- BRAFTOVI + MEKTOVI continued to show substantial antitumor
activity after a minimum follow up of approximately three years,
corresponding to the longest duration of response and
progression-free survival in treatment-naïve patients compared to
historical outcomes
- Results support BRAFTOVI + MEKTOVI as a standard of care option
for this population
Pfizer Inc. (NYSE: PFE) today announced longer-term follow-up
results from the Phase 2 single-arm PHAROS clinical trial
evaluating the efficacy and safety of BRAFTOVI® (encorafenib) in
combination with MEKTOVI® (binimetinib) for patients with BRAF
V600E-mutant metastatic non-small cell lung cancer (NSCLC). After
an additional 18 months of follow-up, the objective response rate
(ORR) and the median duration of response (DoR) as assessed by
independent radiology review were 75% and 40 months in
treatment-naïve patients and 46% and 16.7 months in previously
treated patients, respectively. In addition, after approximately
three years of follow-up in treatment-naïve patients, the median
progression-free survival (PFS) with BRAFTOVI + MEKTOVI was 30.2
months (95% confidence interval [CI], 15.7-not estimable [NE]),
while median overall survival (OS) was not yet reached (95% CI,
31.3-NE). These data will be presented today during a late-breaking
oral session (Abstract LBA56) at the European Society for Medical
Oncology (ESMO) Congress 2024 in Barcelona, Spain.
“BRAF V600E-mutant metastatic non-small cell lung cancer tends
to be aggressive, and effective targeted first-line treatment
options with manageable safety profiles are critical for the
thousands of people who are diagnosed globally each year,” said
Gregory Riely, M.D., Ph.D., Vice Chair, Clinical Research in the
Department of Medicine at Memorial Sloan Kettering Cancer Center
(MSK) and PHAROS investigator. “The longer-term follow-up results
from the PHAROS trial represent an important step forward in the
treatment of BRAF V600E-mutant metastatic NSCLC, especially for
treatment-naïve patients. These compelling results support the
BRAFTOVI + MEKTOVI combination as a standard of care option for
these patients.”
Lung cancer is the number one cause of cancer-related death
around the world.1 NSCLC accounts for approximately 80-85% of lung
cancers,2 with BRAF V600E mutations occurring in about 2% of
patients with NSCLC.3 Understanding the role of the
mitogen-activated protein within the pathway including BRAF
V600E-mutant metastatic NSCLC.
The Phase 2 PHAROS trial (NCT03915951) is an open-label,
multicenter, single arm study examining BRAFTOVI + MEKTOVI
combination therapy in treatment-naïve and previously treated
patients with BRAF V600E-mutant metastatic NSCLC. Notably, upon
longer-term follow-up in previously treated patients, BRAFTOVI +
MEKTOVI showed a median PFS of 9.3 months (95% CI, 6.2-24.8) and a
median OS of 22.7 months (95% CI, 14.1-32.2), with a safety profile
that was consistent with previous findings; no new safety concerns
were identified. In this analysis, treatment-related adverse events
(AEs) led to dose reduction in 26% of patients, and to permanent
discontinuation in 16% of patients. Nausea, diarrhea, and fatigue
remained the most common treatment-related AEs.
“These potentially practice-changing results from the PHAROS
trial show that the combination of BRAFTOVI + MEKTOVI is providing
long-term compelling efficacy for patients, and although no
definitive conclusions can be made across trials, the duration of
response and progression-free survival in treatment naïve patients
appear to be the longest observed for BRAF V600E–mutant metastatic
NSCLC compared with historical outcomes,” said Roger Dansey, M.D.,
Chief Development Officer, Oncology, Pfizer. “These latest data
reflect our deep understanding of the science behind
biomarker-driven cancers and add to our legacy in developing
innovative targeted treatments in NSCLC. We are continuing to build
upon this strong foundation with a pipeline of targeted medicines
and combinations across our tumor areas of focus, including the
ongoing investigation of BRAFTOVI in earlier settings of metastatic
colorectal cancer, and the exploration of a next-generation
brain-penetrant BRAF inhibitor.”
