— Phase 3 POD1UM-304 trial met primary
endpoint of overall survival (OS) and all secondary endpoints in
patients with previously untreated metastatic non-small cell lung
cancer (NSCLC)
— Data presented at the European Society for
Medical Oncology (ESMO) Asia Congress 2024 support the planned 2025
filing of a supplemental Biologics License Application (sBLA) in
the U.S. for retifanlimab in NSCLC
Incyte (Nasdaq:INCY) today announced results from the Phase 3
POD1UM-304 trial of retifanlimab (Zynyz®), a humanized monoclonal
antibody targeting programmed death receptor-1 (PD-1), in
combination with platinum-based chemotherapy for the treatment of
adults with previously untreated non-squamous and squamous
metastatic non-small cell lung cancer (NSCLC) not harboring a
driver mutation. These data were featured today in a mini oral
presentation at the European Society for Medical Oncology (ESMO)
Asia Congress 2024, held in Singapore and virtually.
The POD1UM-304 trial results show a clinically meaningful and
statistically significant improvement over chemotherapy alone.
Patients in the retifanlimab and chemotherapy combination treatment
group achieved a median overall survival (OS) of 18.1 months
compared to 13.4 months in the placebo and chemotherapy combination
group (Hazard Ratio [HR]: 0.75; 95% Confidence Interval [CI] (0.60,
0.93); P=0.0042).
“The positive POD1UM-304 trial results provide additional proof
of retifanlimab’s safety and efficacy profile in solid tumors,”
said Pablo J. Cagnoni, M.D., President and Head of Research and
Development, Incyte. “We look forward to leveraging these results
to advance our pipeline, particularly in hard-to-treat cancers like
NSCLC, and to submitting a supplemental Biologic License
Application for this indication to the U.S. Food and Drug
Administration next year.”
The trial also met secondary endpoints, including:
- Patients who received retifanlimab in combination with
chemotherapy had a 2-month improvement in median progression-free
survival (PFS) compared to the placebo and chemotherapy combination
group (7.7 vs 5.5 months; [HR: 0.64; 95% CI (0.52, 0.79);
P<0.0001]).
- Overall response rate (ORR) and duration of response (DOR) by
Blinded Independent Central Review (BICR) each showed improvement
in the retifanlimab and chemotherapy combination treatment group
versus the placebo and chemotherapy combination group (ORR of 52%
[95% CI (47, 57) vs. 39% (95% CI 32, 46), respectively; P=0.0012];
DOR of 12.7 months [95% CI (9.4, 15.2) vs. 6.1 months and [95% CI
(4.2, 8.3), respectively]).
Retifanlimab was generally well-tolerated and no new safety
issues were identified. The most common treatment-emergent adverse
events (TEAEs), in >10% of patients in the retifanlimab and
chemotherapy combination treatment group, were anemia (62.7%),
decreased appetite (22.6%) and decreased neutrophil count (22.1%).
Chemotherapy administration was not compromised by the addition of
retifanlimab.
“Lung cancer is the leading cause of cancer deaths globally,
with the high majority of cases being NSCLC,” said Shun Lu, M.D.,
Ph.D., Shanghai Chest Hospital. “I am encouraged by the observed
safety and efficacy profile of retifanlimab when added to
platinum-based chemotherapy in this patient population and believe
the positive results from the POD1UM-304 trial support retifanlimab
in combination with chemotherapy as an additional treatment option
for previously untreated metastatic NSCLC.”
About Non-Small Cell Lung Cancer
Non-small cell lung cancer (NSCLC) is the most common type of
lung cancer, accounting for approximately 85% of all lung cancer
cases worldwide.1 It is characterized by the uncontrolled growth of
malignant cells in the lungs and is often diagnosed at an advanced
stage, making it a leading cause of cancer-related mortality
globally.1, 2, 3
About POD1UM
The POD1UM (PD1 Clinical Program in Multiple Malignancies)
clinical trial program for retifanlimab includes POD1UM-304 in
non-small cell lung cancer (NSCLC) and POD1UM-303 in squamous cell
anal carcinoma (SCAC), as well as other Phase 1 and 2 studies for
patients with solid tumors, including registration-directed trials
evaluating retifanlimab as a monotherapy for patients with Merkel
cell carcinoma and microsatellite instability-high endometrial
cancer.
