CALQUENCE also maintained efficacy and a
sustained safety profile at four years for previously treated
patients in ASCEND trial
Updated results from the ELEVATE-TN Phase III trial showed
AstraZeneca’s CALQUENCE® (acalabrutinib) maintained a statistically
significant progression-free survival (PFS) benefit versus
chlorambucil plus obinutuzumab and a safety and tolerability
profile consistent with the known profile for CALQUENCE at a median
follow up of approximately five years in combination and as a
monotherapy in chronic lymphocytic leukemia (CLL).1
Results also showed longer overall survival (OS) for CALQUENCE
combined with obinutuzumab compared with chlorambucil combined with
obinutuzumab in previously untreated adults with CLL.1 CLL is the
most prevalent type of leukemia in adults, with over 100,000
patients diagnosed globally in 2019.2
At a median follow-up of 58.2 months, CALQUENCE plus
obinutuzumab reduced the risk of disease progression or death by
89% (based on a hazard ratio [HR] of 0.11, 95% confidence interval
[CI] 0.07-0.16) and as a monotherapy by 79% (based on a HR of 0.21,
95% CI 0.15-0.30), compared with chlorambucil plus obinutuzumab.1
OS data are immature, and medians were not yet reached in any
treatment arm.1 The relative risk for death was 45% lower in the
CALQUENCE plus obinutuzumab arm (based on a HR of 0.55, 95% CI
0.30-0.99).1 An estimated 90% of patients treated with the
CALQUENCE combination were alive at five years versus 84% for
CALQUENCE alone and 82% for chlorambucil plus obinutuzumab.1
Separately, follow-up data from the ASCEND Phase III trial
showed CALQUENCE demonstrated a sustained PFS benefit at four years
based on investigator assessment compared with investigator’s
choice of rituximab combined with either idelalisib (IdR) or
bendamustine (BR) in adults with relapsed or refractory CLL.3 At 42
months, an estimated 62% of patients treated with CALQUENCE were
alive and had not progressed in comparison with 19% of patients
treated with IdR/BR.3 The median follow-up was 46.5 months for
CALQUENCE and 45.3 months for IdR/BR.3
The safety and tolerability of CALQUENCE in the ELEVATE-TN and
ASCEND trials were consistent with earlier findings, with no new
safety signals identified.1,3
Jeff P. Sharman, MD, Director of Research at Willamette Valley
Cancer Institute, Medical Director of Hematology Research for the
US Oncology Network, and a lead investigator of the ELEVATE-TN
trial, said: “These data from ELEVATE-TN with nearly five years of
follow-up support what I have seen in clinical practice and provide
clinicians further reassurance when prescribing this therapy.
Patients with chronic lymphocytic leukemia often remain on therapy
for many years, so long-term efficacy and tolerability are critical
factors that physicians consider when deciding on a treatment plan.
These data show that acalabrutinib combined with obinutuzumab
helped previously untreated patients live longer compared with
chlorambucil plus obinutuzumab and was generally
well-tolerated.”
Anas Younes, Senior Vice President, Haematology R&D,
AstraZeneca, said: “We are committed to bringing efficacious and
safe treatments to patients with hematological diseases. With
chronic lymphocytic leukemia, these two factors are particularly
important due to the chronic nature of the disease and the
likelihood of patients having comorbidities. The totality of our
longer-term data at ASCO show CALQUENCE’s efficacy benefits and
sustained safety profile in key treatment settings, providing more
options for patients and their physicians.”
The results were presented at the 2022 American Society of
Clinical Oncology (ASCO) Annual Meeting on June 4, 2022.