BRAFTOVI + MEKTOVI was approved by the U.S. Food and Drug
Administration (FDA) in October 2023, and by the European
Commission in August 2024, for the treatment of BRAF V600E-mutant
metastatic NSCLC based on the initial ORR (the primary endpoint)
and DoR (key secondary endpoint) results from the PHAROS clinical
trial.
In addition to PHAROS, safety lead-in data from the ongoing
Phase 3 BREAKWATER study investigating BRAFTOVI in combination with
cetuximab and FOLFIRI chemotherapy in previously untreated BRAF
V600E-mutant metastatic colorectal cancer (CRC) will also be
presented as a mini-oral session at ESMO (Abstract 515MO). BRAFTOVI
in combination with cetuximab and FOLFIRI was found to be generally
tolerable in this patient population, with no new safety concerns
identified. These findings support the ongoing investigation of
this combination regimen as a potential treatment option for BRAF
V600E-mutant metastatic CRC. The Phase 3 BREAKWATER trial is
ongoing, with updated data expected in 2025.
BRAF mutations can occur in a number of tumor types, including
metastatic melanoma, metastatic CRC and metastatic NSCLC. Among
different types of BRAF mutations, the BRAF V600E mutation is
particularly important as it occurs in approximately half of
patients with BRAF-mutant metastatic NSCLC.4 Further, this mutation
represents up to 90% of BRAF mutations in melanoma5 and more than
doubles the risk of mortality for patients with CRC.6 In addition
to our continued investigation of BRAFTOVI + MEKTOVI for
BRAF-mutant cancers, Pfizer is also exploring a next-generation
BRAF inhibitor designed to selectively inhibit mutant BRAF monomers
and mutant BRAF-containing dimers and be brain penetrant. The
investigational drug is currently being evaluated in a Phase 1
clinical study.
Pfizer has exclusive rights to BRAFTOVI + MEKTOVI in the U.S.,
Canada, and all countries in Latin America, Africa and the Middle
East. Ono Pharmaceutical Co., Ltd. has exclusive rights to
commercialize both products in Japan and South Korea, Medison has
exclusive rights in Israel, and Pierre Fabre Laboratories has
exclusive rights in all other countries, including Europe and
Asia-Pacific (excluding Japan and South Korea). The PHAROS trial is
conducted with support from Pierre Fabre Laboratories.
INDICATION AND USAGE
BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) are kinase
inhibitors indicated for use in combination for the treatment of
patients with unresectable or metastatic melanoma with a BRAF V600E
or V600K mutation, as detected by an FDA-approved test.
BRAFTOVI is indicated, in combination with cetuximab, for the
treatment of adult patients with metastatic colorectal cancer (CRC)
with a BRAF V600E mutation, as detected by an FDA-approved test,
after prior therapy.
BRAFTOVI and MEKTOVI are kinase inhibitors indicated for use in
combination for the treatment of adult patients with metastatic
non-small cell lung cancer (NSCLC) with a BRAF V600E mutation, as
detected by an FDA-approved test.
Limitations of Use: BRAFTOVI is not indicated for treatment of
patients with wild-type BRAF melanoma, wild-type BRAF CRC, or
wild-type BRAF NSCLC.
IMPORTANT SAFETY INFORMATION
This information applies to the safety of BRAFTOVI when used
in combination with either MEKTOVI or cetuximab.
WARNINGS AND PRECAUTIONS
New Primary Malignancies: New primary malignancies,
cutaneous and non-cutaneous, can occur. BRAFTOVI may promote
malignancies associated with activation of RAS through mutation or
other mechanisms. Perform dermatopathologic evaluations prior to
initiating treatment, every 2 months during treatment, and for up
to 6 months following discontinuation of treatment. Manage
suspicious skin lesions with excision and dermatopathologic
evaluation. Dose modification is not recommended for new primary
cutaneous malignancies. Monitor patients receiving BRAFTOVI for
signs and symptoms of non-cutaneous malignancies. Discontinue
BRAFTOVI for RAS mutation-positive non-cutaneous malignancies.
