— First regulatory approval for Incyte PD-1
inhibitor based on the results of the POD1UM-201 trial
— Zynyz is also being studied in additional
tumor types and in combination with other Incyte pipeline
compounds
Incyte (Nasdaq:INCY) today announced that the U.S. Food and Drug
Administration (FDA) has approved Zynyz™ (retifanlimab-dlwr), a
humanized monoclonal antibody targeting programmed death receptor-1
(PD-1), for the treatment of adults with metastatic or recurrent
locally advanced Merkel cell carcinoma (MCC). The Biologics License
Application (BLA) for Zynyz for this indication has been approved
under accelerated approval by the U.S. FDA based on tumor response
rate and duration of response (DOR). Continued approval of Zynyz
for this indication may be contingent on verification and
description of clinical benefit in confirmatory trials.
MCC is a rare and aggressive type of skin cancer that frequently
appears as a single, painless, reddish-purple skin nodule on the
head, neck and arms in skin exposed to sunlight1. MCC tends to grow
quickly and has a high rate of metastatic disease, leading to a
poor prognosis2,3. The estimated five-year overall survival (OS)
rate is 14% in patients with MCC who present with distant
metastatic disease3. MCC impacts less than 1 per 100,000 people in
the U.S., but incidence rates are rapidly rising, especially in
adults over the age of 654,5.
“More than a third of patients with MCC present with regional or
distant metastases, which are associated with high rates of
mortality,” said Dr. Shailender Bhatia, University of Washington
and Fred Hutchinson Cancer Center. “The approval of Zynyz offers
healthcare providers another first-line treatment option against
MCC that can result in durable responses in patients with
metastatic disease, and I look forward to having Zynyz in our
treatment portfolio for these difficult-to-treat patients.”
The FDA approval was based on data from the POD1UM-201 trial, an
open-label, multiregional, single-arm study that evaluated Zynyz in
adults with metastatic or recurrent locally advanced MCC who had
not received prior systemic therapy for their advanced disease.
Among chemotherapy-naïve patients (n=65), Zynyz monotherapy
resulted in an objective response rate (ORR) of 52% (95% confidence
interval [CI]: 40-65) as determined by independent central review
(ICR) using RECIST v1.1. Complete response was seen in 12 patients
(18%), and 22 patients (34%) showed partial response. Among the
responding patients, the duration of response (DOR) ranged from 1.1
to 24.9+ months, and 76% (26/34) experienced a DOR of six months or
longer, and 62% (21/34) experienced a DOR of 12 months or longer by
landmark analysis.
Serious adverse reactions occurred in 22% of patients receiving
Zynyz. The most frequent serious adverse reactions (≥ 2% of
patients) were fatigue, arrhythmia and pneumonitis. Permanent
discontinuation of Zynyz due to an adverse reaction occurred in 11%
of patients. The most common (≥10%) adverse reactions that occurred
in patients receiving Zynyz were fatigue, musculoskeletal pain,
pruritus, diarrhea, rash, pyrexia and nausea.
“Zynyz offers patients and healthcare professionals an
additional first-line anti-PD-1 option for patients with metastatic
or recurrent locally advanced MCC, which can be a challenging and
aggressive disease to treat,” said Hervé Hoppenot, Chief Executive
Officer, Incyte. “Incyte is grateful to the investigators and
patients around the world who participated in the POD1UM-201 trial.
We continue to study the potential of Zynyz in additional tumor
types and in combination with other Incyte pipeline compounds.”
Incyte is committed to supporting patients and removing barriers
to access medicines. Eligible patients in the U.S. who are
prescribed Zynyz have access to IncyteCARES (Connecting to Access,
Reimbursement, Education and Support), a comprehensive program
offering personalized patient support, including financial
assistance and ongoing education and additional resources. More
information about IncyteCARES is available by visiting
www.incytecares.com or calling 1-855-452-5234.
