Data focused on breaking treatment boundaries,
treating patients earlier in their disease, and raising the bar for
better outcomes
Presentations highlight LYNPARZA®’s benefit in
PARP-mediated cancers and IMFINZI®’s three-year overall survival in
unresectable, Stage III non-small cell lung cancer
AstraZeneca will present new research across an industry-leading
Oncology portfolio, including data for its transformational cancer
medicines LYNPARZA® (olaparib) and IMFINZI® (durvalumab) at the
2019 American Society of Clinical Oncology (ASCO) Annual Meeting in
Chicago, May 31 to June 4, 2019.
In all, the Company will present 93 abstracts spanning multiple
tumor types, including 12 oral presentations with one plenary
session and four late-breakers. Highlights include:
- Late-breaking results from the LYNPARZA
POLO trial, the first positive Phase III trial of any PARP
inhibitor in germline BRCA-mutated (gBRCAm) metastatic pancreatic
cancer, a devastating diagnosis with critical unmet medical need.
This is the first Phase III trial to validate a targeted treatment
in a biomarker-selected population of pancreatic cancer.
- Results of the Phase III SOLO-3 trial
highlighting the efficacy and safety for LYNPARZA monotherapy vs.
standard-of-care chemotherapy in treating patients with gBRCAm
advanced ovarian cancer who had two or more prior lines of
treatment. This data underscores LYNPARZA’s clinical benefit
irrespective of line of therapy for women with BRCAm advanced
ovarian cancer and the importance of knowing BRCA status at
diagnosis.
- Three-year overall survival (OS) data
from the Phase III PACIFIC trial providing new longer-term survival
evidence for IMFINZI in unresectable, Stage III non-small cell lung
cancer (NSCLC) in patients whose disease had not progressed
following chemoradiation therapy. IMFINZI is the only immunotherapy
to have demonstrated significant OS benefits in this
curative-intent setting, and these updated data reaffirm the
PACIFIC regimen as a standard of care for these patients.
Dave Fredrickson, Executive Vice President, Oncology, said:
“AstraZeneca continues to break traditional treatment boundaries
through new targeted approaches and the prioritization of earlier
intervention. This year at ASCO, our data for LYNPARZA in
BRCA-mutated metastatic pancreatic cancer and for IMFINZI in
unresectable Stage III non-small cell lung cancer illustrate our
ambition to change medical practice for better patient
outcomes.”
Breaking treatment boundaries
AstraZeneca is committed to redefining disease treatment for
patient populations with unmet needs. This will be evidenced at the
ASCO meeting for patients with BRCA-mutated PARP-mediated tumors,
those with HER2-low expressing tumors or those with AKT-mutated
tumors.
The plenary presentation of results from the Phase III POLO
trial will detail the progression-free survival (PFS) and important
clinical activity of LYNPARZA in patients with metastatic
pancreatic cancer, a population that has seen very little treatment
progress over the past 40 years (Abstract #LBA4).
New data on LYNPARZA will also be shared in advanced ovarian
cancer, including the results of the Phase III SOLO-3 trial
highlighting the efficacy and safety for LYNPARZA monotherapy vs.
standard-of-care chemotherapy in treating patients with gBRCAm
advanced ovarian cancer who had two or more prior lines of
treatment (Abstract #5506).
Furthermore, the Phase II TOPARP-B trial, sponsored by the
Institute of Cancer Research (UK), will highlight the anti-tumor
activity of LYNPARZA in patients with heavily pretreated metastatic
castration resistant prostate cancer with DDR gene defects
(Abstract #5005). The Phase II GeparOLA trial, conducted by the
German Breast Group and German AGO-B Breast Study Group, will help
define the safety and efficacy of LYNPARZA, compared to
platinum-based chemotherapy, in the neoadjuvant setting in
HER2-negative early breast cancer and in patients with homologous
recombination deficiency (Abstract #506).