Monitor patients for new malignancies prior to initiation of
treatment, while on treatment, and after discontinuation of
treatment.
- BRAF-mutant type (BRAF-mt) metastatic melanoma (COLUMBUS
study): Cutaneous squamous cell carcinoma (cuSCC), including
keratoacanthoma (KA), occurred in 2.6% and basal cell carcinoma
occurred in 1.6% of patients receiving BRAFTOVI with MEKTOVI.
Median time to first occurrence of cuSCC/KA was 5.8 months.
- BRAF-mt metastatic CRC (BEACON CRC study): cuSCC,
including KA, occurred in 1.4% of patients with CRC, and a new
primary melanoma occurred in 1.4% of patients who received BRAFTOVI
with cetuximab.
- BRAF-mt metastatic NSCLC (PHAROS study): cuSCC and skin
papilloma (SP), each occurred in 2% of patients.
Tumor Promotion in BRAF Wild-Type Tumors: In vitro
experiments have demonstrated paradoxical activation of MAP-kinase
signaling and increased cell proliferation in BRAF wild-type cells
exposed to BRAF inhibitors. Confirm evidence of BRAF V600E or V600K
mutation using an FDA-approved test prior to initiating
BRAFTOVI.
Cardiomyopathy: Cardiomyopathy manifesting as left
ventricular dysfunction associated with symptomatic or asymptomatic
decreases in ejection fraction, has been reported. Patients with
cardiovascular risk factors should be monitored closely. Withhold,
reduce dose, or permanently discontinue based on severity of
adverse reaction.
- Assess left ventricular ejection fraction (LVEF) by
echocardiogram or multi-gated acquisition (MUGA) scan prior to
initiating treatment, 1 month after initiating treatment, and then
every 2 to 3 months during treatment.
- The safety has not been established in patients with a baseline
ejection fraction that is either below 50% or below the
institutional lower limit of normal (LLN).
- BRAF-mt metastatic melanoma (COLUMBUS study): Evidence
of cardiomyopathy occurred in 7% and Grade 3 left ventricular
dysfunction occurred in 1.6% of patients receiving BRAFTOVI with
MEKTOVI. The median time to first occurrence of left ventricular
dysfunction (any grade) was 3.6 months. Cardiomyopathy resolved in
87% of patients.
- BRAF-mt metastatic NSCLC (PHAROS study): Evidence of
cardiomyopathy occurred in 11% and Grade 3 left ventricular
dysfunction occurred in 1% of patients. Cardiomyopathy resolved in
82% of patients.
Hepatotoxicity: Hepatotoxicity can occur. Monitor liver
laboratory tests before initiation, monthly during treatment, and
as clinically indicated. Withhold, reduce dose, or permanently
discontinue based on severity of adverse reaction.
- BRAF-mt metastatic melanoma (COLUMBUS study): The
incidence of Grade 3 or 4 increases in liver function laboratory
tests in patients receiving MEKTOVI with BRAFTOVI was 6% for
alanine aminotransferase (ALT), 2.6% for aspartate aminotransferase
(AST), and 0.5% for alkaline phosphatase.
- BRAF-mt metastatic NSCLC (PHAROS study): The incidence
of Grade 3 or 4 increases in liver function laboratory tests was
10% for AST, 9% for ALT, and 3.2% for alkaline phosphatase.
Hemorrhage: Hemorrhage can occur when BRAFTOVI is
administered in combination with MEKTOVI or cetuximab. Withhold,
reduce dose, or permanently discontinue based on severity of
adverse reaction.
- BRAF-mt metastatic melanoma (COLUMBUS study): Hemorrhage
occurred in 19% of patients receiving BRAFTOVI with MEKTOVI and
Grade 3 or higher hemorrhage occurred in 3.2% of patients. The most
frequent hemorrhagic events were gastrointestinal, including rectal
hemorrhage (4.2%), hematochezia (3.1%), and hemorrhoidal hemorrhage
(1%). Fatal intracranial hemorrhage in the setting of new or
progressive brain metastases occurred in 1.6% of patients.
