Pfizer Inc. (NYSE: PFE) today announced that the European
Commission has approved VIZIMPRO® (dacomitinib), a tyrosine kinase
inhibitor (TKI), as monotherapy for the first-line treatment of
adult patients with locally advanced or metastatic non-small cell
lung cancer (NSCLC) with epidermal growth factor receptor
(EGFR)-activating mutations.
“Lung cancer remains the leading cause of cancer-related death
worldwide and despite advances in biomarker-driven therapies,
overcoming resistance continues to be crucial in treating
EGFR-mutated non-small cell lung cancer,” said Andreas Penk, M.D.,
regional president, Oncology International Developed Markets at
Pfizer. “The marketing authorization of VIZIMPRO, which has shown a
more than five-month improvement in progression-free survival over
an existing therapy in a Phase 3 clinical trial, provides a new
option for patients with EGFR-mutated non-small cell lung cancer
and reinforces Pfizer’s ongoing commitment to addressing the
remaining needs of the thousands of EU patients with this
disease.”
The European Commission’s approval of VIZIMPRO was supported by
data from ARCHER 1050, a randomized, multicenter, multinational,
open-label, Phase 3 study conducted in patients with unresectable,
metastatic or recurrent NSCLC harboring EGFR exon 19 deletion or
exon 21 L858R substitution mutations. A total of 452 patients were
randomized 1:1 to VIZIMPRO 45 mg (n=227) or gefitinib 250 mg
(n=225). The primary endpoint was progression-free survival (PFS)
as determined by blinded Independent Radiologic Central (IRC)
review. Key secondary endpoints included PFS assessed by the
investigator, objective response rate (ORR), duration of response
(DoR) and overall survival (OS).
A statistically significant improvement in PFS as determined by
the IRC was demonstrated for patients randomized to VIZIMPRO
compared with gefitinib (HR = 0.59 [95% CI: 0.47, 0.74], p
<0.0001). Median PFS in the VIZIMPRO group was 14.7 months (95%
CI: 11.1, 16.6) compared with 9.2 months (95% CI: 9.1, 11.0) in the
gefitinib arm.
“Over the last two decades, biomarker-driven therapies have
become standard-of-care for patients with EGFR-mutated non-small
cell lung cancer,” said Dr. Federico Cappuzzo, Director of Oncology
and Hematology Department AUSL della Romagna-Ravenna. “The
improvement in progression-free survival for VIZIMPRO over a
first-generation standard-of-care therapy in the ARCHER 1050 study
is impressive, and I’m pleased it will be available for appropriate
patients with non-small cell lung cancer in the EU.”
OS results from the final analysis (data cut-off date of
17-Feb-2017) performed when 48.7 percent of events had occurred,
showed a gain of 7.3 months in median OS for patients treated with
VIZIMPRO compared to those treated with gefitinib (34.1 months vs.
26.8 months; HR: 0.760 [95% CI: 0.582, 0.993]). However, the
statistical significance of the OS improvement could not formally
be assessed, as the secondary endpoints from the study were tested
in descending order of perceived importance and stopped when no
additional statistical significance of ORR was reached.
Among 227 patients with EGFR-mutated metastatic NSCLC who
received VIZIMPRO in ARCHER 1050, the most common (≥ 20%) adverse
reactions were diarrhea (87%), rash (77%), stomatitis (70%), nail
disorder (66%), decreased appetite (31%), dry skin (30%), weight
decreased (26%), transaminases increased (24%), conjunctivitis
(23%), alopecia (23%), and pruritus (20%). Serious adverse
reactions occurred in 6.2 percent of patients treated with
VIZIMPRO. The most common (≥ 1%) serious adverse reactions reported
were diarrhea (2.2%) and interstitial lung disease (1.3%).1,2
About VIZIMPRO® (dacomitinib), 45 mg, 30 mg and
15 mg tablets
VIZIMPRO is an oral, once-daily, irreversible pan-human
epidermal growth factor receptor kinase inhibitor. VIZIMPRO is
approved in the EU for the first-line treatment of adult patients
with locally advanced or metastatic non-small cell lung cancer
(NSCLC) with epidermal growth factor receptor (EGFR)-activating
mutations.