About POD1UM
The POD1UM (PD1 Clinical Program in Multiple Malignancies)
clinical trial program for retifanlimab includes POD1UM-201 and
several other Phase 1, 2 and 3 studies for patients with solid
tumors, including registration-directed POD1UM trials evaluating
retifanlimab as a monotherapy for patients with microsatellite
instability-high endometrial cancer and squamous cell carcinoma of
the anal canal (SCAC); and in combination with platinum-based
chemotherapy for patients with non-small cell lung cancer and
SCAC.
About POD1UM-201
POD1UM-201 (NCT03599713) is an open label, multiregional, single
arm study evaluating retifanlimab in patients with metastatic or
recurrent locally advanced Merkel cell carcinoma (MCC) who had not
received prior systemic therapy for their advanced disease.
Patients received Zynyz 500 mg intravenously every four weeks
until disease progression, unacceptable toxicity, for up to 24
months. Tumor response assessments were performed every eight weeks
for the first year of therapy and 12 weeks thereafter.
The primary endpoint was objective response rate (ORR) as
determined by independent central radiographic review using RECIST
v1.1. Secondary endpoints included duration of response (DOR),
disease control rate (DCR), progression-free survival (PFS) and
overall survival (OS); safety and pharmacokinetics.
For more information about the study, please visit:
https://clinicaltrials.gov/ct2/show/NCT03599713.
About Zynyz™ (retifanlimab-dlwr)
Zynyz (retifanlimab-dlwr), is an intravenous PD-1 inhibitor
indicated in the U.S. for the treatment of adult patients with
metastatic or recurrent locally advanced Merkel cell carcinoma
(MCC). This indication is approved under accelerated approval based
on tumor response rate and duration of response. Continued approval
for this indication may be contingent upon verification and
description of clinical benefit in confirmatory trials.
Zynyz is marketed by Incyte in the U.S. In 2017, Incyte entered
into an exclusive collaboration and license agreement with
MacroGenics, Inc. for global rights to retifanlimab.
Zynyz is a trademark of Incyte.
Important Safety Information
What is the most important information I should know about
ZYNYZ?
ZYNYZ is a medicine that may treat a certain type of skin cancer
by working with your immune system. ZYNYZ can cause your immune
system to attack normal organs and tissues in any area of your body
and can affect the way they work. These problems can sometimes
become severe or life-threatening and can lead to death. You can
have more than one of these problems at the same time. These
problems may happen anytime during treatment or even after your
treatment has ended.
Call or see your healthcare provider right away if you
develop any new or worsening signs or symptoms, including:
Lung problems: cough, shortness of breath, chest pain
Intestinal problems: diarrhea (loose stools) or more
frequent bowel movements than usual; stools that are black, tarry,
sticky, or have blood or mucus; severe stomach-area (abdomen) pain
or tenderness
Liver problems: yellowing of your skin or the whites of
your eyes; severe nausea or vomiting; pain on the right side of
your stomach area (abdomen); dark urine (tea colored); bleeding or
bruising more easily than normal
Hormone gland problems: headaches that will not go away
or unusual headaches; eye sensitivity to light; eye problems; rapid
heartbeat; increased sweating; extreme tiredness; weight gain or
weight loss; feeling more hungry or thirsty than usual; urinating
more often than usual; hair loss; feeling cold; constipation; your
voice gets deeper; dizziness or fainting; changes in mood or
behavior, such as decreased sex drive, irritability, or
forgetfulness
Kidney problems: decrease in your amount of urine, blood
in your urine, swelling of your ankles, loss of appetite
Skin problems: rash; itching; skin blistering or peeling;
painful sores or ulcers in your mouth or nose, throat, or genital
area; fever or flu-like symptoms; swollen lymph nodes
Problems can also happen in other organs and tissues. These
are not all of the signs and symptoms of immune system problems
that can happen with ZYNYZ. Call or see your healthcare provider
right away for any new or worsening signs or symptoms, which may
include:
- chest pain, irregular heartbeat, shortness of breath, or
swelling of ankles
- confusion, sleepiness, memory problems, changes in mood or
behavior, stiff neck, balance problems, tingling or numbness of the
arms or legs
- double vision, blurry vision, sensitivity to light, eye pain,
changes in eyesight
- persistent or severe muscle pain or weakness, muscle
cramps
- low red blood cells, bruising
Infusion reactions that can sometimes be severe. Signs and
symptoms of infusion reactions may include: chills or shaking,
itching or rash, flushing, shortness of breath or wheezing,
dizziness, feel like passing out, fever, back or neck pain
Rejection of a transplanted organ. Your healthcare
provider should tell you what signs and symptoms you should report
and monitor you, depending on the type of organ transplant that you
have had.