Summary of key efficacy
results from the ELEVATE-TN trial1
Median follow-up of 58.2 months
(range: 0.0-72.0)
Efficacy measure
CALQUENCE plus
obinutuzumab
N=179
CALQUENCE
monotherapy
N=179
Chlorambucil
plus
obinutuzumab
N=177
PFS*
Median PFS, months
NR
NR
27.8
HR (95% CI)
0.11 (0.07-0.16)
0.21 (0.15-0.30)
-
p-value
<0.0001
<0.0001
-
Estimated PFS at 60 months, %
84
72
21
OS†
Median OS, months
NR
NR
NR
HR (95% CI)
0.55 (0.30-0.99)
0.98 (0.58-1.64)
-
p-value†
0.0474
0.9816
-
Estimated OS at 60 months, %
90
84
82
ORR*
ORR, % (95% CI)
96.1 (92.1-98.1)
89.9 (84.7-93.5)
83.1 (76.8-87.9)
p-value
<0.0001
0.0499
-
NR, not reached; ORR, overall response
rate
*Investigator-assessed
†P-values are descriptive and not adjusted
for multiplicity
Treatment is ongoing in 65% of patients on CALQUENCE plus
obinutuzumab and 60% of patients on CALQUENCE monotherapy.1 The
most common reasons for treatment discontinuation were adverse
events (AEs) (17%, 16% and 14% for CALQUENCE plus obinutuzumab,
CALQUENCE monotherapy and chlorambucil plus obinutuzumab,
respectively) and progressive disease (6%, 10% and 2%,
respectively).1
Median treatment exposures were 58.1 months and 5.5 months,
respectively, for CALQUENCE and obinutuzumab in the CALQUENCE
combination arm; 58.0 months for CALQUENCE in the monotherapy arm;
and 5.5 months and 5.6 months, respectively, for chlorambucil and
obinutuzumab in the chlorambucil plus obinutuzumab arm.1 Selected
AEs of interest of any grade in the CALQUENCE combination arm,
CALQUENCE monotherapy arm and chlorambucil plus obinutuzumab arm
included bleeding (49.4%, 43.6% and 11.8%, respectively),
hypertension (9.6%, 8.9% and 3.6%, respectively) and atrial
fibrillation (6.2%, 7.3% and 0.6%, respectively).1 Common AEs (any
grade, greater than or equal to 30% of patients) observed with
CALQUENCE with or without obinutuzumab included diarrhea, headache,
arthralgia and neutropenia.1
Summary of key efficacy
results from the ASCEND trial3
Median follow-up of 46.5 months
for CALQUENCE and 45.3 months for IdR/BR
Efficacy measure
CALQUENCE monotherapy
Median follow-up of 46.5
months
IdR/BR
Median follow-up of 45.3
months
(N=155)
(N=155)
PFS*
Median PFS, months
NR
16.8
HR (95% CI)
0.28 (0.20-0.38)
-
p-value
<0.0001
-
Estimated PFS rate at 42 months, %
62
19
PFS*: Patients with 17p deletion or
unmutated IGHV
Median PFS, months
NR (17p deletion or unmutated
IGHV)
13.8 (17p deletion)
16.2 (unmutated IGHV)
HR (95% CI)
0.13 (0.06-0.29) (17p
deletion)
0.29 (0.20-0.41) (unmutated
IGHV)
- (17p deletion or unmutated
IGHV)
p-value
<0.0001
-
OS
Median OS, months
NR
NR
HR (95% CI)
0.69 (0.46-1.04)
-
p-value
0.0783
-
Estimated OS rate at 42 months, %
78
65
ORR
ORR, % (95% CI)
83 (76-88)
84 (77-89)
p-value
0.73
-
INV-assessed ORR inc. PR with
lymphocytosis, %
92
88
*Investigator-assessed
Median treatment exposures were 44.2 months for CALQUENCE; 11.5
months and 5.5 months, respectively, for idelalisib and rituximab
in the IdR arm; and 5.6 months and 5.5 months, respectively, for
bendamustine and rituximab in the BR arm.3 AEs led to treatment
discontinuation in 23% of patients in the CALQUENCE arm, 67% of
patients in the IdR arm and 17% of patients in the BR arm.3 Events
of clinical interest for CALQUENCE versus comparators included
atrial fibrillation/flutter (all grade, 8% and 3%, respectively),
hypertension (all grade, 8% and 5%, respectively), major hemorrhage
(all grade, 3% in both arms) and infections (greater than or equal
to Grade 3, 29% in both arms).3 Common AEs (any grade, greater than
or equal to 15% of patients; or Grade 3 or higher, greater than or
equal to 5% of patients) observed with CALQUENCE included
neutropenia, headache, diarrhea and upper respiratory tract
infection.3
INDICATION AND USAGE
CALQUENCE is a Bruton tyrosine kinase (BTK) inhibitor indicated
for the treatment of adult patients with mantle cell lymphoma (MCL)
who have received at least one prior therapy.
