– ALUNBRIG Reduced the Risk of Disease Progression or Death by 76%
in Patients whose Disease Had Spread to the Brain, and by 57% in All
Patients, when Compared to Crizotinib –
– Median Progression-Free Survival with ALUNBRIG was Three Times Longer than that with Crizotinib –
CAMBRIDGE, Mass. & OSAKA, Japan-Wednesday 27 November 2019 [ AETOS Wire ]
WIRE) -- Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK)
today announced updated data from the Phase 3 ALTA-1L trial, which
evaluated ALUNBRIG versus crizotinib in adults with advanced anaplastic
lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who
had not received a prior ALK inhibitor. Results show after more than two
years of follow-up, ALUNBRIG reduced the risk of disease progression or
death by 76% (hazard ratio [HR] = 0.24, 95% CI: 0.12–0.45) as assessed
by investigators in newly diagnosed patients whose disease had spread to
the brain at time of enrollment. ALUNBRIG also demonstrated a 57% (HR =
0.43, 95% CI: 0.31–0.61) reduction in risk of disease progression or
death in all patients. These data will be presented during the
Presidential Session at the 2019 European Society for Medical Oncology
(ESMO) Asia Congress on Saturday, November 23 in Singapore.
from the ALTA-1L trial were evaluated by two separate review bodies –
study investigators and a blinded independent review committee (BIRC) –
and results from both assessments were reported. At the data cutoff for
the second interim analysis (June 28, 2019), the BIRC-assessed HR of
progression-free survival (PFS), which is the primary endpoint, was 0.49
(95% CI: 0.35–0.68, log-rank P<0.0001), demonstrating a reduced risk
of disease progression or death by 51%.
“Given the complexity of
this disease and the expected longevity of the population, it is
important for physicians to have multiple well-tolerated and durable
treatment options to address the needs of their patients,” said D. Ross
Camidge, M.D., Ph.D., Joyce Zeff Chair in Lung Cancer Research at the
University of Colorado Cancer Center and the lead investigator of
ALTA-1L. “With 25 months of follow up from the ALTA-1L trial, brigatinib
continues to demonstrate overall and intracranial effectiveness, while
also significantly improving quality of life compared to crizotinib,
reinforcing its potential as a first-line therapy for ALK+ NSCLC.”
data from the long-term analysis showed that newly diagnosed patients
treated with ALUNBRIG benefited regardless of the presence or absence of
brain metastases at baseline, which is one of the most common sites of
first progression and associated with poor quality of life.
ALUNBRIG demonstrated high and durable responses in the brain, with
patients with baseline brain metastases having superior efficacy
compared to crizotinib, as assessed by a BIRC, and an early separation
of the PFS curves in these patients was observed.
reduced the risk of intracranial disease progression or death by 69% in
patients with brain metastases at baseline (HR = 0.31, 95% CI:
0.17–0.56), with a median intracranial PFS of 24 months compared to 5.6
months with crizotinib. Median PFS for patients with brain metastases at
baseline was not reached with ALUNBRIG and was 5.9 months with
crizotinib, as assessed by investigators.
intracranial objective response rate (ORR) for patients with measurable
brain metastases at baseline was 78% (95% CI: 52.4–93.6) for patients
treated with ALUNBRIG and 26% (95% CI: 10.2–48.4) for patients treated
Median intracranial duration of response
(DOR) in confirmed responders with measurable brain metastases at
baseline was not reached (95% CI: 5.7–NE) with ALUNBRIG and was 9.2
months (95% CI: 3.9–9.2) with crizotinib.
ALUNBRIG demonstrated consistent overall efficacy (intent to treat population) with a longer follow-up of 25 months.
Median PFS with ALUNBRIG was 29.4 months (95% CI: 21.2–NE) versus 9.2
months (95% CI: 7.4–12.9) with crizotinib, as assessed by investigators.
The BIRC-assessed median PFS was 24.0 months (95% CI: 18.5–NE) for
ALUNBRIG and 11.0 months (95% CI: 9.2–12.9) for crizotinib.
