- An unprecedented 60% of patients remain alive without disease
progression after five years
- Updated results show continued 81% reduction in risk of
progression or death and 94% reduction in progression of brain
metastases compared to XALKORI®
Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up
results from the Phase 3 CROWN trial evaluating LORBRENA®
(lorlatinib, a third-generation ALK inhibitor, available in Europe
under the brand name LORVIQUA®) versus XALKORI® (crizotinib) in
people with previously untreated, anaplastic lymphoma kinase
(ALK)-positive advanced non-small cell lung cancer (NSCLC). After
five years of median follow-up, median progression-free survival
(PFS) based on investigator assessment was not reached with
LORBRENA, with an observed Hazard Ratio (HR) of 0.19 (95%
Confidence Interval [CI], 0.13-0.27), representing an 81% reduction
in the rate of disease progression or death compared to XALKORI.
Further, 60% of patients treated with LORBRENA (95% CI, 51-68) were
alive without disease progression after five years compared to 8%
(3-14) on the XALKORI treatment arm. These data will be presented
today in an oral presentation at the 2024 American Society of
Clinical Oncology (ASCO) Annual Meeting (Abstract LBA8503) and have
been simultaneously published in the Journal of Clinical
Oncology.
“These results from the CROWN trial are unprecedented, as the
majority of patients on LORBRENA are living beyond five years
without disease progression,” said Roger Dansey, M.D., Chief
Development Officer, Oncology, Pfizer. “These results are an
excellent example of Pfizer’s long-standing commitment to
discovering and developing scientific breakthroughs for patients,
and support LORBRENA as a standard of care for the first-line
treatment of people with ALK-positive advanced NSCLC.”
Lung cancer is the number one cause of cancer-related death
around the world,i and an estimated 234,580 new cases of lung
cancer are expected to be diagnosed in the U.S. in 2024.ii NSCLC
accounts for approximately 80-85% of lung cancers,iii with
ALK-positive tumors occurring in about 3-5% of NSCLC cases.iv
Approximately 25-40% of people with ALK-positive advanced NSCLC may
develop brain metastases within two years from initial diagnosis.v
LORBRENA was specifically designed and developed by Pfizer to
inhibit tumor mutations that drive resistance to other ALK
inhibitors and to penetrate the blood-brain barrier.
“ALK-positive advanced NSCLC is typically aggressive and often
impacts younger people in the prime of their lives,” said Benjamin
Solomon, MBBS, Ph.D., Department of Medical Oncology, Peter
MacCallum Cancer Centre, and Principal Investigator of the CROWN
trial. “This updated analysis shows that LORBRENA helped patients
live longer without disease progression, with the majority of
patients experiencing sustained benefit for over five years,
including nearly all patients having protection from progression of
disease in the brain. These improvements in outcomes for patients
with ALK-positive NSCLC represent a remarkable advancement in lung
cancer.”
In this updated analysis, LORBRENA showed a 94% reduction in the
risk of developing intracranial (IC) progression (HR, 0.06; 95% CI,
0.03-0.12). The median time to IC progression was not reached (95%
CI, NR-NR) with LORBRENA and was 16.4 months (12.7-21.9) with
XALKORI. In people without brain metastases at baseline receiving
LORBRENA, only 4 of 114 developed brain metastases within the first
16 months of treatment, compared to 39 of 109 patients who received
XALKORI. At the time of analysis, 50% of patients in the CROWN
trial were still receiving LORBRENA compared to 5% of patients
receiving XALKORI.
“Although ALK-positive advanced NSCLC accounts for only
approximately five percent of all NSCLC cases, this translates to
72,000 people who are diagnosed worldwide each year,” said Kenneth
Culver, M.D., Director of Research and Clinical Affairs at the
non-profit organization ALK Positive. “These new results of the
CROWN trial symbolize significant progress in the first-line
setting for the targeted treatment of ALK-positive lung cancer,
which has led to notable improvements for the patient
community.”
The safety profiles of LORBRENA and XALKORI in the five-year
follow-up were consistent with previous findings, with no new
safety signals reported for LORBRENA. In this analysis, the most
frequent (≥20%) adverse events (AEs) reported in patients treated
with LORBRENA were consistent with the 2020 analysis of the CROWN
trial, which included edema, weight gain, peripheral neuropathy,
cognitive effects, mood effects, diarrhea, dyspnea, arthralgia,
hypertension, headache, cough, pyrexia, hypercholesterolemia, and
hypertriglyceridemia. Grade 3/4 AEs occurred in 77% of patients
with LORBRENA and in 57% of patients with XALKORI.
