Ipsen’s Onivyde® regimen, a potential new standard-of-care
first-line therapy in metastatic pancreatic adenocarcinoma,
approved by FDA
- Approval based
on Phase III NAPOLI 3 clinical trial in which Onivyde® regimen
(NALIRIFOX) demonstrated statistically significant superiority and
clinically meaningful improvements in overall survival and
progression-free survival versus nab-paclitaxel and gemcitabine
1
- NAPOLI 3
represents the first positive Phase III trial in first-line
metastatic pancreatic adenocarcinoma (mPDAC) to demonstrate
superior overall survival versus the currently approved regimen of
nab-paclitaxel and gemcitabine1
- Onivyde is the
only FDA-approved treatment regimen to demonstrate efficacy in two
Phase III trials across lines of therapy in mPDAC1,2
PARIS, FRANCE, 13 February 2024
- Ipsen (Euronext: IPN; ADR: IPSEY) announced today that the U.S.
Food and Drug Administration (FDA) has approved the supplemental
new drug application for Onivyde® (irinotecan liposome injection)
plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX) as a
first-line treatment in adults living with metastatic pancreatic
adenocarcinoma (mPDAC). This is the second approval for an Onivyde
regimen in mPDAC, following the FDA’s approval in 2015 of Onivyde
plus fluorouracil and leucovorin following disease progression with
gemcitabine-based therapy.
“The results from the Phase III NAPOLI 3 trial
represent the first positive data for an investigational regimen in
first-line metastatic pancreatic adenocarcinoma versus the
currently approved nab-paclitaxel and gemcitabine regimen," said
Christelle Huguet, EVP and Head of Research and Development, Ipsen.
"With today’s approval, this Onivyde (NALIRIFOX) regimen can now
offer a potential new standard-of-care treatment option with proven
survival benefits for people living with metastatic pancreatic
adenocarcinoma in the U.S.”
Pancreatic adenocarcinoma (PDAC) is the most
common type of cancer that forms in the pancreas, with more than
60,000 people diagnosed in the U.S. each year and nearly 500,000
people globally.3,4 Since there are no specific symptoms in the
early stages, PDAC is often detected late and after the disease has
spread to other parts of the body (metastatic or stage IV).5
Characterized as a complex cancer due to rapid tumor progression,
limited genetic targets and multiple resistance mechanisms,6 mPDAC
has a poor prognosis with fewer than 20% of people surviving longer
than one year.4,5 Overall, pancreatic cancer has the lowest
five-year survival rate of all cancer types globally and in the
U.S.4,5
“Metastatic pancreatic adenocarcinoma is a
difficult disease to manage with very few available treatment
options. Given the reality of this aggressive form of cancer and
the complexity of the disease, every advance in the treatment
landscape represents a meaningful improvement in patient outcomes.”
said Dr. Zev Wainberg, Professor of Medicine and Co-Director of the
UCLA GI Oncology Program. “The approval of this Onivyde regimen is
an important milestone for people living with mPDAC, their families
and healthcare providers, with the NAPOLI 3 trial having
demonstrated survival benefits versus a current standard of care
treatment option.”
“We are pleased that the U.S. Food and Drug
Administration has issued this new approval of the NALIRIFOX
regimen. With each new approved treatment, there is more hope for
those who will be diagnosed in the future and people currently
living with pancreatic cancer may have more time with their loved
ones,” said Julie Fleshman, JD, MBA, President and CEO of
Pancreatic Cancer Action Network (PanCAN), a patient advocacy
organization committed to providing evidence-based information and
resources to patients and caregivers, along with advancing research
to improve patient outcomes. “We are thankful to the patients who
participated in this clinical trial as they play a crucial role in
advancing treatments for pancreatic cancer.”