- BRAF-mt metastatic CRC (BEACON CRC study): Hemorrhage
occurred in 19% of patients receiving BRAFTOVI with cetuximab;
Grade 3 or higher hemorrhage occurred in 1.9% of patients,
including fatal gastrointestinal hemorrhage in 0.5% of patients.
The most frequent hemorrhagic events were epistaxis (6.9%),
hematochezia (2.3%), and rectal hemorrhage (2.3%).
- BRAF-mt metastatic NSCLC (PHAROS study): Hemorrhage
occurred in 12% of patients including fatal intracranial hemorrhage
(1%); Grade 3 or 4 hemorrhage occurred in 4.1% of patients. The
most frequent hemorrhagic events were anal hemorrhage and
hemothorax (2% each).
Uveitis: Uveitis, including iritis and iridocyclitis, has
been reported in patients treated with BRAFTOVI with MEKTOVI.
Assess for visual symptoms at each visit. Perform an
ophthalmological evaluation at regular intervals and for new or
worsening visual disturbances, and to follow new or persistent
ophthalmologic findings. Withhold, reduce dose, or permanently
discontinue based on severity of adverse reaction.
- BRAF-mt metastatic melanoma (COLUMBUS study): The
incidence of uveitis among patients treated with BRAFTOVI with
MEKTOVI was 4%.
- BRAF-mt metastatic NSCLC (PHAROS study): The incidence
of uveitis among patients treated with BRAFTOVI with MEKTOVI was
1%.
QT Prolongation: BRAFTOVI is associated with
dose-dependent QTc interval prolongation in some patients. Monitor
patients who already have or who are at significant risk of
developing QTc prolongation, including patients with known long QT
syndromes, clinically significant bradyarrhythmias, severe or
uncontrolled heart failure and those taking other medicinal
products associated with QT prolongation. Correct hypokalemia and
hypomagnesemia prior to and during BRAFTOVI administration.
Withhold, reduce dose, or permanently discontinue for QTc >500
ms.
- BRAF-mt metastatic melanoma (COLUMBUS study): An
increase in QTcF to >500 ms was measured in 0.5% (1/192) of
patients who received BRAFTOVI with MEKTOVI.
- BRAF-mt metastatic NSCLC (PHAROS study): An increase in
QTcF to >500 ms was measured in 2.1% (2/95) of patients who
received BRAFTOVI with MEKTOVI.
Embryo-Fetal Toxicity: Both BRAFTOVI and MEKTOVI can
cause fetal harm when administered to a pregnant woman. BRAFTOVI
can render hormonal contraceptives ineffective.
- BRAF-mt metastatic melanoma (COLUMBUS study) and BRAF-mt
metastatic NSCLC (PHAROS study): Effective, non-hormonal
contraceptives should be used during treatment and for at least 30
days after the final dose for patients taking BRAFTOVI with
MEKTOVI.
- BRAF-mt metastatic CRC (BEACON CRC study): Advise
females of reproductive potential to use effective nonhormonal
contraception during treatment with BRAFTOVI and for 2 weeks after
the final dose.
BRAFTOVI as a Single Agent is associated with increased
risk of certain adverse reactions compared to when BRAFTOVI is used
with MEKTOVI.
- BRAF-mt metastatic melanoma (COLUMBUS study): Grades 3
or 4 dermatologic reactions occurred in 21% of patients receiving
BRAFTOVI as a single agent compared to 2% in patients receiving the
combination of BRAFTOVI with MEKTOVI.
- If MEKTOVI is temporarily interrupted or permanently
discontinued, reduce the dose of BRAFTOVI as recommended.
Risks Associated with Combination Treatment
- In BRAF-mt metastatic melanoma (COLUMBUS study),
BRAFTOVI is used in combination with MEKTOVI so refer to the
prescribing information for MEKTOVI for additional risk
information.