Treatment-related AEs led to permanent treatment discontinuation in
5% and 6% of patients in the LORBRENA and XALKORI arms,
respectively.
Pfizer is continuing its commitment to help non-scientists
understand the latest findings with the development of abstract
plain language summaries (APLS) for company-sponsored research
being presented at ASCO, which are written in non-technical
language. Those interested in learning more can visit
www.Pfizer.com/apls to access the summaries.
About the CROWN Trial
CROWN is a Phase 3, randomized, open-label, parallel 2-arm trial
in which 296 people with previously untreated ALK-positive advanced
NSCLC were randomized 1:1 to receive LORBRENA monotherapy (n=149)
or XALKORI monotherapy (n=147). The primary endpoint of the CROWN
trial is PFS based on Blinded Independent Central Review (BICR).
Secondary endpoints include PFS based on investigator’s assessment,
overall survival (OS), objective response rate (ORR), intracranial
objective response (IOR), and safety. Given that median PFS was not
reached after three years of follow-up, an unplanned post hoc
analysis was executed with the intent to further quantify long-term
outcomes based on investigator tumor assessment from this study at
a clinically meaningful landmark follow-up of five years.
About LORBRENA® (lorlatinib)
LORBRENA is approved in the U.S. for the treatment of adults
with metastatic NSCLC whose tumors are ALK-positive as detected by
an FDA-approved test.
Please see Full Prescribing Information for
LORBRENA® (lorlatinib) or visit
https://www.lorbrena.com.
IMPORTANT LORBRENA® (lorlatinib) SAFETY INFORMATION FROM THE
U.S. PRESCRIBING INFORMATION
Contraindications: LORBRENA is contraindicated in
patients taking strong CYP3A inducers, due to the potential for
serious hepatotoxicity.
Risk of Serious Hepatotoxicity with Concomitant Use of Strong
CYP3A Inducers: Severe hepatotoxicity occurred in 10 of 12
healthy subjects receiving a single dose of LORBRENA with multiple
daily doses of rifampin, a strong CYP3A inducer. Grade 4 ALT or AST
elevations occurred in 50% of subjects, Grade 3 in 33% of subjects,
and Grade 2 in 8% of subjects. ALT or AST elevations occurred
within 3 days and returned to within normal limits after a median
of 15 days (7 to 34 days); median time to recovery in subjects with
Grade 3 or 4 or Grade 2 ALT or AST elevations was 18 days and 7
days, respectively. LORBRENA is contraindicated in patients taking
strong CYP3A inducers. Discontinue strong CYP3A inducers for 3
plasma half-lives of the strong CYP3A inducer prior to initiating
LORBRENA.
Central Nervous System (CNS) Effects: A broad spectrum of
CNS effects can occur; overall, CNS effects occurred in 52% of the
476 patients receiving LORBRENA. These included seizures (1.9%,
sometimes in conjunction with other neurologic findings), psychotic
effects (7%; 0.6% severe [Grade 3 or 4]), and changes in cognitive
function (28%; 2.9% severe), mood (including suicidal ideation)
(21%; 1.7% severe), speech (11%; 0.6% severe), mental status (1.3%;
1.1% severe), and sleep (12%). Median time to first onset of any
CNS effect was 1.4 months (1 day to 3.4 years). Overall, 2.1% and
10% of patients required permanent or temporary discontinuation of
LORBRENA, respectively, for a CNS effect; 8% required dose
reduction. Withhold and resume at same or reduced dose or
permanently discontinue based on severity.
Hyperlipidemia: Increases in serum cholesterol and
triglycerides can occur. Grade 3 or 4 elevations in total
cholesterol occurred in 18% and Grade 3 or 4 elevations in
triglycerides occurred in 19% of the 476 patients who received
LORBRENA. Median time to onset was 15 days for both
hypercholesterolemia and hypertriglyceridemia. Approximately 4% and
7% of patients required temporary discontinuation and 1% and 3% of
patients required dose reduction of LORBRENA for elevations in
cholesterol and in triglycerides in Study B7461001 and Study
B7461006, respectively. Eighty-three percent of patients required
initiation of lipid-lowering medications, with a median time to
onset of start of such medications of 17 days. Initiate or increase
the dose of lipid-lowering agents in patients with hyperlipidemia.