This indication is approved under accelerated approval based on
overall response rate. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in confirmatory trials.
CALQUENCE is also indicated for the treatment of adult patients
with chronic lymphocytic leukemia (CLL) or small lymphocytic
lymphoma (SLL).
IMPORTANT SAFETY INFORMATION ABOUT CALQUENCE® (acalabrutinib)
capsules
Serious and Opportunistic Infections
Fatal and serious infections, including opportunistic
infections, have occurred in patients with hematologic malignancies
treated with CALQUENCE.
Serious or Grade 3 or higher infections (bacterial, viral, or
fungal) occurred in 19% of 1029 patients exposed to CALQUENCE in
clinical trials, most often due to respiratory tract infections
(11% of all patients, including pneumonia in 6%). These infections
predominantly occurred in the absence of Grade 3 or 4 neutropenia,
with neutropenic infection reported in 1.9% of all patients.
Opportunistic infections in recipients of CALQUENCE have included,
but are not limited to, hepatitis B virus reactivation, fungal
pneumonia, Pneumocystis jiroveci pneumonia, Epstein-Barr virus
reactivation, cytomegalovirus, and progressive multifocal
leukoencephalopathy (PML). Consider prophylaxis in patients who are
at increased risk for opportunistic infections. Monitor patients
for signs and symptoms of infection and treat promptly.
Hemorrhage
Fatal and serious hemorrhagic events have occurred in patients
with hematologic malignancies treated with CALQUENCE. Major
hemorrhage (serious or Grade 3 or higher bleeding or any central
nervous system bleeding) occurred in 3.0% of patients, with fatal
hemorrhage occurring in 0.1% of 1029 patients exposed to CALQUENCE
in clinical trials. Bleeding events of any grade, excluding
bruising and petechiae, occurred in 22% of patients.
Use of antithrombotic agents concomitantly with CALQUENCE may
further increase the risk of hemorrhage. In clinical trials, major
hemorrhage occurred in 2.7% of patients taking CALQUENCE without
antithrombotic agents and 3.6% of patients taking CALQUENCE with
antithrombotic agents. Consider the risks and benefits of
antithrombotic agents when co-administered with CALQUENCE. Monitor
patients for signs of bleeding.
Consider the benefit-risk of withholding CALQUENCE for 3-7 days
pre- and post-surgery depending upon the type of surgery and the
risk of bleeding.
Cytopenias
Grade 3 or 4 cytopenias, including neutropenia (23%), anemia
(8%), thrombocytopenia (7%), and lymphopenia (7%), developed in
patients with hematologic malignancies treated with CALQUENCE.
Grade 4 neutropenia developed in 12% of patients. Monitor complete
blood counts regularly during treatment. Interrupt treatment,
reduce the dose, or discontinue treatment as warranted.
Second Primary Malignancies
Second primary malignancies, including skin cancers and other
solid tumors, occurred in 12% of 1029 patients exposed to CALQUENCE
in clinical trials. The most frequent second primary malignancy was
skin cancer, reported in 6% of patients. Monitor patients for skin
cancers and advise protection from sun exposure.
Atrial Fibrillation and Flutter
Grade 3 atrial fibrillation or flutter occurred in 1.1% of 1029
patients treated with CALQUENCE, with all grades of atrial
fibrillation or flutter reported in 4.1% of all patients. The risk
may be increased in patients with cardiac risk factors,
hypertension, previous arrhythmias, and acute infection. Monitor
for symptoms of arrhythmia (e.g., palpitations, dizziness, syncope,
dyspnea) and manage as appropriate.