- In BRAF-mt metastatic CRC (BEACON CRC study), BRAFTOVI
is used in combination with cetuximab so refer to the prescribing
information for cetuximab for additional risk information.
- In BRAF-mt metastatic NSCLC (PHAROS study), BRAFTOVI is
indicated for use as part of a regimen in combination with MEKTOVI,
so refer to the prescribing information for MEKTOVI for additional
risk information.
Additional WARNINGS AND PRECAUTIONS for MEKTOVI When Used
With BRAFTOVI
Venous Thromboembolism (VTE): VTE occurred in 6% of
patients with BRAF-mt metastatic melanoma (COLUMBUS study),
including 3.1% of patients who developed pulmonary embolism. VTE
occurred in 7% of patients with BRAF-mt metastatic NSCLC (PHAROS
study), including 1% of patients who developed pulmonary
embolism. Withhold, reduce dose, or permanently discontinue based
on severity of adverse reaction.
Other Ocular Toxicities
- Serous retinopathy
- Assess for visual symptoms at each visit. Perform an
ophthalmologic examination at regular intervals, for new or
worsening visual disturbances, and to follow new or persistent
ophthalmologic findings. Withhold, reduce dose, or permanently
discontinue based on severity of adverse reaction.
- BRAF-mt metastatic melanoma (COLUMBUS study): serous
retinopathy occurred in 20% of patients receiving MEKTOVI with
BRAFTOVI; 8% were retinal detachment and 6% were macular edema.
Symptomatic serous retinopathy occurred in 8% of patients with no
cases of blindness. The median time to onset of the first event of
serous retinopathy (all grades) was 1.2 months.
- BRAF-mt metastatic NSCLC (PHAROS study): serous
retinopathy (retinal detachment) occurred in 2% of patients with no
cases of blindness.
- Retinal vein occlusion (RVO) is a known class-related
adverse reaction of MEK inhibitors and may occur in patients
receiving MEKTOVI with BRAFTOVI. In BRAF-mt metastatic melanoma
(COLUMBUS study), 1 patient experienced RVO (0.1%) in the
MEKTOVI with BRAFTOVI group (n=690).
- The safety of MEKTOVI has not been established in patients with
a history of RVO or current risk factors for RVO, including
uncontrolled glaucoma or a history of hyperviscosity or
hypercoagulability syndromes.
- Perform ophthalmological evaluation for patient-reported acute
vision loss or other visual disturbance within 24 hours.
Permanently discontinue MEKTOVI in patients with documented
RVO.
Interstitial Lung Disease (ILD): ILD, including
pneumonitis, occurred in 0.3% (2 of 690 patients) with BRAF-mt
metastatic melanoma (COLUMBUS study) receiving MEKTOVI with
BRAFTOVI. One patient (1%) with BRAF-mt metastatic NSCLC (PHAROS
study) receiving MEKTOVI with BRAFTOVI developed pneumonitis.
Assess new or progressive unexplained pulmonary symptoms or
findings for possible ILD. Withhold, reduce dose, or permanently
discontinue based on severity of adverse reaction.
Rhabdomyolysis: Rhabdomyolysis can occur when MEKTOVI is
taken with BRAFTOVI. Monitor creatine phosphokinase (CPK) and
creatinine levels prior to initiating MEKTOVI, periodically during
treatment, and as clinically indicated. Withhold, reduce dose, or
permanently discontinue based on severity of adverse reaction.
- BRAF-mt metastatic melanoma (COLUMBUS study): Elevation
of laboratory values of serum CPK occurred in 58% of patients
receiving MEKTOVI with BRAFTOVI. Rhabdomyolysis was reported in
0.1% (1 of 690 patients) with BRAF mutation-positive melanoma
receiving MEKTOVI with BRAFTOVI.
- BRAF-mt metastatic NSCLC (PHAROS study): Elevation of
laboratory values of serum creatine kinase (CK) occurred in 41% of
patients. No patient experienced rhabdomyolysis.
