- Phase 2 data demonstrate that the addition of
parsaclisib to ruxolitinib (Jakafi®) resulted in spleen volume
reduction and improvement in symptom burden in patients with
myelofibrosis (MF)
- Initial results of a Phase 1/2 study
evaluating the safety and tolerability of INCB00928, an ALK2
inhibitor, show INCB00928 improves anemia in patients with MF both
as monotherapy and in combination with ruxolitinib
- These studies are part of our LIMBER program
evaluating ruxolitinib combinations and potential new targets for
appropriate patients with myeloproliferative neoplasms (MPNs)
Incyte (Nasdaq:INCY) today announced new data from two of its
LIMBER (Leadership In MPNs and GVHD BEyond Ruxolitinib) trials
evaluating monotherapy and combination strategies using ruxolitinib
(Jakafi®) with parsaclisib, its investigational
phosphatidylinositol 3-kinase delta (PI3Kδ) inhibitor, and
INCB00928 (zilurgisertib), its activin receptor-like kinase (ALK2)
inhibitor, in patients with myelofibrosis (MF). These Phase 2 and
Phase 1/2 trials (Abstract #236 and Abstract #1714, respectively)
were presented at the 64th American Society of Hematology (ASH)
Annual Meeting, held December 10-13, 2022, in New Orleans and
virtually1,2.
“Despite the significant advances we have made in the treatment
of myeloproliferative neoplasms (MPNs) like MF, a need for
additional options remains for those who have an inadequate
response to or are unable to tolerate current therapies,” said
Peter Langmuir, M.D., Vice President, Oncology Drug Development,
Incyte. “The parsaclisib and ruxolitinib data presented at ASH
demonstrate the clinical potential of the combination to improve
upon the standard of care and continue to support the safety
profile. We look forward to building on these results through our
Phase 3 LIMBER-304 and LIMBER-313 trials evaluating parsaclisib as
an add-on to ruxolitinib and in the frontline setting, both of
which are currently underway.”
Final results from the Phase 2 trial (Abstract #236;
NCT02718300) evaluating the efficacy and safety of add-on
parsaclisib to ruxolitinib for patients with MF who had a
suboptimal response to ruxolitinib resulted in additional spleen
volume reduction and improvement in symptom burden with add-on
parsaclisib. Patients in the trial received parsaclisib daily for
eight weeks in combination with stable dose ruxolitinib and then
daily or weekly thereafter. Patients who received an all daily
parsaclisib dosing schedule appeared to have a more durable
efficacy profile compared with daily followed by weekly dosing of
parsaclisib. Specifically:
- At 12 weeks of treatment, 59.5% (25), 21.4% (9) and 4.8% (2) of
patients who received all daily dosing experienced ≥10%, ≥25% and
≥35% reduction in spleen volume, respectively.
- Comparatively, 28.1% (9), 3.1% (1) and 0% of patients who
received daily followed by weekly dosing experienced ≥10%, ≥25% and
≥35% reduction in spleen volume, respectively.
- At 24 weeks of treatment the reduction was maintained, with 50%
(21), 28.6% (12) and 7.1% (3) patients who received all daily
dosing experiencing ≥10%, ≥25% and ≥35% reduction in spleen volume,
respectively.
- Comparatively, 12.5% (4), 12.5% (4) and 3.1% (1) of patients
who received daily followed by weekly dosing experienced ≥10%, ≥25%
and ≥35% reduction in spleen volume, respectively.
- Addition of parsaclisib to ruxolitinib was generally
well-tolerated, with limited grade 3 or 4 adverse events and
treatment-emergent adverse event (TEAE)-related discontinuations.
TEAEs common to PI3Kδ inhibitors in lymphoma (e.g., hepatotoxicity,
rash, colitis) were infrequent or absent with the addition of
parsaclisib.
- Serious TEAEs occurring in ≥2 patients overall included
pneumonia (n=6; 2 daily/weekly, 1 all daily), fall (n=3; 2
daily/weekly, 1 all daily) and pyrexia (n=2; 1 daily/weekly, 1 all
daily).
- Overall, 9 patients (5 daily/weekly, 4 all daily) had a TEAE
leading to parsaclisib discontinuation, and 4 patients (2
daily/weekly, 2 all daily) had a TEAE leading to ruxolitinib
discontinuation.