VIZIMPRO is also approved in the United States for the
first-line treatment of patients with metastatic NSCLC with EGFR
exon 19 deletion or exon 21 L858R substitution mutations as
detected by an FDA-approved test. Additionally, VIZIMPRO is
approved in Japan for EGFR gene mutation-positive, inoperable or
recurrent NSCLC, and in Canada for the first-line treatment of
adult patients with unresectable locally advanced or metastatic
NSCLC with confirmed EGFR exon 19 deletion or exon 21 L858R
substitution mutations. The applications in the US and Japan were
reviewed and approved under the Priority Review program.
In 2012, Pfizer and SFJ Pharmaceuticals entered into a
collaborative development agreement to conduct ARCHER 1050 across
multiple sites. SFJ is a global drug development company, which
provides a unique and highly customized co-development partnering
model for the world’s top pharmaceutical and biotechnology
companies. Under the terms of this agreement, SFJ Pharmaceuticals
provided the funding and conducted the trial to generate the
clinical data used to support this application. Pfizer retains all
rights to commercialize VIZIMPRO globally.
About ARCHER 1050
The efficacy of VIZIMPRO was demonstrated in ARCHER 1050, a
global Phase 3 head-to-head trial conducted in patients with
unresectable, metastatic or recurrent non-small cell lung cancer
(NSCLC) harboring epidermal growth factor receptor (EGFR) exon 19
deletion or exon 21 L858R substitution mutations, with no prior
therapy for metastatic disease or recurrent disease with a minimum
of 12 months disease-free after completion of systemic therapy. A
total of 452 patients were randomized 1:1 to VIZIMPRO 45 mg (n=227)
or gefitinib 250 mg (n=225). Randomization was stratified by region
and EGFR mutation status. The primary endpoint of the study was
progression-free survival (PFS) as determined by blinded
Independent Radiology Central (IRC) review. Key secondary endpoints
included PFS assessed by the investigator, objective response rate
(ORR), duration of response (DoR), overall survival (OS), and
patient-reported outcomes (PROs).
VIZIMPRO® (dacomitinib) IMPORTANT SAFETY
INFORMATION FROM THE U.S. PRESCRIBING INFORMATION
There are no contraindications for VIZIMPRO.
Interstitial Lung Disease (ILD): Severe and fatal
ILD/pneumonitis occurred in patients treated with VIZIMPRO and
occurred in 0.5% of the 394 VIZIMPRO-treated patients; 0.3% of
cases were fatal. Monitor patients for pulmonary symptoms
indicative of ILD/pneumonitis. Withhold VIZIMPRO and promptly
investigate for ILD in patients who present with worsening of
respiratory symptoms which may be indicative of ILD (e.g., dyspnea,
cough, and fever). Permanently discontinue VIZIMPRO if ILD is
confirmed.
Diarrhea: Severe and fatal diarrhea occurred in patients
treated with VIZIMPRO. Diarrhea occurred in 86% of the 394
VIZIMPRO-treated patients. Grade 3 or 4 diarrhea was reported in
11% of patients and 0.3% of cases were fatal. Withhold VIZIMPRO for
Grade 2 or greater diarrhea until recovery to less than or equal to
Grade 1 severity, then resume VIZIMPRO at the same or a reduced
dose depending on the severity of diarrhea. Promptly initiate
anti-diarrheal treatment (loperamide or diphenoxylate hydrochloride
with atropine sulfate) for diarrhea.
Dermatologic Adverse Reactions: Rash and exfoliative skin
reactions occurred in patients treated with VIZIMPRO. Rash occurred
in 78% of the 394 VIZIMPRO-treated patients. Grade 3 or 4 rash was
reported in 21% of patients. Exfoliative skin reactions of any
severity were reported in 7% of patients. Grade 3 or 4 exfoliative
skin reactions were reported in 1.8% of patients. Withhold VIZIMPRO
for persistent Grade 2 or any Grade 3 or 4 dermatologic adverse
reaction until recovery to less than or equal to Grade 1 severity,
then resume VIZIMPRO at the same or a reduced dose depending on the
severity of the dermatologic adverse reaction. The incidence and
severity of rash and exfoliative skin reactions may increase with
sun exposure. At the time of initiation of VIZIMPRO, initiate use
of moisturizers and appropriate measures to limit sun exposure.