About POD1UM-304
POD1UM-304 is a Phase 3, global, multicenter, randomized,
double-blind study evaluating platinum-based chemotherapy with
retifanlimab or placebo in patients with first-line, metastatic
squamous or non-squamous NSCLC.
During the study, patients were randomized to receive
retifanlimab or placebo intravenously in combination with
pemetrexed and carboplatin/cisplatin for non-squamous NSCLC, and
with paclitaxel and carboplatin for squamous NSCLC. The primary
endpoint is overall survival (OS), and secondary endpoints include
progression-free survival (PFS), overall response rate (ORR) and
duration of response (DOR) as assessed by blinded independent
central review (BICR). After verified progressive disease by BICR,
patients assigned to the placebo and chemotherapy combination group
had the option to cross over to open-label retifanlimab
monotherapy.
For more information about the study, please visit
https://clinicaltrials.gov/study/NCT04205812.
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.
In Europe, Zynyz is approved as a monotherapy for the first-line
treatment of adult patients with metastatic or recurrent locally
advanced MCC not amenable to curative surgery or radiation
therapy.
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 registered 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:
- have immune system problems such as Crohn’s disease, ulcerative
colitis, or lupus
- have received an organ transplant
- have received or plan to receive a stem cell transplant that
uses donor stem cells (allogeneic)
- have received radiation treatment to your chest area
- have a condition that affects your nervous system, such as
myasthenia gravis or Guillain-Barré syndrome
- are pregnant or plan to become pregnant. ZYNYZ can harm your
unborn baby. Females who are able to become pregnant: — Your
healthcare provider should do a pregnancy test before you start
treatment with ZYNYZ. — You should use an effective method of birth
control during your treatment and for 4 months after your last dose
of ZYNYZ. Talk to your healthcare provider about birth control
methods that you can use during this time. — Tell your healthcare
provider right away if you become pregnant or think you may be
pregnant during treatment with ZYNYZ.
- are breastfeeding or plan to breastfeed. It is not known if
ZYNYZ passes into your breast milk. Do not breastfeed during
treatment and for 4 months after your last dose of ZYNYZ.
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
A global biopharmaceutical company on a mission to Solve On.,
Incyte follows the science to find solutions for patients with
unmet medical needs. Through the discovery, development and
commercialization of proprietary therapeutics, Incyte has
established a portfolio of first-in-class medicines for patients
and a strong pipeline of products in Oncology and Inflammation
& Autoimmunity. Headquartered in Wilmington, Delaware, Incyte
has operations in North America, Europe and Asia.
For additional information on Incyte, please visit Incyte.com or
follow us on social media: LinkedIn, X, Instagram, Facebook,
YouTube.
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 Phase 3 POD1UM-304
trial of retifanlimab (Zynyz), the potential presented by
retifanlimab, whether or when retifanlimab, alone or in
combination, 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 our current
expectations and are 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 and the
ability to enroll subjects in accordance with planned schedules;
determinations made by the FDA and regulatory agencies outside of
the United States; the efficacy or safety of our products; the
acceptance of our products in the marketplace; market competition;
unexpected variations in the demand for our products and the
products of our collaboration partners; the effects of announced or
unexpected price regulation or limitations on reimbursement or
coverage for our products; sales, marketing, manufacturing, and
distribution requirements, including our ability to successfully
commercialize and build commercial infrastructure for newly
approved products and any additional new products that become
approved; and other risks detailed from time to time in our reports
filed with the U.S. Securities and Exchange Commission, including
our annual report on Form 10-K and our quarterly report on Form
10-Q for the quarter ended September 30, 2024. We disclaim any
intent or obligation to update these forward-looking
statements.
1 Duma N, et al. Mayo Clin Proc. 2019;94:1623-1640.
2 Yang SR, et al. Front Oncol. 2022;12.
3 Alexander M, et al. Lung. 2020;198:897-907.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20241207511994/en/
Incyte Contacts:
Media media@incyte.com Investors ir@incyte.com
Incyte (NASDAQ:INCY)
過去 株価チャート
から 12 2024 まで 1 2025
Incyte (NASDAQ:INCY)
過去 株価チャート
から 1 2024 まで 1 2025