Confirmed ORR was 74% (95% CI: 65.5–80.9) for ALUNBRIG and 62% (95% CI: 52.9–69.7) for crizotinib as assessed by a BIRC.
Median DOR was not reached (95% CI: 19.4–NE) with ALUNBRIG and was 13.8
months (95% CI: 9.3–20.8) with crizotinib as assessed by a BIRC.
Quality of life (QoL) for newly diagnosed ALK+ NSCLC patients was also
evaluated, with results showing patients treated with ALUNBRIG
experienced significant improvements in health-related QoL (HRQoL).
ALUNBRIG delayed median time to worsening in Global Health Score
(GHS)/QoL score (≥10 point worsening in score) by 27 months versus 8
months with crizotinib.
Patients treated with ALUNBRIG had
longer duration of improvement in GHS/ QoL, with duration of improvement
not yet reached versus 12 months with crizotinib.
also delayed time to worsening and prolonged duration of improvement in
multiple subscales such as fatigue, nausea and vomiting, appetite loss,
and emotional and social functioning.
“At Takeda, we are
committed to developing products that seek to advance the lung cancer
treatment landscape and address the unmet needs of patients,” said Phil
Rowlands, Head, Oncology Therapeutic Area Unit. “We are proud of the
progress made thus far, including these updated results from the ALTA-1L
trial, which show that ALUNBRIG delayed disease progression by more
than two years and significantly reduced the risk of disease progression
in patients with baseline brain metastasis. We look forward to
submitting these data to regulatory authorities around the globe with
the goal of making ALUNBRIG available to ALK+ NSCLC patients worldwide.”
treatment needs for patients with ALK+ NSCLC are diverse because cancer
is not a one-size-fits-all disease,” said Bonnie Addario, Co-Founder,
Board Chair, GO2 Foundation for Lung Cancer. “Ongoing research and
clinical trials such as ALTA-1L are critical to achieving our goal of
improving outcomes and quality of life for patients early on in their
treatment journey. We’re grateful for the patients, families and
investigators who participated in this clinical trial, which shows
meaningful results for those with newly diagnosed ALK+ NSCLC.”
The safety profile of ALUNBRIG in the ALTA-1L trial was generally consistent with the existing U.S. prescribing information.
Most common treatment-emergent adverse events (TEAEs) Grade ≥3 in the
ALUNBRIG arm were increased CPK (24.3%), increased lipase (14.0%) and
hypertension (11.8%); and for crizotinib were increased ALT (10.2%), AST
(6.6%), and lipase (6.6%).
The frequency of early pulmonary
events (interstitial lung disease/pneumonitis) in the ALTA-1L trial was
slightly lower compared with the ALTA study in a post-crizotinib
Pulmonary events at any time occurred in 5.1% of patients in the ALUNBRIG arm and 2.2% in the crizotinib arm.
Discontinuations due to AEs occurred in 12.5% of patients in the ALUNBRIG arm and 8.8% in the crizotinib arm.
ALUNBRIG is not currently approved for use in the first-line.
About the ALTA-1L Trial
Phase 3 ALTA-1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line)
trial of ALUNBRIG in adults is a global, ongoing, randomized,
open-label, comparative, multicenter trial, which enrolled 275 patients
(ALUNBRIG, n=137, crizotinib, n=138) with anaplastic lymphoma
kinase-positive (ALK+) locally advanced or metastatic non-small cell
lung cancer (NSCLC) who have not received prior treatment with an ALK
inhibitor. Patients received either ALUNBRIG, 180 mg once daily with
seven-day lead-in at 90 mg once daily, or crizotinib, 250 mg twice
The median age was 58 years in the ALUNBRIG arm and 60
years in the crizotinib arm. Twenty-nine percent of patients had brain
metastases at baseline in the ALUNBRIG arm versus 30% in the crizotinib
arm. Twenty-six percent of patients received prior chemotherapy for
advanced or metastatic disease in the ALUNBRIG arm versus 27% in the
Blinded independent review committee
(BIRC)-assessed progression-free survival (PFS) was the primary
endpoint. Secondary endpoints included objective response rate (ORR) per
RECIST v1.1, intracranial ORR, intracranial PFS, overall survival (OS),
safety and tolerability.