Complications, including graft-versus-host disease, in people
who have received a bone marrow (stem cell) transplant that uses
donor stem cells (allogeneic). These complications can be
serious and can lead to death. These complications may happen if
you underwent transplantation either before or after being treated
with ZYNYZ. Your healthcare provider will monitor you for these
complications.
Getting medical treatment right away may help keep these
problems from becoming more serious. Your healthcare provider
will check you for these problems during your treatment with ZYNYZ.
Your healthcare provider may treat you with corticosteroid or
hormone replacement medicines. Your healthcare provider may also
need to delay or completely stop treatment with ZYNYZ if you have
severe side effects.
Before you receive ZYNYZ, tell your healthcare provider about
all of your medical conditions, including if you:
Tell your healthcare provider about all the medicines you
take, including prescription and over-the-counter medicines,
vitamins, and herbal supplements.
The most common side effects of ZYNYZ include tiredness,
muscle and bone pain, itching, diarrhea, rash, fever, nausea
These are not all the possible side effects of ZYNYZ. Call your
doctor for medical advice about side effects.
General information about the safe and effective use of
ZYNYZ.
Medicines are sometimes prescribed for purposes other than those
listed in a Medication Guide. If you would like more information
about ZYNYZ, talk with your healthcare provider. You can ask your
healthcare provider for information about ZYNYZ that is written for
health professionals.
You may report side effects to the FDA at (800) FDA-1088 or
http://www.fda.gov/medwatch. You may also report side effects to
Incyte Corporation at 1-855-463-3463.
Please see the full Prescribing Information for
ZYNYZ for additional Important Safety Information.
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 whether and when Zynyz might provide a successful
treatment option for patients with MCC and Incyte’s POD1UM clinical
program generally, 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 for the year ended December 31, 2022.
Incyte disclaims any intent or obligation to update these
forward-looking statements.
1 Müller-Richter UDA, et al. Merkel Cell Carcinoma of the Head
and Neck: Recommendations for Diagnostics and Treatment. Ann Surg
Oncol. 2017;24:3430–3437. 2 Paulson KG, Bhatia S., et al. Advances
in Immunotherapy for Metastatic Merkel Cell Carcinoma: A
Clinician's Guide. JNCCN. 2018;16(6):782-790. 3 Harms KL, et al.
Analysis of Prognostic Factors from 9387 Merkel Cell Carcinoma
Cases Forms the Basis for the New 8th Edition AJCC Staging System.
Ann Surg Oncol. 2016;23:3564-3571. 4 Jacobs D, et al. Assessment of
Age, Period, and Birth Cohort Effects and Trends in Merkel Cell
Carcinoma Incidence in the United States. JAMA Dermatol.
2021;157:59–65. 5 Paulson KG, et al. Merkel cell carcinoma: Current
US incidence and projected increases based on changing
demographics. J Am Acad Dermatol. 2018;78:457–463.e2
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version on businesswire.com: https://www.businesswire.com/news/home/20230322005618/en/
Media Jenifer Antonacci +1 302 498 7036
jantonacci@incyte.com
Investors Christine Chiou +1 302 274 4773
cchiou@incyte.com
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