ADVERSE REACTIONS
The most common adverse reactions (≥ 20%) of any grade in
patients with relapsed or refractory MCL were anemia,*
thrombocytopenia,* headache (39%), neutropenia,* diarrhea (31%),
fatigue (28%), myalgia (21%), and bruising (21%). The most common
Grade ≥ 3 non-hematological adverse reaction (reported in at least
2% of patients) was diarrhea (3.2%).
*Treatment-emergent decreases (all grades) of hemoglobin (46%),
platelets (44%), and neutrophils (36%) were based on laboratory
measurements and adverse reactions.
Dose reductions or discontinuations due to any adverse reaction
were reported in 1.6% and 6.5% of patients, respectively. Increases
in creatinine 1.5 to 3 times the upper limit of normal occurred in
4.8% of patients.
The most common adverse reactions (≥ 30%) of any grade in
patients with CLL were anemia,* neutropenia,* thrombocytopenia,*
headache, upper respiratory tract infection, and diarrhea.
*Treatment-emergent decreases (all grades) of hemoglobin,
platelets, and neutrophils were based on laboratory measurements
and adverse reactions.
In patients with previously untreated CLL exposed to CALQUENCE,
fatal adverse reactions that occurred in the absence of disease
progression and with onset within 30 days of the last study
treatment were reported in 2% for each treatment arm, most often
from infection. Serious adverse reactions were reported in 39% of
patients in the CALQUENCE plus obinutuzumab arm and 32% in the
CALQUENCE monotherapy arm, most often due to events of pneumonia
(7% and 2.8%, respectively).
Adverse reactions led to CALQUENCE dose reduction in 7% and 4%
of patients in the CALQUENCE plus obinutuzumab arm (N=178) and
CALQUENCE monotherapy arm (N=179), respectively. Adverse events led
to discontinuation in 11% and 10% of patients, respectively.
Increases in creatinine 1.5 to 3 times the upper limit of normal
occurred in 3.9% and 2.8% of patients in the CALQUENCE combination
arm and monotherapy arm, respectively.
In patients with relapsed/refractory CLL exposed to CALQUENCE,
serious adverse reactions occurred in 29% of patients. Serious
adverse reactions in > 5% of patients who received CALQUENCE
included lower respiratory tract infection (6%). Fatal adverse
reactions within 30 days of the last dose of CALQUENCE occurred in
2.6% of patients, including from second primary malignancies and
infection.
Adverse reactions led to CALQUENCE dose reduction in 3.9% of
patients (N=154), dose interruptions in 34% of patients, most often
due to respiratory tract infections followed by neutropenia, and
discontinuation in 10% of patients, most frequently due to second
primary malignancies followed by infection. Increases in creatinine
1.5 to 3 times the upper limit of normal occurred in 1.3% of
patients who received CALQUENCE.
DRUG INTERACTIONS
Strong CYP3A Inhibitors: Avoid co-administration with a
strong CYP3A inhibitor. If a strong CYP3A inhibitor will be used
short-term, interrupt CALQUENCE.
Moderate CYP3A Inhibitors: When CALQUENCE is
co-administered with a moderate CYP3A inhibitor, reduce CALQUENCE
dose to 100 mg once daily.
Strong CYP3A Inducers: Avoid co-administration with a
strong CYP3A inducer. If a strong CYP3A inducer cannot be avoided,
increase the CALQUENCE dose to 200 mg approximately every 12
hours.
Gastric Acid Reducing Agents: If treatment with a gastric
acid reducing agent is required, consider using an H2-receptor
antagonist or an antacid. Take CALQUENCE 2 hours before taking an
H2-receptor antagonist. Separate dosing with an antacid by at least
2 hours.
Avoid co-administration with proton pump inhibitors. Due to the
long-lasting effect of proton pump inhibitors, separation of doses
may not eliminate the interaction with CALQUENCE.
SPECIFIC POPULATIONS
Based on findings in animals, CALQUENCE may cause fetal harm and
dystocia when administered to a pregnant woman. There are no
available data in pregnant women to inform the drug-associated
risk. Advise pregnant women of the potential risk to a fetus.