About ALUNBRIG® (brigatinib)
is a potent and selective next-generation tyrosine kinase inhibitor
(TKI) that was designed to target and inhibit the anaplastic lymphoma
kinase (ALK) fusion protein in non-small cell lung cancer (NSCLC). In
April 2017, ALUNBRIG received Accelerated Approval from the U.S. Food
and Drug Administration (FDA) for anaplastic lymphoma kinase-positive
(ALK+) metastatic NSCLC patients who have progressed on or are
intolerant to crizotinib. This indication is approved under Accelerated
Approval based on tumor response rate and duration of response.
Continued approval for this indication may be contingent upon
verification and description of clinical benefit in a confirmatory
ALUNBRIG is currently approved in more than 40 countries,
including the U.S., Canada and the European Union, for the treatment of
people with ALK+ metastatic NSCLC whose disease has worsened during
crizotinib treatment or they could not tolerate taking crizotinib.
received Breakthrough Therapy Designation from the FDA for the
treatment of patients with ALK+ NSCLC whose tumors are resistant to
crizotinib and was granted Orphan Drug Designation by the FDA for the
treatment of ALK+ NSCLC, ROS1+ and EGFR+ NSCLC.
Takeda in Lung Cancer
is dedicated to expanding experience in the ALK+ NSCLC and EGFR exon 20
treatment landscapes. Our comprehensive programs include the following
clinical trials to continue to address unmet needs for people living
with lung cancer:
Phase 1/2 trial, which was
designed to evaluate the safety, tolerability, pharmacokinetics and
preliminary anti-tumor activity of ALUNBRIG.
Pivotal Phase 2 ALTA
trial investigating the efficacy and safety of ALUNBRIG at two dosing
regimens in patients with ALK+ locally advanced or metastatic NSCLC who
had progressed on crizotinib.
Phase 3 ALTA-1L, global, randomized
trial assessing the efficacy and safety of ALUNBRIG in comparison to
crizotinib in patients with ALK+ locally advanced or metastatic NSCLC
who have not received prior treatment with an ALK inhibitor.
Phase 2 J-ALTA, single-arm, multicenter trial in Japanese patients with
ALK+ NSCLC, focusing on patients who have progressed on alectinib. This
trial is now enrolling.
Phase 2 ALTA 2, global, single-arm trial
evaluating ALUNBRIG in patients with advanced ALK+ NSCLC who have
progressed on alectinib or ceritinib. This trial is now enrolling.
Phase 3 ALTA 3, global randomized trial comparing the efficacy and
safety of ALUNBRIG versus alectinib in participants with ALK+ NSCLC who
have progressed on crizotinib. This trial is now enrolling.
Phase 1/2 study evaluating the safety, pharmacokinetics and antitumor
activity of oral EGFR/HER2 inhibitor TAK-788 in patients with NSCLC.
Phase 2 EXCLAIM, pivotal extension cohort of the Phase 1/2 trial, which
was designed to evaluate the efficacy and safety of TAK-788 at 160 mg
once daily in previously treated patients with EGFR exon 20 insertion
mutations. This trial is closed to enrollment.
Phase 3 EXCLAIM 2,
global, randomized study evaluating the efficacy of TAK-788 as a
first-line treatment compared to platinum-based chemotherapy in
treatment-naïve patients with locally advanced or metastatic NSCLC whose
tumors harbor EGFR exon 20 insertion mutations.
open-label, multicenter, dose-escalation study evaluating the safety,
tolerability and pharmacokinetics of TAK-788 in Japanese patients with
locally advanced or metastatic NSCLC. This trial has been fully
Phase 2, open label, single-arm study evaluating the
efficacy of TAK-788 in treatment-naïve patients with locally advanced or
metastatic NSCLC whose tumors harbor EGFR exon 20 insertion mutations.
