REG - AstraZeneca PLC - AZN: 1st Quarter Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 2
29/04/2016 07:06
- Part 2: For the preceding part double click ID:nRSc7470Wa
terms of the agreement, Ironwood will acquire exclusive US rights to Zurampic. In addition, Ironwood will gain
the exclusive US rights to the fixed-dose combination of lesinurad and allopurinol. AstraZeneca plans to submit the
fixed-dose combination programme for regulatory review in the second half of 2016. Ironwood will pay AstraZeneca
sales-related and other milestone payments of up to $265m and tiered single-digit royalties on Product Sales. AstraZeneca
will manufacture and supply Zurampic, provide certain support and services to Ironwood and undertake the FDA post-approval
commitment on their behalf.
Research and Development Update
______________________________________________________________________________________
A comprehensive table with AstraZeneca's pipeline of medicines in human trials can be found later in this document.
Since the results announcement on 4 February 2016 (the period):
Regulatory Approvals 4 - Bevespi Aerosphere - COPD (US)- Zurampic - gout (EU)- Brilique - post-MI (EU)- Tagrisso - lung cancer (JP)
Other Key Developments 4 - Breakthrough Therapy Designation:
- durvalumab - bladder cancer (US)- Orphan Drug Designation:
- acalabrutinib - blood cancers (EU)
- MEDI-551 - neuromyelitis optica (US)- Fast Track Designation:
- MEDI8852 - hospitalised influenza (US)
New Molecular Entities (NMEs) in Pivotal Trials or under Regulatory Review* 13 RIA- brodalumab - psoriasis*- benralizumab - severe asthma- tralokinumab - severe asthma- PT010 - COPD- anifrolumab - lupus (SLE) CVMD- roxadustat - anaemia- ZS-9* - hyperkalaemia Oncology- cediranib* - ovarian cancer- durvalumab - multiple cancers- acalabrutinib - blood cancers- moxetumomab pasudotox - leukaemia- selumetinib - lung cancer ING- CAZ AVI* - serious infections
Projects in clinical pipeline 124
Key: RIA - Respiratory, Inflammation & Autoimmunity, CVMD - Cardiovascular & Metabolic Disease, ING - Infection,
Neuroscience & Gastrointestinal
1. Respiratory, Inflammation & Autoimmunity (RIA)
Five potential medicines in RIA remain in pivotal trials or under registration. AstraZeneca's Respiratory portfolio
includes a range of differentiated potential medicines such as novel combinations, biologics and devices for the treatment
of asthma and COPD. The pipeline also includes a number of potential medicines in inflammatory and autoimmune diseases
within areas such as psoriasis, systemic lupus and rheumatoid arthritis.
a) Symbicort (COPD)
During the period, AstraZeneca obtained approval for Symbicort pMDI (pressurised metered dose inhaler device) in the EU.
Symbicort pMDI is now indicated for use in adults, aged 18 and older, for the symptomatic treatment of COPD in patients
with a forced expiratory volume in one second (FEV1) below 70% of the predicted normal (post-bronchodilator) level and an
exacerbation history, despite regular bronchodilator therapy. This development further augments Symbicort's prevailing
approvals in the EU.
b) Bevespi Aerosphere (COPD)
During the period the FDA approved Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) inhalation for the
long-term, maintenance treatment of airflow obstruction in patients with COPD, including chronic bronchitis and/or
emphysema. Bevespi Aerosphere is the first LAMA/LABA medicine to be delivered in a pMDI and the first medicine using
AstraZeneca's unique Co-Suspension technology.
c) Zurampic (gout)
On 19 February 2016, Zurampic (lesinurad) 200mg tablets received marketing authorisation in the EU in combination with a
XOI for the adjunctive treatment of hyperuricemia in adult gout patients who have not achieved target serum uric-acid
levels with an XOI alone. The EU approval of Zurampic was based on data from three pivotal Phase III trials, CLEAR1, CLEAR2
and CRYSTAL, which represented the largest clinical-trial data set of gout patients (n=1,537 total) treated with
combination urate-lowering therapy.
d) Tralokinumab (atopic dermatitis)
A Phase II trial of tralokinumab in atopic dermatitis was completed in the period. Top-line results from the trial showed
that at week 12, a statistically-significant improvement from baseline in EASI score (Eczema Area and Severity Index) was
observed in the two highest tralokinumab dosage arms tested compared to the placebo arm. Significant improvements in DLQI
(dermatology life quality index) were also observed. No safety issues were detected. Full trial results will be disclosed
at a future medical congress.
e) MEDI-551 (neuromyelitis optica)
In the period AstraZeneca's global biologics research and development arm, MedImmune, obtained Orphan Drug Designation from
the FDA for MEDI-551, a CD19 monoclonal antibody, for the treatment of patients with neuromyelitis optica (NMO), as well as
NMO spectrum disorders. NMO is a rare, life-threatening autoimmune disease of the central nervous system, in which the
body's immune system attacks healthy cells most commonly present in the optic nerves and spinal cord, resulting in severe
damage. MEDI-551 is currently in Phase IIb clinical development.