Monitor serum cholesterol and triglycerides before initiating
LORBRENA, 1 and 2 months after initiating LORBRENA, and
periodically thereafter. Withhold and resume at same dose for the
first occurrence; resume at same or reduced dose of LORBRENA for
recurrence based on severity.
Atrioventricular (AV) Block: PR interval prolongation and
AV block can occur. In 476 patients who received LORBRENA at a dose
of 100 mg orally once daily and who had a baseline
electrocardiography (ECG), 1.9% experienced AV block and 0.2%
experienced Grade 3 AV block and underwent pacemaker placement.
Monitor ECG prior to initiating LORBRENA and periodically
thereafter. Withhold and resume at reduced or same dose in patients
who undergo pacemaker placement. Permanently discontinue for
recurrence in patients without a pacemaker.
Interstitial Lung Disease (ILD)/Pneumonitis: Severe or
life-threatening pulmonary adverse reactions consistent with
ILD/pneumonitis can occur. ILD/pneumonitis occurred in 1.9% of
patients, including Grade 3 or 4 ILD/pneumonitis in 0.6% of
patients. Four patients (0.8%) discontinued LORBRENA for
ILD/pneumonitis. Promptly investigate for ILD/pneumonitis in any
patient who presents with worsening of respiratory symptoms
indicative of ILD/pneumonitis (e.g., dyspnea, cough, and fever).
Immediately withhold LORBRENA in patients with suspected
ILD/pneumonitis. Permanently discontinue LORBRENA for
treatment-related ILD/pneumonitis of any severity.
Hypertension: Hypertension can occur. Hypertension
occurred in 13% of patients, including Grade 3 or 4 in 6% of
patients. Median time to onset of hypertension was 6.4 months (1
day to 2.8 years), and 2.3% of patients temporarily discontinued
LORBRENA for hypertension. Control blood pressure prior to
initiating LORBRENA. Monitor blood pressure after 2 weeks and at
least monthly thereafter. Withhold and resume at reduced dose or
permanently discontinue based on severity.
Hyperglycemia: Hyperglycemia can occur. Hyperglycemia
occurred in 9% of patients, including Grade 3 or 4 in 3.2% of
patients. Median time to onset of hyperglycemia was 4.8 months (1
day to 2.9 years), and 0.8% of patients temporarily discontinued
LORBRENA for hyperglycemia. Assess fasting serum glucose prior to
initiating LORBRENA and monitor periodically thereafter. Withhold
and resume at reduced dose or permanently discontinue based on
severity.
Embryo-fetal Toxicity: LORBRENA can cause fetal harm.
Advise pregnant women of the potential risk to a fetus. Advise
females of reproductive potential to use an effective non-hormonal
method of contraception, since LORBRENA can render hormonal
contraceptives ineffective, during treatment with LORBRENA and for
at least 6 months after the final dose. Advise males with female
partners of reproductive potential to use effective contraception
during treatment with LORBRENA and for 3 months after the final
dose.
Adverse Reactions: In the pooled safety population of 476
patients who received 100 mg LORBRENA once daily, the most frequent
(≥ 20%) adverse reactions were edema (56%), peripheral neuropathy
(44%), weight gain (31%), cognitive effects (28%), fatigue (27%),
dyspnea (27%), arthralgia (24%), diarrhea (23%), mood effects
(21%), and cough (21%). The most frequent (≥ 20%) Grade 3-4
laboratory abnormalities in patients receiving LORBRENA were
hypercholesterolemia (21%) and hypertriglyceridemia (21%).