Phase 1, open-label, two-period, fixed-sequence study designed to
characterize drug-drug interaction between TAK-788 and either a strong
cytochrome P-450 (CYP)3A inhibitor, itraconazole (Part 1) or a strong
CYP3A inducer, rifampin (Part 2) in healthy adult subjects.
For additional information on the ALUNBRIG and TAK-788 clinical trials, please visit www.clinicaltrials.gov.
About ALK+ NSCLC
cell lung cancer (NSCLC) is the most common form of lung cancer,
accounting for approximately 85% of the estimated 1.8 million new cases
of lung cancer diagnosed each year worldwide, according to the World
Health Organization.1,2 Genetic studies indicate that chromosomal
rearrangements in anaplastic lymphoma kinase (ALK) are key drivers in a
subset of NSCLC patients.3 Approximately three to five percent of
patients with metastatic NSCLC have a rearrangement in the ALK
Takeda is committed to continuing research and
development in NSCLC to improve the lives of the approximately 40,000
patients diagnosed with this serious and rare form of lung cancer
worldwide each year.7
ALUNBRIG IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
Lung Disease (ILD)/Pneumonitis: Severe, life-threatening, and fatal
pulmonary adverse reactions consistent with interstitial lung disease
(ILD)/pneumonitis have occurred with ALUNBRIG. In Trial ALTA (ALTA),
ILD/pneumonitis occurred in 3.7% of patients in the 90 mg group (90 mg
once daily) and 9.1% of patients in the 90→180 mg group (180 mg once
daily with 7-day lead-in at 90 mg once daily). Adverse reactions
consistent with possible ILD/pneumonitis occurred early (within 9 days
of initiation of ALUNBRIG; median onset was 2 days) in 6.4% of patients,
with Grade 3 to 4 reactions occurring in 2.7%. Monitor for new or
worsening respiratory symptoms (e.g., dyspnea, cough, etc.),
particularly during the first week of initiating ALUNBRIG. Withhold
ALUNBRIG in any patient with new or worsening respiratory symptoms, and
promptly evaluate for ILD/pneumonitis or other causes of respiratory
symptoms (e.g., pulmonary embolism, tumor progression, and infectious
pneumonia). For Grade 1 or 2 ILD/pneumonitis, either resume ALUNBRIG
with dose reduction after recovery to baseline or permanently
discontinue ALUNBRIG. Permanently discontinue ALUNBRIG for Grade 3 or 4
ILD/pneumonitis or recurrence of Grade 1 or 2 ILD/pneumonitis.
In ALTA, hypertension was reported in 11% of patients in the 90 mg
group who received ALUNBRIG and 21% of patients in the 90→180 mg group.
Grade 3 hypertension occurred in 5.9% of patients overall. Control blood
pressure prior to treatment with ALUNBRIG. Monitor blood pressure after
2 weeks and at least monthly thereafter during treatment with ALUNBRIG.
Withhold ALUNBRIG for Grade 3 hypertension despite optimal
antihypertensive therapy. Upon resolution or improvement to Grade 1
severity, resume ALUNBRIG at a reduced dose. Consider permanent
discontinuation of treatment with ALUNBRIG for Grade 4 hypertension or
recurrence of Grade 3 hypertension. Use caution when administering
ALUNBRIG in combination with antihypertensive agents that cause
Bradycardia: Bradycardia can occur with ALUNBRIG. In
ALTA, heart rates less than 50 beats per minute (bpm) occurred in 5.7%
of patients in the 90 mg group and 7.6% of patients in the 90→180 mg
group. Grade 2 bradycardia occurred in 1 (0.9%) patient in the 90 mg
group. Monitor heart rate and blood pressure during treatment with
ALUNBRIG. Monitor patients more frequently if concomitant use of drug
known to cause bradycardia cannot be avoided. For symptomatic
bradycardia, withhold ALUNBRIG and review concomitant medications for
those known to cause bradycardia. If a concomitant medication known to
cause bradycardia is identified and discontinued or dose adjusted,
resume ALUNBRIG at the same dose following resolution of symptomatic
bradycardia; otherwise, reduce the dose of ALUNBRIG following resolution
of symptomatic bradycardia. Discontinue ALUNBRIG for life-threatening
bradycardia if no contributing concomitant medication is identified.