NAPOLI 3 data
The FDA approval was based on efficacy and
safety data from NAPOLI 3, a randomized, open-label, Phase III
pivotal trial that enrolled 770 people living with mPDAC between
the ages of 20 and 85 without prior treatment across 187 trial site
locations in 18 countries. The study, which met the primary and
secondary endpoints, was presented as a late-breaking presentation
at the ASCO Gastrointestinal conference 2023 and subsequently
published in The Lancet.1,7Additionally, NALIRIFOX was recognized
by the National Comprehensive Cancer Network® (NCCN) guidelines*
and recommended as a preferred, Category 1 treatment option in
first-line metastatic disease and as a preferred option in
first-line locally advanced disease.8
- The study demonstrated NALIRIFOX
(n=383) provided a statistically significant improvement in median
overall survival (mOS) of 11.1 months (95% confidence interval (CI)
(10.0, 12.1)) compared to 9.2 months (95% CI (8.3, 10.6)) in
nab-paclitaxel and gemcitabine treated patients (n=387); (hazard
ratio (HR) 0.84 [95% CI 0.71–0.99]; p=0.0403).9
- NALIRIFOX regimen also demonstrated
a statistically significant improvement in median progression-free
survival (mPFS) of 7.4 months (95% CI (6.0, 7.7)) versus 5.6 months
(95% CI (5.3, 5.8)) for nab-paclitaxel and gemcitabine treated
patients (HR 0.70 [95% CI 0.59–0.85]; p=0.0001).9
- The objective response rate was
41.8% (36.8%-46.9%; 95% CI) for patients treated with the NALIRIFOX
regimen versus 36.2% (31.4%-41.2%; 95% CI) for patients treated
with nab-paclitaxel and gemcitabine.9
- The safety profile of the Onivyde
regimen was manageable and consistent with the profiles of the
treatment components, with the potential of serious adverse events
of fatal neutropenic fever and severe diarrhea. The most common
Grade 3/4 treatment-emergent adverse events were diarrhea, fatigue,
nausea, vomiting, decreased appetite, abdominal pain, mucosal
inflammation, constipation and decreased weight.9 In NAPOLI 3,
Grade 3 and 4 diarrhea (early and late-onset) occurred in 20%
receiving NALIRIFOX. In the clinical trial, diarrhea was managed
following institutional guidelines and appropriate antidiarrheal
medications.9
*NCCN makes no warranties of any kind whatsoever
regarding their content, use or application and disclaims any
responsibility for their application or use in any way.
ENDS
About Onivyde (irinotecan liposome
injection)
Onivyde is a cancer medicine that blocks an
enzyme called topoisomerase I, which is involved in copying cell
DNA needed to make new cells. By blocking the enzyme, cancer cells
are prevented from multiplying and eventually die. In Onivyde,
irinotecan is enclosed in tiny fat particles called ‘liposomes’,
which accumulate in the tumor and release slowly over time. Onivyde
is administered via intravenous infusion over 90 minutes every two
weeks, with recommendations on dosing modifications. Onivyde may be
prescribed immediately in the U.S. for eligible people living with
mPDAC who are treatment naïve or following gemcitabine-based
therapy.
To support access to Onivyde for eligible
individuals in the U.S., Ipsen Cares patient support program is
available as a resource to people living with mPDAC and their
caregivers to provide educational support and address coverage,
access and reimbursement questions (1-866-435-5677).
Onivyde is currently approved in most major
markets including the U.S., Europe and Asia in combination with
fluorouracil (FU) and leucovorin (LV) for the treatment of adult
patients with metastatic pancreatic adenocarcinoma after disease
progression following gemcitabine-based therapy. Onivyde is not
indicated as a single agent for the treatment of adult patients
with metastatic pancreatic adenocarcinoma.
In 2020, the FDA granted Ipsen Fast Track
designation for Onivyde as a first-line combination treatment for
mPDAC. The FDA’s Fast Track program facilitates the development and
expedites the review of medicines that treat serious conditions and
have the potential to address an unmet medical need.