Upon development of Grade 1 rash, initiate treatment with topical
antibiotics and topical steroids. Initiate oral antibiotics for
Grade 2 or more severe dermatologic adverse reactions.
Embryo-Fetal Toxicity: VIZIMPRO can cause fetal harm when
administered to a pregnant woman. Advise pregnant women of the
potential risk to the fetus. Advise females of reproductive
potential to use effective contraception during treatment with
VIZIMPRO and for at least 17 days after the final dose.
Adverse Reactions: The most common (>20%) adverse
reactions were diarrhea (87%), rash (69%), paronychia (64%),
stomatitis (45%), decreased appetite (31%), dry skin (30%),
decreased weight (26%), alopecia (23%), cough (21%), and pruritus
(21%). The most common (≥1%) serious adverse reactions were
diarrhea (2.2%) and interstitial lung disease (1.3%).
Drug Interactions: Concomitant use with a proton pump
inhibitor (PPI) decreases dacomitinib concentrations, which may
reduce VIZIMPRO efficacy. Avoid the concomitant use of PPIs with
VIZIMPRO. As an alternative to PPIs, use locally-acting antacids or
an H2-receptor antagonist. Administer VIZIMPRO at least 6 hours
before or 10 hours after taking an H2-receptor antagonist.
Concomitant use of VIZIMPRO increases the concentration of drugs
that are CYP2D6 substrates which may increase the risk of
toxicities of these drugs. Avoid concomitant use of VIZIMPRO with
CYP2D6 substrates where minimal increases in concentration of the
CYP2D6 substrate may lead to serious or life-threatening
toxicities.
Lactation: Because of the potential for serious adverse
reactions in breastfed infants from VIZIMPRO, advise women not to
breastfeed during treatment with VIZIMPRO and for at least
17 days after the last dose.
Hepatic Impairment: No dose adjustment is
recommended in patients with mild or moderate hepatic impairment.
The recommended dose of VIZIMPRO has not been established for
patients with severe hepatic impairment.
Renal Impairment: No dose adjustment is recommended
for patients with mild or moderate renal impairment. The
recommended dose of VIZIMPRO has not been established for patients
with severe renal impairment.
Please see full prescribing information at Pfizer.com
About Non-Small Cell Lung Cancer
Lung cancer is the most common cancer worldwide, with more than
two million new cases diagnosed globally in 2018.1 About 85 percent
of all lung cancers are identified as non-small cell, and
approximately 75 percent of these are metastatic, or advanced, at
diagnosis.2
EGFR is a protein that helps cells grow and divide. When the
EGFR gene is mutated it can cause the protein to be overactive
resulting in cancer cells to form. EGFR mutations may occur in 10
to 35 percent of NSCLC tumors globally, and the most common
activating mutations are deletions in exon 19 and exon 21 L858R
substitution, which together account for more than 80 percent of
known activating EGFR mutations. The disease is associated with low
survival rates and disease progression remains a challenge.3,4
About Pfizer in Lung Cancer
Pfizer Oncology is committed to addressing the unmet needs of
patients with lung cancer, the leading cause of cancer-related
deaths worldwide and a particularly difficult-to-treat disease.
Pfizer strives to address the diverse and evolving needs of
patients with non-small cell lung cancer (NSCLC) by developing
efficacious and tolerable therapies, including biomarker-driven
therapies and immuno-oncology (IO) agents and combinations. By
combining leading scientific insights with a patient-centric
approach, Pfizer is continually advancing its work to match the
right patient with the right medicine at the right time. Through
our growing research pipeline and collaboration efforts, we are
committed to delivering renewed hope to patients living with
NSCLC.