Disturbance: In ALTA, adverse reactions leading to visual disturbance
including blurred vision, diplopia, and reduced visual acuity, were
reported in 7.3% of patients treated with ALUNBRIG in the 90 mg group
and 10% of patients in the 90→180 mg group. Grade 3 macular edema and
cataract occurred in one patient each in the 90→180 mg group. Advise
patients to report any visual symptoms. Withhold ALUNBRIG and obtain an
ophthalmologic evaluation in patients with new or worsening visual
symptoms of Grade 2 or greater severity. Upon recovery of Grade 2 or
Grade 3 visual disturbances to Grade 1 severity or baseline, resume
ALUNBRIG at a reduced dose. Permanently discontinue treatment with
ALUNBRIG for Grade 4 visual disturbances.
(CPK) Elevation: In ALTA, creatine phosphokinase (CPK) elevation
occurred in 27% of patients receiving ALUNBRIG in the 90 mg group and
48% of patients in the 90 mg→180 mg group. The incidence of Grade 3‑4
CPK elevation was 2.8% in the 90 mg group and 12% in the 90→180 mg
group. Dose reduction for CPK elevation occurred in 1.8% of patients in
the 90 mg group and 4.5% in the 90→180 mg group. Advise patients to
report any unexplained muscle pain, tenderness, or weakness. Monitor CPK
levels during ALUNBRIG treatment. Withhold ALUNBRIG for Grade 3 or 4
CPK elevation. Upon resolution or recovery to Grade 1 or baseline,
resume ALUNBRIG at the same dose or at a reduced dose.
Enzyme Elevation: In ALTA, amylase elevation occurred in 27% of
patients in the 90 mg group and 39% of patients in the 90→180 mg group.
Lipase elevations occurred in 21% of patients in the 90 mg group and 45%
of patients in the 90→180 mg group. Grade 3 or 4 amylase elevation
occurred in 3.7% of patients in the 90 mg group and 2.7% of patients in
the 90→180 mg group. Grade 3 or 4 lipase elevation occurred in 4.6% of
patients in the 90 mg group and 5.5% of patients in the 90→180 mg group.
Monitor lipase and amylase during treatment with ALUNBRIG. Withhold
ALUNBRIG for Grade 3 or 4 pancreatic enzyme elevation. Upon resolution
or recovery to Grade 1 or baseline, resume ALUNBRIG at the same dose or
at a reduced dose.
Hyperglycemia: In ALTA, 43% of patients who
received ALUNBRIG experienced new or worsening hyperglycemia. Grade 3
hyperglycemia, based on laboratory assessment of serum fasting glucose
levels, occurred in 3.7% of patients. Two of 20 (10%) patients with
diabetes or glucose intolerance at baseline required initiation of
insulin while receiving ALUNBRIG. Assess fasting serum glucose prior to
initiation of ALUNBRIG and monitor periodically thereafter. Initiate or
optimize anti-hyperglycemic medications as needed. If adequate
hyperglycemic control cannot be achieved with optimal medical
management, withhold ALUNBRIG until adequate hyperglycemic control is
achieved and consider reducing the dose of ALUNBRIG or permanently
Embryo-Fetal Toxicity: Based on its
mechanism of action and findings in animals, ALUNBRIG can cause fetal
harm when administered to pregnant women. There are no clinical data on
the use of ALUNBRIG in pregnant women. Advise pregnant women of the
potential risk to a fetus. Advise females of reproductive potential to
use effective non-hormonal contraception during treatment with ALUNBRIG
and for at least 4 months following the final dose. Advise males with
female partners of reproductive potential to use effective contraception
during treatment and for at least 3 months after the last dose of
Serious adverse reactions occurred
in 38% of patients in the 90 mg group and 40% of patients in the 90→180
mg group. The most common serious adverse reactions were pneumonia
(5.5% overall, 3.7% in the 90 mg group, and 7.3% in the 90→180 mg group)
and ILD/pneumonitis (4.6% overall, 1.8% in the 90 mg group and 7.3% in
the 90→180 mg group). Fatal adverse reactions occurred in 3.7% of
patients and consisted of pneumonia (2 patients), sudden death, dyspnea,
respiratory failure, pulmonary embolism, bacterial meningitis and
urosepsis (1 patient each).