ADVERSE REACTIONS
BRAF-mt Metastatic Melanoma (COLUMBUS study)
- Most common adverse reactions (≥20%, all grades) for
patients receiving BRAFTOVI with MEKTOVI compared to vemurafenib
were fatigue (43% vs 46%), nausea (41% vs 34%), diarrhea (36% vs
34%), vomiting (30% vs 16%), abdominal pain (28% vs 16%),
arthralgia (26% vs 46%), myopathy (23% vs 22%), hyperkeratosis (23%
vs 49%), rash (22% vs 53%), headache (22% vs 20%), constipation
(22% vs 6%), visual impairment (20% vs 4%), serous retinopathy/RPED
(20% vs 2%).
- Other clinically important adverse reactions occurring
in <10% of patients who received BRAFTOVI with MEKTOVI were
facial paresis, pancreatitis, panniculitis, drug hypersensitivity,
and colitis.
- Most common laboratory abnormalities (≥20%, all grades)
for BRAFTOVI with MEKTOVI compared to vemurafenib included
increased creatinine (93% vs 92%), increased CPK (58% vs 3.8%),
increased gamma glutamyl transferase (GGT) (45% vs 34%), anemia
(36% vs 34%), increased ALT (29% vs 27%), hyperglycemia (28% vs
20%), increased AST (27% vs 24%), and increased alkaline
phosphatase (21% vs 35%).
BRAF-mt Metastatic CRC (BEACON CRC study)
- Most common adverse reactions (≥25%, all grades) in
patients receiving BRAFTOVI with cetuximab compared to irinotecan
with cetuximab or FOLFIRI with cetuximab (control) were fatigue
(51% vs 50%), nausea (34% vs 41%), diarrhea (33% vs 48%),
dermatitis acneiform (32% vs 43%), abdominal pain (30% vs 32%),
decreased appetite (27% vs 27%), arthralgia (27% vs 3%), and rash
(26% vs 26%).
- Other clinically important adverse reactions occurring
in <10% of patients who received BRAFTOVI with cetuximab was
pancreatitis.
- Most common laboratory abnormalities (≥20%, all grades)
in the BRAFTOVI with cetuximab arm compared to irinotecan with
cetuximab or FOLFIRI with cetuximab (control) were: anemia (34% vs
48%) and lymphopenia (24% vs 35%).
BRAF-mt Metastatic NSCLC (PHAROS study)
- Most common adverse reactions (≥25%, all grades) in
patients receiving BRAFTOVI with MEKTOVI were fatigue (61%), nausea
(58%), diarrhea (52%), musculoskeletal pain (48%), vomiting (37%),
abdominal pain (32%), visual impairment (29%), constipation (27%),
dyspnea (27%), rash (27%), and cough (26%).
- Serious adverse reactions occurred in 38% of patients
receiving BRAFTOVI with MEKTOVI. Serious adverse reactions
occurring in ≥2% of patients were hemorrhage (6%), diarrhea (4.1%),
anemia (3.1%), dyspnea (3.1%), pneumonia (3.1%), arrhythmia (2%),
device related infection (2%), edema (2%), myocardial infarction
(2%), and pleural effusion (2%).
- Fatal adverse reactions occurred in 2% of patients,
including intracranial hemorrhage (1%) and myocardial infarction
(1%).
- Other clinically important adverse reactions occurring
in <10% of patients who received BRAFTOVI with MEKTOVI were
peripheral neuropathy, dysgeusia, facial paresis, pancreatitis,
hyperkeratosis, erythema, and drug hypersensitivity.
- Most common laboratory abnormalities (≥20%, all grades)
for BRAFTOVI and MEKTOVI included increased creatinine (91%),
hyperglycemia (48%), anemia (47%), increased creatine kinase (41%),
lipase increased (40%), increased ALT (34%), hypoalbuminemia (32%),
increased alkaline phosphatase (31%), increased AST (31%),
hyperkalemia (31%), hyponatremia (26%), lymphopenia (24%), serum
amylase increased (22%), and thrombocytopenia (20%).