Pregnancy testing is recommended for females of reproductive
potential prior to initiating CALQUENCE therapy. Advise female
patients of reproductive potential to use effective contraception
during treatment with CALQUENCE and for at least 1 week following
the last dose of CALQUENCE.
It is not known if CALQUENCE is present in human milk. Advise
lactating women not to breastfeed while taking CALQUENCE and for at
least 2 weeks after the final dose.
Avoid administration of CALQUENCE in patients with severe
hepatic impairment. Dose modifications are not required for
patients with mild or moderate hepatic impairment.
Please see full Prescribing
Information, including Patient Information.
Notes
CLL
CLL is the most prevalent type of leukemia in adults, with over
100,000 new cases globally in 2019 and an estimated 20,160 new
cases in the US in 2022.2,4 Although some people with CLL may not
experience any symptoms at diagnosis, others may experience
symptoms, such as weakness, fatigue, weight loss, chills, fever,
night sweats, swollen lymph nodes and abdominal pain.5
In CLL, too many blood stem cells in the bone marrow become
abnormal lymphocytes and these abnormal cells have difficulty
fighting infections.6 As the number of abnormal cells grows, there
is less room for healthy white blood cells, red blood cells and
platelets.6 This could result in anemia, infection and bleeding.6
B-cell receptor signaling through Bruton’s tyrosine kinase (BTK) is
one of the essential growth pathways for CLL.6
ELEVATE-TN
ELEVATE-TN (ACE-CL-007) is a randomized, multicenter, open-label
Phase III trial evaluating the safety and efficacy of CALQUENCE
alone or in combination with obinutuzumab versus chlorambucil in
combination with obinutuzumab in previously untreated patients with
CLL. In the trial, 535 patients were randomized (1:1:1) into three
arms.7 Patients in the first arm received chlorambucil in
combination with obinutuzumab.7 Patients in the second arm received
CALQUENCE (100mg twice daily until disease progression) in
combination with obinutuzumab.7 Patients in the third arm received
CALQUENCE monotherapy (100mg twice daily until disease
progression).7
The primary endpoint was PFS in the CALQUENCE and obinutuzumab
arm compared to the chlorambucil and obinutuzumab arm, assessed by
an independent review committee (IRC), and a key secondary endpoint
was IRC-assessed PFS in the CALQUENCE monotherapy arm compared to
the chlorambucil and obinutuzumab arm.7 Other secondary endpoints
included overall response rate, time to next treatment, OS and
investigator assessed PFS.7 After interim analysis, assessments
were by investigator only.7,8
Initial results from the ELEVATE-TN Phase III trial were
presented in December 2019 at the American Society of Hematology
Annual Meeting and Exhibition.9 The trial met its primary endpoint
(IRC-assessed PFS with CALQUENCE plus obinutuzumab versus
chlorambucil plus obinutuzumab) at the data cut-off for the interim
analysis after a median follow-up of 28.3 months.8 The findings,
along with previously reported data from the Phase III ASCEND trial
in relapsed or refractory CLL, supported the approvals of CALQUENCE
by the US FDA and the Australian Therapeutic Goods Administration
for the treatment of adult patients with CLL or small lymphocytic
lymphoma (SLL) and by the European Medicines Agency (EMA) and
Health Canada for CLL.