Ipsen has exclusive commercialization rights for
the current and potential future indications for Onivyde in the
U.S. Servier, an independent international pharmaceutical company
with an international presence in 150 countries, is responsible for
the commercialization of Onivyde outside of the U.S. and Taiwan.
PharmaEngine is a commercial stage oncology company headquartered
in Taipei and is responsible for the commercialization of Onivyde
in Taiwan.
About PDAC
PDAC is the most common type of cancer that
forms in the pancreas, with more than 60,000 people diagnosed in
the U.S. each year and nearly 500,000 people globally.3,4 Since
there are no specific symptoms in the early stages, PDAC is often
detected late and after the disease has spread to other parts of
the body (metastatic or stage IV).5 Weight loss, abdominal pain and
jaundice are the most common symptoms, making PDAC difficult to
detect.10 Despite significant advances in cancer treatments since
the 1970s, no treatment options for PDAC significantly extend
life.5 Currently, fewer than 20% of people diagnosed with PDAC
survive longer than one year and, overall, pancreatic cancer has
the lowest five-year survival rate of all cancer types globally and
in the U.S.3,4
About the NAPOLI 3
trial1
NAPOLI 3 is a randomized, open-label Phase III
trial of an investigational Onivyde treatment regimen (NALIRIFOX)
in patients who have not previously received chemotherapy for
mPDAC. NAPOLI 3 enrolled 770 patients across 187 trial site
locations in 18 countries across Europe, North America, South
America, Asia, and Australia. Patients were randomized to receive
Onivyde plus oxaliplatin, fluorouracil and leucovorin (NALIRIFOX
regimen; n=383) twice in a month (days 1 and 15 of 28-day cycle)
compared to an injection of nab-paclitaxel and gemcitabine (n=387)
administered three times a month (days 1, 8, 15 of a 28-day
cycle).
About Ipsen
We are a global biopharmaceutical company with a
focus on bringing transformative medicines to patients in three
therapeutic areas: Oncology, Rare Disease and Neuroscience.
Our pipeline is fueled by external innovation
and supported by nearly 100 years of development experience and
global hubs in the U.S., France and the U.K. Our teams in more than
40 countries and our partnerships around the world enable us to
bring medicines to patients in more than 100 countries.
Ipsen is listed in Paris (Euronext: IPN) and in
the U.S. through a Sponsored Level I American Depositary Receipt
program (ADR: IPSEY). For more information, visit ipsen.com.
U.S. IMPORTANT SAFETY
INFORMATION
Indications
- ONIVYDE® (irinotecan liposome
injection) is indicated, in combination with oxaliplatin,
fluorouracil, and leucovorin for the first-line treatment of adult
patients with metastatic pancreatic adenocarcinoma.
- ONIVYDE is indicated, in
combination with fluorouracil, and leucovorin, for the treatment of
adult patients with metastatic pancreatic adenocarcinoma after
disease progression following gemcitabine-based therapy.
Limitations of Use: ONIVYDE is not indicated as
a single agent for the treatment of patients with metastatic
pancreatic adenocarcinoma.
WARNING: SEVERE Neutropenia and SEVERE
DIARRHEA Neutropenia
- Severe and life-threatening
neutropenia, including fatal neutropenic sepsis and fatal
neutropenic fever, has occurred in patients receiving ONIVYDE in
combination with oxaliplatin, fluorouracil and leucovorin and in
combination with fluorouracil and leucovorin. Withhold ONIVYDE for
absolute neutrophil count below 1500/mm3
or neutropenic fever. Monitor blood cell counts
periodically during treatment.
Diarrhea
- Severe and life-threatening
diarrhea has occurred in patients receiving ONIVYDE in combination
with oxaliplatin, fluorouracil and leucovorin and in combination
with fluorouracil and leucovorin. Do not administer ONIVYDE to
patients with bowel obstruction. Withhold ONIVYDE for diarrhea of
Grade 2-4 severity. Administer loperamide for late diarrhea of any
severity. Administer atropine, if not contraindicated, for early
diarrhea of any severity.
|
CONTRAINDICATIONS
ONIVYDE is contraindicated in patients who have
experienced a severe hypersensitivity reaction or anaphylaxis to
ONIVYDE or irinotecan HCl.