The design of the Phase III DESTINY-Breast04 trial evaluating
trastuzumab deruxtecan (DS-8201) in metastatic breast cancer with
HER2-low expressing tumors will be presented at this year’s ASCO
meeting (Abstract #TPS1102). This antibody-drug conjugate (ADC)
co-developed with Daiichi Sankyo has the potential to redefine
breast cancer treatment. Two publications in Lancet Oncology
recently highlighted the Phase I dose-expansion results for
trastuzumab deruxtecan in HER2-positive metastatic breast and
gastric cancers.
In addition, data will be presented from the Phase II FAKTION
trial, sponsored by Velindre NHS Trust, on the combination of the
AKT inhibitor capivasertib (AZD5363) plus FASLODEX® (fulvestrant)
in patients with relapsed metastatic estrogen receptor
(ER)-positive breast cancer (Abstract #1005). AKT mutations occur
across several different cancers and may be a target for therapy
tailored to tumor genes rather than cancer types.
Treating patients earlier in their disease
AstraZeneca made a significant breakthrough in the treatment of
NSCLC beginning in 2017 with the Phase III PACIFIC trial
demonstrating unprecedented PFS and subsequently OS benefits for
patients with unresectable Stage III NSCLC treated with IMFINZI
following concurrent chemoradiotherapy vs. standard of care. At
this year’s ASCO meeting, AstraZeneca will provide new longer-term
survival evidence of IMFINZI with a three-year OS update (Abstract
#8526).
Sub-analysis presentations of Phase III data from SOLO-1, the
only trial of a PARP inhibitor to demonstrate improvement in PFS
for women with BRCAm advanced ovarian cancer as a 1st-line
maintenance treatment, will reinforce the potential of using
LYNPARZA earlier in the treatment pathway (Abstract #5539).
Raising the bar for better outcomes
New data from the Phase III FLAURA trial will explore clinical
outcomes associated with the detection of epidermal growth factor
receptor (EGFR) mutations in plasma at three or six weeks after
starting treatment with TAGRISSO® (osimertinib) (Abstract #9020).
With the presentation of the Phase II SAVANNAH trial design,
AstraZeneca will explain how it will explore the combination of
TAGRISSO and savolitinib to potentially overcome MET-driven EGFR
tyrosine kinase inhibitor (TKI) resistance following TAGRISSO
treatment in EGFR-mutated NSCLC (Abstract #TPS9119).
Despite recent therapeutic progress, platinum-resistant ovarian
cancer remains a therapeutic challenge. Results of a multicenter,
double-blind Phase II trial conducted by the Princess Margaret,
California, Chicago and Mayo Phase II Consortia will show for the
first time increased OS data with the Wee-1 inhibitor adavosertib
when associated with the antimetabolite therapy Gemcitabine
(Abstract #5518).
A focus on hematology
Our diverse hematology pipeline aims to deliver therapies in
a range of blood cancers with critical unmet medical need
AstraZeneca has established hematology as one of its key areas
of focus. At the ASCO meeting and the upcoming 24th Congress of the
European Hematology Association (EHA), June 13-16, 2019, the
Company will present long-term trial follow-up data showing the
promising response rate, duration of response and safety profile of
the Bruton’s tyrosine kinase (BTK) inhibitor CALQUENCE®
(acalabrutinib) in chronic lymphocytic leukemia (CLL),
including:
- Three-year results from the Phase Ib/II
ACE-CL-003 trial evaluating CALQUENCE and obinutuzumab in
treatment-naïve and previously-treated CLL (Abstract #7500).
- 19-month results from the Phase II
ACE-CL-208 trial of CALQUENCE in patients with relapsed or
refractory CLL intolerant to ibrutinib (Abstract #7530).
These data are part of a robust development program that
includes two pivotal clinical trials for CALQUENCE in CLL with data
anticipated in 2019: the Phase III ASCEND (ACE-CL-309) trial in
relapsed or refractory CLL, which recently met its primary
endpoint, and the ongoing Phase III ELEVATE-TN (ACE-CL-007) trial
evaluating CALQUENCE® with and without obinutuzumab in 1st-line
CLL.
Key AstraZeneca presentations at ASCO 2019
Lead author
Abstract title
Presentation details
Immuno-Oncology
Gray, JE
Three-year overall survival update from the
PACIFIC trial.