In previously untreated patients, serious adverse reactions
occurred in 34% of the 149 patients treated with LORBRENA; the most
frequently reported serious adverse reactions were pneumonia
(4.7%), dyspnea (2.7%), respiratory failure (2.7%), cognitive
effects (2.0%), and pyrexia (2.0%). Fatal adverse reactions
occurred in 3.4% of patients and included pneumonia (0.7%),
respiratory failure (0.7%), cardiac failure acute (0.7%), pulmonary
embolism (0.7%), and sudden death (0.7%). In the Phase 1/2 study,
serious adverse reactions occurred in 32% of the 295 patients; the
most frequently reported serious adverse reactions were pneumonia
(3.4%), dyspnea (2.7%), pyrexia (2%), mental status changes (1.4%),
and respiratory failure (1.4%). Fatal adverse reactions occurred in
2.7% of patients and included pneumonia (0.7%), myocardial
infarction (0.7%), acute pulmonary edema (0.3%), embolism (0.3%),
peripheral artery occlusion (0.3%), and respiratory distress
(0.3%).
Drug Interactions: LORBRENA is contraindicated in
patients taking strong CYP3A inducers. Avoid concomitant use with
moderate CYP3A inducers, strong CYP3A inhibitors, and fluconazole.
If concomitant use of moderate CYP3A inducers cannot be avoided,
increase the LORBRENA dose as recommended. If concomitant use with
a strong CYP3A inhibitor or fluconazole cannot be avoided, reduce
the LORBRENA dose as recommended. Avoid concomitant use of LORBRENA
with CYP3A substrates and P-gp substrates, which may reduce the
efficacy of these substrates.
Lactation: Because of the potential for serious adverse
reactions in breastfed infants, instruct women not to breastfeed
during treatment with LORBRENA and for 7 days after the final
dose.
Hepatic Impairment: No dose adjustment is recommended for
patients with mild hepatic impairment. The recommended dose of
LORBRENA has not been established for patients with moderate or
severe hepatic impairment.
Renal Impairment: Reduce the dose of LORBRENA for
patients with severe renal impairment. No dose adjustment is
recommended for patients with mild or moderate renal
impairment.
About XALKORI® (crizotinib)
XALKORI is a tyrosine kinase inhibitor (TKI) indicated for the
treatment of patients with metastatic NSCLC whose tumors are ALK-
or ROS1-positive as detected by an FDA-approved test. XALKORI has
received approval for patients with ALK-positive NSCLC in more than
90 countries including Australia, Canada, China, Japan, South Korea
and the European Union. XALKORI is also approved for ROS1-positive
NSCLC in more than 60 countries.
The full prescribing information for XALKORI can be found
here.
IMPORTANT XALKORI® (crizotinib) SAFETY INFORMATION FROM THE
U.S. PRESCRIBING INFORMATION
Hepatotoxicity: Drug-induced hepatotoxicity with fatal
outcome occurred in 0.1% of patients treated with XALKORI across
clinical trials (n=1719). Increased transaminases generally
occurred within the first 2 months. Monitor liver function tests,
including ALT, AST, and total bilirubin, every 2 weeks during the
first 2 months of treatment, then once a month, and as clinically
indicated, with more frequent repeat testing for increased liver
transaminases, alkaline phosphatase, or total bilirubin in patients
who develop increased transaminases. Permanently discontinue for
ALT/AST elevation >3 times ULN with concurrent total bilirubin
elevation >1.5 times ULN (in the absence of cholestasis or
hemolysis); otherwise, temporarily suspend and dose-reduce XALKORI
as indicated.
Interstitial Lung Disease/Pneumonitis: Severe,
life-threatening, or fatal interstitial lung disease
(ILD)/pneumonitis can occur. Across clinical trials (n=1719), 2.9%
of XALKORI-treated patients had any grade ILD, 1.0% had Grade 3/4,
and 0.5% had fatal ILD. ILD generally occurred within 3 months
after initiation of treatment. Monitor for pulmonary symptoms
indicative of ILD/pneumonitis. Exclude other potential causes and
permanently discontinue XALKORI in patients with drug-related
ILD/pneumonitis.
QT Interval Prolongation: QTc prolongation can occur.
Across clinical trials (n=1616), 2.1% of patients had QTcF
(corrected QT by the Fridericia method) ≥500 ms and 5% of 1582
patients had an increase from baseline QTcF ≥60 ms by automated
machine-read evaluation of ECGs. Avoid use in patients with
congenital long QT syndrome. Monitor ECGs and electrolytes in
patients with congestive heart failure, bradyarrhythmias,
electrolyte abnormalities, or who are taking medications that
prolong the QT interval. Permanently discontinue XALKORI in
patients who develop QTc >500 ms or ≥60 ms change from baseline
with Torsade de pointes, polymorphic ventricular tachycardia, or
signs/symptoms of serious arrhythmia. Withhold XALKORI in patients
who develop QTc >500 ms on at least 2 separate ECGs until
recovery to a QTc ≤480 ms, then resume at next lower dosage.