WARNINGS AND PRECAUTIONS
Severe Neutropenia: See Boxed
WARNING. In NAPOLI 3, Grade 3 and 4 neutropenia occurred in 26% of
patients receiving ONIVYDE in combination with oxaliplatin,
fluorouracil, and leucovorin (NALIRIFOX) and fatal neutropenic
fever in 0.3% of patients. In NAPOLI 3, the incidence of Grade 3 or
4 neutropenia was similar among Asian patients [6 of 20 (30%)]
compared to White patients [76 of 289 (26%)]. Neutropenic
fever/neutropenic sepsis was reported in 5% of Asian patients (1 of
20) compared to 2.3% of White patients (7 of 306). In NAPOLI-1,
Grade 3 and 4 neutropenia occurred in 20% of patients receiving
ONIVYDE in combination with fluorouracil and leucovorin
(ONIVYDE/FU/LV). Neutropenic sepsis occurred in 3% and fatal
neutropenic sepsis in 0.8%. In NAPOLI-1, the incidence of Grade 3
or 4 neutropenia was higher among Asian patients [18 of 33 (55%)]
compared to White patients [13 of 73 (18%)]. Neutropenic
fever/neutropenic sepsis was reported in 6% of Asian patients
compared to 1% of White patients.
Severe Diarrhea: See Boxed
WARNING. In NAPOLI 3, Grade 3 and 4 diarrhea (early-onset [within
24 hours of chemotherapy] and late-onset [more than 24 hours
following chemotherapy]) occurred in 20% receiving NALIRIFOX. In
NAPOLI-1, Grade 3 or 4 diarrhea occurred in 13% receiving
ONIVYDE/FU/LV. The incidence of Grade 3 or 4 late-onset diarrhea
was 9% in patients receiving ONIVYDE/FU/LV. The incidence of Grade
3 or 4 early-onset diarrhea was 3% in patients receiving
ONIVYDE/FU/LV. To reduce the risk of severe diarrhea, patients
should stop lactose-containing products, eat a low-fat diet, and
maintain hydration during treatment with ONIVYDE. Withhold ONIVYDE
for Grade 2-4 diarrhea. Local institutional guidelines should be
followed for the treatment of diarrhea that does not improve within
48 hours and may include the addition of diphenoxylate
hydrochloride plus atropine sulfate or octreotide. Following
recovery to Grade 1 diarrhea, resume ONIVYDE at a reduced dose.
Interstitial Lung Disease
(ILD): Irinotecan HCl can cause severe and fatal ILD.
Withhold ONIVYDE in patients with new or progressive dyspnea,
cough, and fever, pending diagnostic evaluation. Discontinue
ONIVYDE in patients with a confirmed diagnosis of ILD.
Severe Hypersensitivity
Reaction: Irinotecan, including ONIVYDE, can cause severe
hypersensitivity reactions, including anaphylactic reactions.
Permanently discontinue ONIVYDE in patients who experience a severe
hypersensitivity reaction.
Embryo-Fetal Toxicity: ONIVYDE
can cause fetal harm when administered to a pregnant woman. Advise
pregnant women of the potential risk to a fetus. Advise females of
reproductive potential to use effective contraception during and
for 7 months after the last dose of ONIVYDE treatment.
ADVERSE REACTIONS FOR
NALIRIFOX
- The most common
adverse reactions (≥20% with a difference between arms of ≥5% for
all grades or ≥2% for Grades 3 or 4 compared to nab-paclitaxel and
gemcitabine) of NALIRIFOX were diarrhea (72%), fatigue (62%),
nausea (59%), neutropenia (48%), vomiting (40%), decreased appetite
(37%), abdominal pain (35%), hypokalemia (32%), mucosal
inflammation (28%), constipation (25%) and weight decreased
(22%).