Abstract #8526Poster Board #282Poster
Session – Lung Cancer – Non-Small Cell Local-Regional/Small
Cell/Other Thoracic CancersSunday, June 28:00-11:00amHall A
Planchard, D
First subsequent treatment after
discontinuation of durvalumab in unresectable, Stage III NSCLC
patients from PACIFIC.
Abstract #9054Poster Board #377Poster
Session – Lung Cancer – Non-Small Cell MetastaticSunday, June
28:00-11:00amHall A
Rizvi, NA
Blood tumor mutational burden (bTMB) and tumor
PD-L1 as predictive biomarkers of survival in MYSTIC: first-line
durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT) in
metastatic (m) NSCLC.
Abstract #9016Poster Board #339Poster
Discussion – Lung Cancer – Non-Small Cell MetastaticSunday, June
24:30 – 6:00pmHall D1
Garon, EB
Patient-reported outcomes (PROs) with
first-line durvalumab (D) ± tremelimumab (T) vs chemotherapy (CT)
in metastatic NSCLC: results from MYSTIC.
Abstract #9048Poster Board #371Poster
Presentation – Lung Cancer – Non-Small Cell MetastaticSunday, June
28:00am – 11:00amHall A
Bradley, JD
PACIFIC-2: phase 3 study of concurrent
durvalumab and platinum-based chemoradiotherapy in patients with
unresectable, stage III NSCLC.
Abstract #TPS8573Poster Board #327aPoster
Presentation – Lung Cancer – Non-Small Cell Local-Regional/Small
Cell/Other Thoracic CancersSunday, June 28:00am – 11:00amHall A
DNA damage response
Kindler, H
Olaparib as maintenance treatment following
first-line platinum-based chemotherapy (PBC) in patients (pts) with
a germline BRCA mutation and metastatic pancreatic cancer (mPC):
Phase III POLO trial.
Abstract #LBA4Plenary Session Including
the Distinguished Achievement Award and Science of Oncology Award
LectureSunday, June 23:15-3:30pmHall B1
Penson, R
Olaparib monotherapy versus (vs) chemotherapy
for germline BRCA-mutated (gBRCAm) platinum-sensitive relapsed
ovarian cancer (PSR OC) patients (pts): Phase III SOLO3 trial.
Abstract #5506Oral Abstract Session –
Gynecologic CancerMonday, June 33:15-3:27pmS406
Colombo, N
Adverse events (AEs) with maintenance olaparib
in newly diagnosed patients (pts) with advanced ovarian cancer (OC)
and a BRCA mutation (BRCAm): Phase III SOLO1 trial.
Abstract #5539Poster Board #362Poster
Session – Gynecologic CancerSaturday, June 11:15-4:15pmHall A
Mateo, J
TOPARP-B: A phase II randomized trial of the
poly(ADP)-ribose polymerase (PARP) inhibitor olaparib for
metastatic castration resistant prostate cancers (mCRPC) with DNA
damage repair (DDR) alterations.
Abstract #5005Oral Abstract Session –
Genitourinary (Prostate) CancerFriday, May 314:09-4:21pmArie Crown
Theater
Lheureux, S
A randomized double-blind placebo-controlled
phase II trial comparing gemcitabine monotherapy to gemcitabine in
combination with adavosertib in women with recurrent, platinum
resistant epithelial ovarian cancer: A trial of the Princess
Margaret, California, Chicago and Mayo Phase II Consortia.
Abstract #5518Poster Board #341Poster
Session – Gynecologic CancerSaturday, June 14:30-6:00pmHall A
Fasching, P
GeparOLA: A randomized phase II trial to
assess the efficacy of paclitaxel and olaparib in comparison to
paclitaxel/carboplatin followed by epirubicin/cyclophosphamide as
neoadjuvant chemotherapy in patients (pts) with HER2-negative early
breast cancer (BC) and homologous recombination deficiency (HRD).