Bradycardia: Symptomatic bradycardia can occur. Across
clinical trials, bradycardia occurred in 13% of patients treated
with XALKORI (n=1719). Avoid use in combination with other
medications known to cause bradycardia. Monitor heart rate and
blood pressure regularly. If bradycardia occurs, re-evaluate for
the use of concomitant medications known to cause bradycardia.
Permanently discontinue for life-threatening bradycardia due to
XALKORI; however, if associated with concomitant medications known
to cause bradycardia or hypotension, hold XALKORI until recovery to
asymptomatic bradycardia or to a heart rate of ≥60 bpm. If
concomitant medications can be adjusted or discontinued, restart
XALKORI at 250 mg once daily with frequent monitoring.
Severe Visual Loss: Across clinical trials, the incidence
of Grade 4 visual field defect with vision loss was 0.2% of 1719
patients. Discontinue XALKORI in patients with new onset of severe
visual loss (best corrected vision less than 20/200 in one or both
eyes). Perform an ophthalmological evaluation. There is
insufficient information to characterize the risks of resumption of
XALKORI in patients with a severe visual loss; a decision to resume
should consider the potential benefits to the patient.
Vision Disorders: Most commonly visual impairment,
photopsia, blurred vision or vitreous floaters, occurred in 63% of
1719 patients. The majority (95%) of these patients had Grade 1
visual adverse reactions. 0.8% of patients had Grade 3 and 0.2% had
Grade 4 visual impairment. The majority of patients on the XALKORI
arms in Studies 1 and 2 (>50%) reported visual disturbances
which occurred at a frequency of 4-7 days each week, lasted up to 1
minute, and had mild or no impact on daily activities.
Embryo-Fetal Toxicity: XALKORI can cause fetal harm when
administered to a pregnant woman. Advise of the potential risk to
the fetus. Advise females of reproductive potential and males with
female partners of reproductive potential to use effective
contraception during treatment and for at least 45 days (females)
or 90 days (males) respectively, following the final dose of
XALKORI.
ROS1-positive Metastatic NSCLC: Safety was evaluated in
50 patients with ROS1-positive metastatic NSCLC from a single-arm
study and was generally consistent with the safety profile of
XALKORI evaluated in patients with ALK-positive metastatic NSCLC.
Vision disorders occurred in 92% of patients in the ROS1 study; 90%
of patients had Grade 1 vision disorders and 2% had Grade 2.
Adverse Reactions: Safety was evaluated in a phase 3
study in previously untreated patients with ALK-positive metastatic
NSCLC randomized to XALKORI (n=171) or chemotherapy (n=169).
Serious adverse events were reported in 34% of patients treated
with XALKORI, the most frequent were dyspnea (4.1%) and pulmonary
embolism (2.9%). Fatal adverse events in XALKORI-treated patients
occurred in 2.3% of patients, consisting of septic shock, acute
respiratory failure, and diabetic ketoacidosis. Common adverse
reactions (all grades) occurring in ≥25% and more commonly (≥5%) in
patients treated with XALKORI vs chemotherapy were vision disorder
(71% vs 10%), diarrhea (61% vs 13%), edema (49% vs 12%), vomiting
(46% vs 36%), constipation (43% vs 30%), upper respiratory
infection (32% vs 12%), dysgeusia (26% vs 5%), and abdominal pain
(26% vs 12%). Grade 3/4 reactions occurring at a ≥2% higher
incidence with XALKORI vs chemotherapy were QT prolongation (2% vs
0%), esophagitis (2% vs 0%), and constipation (2% vs 0%). In
patients treated with XALKORI vs chemotherapy, the following
occurred: elevation of ALT (any grade [79% vs 33%] or Grade 3/4
[15% vs 2%]); elevation of AST (any grade [66% vs 28%] or Grade 3/4
[8% vs 1%]); neutropenia (any grade [52% vs 59%] or Grade 3/4 [11%
vs 16%]); lymphopenia (any grade [48% vs 53%] or Grade 3/4 [7% vs
13%]); hypophosphatemia (any grade [32% vs 21%] or Grade 3/4 [10%
vs 6%]). In patients treated with XALKORI vs chemotherapy, renal
cysts occurred (5% vs 1%). Nausea (56%), decreased appetite (30%),
fatigue (29%), and neuropathy (21%) also occurred in patients
taking XALKORI.