- Permanent
discontinuation of ONIVYDE due to an adverse reaction occurred in
17% of patients. Adverse reactions that resulted in permanent
discontinuation of ONIVYDE in ≥1% of patients included neutropenia,
thrombocytopenia, diarrhea, fatigue, infections and cerebrovascular
accident.
- Dosage reduction of
ONIVYDE due to an adverse reaction occurred in 52% of patients.
Adverse reactions that required dosage reduction in ≥1% of patients
included anemia, decreased appetite, diarrhea, fatigue, febrile
neutropenia, hypokalemia, liver function test abnormalities,
nausea, mucosal inflammation, neutropenia, peripheral neuropathy,
vomiting, thrombocytopenia and weight decreased.
- Dosage
interruptions of ONIVYDE due to an adverse reaction occurred in
1.9% of patients. Adverse reactions that required dosage
interruption in ≥0.5% of patients included hypersensitivity and
infusion related reaction.
- The most common
laboratory abnormalities (≥10% Grade 3 or 4) were decreased
neutrophils (26%), decreased potassium (22%), decreased lymphocytes
(11%) and decreased hemoglobin (10%).
ADVERSE REACTIONS FOR
ONIVYDE/5-FU/LV
- The most common
adverse reactions (≥20%) were diarrhea (59%), fatigue/asthenia
(56%), vomiting (52%), nausea (51%), decreased appetite (44%),
stomatitis (32%), and pyrexia (23%).
- Adverse reactions
led to permanent discontinuation of ONIVYDE in 11% of patients
receiving ONIVYDE/5-FU/LV; The most frequent adverse reactions
resulting in discontinuation of ONIVYDE were diarrhea, vomiting,
and sepsis.
- Dose reductions of
ONIVYDE for adverse reactions occurred in 33% of patients receiving
ONIVYDE/5-FU/LV; the most frequent adverse reactions requiring dose
reductions were neutropenia, diarrhea, nausea, and anemia.
- ONIVYDE was
withheld or delayed for adverse reactions in 62% of patients
receiving ONIVYDE/5-FU/LV; the most frequent adverse reactions
requiring interruption or delays were neutropenia, diarrhea,
fatigue, vomiting, and thrombocytopenia.
- The most common
laboratory abnormalities (≥10% Grade 3 or 4) were lymphopenia and
neutropenia.
Postmarketing Experience: Immune
system disorders: Hypersensitivity (including anaphylactic reaction
and angioedema)
DRUG INTERACTIONS
- Avoid the use of
strong CYP3A4 inducers, if possible, and substitute non-enzyme
inducing therapies ≥2 weeks prior to initiation of ONIVYDE.
- Avoid the use of
strong CYP3A4 or UGT1A1 inhibitors, if possible, and discontinue
strong CYP3A4 inhibitors ≥1 week prior to starting therapy.
USE IN SPECIFIC POPULATIONS
- Pregnancy and
Reproductive Potential: See WARNINGS & PRECAUTIONS. Advise
males with female partners of reproductive potential to use condoms
during and for 4 months after the last dose of ONIVYDE
treatment.
- Lactation: Advise
nursing women not to breastfeed during and for 1 month after the
last dose of ONIVYDE treatment.
To report SUSPECTED ADVERSE REACTIONS,
contact Ipsen Biopharmaceuticals, Inc. at 1-855-463-5127 or FDA at
1-800-FDA-1088 or
www.fda.gov/medwatch.
Please see full
Prescribing Information, including Boxed
WARNING for ONIVYDE.