“MF is a rare, chronic blood cancer, and despite the
advancements made in treatment, additional options are needed,”
said Abdulraheem Yacoub, Associate Professor, Hematologic
Malignancies and Cellular Therapeutics, University of Kansas Cancer
Center. “I am encouraged by these findings and the potential of
parsaclisib and ruxolitinib to be an efficacious combination
therapy to help improve outcomes for certain patients living with
MF.”
Additionally, data from a Phase 1/2 open-label, dose escalation
and expansion study (Abstract #1714; NCT04455841) assessing the
safety and tolerability of INCB00928 (zilurgisertib), a potent and
selective ALK2 inhibitor, as monotherapy or in combination with
ruxolitinib in patients with anemia due to MF were presented at
ASH. Anemia occurs in more than one-third of patients at MF
diagnosis and can be exacerbated during treatment3,4. Initial
results of the study observed reduction in post-dose hepcidin
levels at all dose levels and observed improvements in anemia among
patients treated in both the monotherapy and combination cohorts,
which suggest the potential for therapeutic activity. The data also
support once-daily dosing of INCB00928 and continued dose
escalation to achieve optimal exposure. Treatment with INCB00928
monotherapy and in combination with ruxolitinib resulted in
predominantly grade 1/2 TEAEs and no dose-limiting toxicities
(DLTs). Few grade ≥3 TEAEs were observed, including
thrombocytopenia in two patients with baseline grade 2
thrombocytopenia, and neutropenia in one patient with baseline
grade 2 neutropenia. No TEAEs led to study drug
discontinuation.
More information regarding the congress and the more than 50
abstracts from Incyte’s oncology portfolio being featured at the
meeting is available on the ASH website:
https://www.hematology.org/meetings/annual-meeting.
About Myeloproliferative Neoplasms
Myeloproliferative neoplasms (MPNs) are a closely related group
of blood cancers in which the bone marrow functions abnormally. The
bone marrow is where the body’s blood cells are made. MPNs are
progressive blood cancers that can strike anyone at any age, but
they are more common in older adults. Estimates of the prevalence
of MPNs vary, but analysis of claims data suggests there may be as
many as 200,000 people in the U.S. living with the most prevalent
MPNs: myelofibrosis, polycythemia vera or essential
thrombocythemia5.
About LIMBER
Incyte is a leader in the discovery and development of therapies
for patients with myeloproliferative neoplasms (MPNs) and
graft-versus-host disease (GVHD). The Leadership In MPNs and GVHD
BEyond Ruxolitinib (LIMBER) program is designed to evaluate
multiple monotherapy and combination strategies to improve and
expand treatments for patients with MPNs and GVHD. The program
currently has three key areas of focus: development of a new,
once-daily formulation of ruxolitinib; ruxolitinib-based
combinations with new targets such as PI3Kδ, BET and ALK2; and new
therapeutic options such as mutant CALR.
About Jakafi® (ruxolitinib)
Jakafi® (ruxolitinib) is a JAK1/JAK2 inhibitor approved by the
U.S. FDA for treatment of polycythemia vera (PV) in adults who have
had an inadequate response to or are intolerant of hydroxyurea;
intermediate or high-risk myelofibrosis (MF), including primary MF,
post-polycythemia vera MF and post-essential thrombocythemia MF in
adults; steroid-refractory acute GVHD in adult and pediatric
patients 12 years and older; and chronic GVHD after failure of one
or two lines of systemic therapy in adult and pediatric patients 12
years and older6.
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 low
platelet, red blood cell, and white blood cell counts. If you
develop bleeding, stop taking Jakafi and call your healthcare
provider. Your healthcare provider will do a blood test 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.
Cancer: Some people have had certain types of
non-melanoma skin cancers during treatment with Jakafi. Your
healthcare provider will regularly check your skin during your
treatment with Jakafi. Tell your healthcare provider if you develop
any new or changing skin lesions during treatment with Jakafi.
Increases in cholesterol: You may have changes in your
blood cholesterol levels during treatment with Jakafi. Your
healthcare provider will do blood tests to check your cholesterol
levels about every 8 to 12 weeks after you start taking Jakafi, and
as needed.