ASCEND
ASCEND (ACE-CL-309) is a global, randomized, multicenter,
open-label Phase III trial evaluating the efficacy of CALQUENCE in
patients with relapsed or refractory CLL.10
In the trial, 310 patients were randomized (1:1) into two
treatment arms.10 Patients in the first arm received CALQUENCE
monotherapy (100mg twice-daily until disease progression or
unacceptable toxicity).10 Patients in the second arm received
physician’s choice of either rituximab, a CD20 monoclonal antibody,
in combination with idelalisib, a PI3-kinase inhibitor, or
rituximab in combination with bendamustine, a chemotherapy.10
The primary endpoint at the interim analysis was PFS assessed by
an IRC, and key secondary endpoints included investigator-assessed
PFS, IRC- and investigator-assessed overall response rate, and
duration of response, as well as overall survival, patient-reported
outcomes and time to next treatment.10,11
ASCEND is the first randomized Phase III trial to directly
compare a BTK inhibitor as monotherapy to these combinations in
relapsed or refractory CLL.11
CALQUENCE
CALQUENCE (acalabrutinib) is a next-generation, selective
inhibitor of BTK. CALQUENCE binds covalently to BTK, thereby
inhibiting its activity.12,13 In B cells, BTK signaling results in
activation of pathways necessary for B-cell proliferation,
trafficking, chemotaxis and adhesion.13
CALQUENCE is approved for the treatment of CLL and SLL in the
US, approved for CLL in the EU and many other countries worldwide
and approved in Japan for relapsed or refractory CLL and SLL. A
Phase I trial is currently underway in Japan for the treatment of
front-line CLL.
In the US and several other countries, CALQUENCE is also
approved for the treatment of adult patients with mantle cell
lymphoma (MCL) who have received at least one prior therapy. The US
MCL indication is approved under accelerated approval based on
overall response rate. Continued approval for this indication may
be contingent upon verification and description of clinical benefit
in confirmatory trials. CALQUENCE is not currently approved for the
treatment of MCL in Europe or Japan.
As part of an extensive clinical development program,
AstraZeneca and Acerta Pharma are currently evaluating CALQUENCE in
more than 20 company-sponsored clinical trials. CALQUENCE is being
evaluated for the treatment of multiple B-cell blood cancers
including CLL, MCL, diffuse large B-cell lymphoma, Waldenstr�m’s
macroglobulinemia, marginal zone lymphoma and other hematologic
malignancies.
AstraZeneca in hematology
AstraZeneca is pushing the boundaries of science to redefine
care in hematology. We have expanded our commitment to patients
with hematologic conditions, not only in oncology but also in rare
diseases with the acquisition of Alexion, allowing us to reach more
patients with the greatest unmet needs. By applying our deep
understanding of blood cancers, leveraging our strength in solid
tumor oncology and delivering on Alexion’s pioneering legacy in
complement science to provide transformative medicines for rare
diseases, we are pursuing the end-to-end development of novel
therapies designed to target underlying drivers of disease.
By targeting hematological conditions with high unmet medical
needs, we aim to deliver innovative medicines and approaches to
improve patient outcomes. Our goal is to transform the lives of
patients living with malignant, rare and other related hematologic
diseases, shaped by insights from patients, caregivers and
physicians to have the most meaningful impact.
AstraZeneca in oncology
AstraZeneca is leading a revolution in oncology with the
ambition to provide cures for cancer in every form, following the
science to understand cancer and all its complexities to discover,
develop and deliver life-changing medicines to patients.
The Company’s focus is on some of the most challenging cancers.
It is through persistent innovation that AstraZeneca has built one
of the most diverse portfolios and pipelines in the industry, with
the potential to catalyze changes in the practice of medicine and
transform the patient experience.
AstraZeneca has the vision to redefine cancer care and, one day,
eliminate cancer as a cause of death.
About AstraZeneca
AstraZeneca is a global, science-led biopharmaceutical company
that focuses on the discovery, development and commercialization of
prescription medicines in Oncology, Rare Diseases and
BioPharmaceuticals, including Cardiovascular, Renal &
Metabolism, and Respiratory & Immunology. Based in Cambridge,
UK, AstraZeneca operates in over 100 countries, and its innovative
medicines are used by millions of patients worldwide. For more
information, please visit www.astrazeneca-us.com and follow us on
Twitter @AstraZenecaUS.
References
1.
Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib ±
Obinutuzumab vs Obinutuzumab + Chlorambucil in Treatment-Naïve
Chronic Lymphocytic Leukemia: 5-Year Follow-up of ELEVATE-TN
[abstract and poster]. Presented at: American Society for Clinical
Oncology (ASCO) Annual Meeting; June 3-7, 2022. Abstract ID: 7539.