The most common adverse reactions
(≥25%) in the 90 mg group were nausea (33%), fatigue (29%), headache
(28%), and dyspnea (27%) and in the 90→180 mg group were nausea (40%),
diarrhea (38%), fatigue (36%), cough (34%), and headache (27%).
Inhibitors: Avoid coadministration of ALUNBRIG with strong or moderate
CYP3A inhibitors. Avoid grapefruit or grapefruit juice as it may also
increase plasma concentrations of brigatinib. If coadministration of a
strong or moderate CYP3A inhibitor cannot be avoided, reduce the dose of
CYP3A Inducers: Avoid coadministration of ALUNBRIG with
strong or moderate CYP3A inducers. If coadministration of moderate CYP3A
inducers cannot be avoided, increase the dose of ALUNBRIG.
Substrates: Coadministration of ALUNBRIG with sensitive CYP3A
substrates, including hormonal contraceptives, can result in decreased
concentrations and loss of efficacy of sensitive CYP3A substrates.
USE IN SPECIFIC POPULATIONS
Pregnancy: ALUNBRIG can cause fetal harm. Advise females of reproductive potential of the potential risk to a fetus.
There are no data regarding the secretion of brigatinib in human milk
or its effects on the breastfed infant or milk production. Because of
the potential adverse reactions in breastfed infants, advise lactating
women not to breastfeed during treatment with ALUNBRIG.
Females and Males of Reproductive Potential:
Pregnancy Testing: Verify pregnancy status in females of reproductive potential prior to initiating ALUNBRIG.
Advise females of reproductive potential to use effective non-hormonal
contraception during treatment with ALUNBRIG and for at least 4 months
after the final dose. Advise males with female partners of reproductive
potential to use effective contraception during treatment with ALUNBRIG
and for at least 3 months after the final dose.
Infertility: ALUNBRIG may cause reduced fertility in males.
Pediatric Use: The safety and effectiveness of ALUNBRIG in pediatric patients have not been established.
Use: Clinical studies of ALUNBRIG did not include sufficient numbers of
patients aged 65 years and older to determine whether they respond
differently from younger patients.
Hepatic or Renal Impairment:
No dose adjustment is recommended for patients with mild or moderate
hepatic impairment or mild or moderate renal impairment. Reduce the dose
of ALUNBRIG for patients with severe hepatic impairment or severe renal
Please see the full U.S. Prescribing Information for ALUNBRIG at www.ALUNBRIG.com.
About Takeda Pharmaceutical Company Limited
Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) is a global,
values-based, R&D-driven biopharmaceutical leader headquartered in
Japan, committed to bringing Better Health and a Brighter Future to
patients by translating science into highly-innovative medicines. Takeda
focuses its R&D efforts on four therapeutic areas: Oncology,
Gastroenterology (GI), Rare Diseases and Neuroscience. We also make
targeted R&D investments in Plasma-Derived Therapies and Vaccines.
We are focusing on developing highly innovative medicines that
contribute to making a difference in people's lives by advancing the
frontier of new treatment options and leveraging our enhanced
collaborative R&D engine and capabilities to create a robust,
modality-diverse pipeline. Our employees are committed to improving
quality of life for patients and to working with our partners in health
care in approximately 80 countries and regions.