About Pfizer Oncology
At Pfizer Oncology, we are committed to advancing medicines
wherever we believe we can make a meaningful difference on the
lives of patients. Today, Pfizer Oncology has an industry-leading
portfolio of 18 approved innovative cancer medicines and
biosimilars across more than 20 indications, including breast,
prostate, kidney, lung and hematology. Pfizer Oncology is striving
to change the trajectory of cancer.
Pfizer Inc: Working together for a healthier
world®
At Pfizer, we apply science and our global resources to bring
therapies to people that extend and significantly improve their
lives. We strive to set the standard for quality, safety and value
in the discovery, development and manufacture of health care
products. Our global portfolio includes medicines and vaccines as
well as many of the world's best-known consumer health care
products. Every day, Pfizer colleagues work across developed and
emerging markets to advance wellness, prevention, treatments and
cures that challenge the most feared diseases of our time.
Consistent with our responsibility as one of the world's premier
innovative biopharmaceutical companies, we collaborate with health
care providers, governments and local communities to support and
expand access to reliable, affordable health care around the world.
For more than 150 years, we have worked to make a difference for
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DISCLOSURE NOTICE:
The information contained in this release is as of April 3,
2019. Pfizer assumes no obligation to update forward-looking
statements contained in this release as the result of new
information or future events or developments.
This release contains forward-looking information about VIZIMPRO
(dacomitinib), a kinase inhibitor, and an approval by the European
Commission, including their potential benefits, that involve
substantial risks and uncertainties that could cause actual results
to differ materially from those expressed or implied by such
statements. Risks and uncertainties include, among other things,
the uncertainties inherent in research and development, including
the ability to meet anticipated clinical endpoints, commencement
and/or completion dates for our clinical trials, regulatory
submission dates, regulatory approval dates and/or launch dates, as
well as the possibility of unfavorable new clinical data and
further analyses of existing clinical data; the risk that clinical
trial data are subject to differing interpretations and assessments
by regulatory authorities; whether regulatory authorities will be
satisfied with the design of and results from our clinical studies;
whether and when applications for VIZIMPRO may be filed in other
jurisdictions; whether and when any such other applications for
VIZIMPRO that may be pending or filed may be approved by regulatory
authorities, which will depend on myriad factors, including making
a determination as to whether the product’s benefits outweigh its
known risks and determination of the product’s efficacy and, if
approved, whether VIZIMPRO will be commercially successful;
decisions by regulatory authorities impacting labeling,
manufacturing processes, safety and/or other matters that could
affect the availability or commercial potential of VIZIMPRO; and
competitive developments.
A further description of risks and uncertainties can be found in
Pfizer’s Annual Report on Form 10-K for the fiscal year ended
December 31, 2018 and in its subsequent reports on Form 10-Q,
including in the sections thereof captioned “Risk Factors” and
“Forward-Looking Information and Factors That May Affect Future
Results”, as well as in its subsequent reports on Form 8-K, all of
which are filed with the U.S. Securities and Exchange Commission
and available at www.sec.gov and www.pfizer.com.
____________
1 VIZIMPRO® (dacomitinib). Summary of Product Characteristics.] 2
Pfizer. Data on File.
3 Lovly CM, Horn L. Molecular profiling of
lung cancer. My Cancer Genome; 2016.
https://www.mycancergenome.org/content/disease/lung-cancer/.
Accessed January 2019.
4 Pao W, Miller VA. Epidermal growth factor receptor mutations,
small-molecule kinase inhibitors, and non-small-cell lung cancer:
current knowledge and future directions. J Clin Oncol.
2005;23:2556-2568.
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version on businesswire.com: https://www.businesswire.com/news/home/20190403005533/en/
Pfizer Media Contacts:Jessica Smith (U.S.)(212)
733-6213Jessica.M.Smith@pfizer.comLisa O’Neill (EU)(44) 7929 339
560Lisa.O'Neill@pfizer.comPfizer Investor Contact:Ryan Crowe(212)
733-8160Ryan.Crowe@pfizer.com
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