2.
Yao Y, Lin X, Li F, et al. The global burden and
attributable risk factors of chronic lymphocytic leukemia in 204
countries and territories from 1990 to 2019: analysis based on the
global burden of disease study 2019. Biomed Eng Online. 2022;1:4.
doi:10.1186/s12938-021-00973-6.
3.
Jurczak W, Pluta A, Wach M, et al. Acalabrutinib vs
Rituximab Plus Idelalisib or Bendamustine in Relapsed/Refractory
Chronic Lymphocytic Leukemia: ASCEND Results at ~4 Years of
Follow-up [abstract and poster]. Presented at: ASCO Annual Meeting;
June 3-7, 2022. Abstract ID: 7538.
4.
National Cancer Institute (NCI). Cancer stat facts: leukemia
— chronic lymphocytic leukemia (CLL). NCI website. Accessed June
2022. https://seer.cancer.gov/statfacts/html/clyl.html
5.
American Cancer Society (ACS). What is chronic lymphocytic
leukemia. ACS website. Accessed June 2022.
https://www.cancer.org/cancer/chronic-lymphocytic-leukemia/about/what-is-cll.html
6.
National Cancer Institute (NCI). Chronic Lymphocytic
Leukemia Treatment (PDQ®)–Patient Version. NCI website. Accessed
June 2022.
https://www.cancer.gov/types/leukemia/patient/cll-treatment-pdq
7.
AstraZeneca. ELEVATE CLL TN: Study of Obinutuzumab +
Chlorambucil, Acalabrutinib (ACP-196) + Obinutuzumab, and
Acalabrutinib in Subjects With Previously Untreated CLL.
ClinicalTrials.gov website. Accessed June 2022.
https://clinicaltrials.gov/ct2/show/NCT02475681
8.
Sharman JP, Egyed M, Jurczak W, et al. Acalabrutinib with or
without obinutuzumab versus chlorambucil and obinutuzumab for
treatment-naive chronic lymphocytic leukaemia (ELEVATE-TN): a
randomized, controlled, phase 3 trial. Lancet. 2020;395:1278-1291.
doi:10.1182/blood-2019-128404.
9.
Sharman JP, Egyed M, Jurczak W, et al. ELEVATE-TN: Phase 3
Study of Acalabrutinib Combined with Obinutuzumab (O) or Alone vs O
Plus Chlorambucil (Clb) in Patients (Pts) With Treatment-Naive
Chronic Lymphocytic Leukemia (CLL) [presentation]. Presented at:
American Society of Hematology 2019 Annual Meeting and Exposition;
December 7-10, 2019; Orlando, FL.
10.
AstraZeneca. A Study of Acalabrutinib vs Investigator's
Choice of Idelalisib Plus Rituximab or Bendamustine Plus Rituximab
in R/R CLL. ClinicalTrials.gov website. Accessed June 2022.
https://clinicaltrials.gov/ct2/show/NCT02970318
11.
Ghia P, Pluta A, Wach M, et al. Acalabrutinib versus
idelalisib plus rituximab or bendamustine plus rituximab in
relapsed or refractory chronic lymphocytic leukemia (ASCEND): a
randomized phase 3 trial. J Clin Oncol. 2020;25: 2849-2861.
doi:10.1200/JCO.19.03355.
12.
CALQUENCE® (acalabrutinib) [prescribing information].
Wilmington, DE; AstraZeneca Pharmaceuticals LP; 2019.14.
13.
Wu J, Zhang M, Liu D. Acalabrutinib (ACP-196): a selective
second-generation BTK inhibitor. J Hematol Oncol. 2016;9(21).
US-64404 Last Updated 6/22
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220604005021/en/
Media Inquiries Brendan McEvoy +1 302 885 2677
Jessica McDuell +1 302 885 2677
US Media Mailbox: usmediateam@astrazeneca.com
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jun 2024 bis Jul 2024
AstraZeneca (NASDAQ:AZN)
Historical Stock Chart
Von Jul 2023 bis Jul 2024