Drug Interactions: Use caution with concomitant use of
moderate CYP3A inhibitors. Avoid grapefruit or grapefruit juice
which may increase plasma concentrations of crizotinib. Avoid
concomitant use of strong CYP3A inducers and inhibitors. Avoid
concomitant use of CYP3A substrates where minimal concentration
changes may lead to serious adverse reactions. If concomitant use
of XALKORI is unavoidable, decrease the CYP3A substrate dosage in
accordance with approved product labeling.
Lactation: Because of the potential for adverse reactions
in breastfed children, advise women not to breastfeed during
treatment with XALKORI and for 45 days after the final dose.
Hepatic Impairment: Crizotinib concentrations increased
in patients with pre-existing moderate (any AST and total bilirubin
>1.5x ULN and ≤3x ULN) or severe (any AST and total bilirubin
>3x ULN) hepatic impairment. Reduce XALKORI dosage in patients
with moderate or severe hepatic impairment. The recommended dose of
XALKORI in patients with pre-existing moderate hepatic impairment
is 200 mg orally twice daily or with pre-existing severe hepatic
impairment is 250 mg orally once daily.
Renal Impairment: Decreases in estimated glomerular
filtration rate occurred in patients treated with XALKORI.
Administer XALKORI at a starting dose of 250 mg taken orally once
daily in patients with severe renal impairment (CLcr <30 mL/min)
not requiring dialysis.
About Pfizer Oncology
At Pfizer Oncology, we are at the forefront of a new era in
cancer care. Our industry-leading portfolio and extensive pipeline
includes three core mechanisms of action to attack cancer from
multiple angles, including small molecules, antibody-drug
conjugates (ADCs), and bispecific antibodies, including other
immune-oncology biologics. We are focused on delivering
transformative therapies in some of the world’s most common
cancers, including breast cancer, genitourinary cancer,
hematology-oncology, and thoracic cancers, which includes lung
cancer. Driven by science, we are committed to accelerating
breakthroughs to help people with cancer live better and longer
lives.
About Pfizer: Breakthroughs That Change Patients’
Lives
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, including innovative medicines and vaccines. 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 175 years, we have worked to make a difference for all
who rely on us. We routinely post information that may be important
to investors on our website at www.Pfizer.com. In addition, to
learn more, please visit us on www.Pfizer.com and follow us on X at
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at Facebook.com/Pfizer.
Disclosure Notice
The information contained in this release is as of May 31, 2024.
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
LORBRENA® (lorlatinib) and Pfizer Oncology, including their
potential benefits, that involves 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, uncertainties regarding
the commercial success of LORBRENA; 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 any drug applications may be filed in any additional
jurisdictions for LORBRENA for the treatment of patients with
ALK-positive advanced NSCLC or in any jurisdictions for any other
potential indications for LORBRENA; whether and when any such other
applications may be approved by regulatory authorities, which will
depend on a 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
LORBRENA 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 LORBRENA; uncertainties regarding the
impact of COVID-19 on Pfizer’s business, operations and financial
results; 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, 2023, 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.
_______________________
i World Health Organization. International
Agency for Research on Cancer. GLOBOCAN 2022: DOI:
10.3322/caac.21834. Global Population Fact sheet:
https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf
ii American Cancer Society. Key Statistics
for Lung Cancer.
https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html.
Access April 2024.
iii American Cancer Society. What is lung
cancer?
https://www.cancer.org/cancer/lung-cancer/about/what-is.html.
Accessed June 2024.
iv Garber K. ALK, lung cancer, and
personalized therapy: portent of the future? J Natl Cancer Inst.
2010;102:672-675.
v Rangachari D, Yamaguchi N, VanderLaan
PA, et al. Brain metastases in patients with EGFR-mutated or
ALK—rearranged non—small—cell lung cancers. Lung Cancer.
2015;88(1):108—111 DOI: 10.1016/j.lungcan.2015.01.020.
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