Abstract #506Oral Abstract Session –
Breast Cancer—Local/Regional/AdjuvantMonday, June
311:45-11:57pmHall D2
Tumor drivers and resistance
Oxnard, GR
SAVANNAH: A Phase II trial of osimertinib plus
savolitinib for patients (pts) with EGFR-mutant, MET-driven (MET+),
locally advanced or metastatic non-small cell lung cancer (NSCLC),
following disease progression on osimertinib.
Abstract #TPS9119Poster Board #439bPoster
Session – Lung Cancer – Non-Small Cell MetastaticSunday, June
28:00-11:00amHall A
Zhou, C
Early clearance of plasma EGFR mutations as a
predictor of response to osimertinib and comparator EGFR-TKIs in
the FLAURA trial.
Abstract #9020Poster Board #343Poster
Session – Lung Cancer – Non-Small Cell MetastaticSunday, June
28:00-11:00amHall A
Jones, RH
Capivasertib (AZD5363) plus fulvestrant versus
placebo plus fulvestrant after relapse or progression on an
aromatase inhibitor in metastatic ER-positive breast cancer
(FAKTION): A randomized, double-blind, placebo-controlled, phase II
trial.
Abstract #1005Oral Abstract Session –
Breast Cancer – MetastaticTuesday, June 411:09-11:21amHall D1
Haematology
Woyach, J
Acalabrutinib with obinutuzumab (Ob) in
treatment-naive (TN) and relapsed/refractory (R/R) chronic
lymphocytic leukemia (CLL): Three-year follow-up.
Abstract #7500Oral Abstract Session –
Hematologic Malignancies – Lymphoma and Chronic Lymphocytic
LeukemiaTuesday, June 49:45-9:57amE451
Rogers, KA
Phase 2 study of acalabrutinib in ibrutinib
(IBR)-intolerant patients (pts) with relapsed/refractory (R/R)
chronic lymphocytic leukemia (CLL).
Abstract #7530Poster Board #284Poster
Session – Hematologic Malignancies – Lymphoma and Chronic
Lymphocytic LeukemiaMonday, June 38:00-11:00amHall A
Trastuzumab deruxtecan
(DS-8201)
Modi, S
A phase III, multicenter, randomized, open
label trial of [fam-] trastuzumab deruxtecan (DS-8201a) versus
investigator’s choice in HER2-low breast cancer.
Abstract #TPS1102Poster Board #182aPoster
Session – Breast Cancer – MetastaticSunday, June 28:00 –
11:00amHall A
In addition to the scientific presentations and press releases
planned at the ASCO meeting, AstraZeneca and its partner MSD (MSD:
known as Merck & Co., Inc. inside the US and Canada) will host
a press briefing on Sunday, June 2, on LYNPARZA. For more
information, please contact AstraZeneca Media Relations.
SELECT SAFETY INFORMATION for LYNPARZA® (olaparib)
tablets
CONTRAINDICATIONS
There are no contraindications for LYNPARZA.
WARNINGS AND PRECAUTIONS
Myelodysplastic Syndrome/Acute Myeloid Leukemia
(MDS/AML): Occurred in <1.5% of patients exposed to LYNPARZA
monotherapy, and the majority of events had a fatal outcome. The
duration of therapy in patients who developed secondary MDS/AML
varied from <6 months to >2 years. All of these patients had
previous chemotherapy with platinum agents and/or other
DNA-damaging agents, including radiotherapy, and some also had a
history of more than one primary malignancy or of bone marrow
dysplasia.
Do not start LYNPARZA until patients have recovered from
hematological toxicity caused by previous chemotherapy (≤Grade 1).
Monitor complete blood count for cytopenia at baseline and monthly
thereafter for clinically significant changes during treatment. For
prolonged hematological toxicities, interrupt LYNPARZA and monitor
blood count weekly until recovery.
If the levels have not recovered to Grade 1 or less after 4
weeks, refer the patient to a hematologist for further
investigations, including bone marrow analysis and blood sample for
cytogenetics. Discontinue LYNPARZA if MDS/AML is confirmed.