For more information, visit https://www.takeda.com.
the purposes of this notice, “press release” means this document, any
oral presentation, any question and answer session and any written or
oral material discussed or distributed by Takeda Pharmaceutical Company
Limited (“Takeda”) regarding this release. This press release (including
any oral briefing and any question-and-answer in connection with it) is
not intended to, and does not constitute, represent or form part of any
offer, invitation or solicitation of any offer to purchase, otherwise
acquire, subscribe for, exchange, sell or otherwise dispose of, any
securities or the solicitation of any vote or approval in any
jurisdiction. No shares or other securities are being offered to the
public by means of this press release. No offering of securities shall
be made in the United States except pursuant to registration under the
U.S. Securities Act of 1933, as amended, or an exemption therefrom. This
press release is being given (together with any further information
which may be provided to the recipient) on the condition that it is for
use by the recipient for information purposes only (and not for the
evaluation of any investment, acquisition, disposal or any other
transaction). Any failure to comply with these restrictions may
constitute a violation of applicable securities laws.
companies in which Takeda directly and indirectly owns investments are
separate entities. In this press release, “Takeda” is sometimes used for
convenience where references are made to Takeda and its subsidiaries in
general. Likewise, the words “we”, “us” and “our” are also used to
refer to subsidiaries in general or to those who work for them. These
expressions are also used where no useful purpose is served by
identifying the particular company or companies.
press release and any materials distributed in connection with this
press release may contain forward-looking statements, beliefs or
opinions regarding Takeda’s future business, future position and results
of operations, including estimates, forecasts, targets and plans for
Takeda. Without limitation, forward-looking statements often include
words such as “targets”, “plans”, “believes”, “hopes”, “continues”,
“expects”, “aims”, “intends”, “ensures”, “will”, “may”, “should”,
“would”, “could” “anticipates”, “estimates”, “projects” or similar
expressions or the negative thereof. Forward-looking statements in this
document are based on Takeda’s estimates and assumptions only as of the
date hereof. Such forward-looking statements do not represent any
guarantee by Takeda or its management of future performance and involve
known and unknown risks, uncertainties and other factors, including but
not limited to: the economic circumstances surrounding Takeda’s global
business, including general economic conditions in Japan and the United
States; competitive pressures and developments; changes to applicable
laws and regulations; the success of or failure of product development
programs; decisions of regulatory authorities and the timing thereof;
fluctuations in interest and currency exchange rates; claims or concerns
regarding the safety or efficacy of marketed products or product
candidates; the timing and impact of post-merger integration efforts
with acquired companies; and the ability to divest assets that are not
core to Takeda’s operations and the timing of any such divestment(s),
any of which may cause Takeda’s actual results, performance,
achievements or financial position to be materially different from any
future results, performance, achievements or financial position
expressed or implied by such forward-looking statements. For more
information on these and other factors which may affect Takeda’s
results, performance, achievements, or financial position, see “Item 3.
Key Information—D. Risk Factors” in Takeda’s most recent Annual Report
on Form 20-F and Takeda’s other reports filed with the U.S. Securities
and Exchange Commission, available on Takeda’s website at:
https://www.takeda.com/investors/reports/sec-filings/ or at www.sec.gov.
Future results, performance, achievements or financial position of
Takeda could differ materially from those expressed in or implied by the
forward-looking statements. Persons receiving this press release should
not rely unduly on any forward-looking statements. Takeda undertakes no
obligation to update any of the forward-looking statements contained in
this press release or any other forward-looking statements it may make,
except as required by law or stock exchange rule. Past performance is
not an indicator of future results and the results of Takeda in this
press release may not be indicative of, and are not an estimate,
forecast or projection of Takeda’s future results.
1 World Health Organization. Latest Global Cancer Data. https://www.who.int/cancer/PRGlobocanFinal.pdf. Accessed May 11, 2019.
American Cancer Society. What is Non-Small Cell Lung Cancer?
Accessed May 11, 2019.
3 Kris MG, et al. JAMA, 2014;311:1998-2006.
4 Gainor JF, Varghese AM, Ou SH, et al. Clin Cancer Res. 2013;19(15):4273-81.
5 Koivunen JP, Mermel C, Zejnullahu K, et al. Clin Cancer Res. 2008; 14(13):4275-83.
6 Wong DW, Leung EL, So KK, et al. Cancer. 2009; 115(8):1723-33.
7 Chia PL, Mitchell P, Dobrovic A, John T. Clin Epidemiol, 2014;6:423-432.
This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20191122005494/en/
Takeda Pharmaceutical Company Limited
+81 (0) 3-3278-2095
Media Outside Japan