Ipsen
contactsEmail:
corporate.communications@ipsen.com
Investors
Craig Marks | + 44 7584 349
193
Media
Joanna Parish | + 44 7840 023
741
Rachel Reiff | +1 908 616
1680
Disclaimers and/or Forward-Looking
StatementsThe forward-looking statements, objectives and
targets contained herein are based on Ipsen’s management strategy,
current views and assumptions. Such statements involve known and
unknown risks and uncertainties that may cause actual results,
performance or events to differ materially from those anticipated
herein. All of the above risks could affect Ipsen’s future ability
to achieve its financial targets, which were set assuming
reasonable macroeconomic conditions based on the information
available today. Use of the words ‘believes’, ‘anticipates’ and
‘expects’ and similar expressions are intended to identify
forward-looking statements, including Ipsen’s expectations
regarding future events, including regulatory filings and
determinations. Moreover, the targets described in this document
were prepared without taking into account external-growth
assumptions and potential future acquisitions, which may alter
these parameters. These objectives are based on data and
assumptions regarded as reasonable by Ipsen. These targets depend
on conditions or facts likely to happen in the future, and not
exclusively on historical data. Actual results may depart
significantly from these targets given the occurrence of certain
risks and uncertainties, notably the fact that a promising medicine
in early development phase or clinical trial may end up never being
launched on the market or reaching its commercial targets, notably
for regulatory or competition reasons. Ipsen must face or might
face competition from generic medicine that might translate into a
loss of market share. Furthermore, the research and development
process involves several stages each of which involves the
substantial risk that Ipsen may fail to achieve its objectives and
be forced to abandon its efforts with regards to a medicine in
which it has invested significant sums. Therefore, Ipsen cannot be
certain that favorable results obtained during preclinical trials
will be confirmed subsequently during clinical trials, or that the
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safe and effective nature of the medicine concerned. There can be
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References
1 Wainberg et al. NALIRIFOX versus nab-paclitaxel
and gemcitabine in treatment-naive patients with metastatic
pancreatic ductal adenocarcinoma (NAPOLI 3): a randomised,
open-label, phase 3 trial. Lancet. 2023 Oct 7;402(10409):1272-1281.
2 Wang-Gillam et al. Nanoliposomal irinotecan with fluorouracil and
folinic acid in metastatic pancreatic cancer after previous
gemcitabine-based therapy (NAPOLI-1): a global, randomised,
open-label, phase 3 trial. Lancet. 2015. DOI:
https://doi.org/10.1016/S0140-6736(15)00986-13 American Cancer
Society – Cancer Facts and Figures 2024. Available :
https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2024/2024-cancer-facts-and-figures-acs.pdf4
https://www.cancer.net/cancer-types/pancreatic-cancer/statistics5
Orth, M., Metzger, P., Gerum, S. et al. Pancreatic ductal
adenocarcinoma: biological hallmarks, current status, and future
perspectives of combined modality treatment approaches. Radiat
Oncol 14, 141 (2019). https://doi.org/10.1186/s13014-019-1345-66
Sarantis et al. Pancreatic ductal adenocarcinoma: Treatment
hurdles, tumor microenvironment and immunotherapy. World J
Gastrointest Oncol. 2020 Feb 15; 12(2): 173–181. DOI:
10.4251/wjgo.v12.i2.1737 Wainberg, Z.A et al. NAPOLI-3: A
Randomized, Open-label Phase 3 Study of Liposomal Irinotecan +
5-fluorouracil/leucovorin + Oxaliplatin (NALIRIFOX) versus
Nab-paclitaxel + Gemcitabine in Treatment-naïve Patients with
Metastatic Pancreatic Ductal Adenocarcinoma (mPDAC). Presented at
ASCO Gastrointestinal Cancers Symposium, 2023, January 19-21; San
Francisco, California.8
https://www.nccn.org/guidelines/guidelines-detail?category=1&id=14559
FDA U.S. Prescribing Information.
https://d2rkmuse97gwnh.cloudfront.net/a88aa6d6-3ca0-4362-a711-d53c45ae33ff/68b50c8f-8577-4904-950d-d82fa1f91417/68b50c8f-8577-4904-950d-d82fa1f91417_source__v.pdf10
www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/signs-and-symptoms
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