Pneumonitis: Occurred in <1% of patients exposed to
LYNPARZA, and some cases were fatal. If patients present with new
or worsening respiratory symptoms such as dyspnea, cough, and
fever, or a radiological abnormality occurs, interrupt LYNPARZA
treatment and initiate prompt investigation. Discontinue LYNPARZA
if pneumonitis is confirmed and treat patient appropriately.
Embryo-Fetal Toxicity: Based on its mechanism of action
and findings in animals, LYNPARZA can cause fetal harm. A pregnancy
test is recommended for females of reproductive potential prior to
initiating treatment.
FemalesAdvise females of reproductive potential of the potential
risk to a fetus and to use effective contraception during treatment
and for 6 months following the last dose.
MalesAdvise male patients with female partners of reproductive
potential or who are pregnant to use effective contraception during
treatment and for 3 months following the last dose of LYNPARZA and
to not donate sperm during this time.
ADVERSE REACTIONS
The most common adverse reactions (>/10%) in clinical trials
were nausea, fatigue (including asthenia), anemia, vomiting,
abdominal pain, dizziness, diarrhea, neutropenia, leukopenia,
nasopharyngitis/upper respiratory tract infection,
arthralgia/myalgia, dysgeusia, headache, dyspepsia, decreased
appetite, constipation and stomatitis.
INDICATIONS
LYNPARZA is a poly (ADP-ribose) polymerase (PARP) inhibitor
indicated:
First-Line Maintenance BRCAm Advanced Ovarian Cancer
For the maintenance treatment of adult patients with deleterious
or suspected deleterious germline or somatic
BRCA-mutated (gBRCAm or sBRCAm) advanced epithelial ovarian,
fallopian tube, or primary peritoneal cancer who are in complete or
partial response to first-line platinum-based chemotherapy. Select
patients with gBRCAm advanced epithelial ovarian, fallopian tube,
or primary peritoneal cancer for therapy based on an FDA-approved
companion diagnostic for LYNPARZA.
Maintenance Recurrent Ovarian Cancer
For the maintenance treatment of adult patients with recurrent
epithelial ovarian, fallopian tube, or primary peritoneal cancer,
who are in complete or partial response to platinum-based
chemotherapy.
Advanced gBRCAm Ovarian Cancer
For the treatment of adult patients with deleterious or
suspected deleterious germline BRCA-mutated (gBRCAm) advanced
ovarian cancer who have been treated with 3 or more prior lines of
chemotherapy. Select patients for therapy based on an FDA-approved
companion diagnostic for LYNPARZA.
gBRCAm, HER2-Negative Metastatic Breast Cancer
In patients with deleterious or suspected deleterious gBRCAm,
human epidermal growth factor receptor 2 (HER2)-negative metastatic
breast cancer who have been treated with chemotherapy in the
neoadjuvant, adjuvant, or metastatic setting. Patients with hormone
receptor (HR)-positive breast cancer should have been treated with
a prior endocrine therapy or be considered inappropriate for
endocrine therapy. Select patients for therapy based on an
FDA-approved companion diagnostic for LYNPARZA.
Please see complete Prescribing
Information, including Patient Information
(Medication Guide).
SELECT SAFETY INFORMATION for IMFINZI®
(durvalumab) injection for intravenous use
There are no contraindications for IMFINZI.
IMFINZI can cause immune-mediated adverse reactions, including
immune-mediated pneumonitis, hepatitis, colitis or diarrhea,
endocrinopathies (including thyroid disorders, adrenal
insufficiency, type 1 diabetes, and hypophysitis), nephritis,
dermatologic reactions, and other immune-mediated adverse
reactions; infection; and infusion-related. Please refer to the
full Prescribing Information for important dosage modification and
management information specific to adverse reactions.
Serious, potentially fatal risks were seen with IMFINZI. Serious
adverse reactions occurred in 29% of patients with unresectable
Stage III NSCLC receiving IMFINZI (n=475). The most frequent
serious adverse reactions (≥2% of patients) were pneumonitis or
radiation pneumonitis (7%) and pneumonia (6%). The most common
adverse reactions (≥20%) were cough (40%), fatigue (34%),
pneumonitis or radiation pneumonitis (34%), upper respiratory tract
infections (26%), dyspnea (25%), and rash (23%).
