight loss.7
Approximately 100,000 patients in the U.S. are living with PV.8
Current standard treatment for PV is phlebotomy (the removal of
blood from the body) plus aspirin. When phlebotomy can no longer
control PV, chemotherapy such as hydroxyurea, or interferon, is
utilized in high-risk patients.9,10 Approximately one in four
patients with PV are considered uncontrolled11,12 because they have
an inadequate response to or are intolerant of hydroxyurea, the
most commonly used chemotherapeutic agent for the treatment of
PV.
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 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: 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 press release, including statements
regarding the potential for Jakafi to be a long-term treatment for
patients with PV, contain predictions, estimates and other
forward-looking statements. These forward-looking statements are
based on the Company’s current expectations and are subject to
risks and uncertainties that may cause actual results to differ
materially, including unanticipated developments and the risks
related to the efficacy or safety of the Company’s development
pipeline, the results of further research and development, the high
degree of risk and uncertainty associated with drug development,
clinical trials and regulatory approval processes, other market or
economic factors and competitive and technological advances; 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,
2017. Incyte disclaims any intent or obligation to update
these forward-looking statements.
References
- Kiladjian J, Verstovsek S, Griesshammer
M, et al. Results From The 208-Week (4-year) Follow-Up Of RESPONSE
Trial, A Phase 3 Study Comparing Ruxolitinib (Rux) With Best
Available Therapy (BAT) For The Treatment Of Polycythemia Vera
(PV). Abstract #322. 59th American Society of Hematology (ASH)
Annual Meeting 2017, Atlanta, Georgia, USA.
- Vannucchi AM, Kiladjian JJ,
Griesshammer M, et al. Ruxolitinib versus standard therapy for the
treatment of polycythemia vera. N Engl J Med.
2015;372(5):426-435.
- Verstovsek S, Vannucchi AM,
Griesshammer M, et al. Ruxolitinib versus best available therapy in
patients with polycythemia vera: 80-week follow-up from the
RESPONSE trial. Haematologica. 2016;101(7):821-829.
- Leukemia & Lymphoma Society.
“Polycythemia Vera Facts.” Available at:
https://www.lls.org/sites/default/files/file_assets/FS13_PolycythemiaVera_FactSheet_final5.1.15.pdf.
Accessed November 2015.
- Marchioli R, Finazzi G, Specchia G, et
al. Cardiovascular Events and Intensity of Treatment in
Polycythemia Vera. N Engl J Med. 2013;368:22-33.
- National Institutes of Health. “What
Are the Signs and Symptoms of Polycythemia Vera?" Available at:
http://www.nhlbi.nih.gov/health/health-topics/topics/poly/signs.
Accessed November 2015.
- Tefferi A. Polycythemia Vera and
Essential Thrombocythemia: 2013 Update on Diagnosis,
Risk-Stratification, and Management. Am J Hematol.
2013;88:507-16.
- Data on file. Incyte Corporation.
- Vannucchi AM. How I treat polycythemia
vera. Blood. 2014; 124(22):3212-20.
- Passamonti F. How I treat polycythemia
vera. Blood. 2012; 120(2):275-84.
- Barosi G, Birgegard G, Finazzi G, et
al. A Unified Definition of Clinical resistance and Intolerance to
Hydroxycarbamide in Polycythaemia Vera and Primary Myelofibrosis:
Results of a European LeukemiaNet (ELN) consensus process. Br J
Haematol. 2010;149:961-3.
- Alvarez-Larrán A, Pereira A, Cervantes
F, et al. Assessment and Prognostic Value of the European
LeukemiaNet criteria for Clinicohematologic Response, Resistance,
and Intolerance to Hydroxyurea in Polycythemia Vera. Blood.
2012;119:1363-9.
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version on businesswire.com: http://www.businesswire.com/news/home/20171210005031/en/
Incyte CorporationMediaJenifer Antonacci, +1
610-427-0369jantonacci@incyte.comorCatalina Loveman, +1
302-498-6171cloveman@incyte.comorInvestorsMichael
Booth, DPhil, +1 302-498-5914mbooth@incyte.com
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