Increased risk of major cardiovascular events such as heart
attack, stroke or death in people who have cardiovascular risk
factors and who are current or past smokers while using another JAK
inhibitor to treat rheumatoid arthritis: Get emergency help
right away if you have any symptoms of a heart attack or stroke
while taking Jakafi, including: discomfort in the center of your
chest that lasts for more than a few minutes, or that goes away and
comes back, severe tightness, pain, pressure, or heaviness in your
chest, throat, neck, or jaw, pain or discomfort in your arms, back,
neck, jaw, or stomach, shortness of breath with or without chest
discomfort, breaking out in a cold sweat, nausea or vomiting,
feeling lightheaded, weakness in one part or on one side of your
body, slurred speech
Increased risk of blood clots: Blood clots in the veins
of your legs (deep vein thrombosis, DVT) or lungs (pulmonary
embolism, PE) have happened in people taking another JAK inhibitor
for rheumatoid arthritis and may be life-threatening. Tell your
healthcare provider right away if you have any signs and symptoms
of blood clots during treatment with Jakafi, including: swelling,
pain, or tenderness in one or both legs, sudden, unexplained chest
or upper back pain, shortness of breath or difficulty breathing
Possible increased risk of new (secondary) cancers:
People who take another JAK inhibitor for rheumatoid arthritis have
an increased risk of new (secondary) cancers, including lymphoma
and other cancers. People who smoke or who smoked in the past have
an added risk of new cancers.
The most common side effects of Jakafi include: for
certain types of myelofibrosis (MF) and polycythemia vera (PV) –
low platelet or red blood cell counts, bruising, dizziness,
headache, and diarrhea; for acute GVHD – low platelet counts, low
red or white blood cell counts, infections, and swelling; and for
chronic GVHD – low red blood cell or platelet counts and infections
including viral infections.
These are not all the possible side effects of Jakafi. Ask your
pharmacist or healthcare provider for more information. Call your
doctor for medical advice about side effects.
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 low white or red blood cell counts,
have or had tuberculosis (TB) or have been in close contact with
someone who has TB, had shingles (herpes zoster), have or had
hepatitis B, have or had liver or kidney problems, are on dialysis,
have high cholesterol or triglycerides, had cancer, are a current
or past smoker, had a blood clot, heart attack, other heart
problems or stroke, or have any other medical condition. Take
Jakafi exactly as your healthcare provider tells you. Do not change
your dose 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 breastfeed during treatment with Jakafi and
for 2 weeks after the final dose.
Please see the Full Prescribing Information,
which includes a more complete discussion of the risks associated
with Jakafi.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call
1-800-FDA-1088.
You may also report side effects to Incyte Medical Information
at 1-855-463-3463.
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
regarding the presentation of data from Incyte’s clinical
development pipeline, whether or when any development compounds or
combinations will be approved or commercially available for use in
humans anywhere in the world outside of the already approved
indications in specific regions and Incyte’s goal of improving the
lives of patients, contain predictions, estimates and other
forward-looking statements. These forward-looking statements are
based on Incyte’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; the effects of the COVID-19 pandemic
and measures to address the pandemic on Incyte and its partners’
clinical trials, supply chain, other third-party providers and
development and discovery operations; determinations made by the
U.S. FDA and other regulatory authorities outside of the United
States; the efficacy or safety of Incyte and its partners’
products; the acceptance of Incyte and its partners’ products in
the marketplace; market competition; sales, marketing,
manufacturing and distribution requirements; and other risks
detailed from time to time in Incyte’s reports filed with the
Securities and Exchange Commission, including its annual report and
its quarterly report on Form 10-Q for the quarter ended September
30, 2022. Incyte disclaims any intent or obligation to update these
forward-looking statements.
____________________________________________ 1 Yacoub A, et al.
Efficacy and Safety of Add-on Parsaclisib to Ruxolitinib Therapy in
Myelofibrosis Patients With Suboptimal Response to Ruxolitinib:
Final Results From a Phase 2 Study. Presented at the 64th ASH
Annual Meeting, December 10-13, 2022. 2 Mohan S, et al. A Phase ½
Study of INCB000928 As Monotherapy or Combined with Ruxolitinib
(RUX) in Patients (Pts) with Anemia Due to Myelofibrosis (MF).
Presented at the 64th ASH Annual Meeting, December 10-13, 2022. 3
Tefferi A, et al. Mayo Clin Proc. 2012;87(1):25-33. 4 Naymagon L,
Mascarenhas J. Hemasphere. 2017;1(1):doi:
10.1097/HS1099.0000000000000001. 5 MPN Research Foundation. “MPN
Landmark Survey.” Available at:
https://www.mpnlandmarksurvey.com/pdf/mpn-landmark-survey-summary.pdf.
Accessed February 2019. 6 Jakafi (ruxolitinib) tablets: Prescribing
Information. U.S. Food and Drug Administration.
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Media Catalina Loveman +1 302 498 6171
cloveman@incyte.com Investors Christine Chiou +1 302 274
4773 cchiou@incyte.com
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