Advise women not to become pregnant or breastfeed during
treatment with IMFINZI and for at least 3 months after the last
dose.
The safety and effectiveness of IMFINZI have not been
established in pediatric patients.
INDICATION
IMFINZI is indicated for the treatment of patients
with unresectable Stage III non-small cell lung
cancer (NSCLC) whose disease has not progressed following
concurrent platinum-based chemotherapy and radiation
therapy.
Please see complete Prescribing
Information, including Patient Information
(Medication Guide).
TAGRISSO® (osimertinib) Important Safety
Information
- There are no contraindications for
TAGRISSO
- Interstitial lung disease
(ILD)/pneumonitis occurred in 3.9% of the 1142 TAGRISSO-treated
patients; 0.4% of cases were fatal. Withhold TAGRISSO and promptly
investigate for ILD in patients who present with worsening of
respiratory symptoms which may be indicative of ILD (eg, dyspnea,
cough and fever). Permanently discontinue TAGRISSO if ILD is
confirmed
- Heart rate-corrected QT (QTc) interval
prolongation occurred in TAGRISSO-treated patients. Of the 1142
TAGRISSO-treated patients in clinical trials, 0.9% were found to
have a QTc > 500 msec, and 3.6% of patients had an
increase from baseline QTc > 60 msec. No QTc-related
arrhythmias were reported. Conduct periodic monitoring with
ECGs and electrolytes in patients with congenital long QTc
syndrome, congestive heart failure, electrolyte abnormalities, or
those who are taking medications known to prolong the QTc interval.
Permanently discontinue TAGRISSO in patients who develop QTc
interval prolongation with signs/symptoms of life-threatening
arrhythmia
- Cardiomyopathy occurred in 2.6% of the
1142 TAGRISSO-treated patients; 0.1% of cardiomyopathy cases were
fatal. A decline in left ventricular ejection fraction (LVEF) ≥10%
from baseline and to <50% LVEF occurred in 3.9% of 908 patients
who had baseline and at least one follow-up LVEF assessment.
Conduct cardiac monitoring, including assessment of LVEF at
baseline and during treatment, in patients with cardiac risk
factors. Assess LVEF in patients who develop relevant cardiac signs
or symptoms during treatment. For symptomatic congestive heart
failure, permanently discontinue TAGRISSO
- Keratitis was reported in 0.7% of 1142
patients treated with TAGRISSO in clinical trials. Promptly refer
patients with signs and symptoms suggestive of keratitis (such as
eye inflammation, lacrimation, light sensitivity, blurred vision,
eye pain and/or red eye) to an ophthalmologist
- Verify pregnancy status of females of
reproductive potential prior to initiating TAGRISSO. Advise
pregnant women of the potential risk to a fetus. Advise females of
reproductive potential to use effective contraception during
treatment with TAGRISSO and for 6 weeks after the final dose.
Advise males with female partners of reproductive potential to use
effective contraception for 4 months after the final dose
- Most common adverse reactions (≥20%)
were diarrhea, rash, dry skin, nail toxicity, stomatitis, fatigue
and decreased appetite
INDICATIONS
- TAGRISSO is indicated for the
first-line treatment of patients with metastatic non-small cell
lung cancer (NSCLC) whose tumors have epidermal growth factor
receptor (EGFR) exon 19 deletions or exon 21 L858R mutations, as
detected by an FDA-approved test
- TAGRISSO is indicated for the treatment
of patients with metastatic EGFR T790M mutation-positive NSCLC, as
detected by an FDA-approved test, whose disease has progressed on
or after EGFR tyrosine kinase inhibitor (TKI) therapy
Please see complete Prescribing
Information including Patient Information.
SELECT SAFETY INFORMATION for CALQUENCE® (acalabrutinib)
capsules
Hemorrhage
Serious hemorrhagic events, including fatal events, have
occurred in the combined safety database of 612 patients with
hematologic malignancies treated with CALQUENCE monotherapy. Grade
3 or higher bleeding events, including gastrointestinal,
intracranial, and epistaxis, have been reported in 2% of patients.