DRUG INTERACTIONS With BRAFTOVI When Used in Combination With
Either MEKTOVI or Cetuximab
- Avoid coadministration of BRAFTOVI with strong or moderate
CYP3A4 inhibitors (including grapefruit juice) or CYP3A4 inducers
and use caution with sensitive CYP3A4 substrates. Avoid
coadministration of BRAFTOVI with hormonal contraceptives.
- Modify BRAFTOVI dose if coadministration with a strong or
moderate CYP3A4 inhibitor cannot be avoided.
- Avoid coadministration of BRAFTOVI with drugs known to prolong
QT/QTc interval.
- Dose reductions of drugs that are substrates of OATP1B1,
OATP1B3, or BCRP may be required when used concomitantly with
BRAFTOVI.
Lactation: Advise women not to breastfeed during
treatment with BRAFTOVI and MEKTOVI and for 2 weeks after the final
dose.
Infertility: Advise males of reproductive potential that
BRAFTOVI may impair fertility.
For BRAF-mt metastatic melanoma and for BRAF-mt metastatic
NSCLC, see full Prescribing Information and
Medication Guide for BRAFTOVI and full Prescribing
Information and Medication Guide for MEKTOVI. See full
Prescribing Information for BRAFTOVI and for MEKTOVI for dose
modifications for adverse reactions. There may be a delay as
the documents are updated with the latest information. They will be
available as soon as possible. Please check back for the updated
full information shortly.
For BRAF-mt metastatic CRC, see full Prescribing Information
and Medication Guide for BRAFTOVI. See full Prescribing Information
for BRAFTOVI for dose modifications for adverse reactions. Refer to
cetuximab prescribing information for recommended dosing and safety
information.
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
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Disclosure Notice
The information contained in this release is as of September 14,
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 the
BRAFTOVI® (encorafenib) and MEKTOVI® (binimetinib) combination for
the treatment of patients with metastatic non-small cell lung
cancer (NSCLC) with a BRAF V600E mutation, other potential
indications and a next-generation BRAF inhibitor, 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 BRAFTOVI plus MEKTOVI; 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 BRAFTOVI plus MEKTOVI for the treatment of
patients with metastatic NSCLC with a BRAF V600E mutation or in any
jurisdictions for any other potential indications for BRAFTOVI and
MEKTOVI or any other product candidates; whether and when any such
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
BRAFTOVI plus MEKTOVI or any such other product candidates 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 BRAFTOVI plus MEKTOVI or any other product candidates;
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.
References
1 World Health Organization. International Agency for Research
on Cancer. GLOBOCAN 2022: Global Population Fact sheet. Available
at:
https://gco.iarc.who.int/media/globocan/factsheets/populations/900-world-fact-sheet.pdf.
Last accessed: September 2024. 2 American Cancer Society. What is
lung cancer? Available at:
https://www.cancer.org/cancer/lung-cancer/about/what-is.html. Last
accessed: September 2024. 3 American Lung Association. BRAF and
lung cancer. Available at:
https://www.lung.org/lung-health-diseases/lung-disease-lookup/lung-cancer/symptoms-diagnosis/biomarker-testing/braf.
Last accessed: September 2024. 4 Paik PK, Arcila ME, Fara M, et al.
Clinical characteristics of patients with lung adenocarcinomas
harboring BRAF mutations. J Clin Oncol. 2011;29(15):2046-51. 5
Cheng L, Lopez-Beltran A, Massari F, et al. Molecular testing for
BRAF mutations to inform melanoma treatment decisions: a move
toward precision medicine. Mod Pathol. 2018;31(1):24-38. 6 Safaee
Ardekani G, Jafarnejad, SM, Tan, L, et al. The prognostic value of
BRAF mutation in colorectal cancer and melanoma: a systematic
review and meta-analysis. PloS ONE. 2012;7(10):e47054.
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