- Phase 3 POD1UM-303/InterAACT2 trial met primary endpoint of
progression-free survival and demonstrated improvement across
secondary endpoints in patients with squamous cell anal carcinoma
(SCAC) taking retifanlimab in combination with platinum-based
chemotherapy (carboplatin-paclitaxel)
- Late-breaking data presented at the European Society for
Medical Oncology (ESMO) Congress 2024 support the planned U.S.
filing of a supplemental Biologics License Application (sBLA) for
retifanlimab in SCAC by year-end 2024
- Incyte to host an in-person analyst and investor event to
review key data at ESMO on Saturday, September 14, 2024 from
1:00-2:30 p.m. ET (7:00-8:30 p.m. CEST)
Incyte (Nasdaq:INCY) today announced results from the Phase 3
POD1UM-303/InterAACT2 trial of retifanlimab (Zynyz®), a humanized
monoclonal antibody targeting programmed death receptor-1 (PD-1),
in combination with platinum-based chemotherapy
(carboplatin–paclitaxel) for the treatment of adults with
inoperable locally recurrent or metastatic squamous cell anal
carcinoma (SCAC). These data were featured today in a Presidential
Symposium (LBA 2) at the European Society for Medical Oncology
(ESMO) Congress 2024, held in Barcelona and virtually.
The POD1UM-303/InterAACT2 trial results build on previously
announced topline results, showing that the study met its primary
endpoint by demonstrating a statistically significant and
clinically meaningful improvement in progression-free survival
(PFS) in patients with SCAC not previously treated with systemic
therapy, as assessed by blinded independent central review (BICR)
using RECIST v1.1. Adding retifanlimab to standard of care
chemotherapy resulted in a clinically meaningful 37% reduction in
the risk of progression or death (Hazard Ratio [HR]: 0.63; 95%
Confidence Interval [CI] (0.47, 0.84); P=0.0006). Patients in the
retifanlimab and chemotherapy combination group achieved a median
PFS of 9.3 months compared to 7.4 months for patients in the
placebo combination group.
“The POD1UM-303/InterAACT2 trial is the first and largest Phase
3 trial evaluating a checkpoint inhibitor for the treatment of
patients with squamous cell anal carcinoma, a disease with
significant medical need. The positive efficacy and safety data
presented today at ESMO illustrate the potential of retifanlimab in
combination with carboplatin and paclitaxel to become a new
standard-of-care treatment for patients with advanced SCAC,” said
Pablo J. Cagnoni, M.D., President and Head of Research and
Development, Incyte. “We look forward to working with regulatory
authorities to progress the supplemental Biologics License
Application (sBLA) for retifanlimab and potentially bring the
first-ever PD-1 or PD-L1 antibody to patients with SCAC.”
The trial also showed improvement in key secondary endpoints,
including:
- In an interim analysis for overall survival (OS), patients that
received retifanlimab in combination with chemotherapy achieved an
approximately 6-month improvement in median OS versus the placebo
combination group, with a strong trend toward statistical
significance (median OS 29.2 months vs. 23 months [HR: 0.70; 95% CI
(0.49, 1.01); P=0.0273]; OS follow-up is ongoing).
- Overall response rate (ORR) and duration of response (DOR) by
BICR each showed improvement in the retifanlimab and chemotherapy
combination group versus the placebo combination group (ORR of 56%
vs. 44% [95% CI (48, 64) and (36, 52), respectively; nominal
P=0.0129]; DOR of 14 months vs. 7 months [95% CI (8.6, 22.2) and
(5.6, 9.3), respectively]).
Retifanlimab was generally well-tolerated, and safety was
consistent with other chemotherapy plus checkpoint inhibitor
regimens. The most common treatment-emergent adverse events (TEAEs)
in the retifanlimab and chemotherapy combination group were anemia
(66.2%), nausea (56.5%) and alopecia (51.3%).
“Advanced SCAC is an often-neglected rare condition that,
despite its increasing incidence and the often poor prognosis, has
had the same standard-of-care treatment for decades with very few
trials,” said Sheela Rao, M.D., Consultant Medical Oncologist, The
Royal Marsden National Health Service Foundation Trust. “I believe
the positive results from the POD1UM-303/InterAACT2 trial may
provide a long-awaited, new treatment option with retifanlimab in
addition to platinum-based chemotherapy for adults with inoperable
locally recurrent or metastatic SCAC.”
About Squamous Cell Anal Carcinoma (SCAC)
Squamous cell anal carcinoma (SCAC) is an orphan disease for
which the incidence is increasing approximately 3% per year,
largely due to endemic human papillomavirus (HPV).1,2,3,4 Human
immunodeficiency virus (HIV) is an important amplifier of SCAC, as
people with HIV are 25 to 35 times more likely to develop SCAC.5,6
Patients with unresectable metastatic SCAC have poor 5-year
survival, and there are currently no FDA-approved treatments for
patients with advanced disease.7
About POD1UM
The POD1UM (PD1 Clinical Program in Multiple Malignancies)
clinical trial program for retifanlimab includes POD1UM-303 and
several other Phase 1, 2 and 3 studies for patients with solid
tumors, including registration-directed trials evaluating
retifanlimab as a monotherapy for patients with microsatellite
instability-high endometrial cancer; and in combination with
platinum-based chemotherapy for patients with non-small cell lung
cancer.
About POD1UM-303/InterAACT 2
POD1UM-303/InterAACT2 (NCT04472429) is a Phase 3, randomized,
multicenter, double-blind, placebo-controlled study evaluating
retifanlimab or placebo in combination with platinum-based
chemotherapy (carboplatin and paclitaxel) in adult patients with
inoperable locally recurrent or metastatic SCAC who have not been
previously treated with systemic chemotherapy.
During the blinded portion of the study, patients, including
those with well-controlled HIV infection, were randomized 1:1 to
receive retifanlimab 500 mg intravenously or placebo during each
28-day cycle for up to 6 months in combination with standard
therapy of carboplatin and paclitaxel followed by monotherapy for
up to 1-year total treatment. Crossover to active therapy
retifanlimab was allowed for patients assigned to placebo upon
verification of progression by blinded independent central review
(BICR).
The primary endpoint is progression-free survival (PFS) as
determined by BICR using RECIST v1.1. The key secondary endpoint
includes overall survival (OS). Secondary objectives include
objective response rate (ORR), duration of response (DOR), disease
control rate (DCR) by BICR, safety and pharmacokinetics.
For more information about the study, please visit
https://clinicaltrials.gov/study/NCT04472429.
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 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 retifanlimab, the POD1UM-303 clinical trial, the
potential for retifanlimab to become an approved treatment option
for SCAC, Incyte’s plans to share data with the scientific
community and Incyte’s expectations with respect to filing an sBLA
or otherwise engaging with regulators, 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;
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 on
Form-10K and its report on Form 10-Q for the quarter ended June 30,
2024. Incyte disclaims any intent or obligation to update these
forward-looking statements.
1 Gondal TA, et al. Curr Oncol. 2023;30:3232-3250. 2 Islami F,
et al. Int J Epidemiol. 2017;46:924-938. 3 Giuliano AR, et al. Int
J Cancer. 2015;136:2752-2760. 4 Morris V, Eng C. J Gastrointest
Oncol. 2016;7:721-726. 5 Wang C-CJ, et al. Surg Oncol Clin N Am.
2017;26:17-31. 6 NCCN Clinical Practice Guidelines in Oncology:
Cancer in People with HIV. Version 1.2021. 2021. 7 Eng C, et al.
Oncotarget 2014;5:11133-11142.
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