Overall, bleeding events, including bruising and petechiae of any
grade, occurred in approximately 50% of patients with hematological
malignancies.
The mechanism for the bleeding events is not well
understood.
CALQUENCE may further increase the risk of hemorrhage in
patients receiving antiplatelet or anticoagulant therapies, and
patients should be monitored for signs of bleeding.
Consider the benefit-risk of withholding CALQUENCE for 3 to 7
days pre- and post-surgery, depending upon the type of surgery and
the risk of bleeding.
Infection
Serious infections (bacterial, viral, or fungal), including
fatal events and opportunistic infections, have occurred in the
combined safety database of 612 patients with hematologic
malignancies treated with CALQUENCE monotherapy. Grade 3 or higher
infections occurred in 18% of these patients. The most frequently
reported Grade 3 or 4 infection was pneumonia. Infections due to
hepatitis B virus (HBV) reactivation and progressive multifocal
leukoencephalopathy (PML) have occurred.
Monitor patients for signs and symptoms of infection and treat
as medically appropriate. Consider prophylaxis in patients who are
at increased risk for opportunistic infections.
Cytopenias
In the combined safety database of 612 patients with hematologic
malignancies, patients treated with CALQUENCE monotherapy
experienced Grade 3 or 4 cytopenias, including neutropenia (23%),
anemia (11%), and thrombocytopenia (8%), based on laboratory
measurements. Monitor complete blood counts monthly during
treatment.
Second Primary Malignancies
Second primary malignancies, including non-skin carcinomas, have
occurred in 11% of patients with hematologic malignancies treated
with CALQUENCE monotherapy in the combined safety database of 612
patients. The most frequent second primary malignancy was skin
cancer, reported in 7% of patients. Advise protection from sun
exposure.
Atrial Fibrillation and Flutter
In the combined safety database of 612 patients with hematologic
malignancies treated with CALQUENCE monotherapy, atrial
fibrillation and atrial flutter of any grade occurred in 3% of
patients, and Grade 3 in 1% of patients. Monitor for atrial
fibrillation and atrial flutter and manage as appropriate.
ADVERSE REACTIONS
The most common adverse reactions (≥20%) of any grade were
anemia,* thrombocytopenia,* headache (39%), neutropenia,* diarrhea
(31%), fatigue (28%), myalgia (21%), and bruising (21%).
*Treatment-emergent decreases (all grades) of hemoglobin (46%),
platelets (44%), and neutrophils (36%) were based on laboratory
measurements and adverse reactions.
The most common Grade ≥ 3 non-hematological adverse reaction
(reported in at least 2% of patients) was diarrhea (3.2%).
Dosage 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.
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.
Please see complete Prescribing
Information, including Patient Information.
– ENDS –
NOTES TO EDITORS
About AstraZeneca in Oncology
AstraZeneca has a deep-rooted heritage in Oncology and offers a
quickly-growing portfolio of new medicines that has the potential
to transform patients’ lives and the Company’s future. With at
least six new medicines to be launched between 2014 and 2020, and a
broad pipeline of small molecules and biologics in development, we
are committed to advance Oncology as a key growth driver for
AstraZeneca focused on lung, ovarian, breast and blood cancers. In
addition to our core capabilities, we actively pursue innovative
partnerships and investments that accelerate the delivery of our
strategy as illustrated by our investment in Acerta Pharma in
hematology.
By harnessing the power of four scientific platforms –
Immuno-Oncology, Tumor Drivers and Resistance, DNA Damage Response
and Antibody Drug Conjugates – and by championing the development
of personalized combinations, AstraZeneca has the vision to
redefine cancer treatment 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, primarily for the treatment of diseases in
three therapy areas - Oncology, Cardiovascular, Renal &
Metabolism and Respiratory. 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.
US-29530 Last Updated 5/19
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190516005389/en/
Media InquiriesMichele Meixell+1 302 885 2677
Stephanie Wiswall+1 302 885 2677
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Mar 2024 to Apr 2024
AstraZeneca (NYSE:AZN)
Historical Stock Chart
From Apr 2023 to Apr 2024