2. Cardiovascular & Metabolic Disease (CVMD)
AstraZeneca's CVMD therapy area focuses on ways to reduce morbidity, mortality and organ damage by addressing multiple risk
factors across cardiovascular (CV) disease, diabetes and chronic kidney disease (CKD) indications. This patient-centric
approach is reinforced by science-led life-cycle management programmes and technologies, including early research into
regenerative methods.
a) Brilinta/Brilique (CV disease)
On 19 February 2016, the European Commission granted marketing authorisation for Brilique for long-term prevention of
cardiovascular death, heart attack and stroke for patients with a history of heart attack. The EU approval was based on the
results from the PEGASUS TIMI-54 trial, a large-scale outcomes trial involving more than 21,000 patients. PEGASUS TIMI-54
investigated Brilinta/Brilique tablets plus low-dose aspirin, compared to placebo plus low dose aspirin, for the long-term
prevention of death from CV disease, heart attack and stroke in patients who had experienced a heart attack one to three
years prior to trial enrollment.
On 23 March 2016, the SOCRATES trial top-line results read out. The trial assessed the efficacy of Brilinta/Brilique 90mg
tablets twice daily when compared to aspirin 100mg once daily in patients with acute ischaemic stroke or transient
ischaemic attack. Fewer events were observed on Brilinta/Brilique versus the comparator in the overall trial population;
the trend however did not reach statistical significance and the primary efficacy endpoint of time to first occurrence of
any event from the composite of stroke (ischaemic or haemorrhagic), myocardial infarction (MI) and death was not met.
AstraZeneca does not anticipate that the results will support a regulatory submission for the stroke indication.
On 29 March 2016, the American College of Cardiology (ACC) and American Heart Association (AHA) updated their
treatment-guidelines for Acute Coronary Syndrome (ACS) and the duration of dual antiplatelet therapy. Brilinta is now
preferred over clopidogrel for the management of patients with ACS who have received a coronary stent and in non-ST
Elevation ACS patients treated with medical therapy alone. This update was also the first time that the ACC and AHA have
recommended Brilinta over clopidogrel for patients who have experienced an ST-elevation myocardial infarction (STEMI). The
update was also the first US guideline to provide the medical community with insights drawn from the PEGASUS-TIMI 54 trial.
The guideline supported continuation of P2Y12 therapy beyond 12 months in prior MI patients who are not at high bleeding
risk.
b) Onglyza and Kombiglyze XR (type-2 diabetes)
In early April 2016, the Company received a communication from the FDA on proposed label changes related to a potential
risk for an increase in heart failure in the SAVOR outcomes trial for Onglyza (saxagliptin). The Company initially
submitted the trial findings to the FDA in February 2014. The SAVOR trial met the primary safety endpoint, demonstrating
that Onglyza did not increase the composite risk for CV death, non-fatal MI and non-fatal ischaemic stroke when added to a
patient's current standard of care (with or without other anti-diabetic therapies), as compared to placebo. To reflect the
recent communication from the FDA, the Onglyza label was updated accordingly and the FDA's review of the data is now
complete.
c) Type-2 diabetes outcomes trials
Two significant type-2 diabetes outcomes trials are underway and fully recruited. Details and updates on those two trials
are listed below:
Medicine Trial Mode of Action Number of Patients Primary Endpoint Timeline
Bydureon EXSCEL GLP-1 agonist ~15,000 Time to first occurrence of CV death, non-fatal MI or non-fatal stroke 2018(final analysis)
Farxiga/Forxiga DECLARE SGLT2 inhibitor ~17,000* Time to first occurrence of CV death, non-fatal MI or non-fatal stroke 2019(final analysis)2017(anticipated interim analysis)
*Includes ~10,000 patients who have had no prior index event (primary prevention) and ~7,000 patients who have suffered an
index event (secondary prevention).
3. 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, the Company is committed to advancing
New Oncology as one of AstraZeneca's six Growth Platforms focused on lung, ovarian, breast and blood cancers. In addition
to core capabilities, the Company is actively pursuing innovative collaborations and investments that accelerate the
delivery of AstraZeneca's strategy, as illustrated by the Company's investment in Acerta Pharma in haematology.
By harnessing the power of four scientific platforms - immuno-oncology (IO), the genetic drivers of cancer and resistance,
DNA damage response and antibody drug conjugates - and by championing the development of personalised combinations,
AstraZeneca has the vision to redefine cancer treatment and, one day, eliminate cancer as a cause of death.
a) Faslodex (breast cancer)
AstraZeneca announced on 2 March 2016 that the FDA had approved a new indication expanding the use of Faslodex, to include
use in combination with palbociclib. The combination use is for the treatment of women with hormone receptor-positive,
human epidermal growth factor receptor 2 negative advanced or metastatic breast cancer whose cancer has progressed after
endocrine therapy. The approval was based on data from the Phase III PALOMA-3 trial, which met the primary endpoint of
progression-free survival.
b) Tagrisso (lung cancer)
On 14 April 2016 AstraZeneca reported new Phase I extended follow-up data on Tagrisso in both 1st- and 2nd-line treatment
of patients with non-small cell lung cancer (NSCLC) at the European Lung Cancer Conference. Late-breaker presentations
reinforced the efficacy and safety profile for Tagrisso previously seen in the AURA clinical-trials programme.
The FLAURA Phase III trial for 1st-line use of Tagrisso in epidermal growth factor receptor (EGFR)-mutated NSCLC randomised
its last patient during the period. Data is expected in 2017 for potential regulatory submission in the earlier metastatic
setting, compared to the prevailing 2nd-line use of the medicine.
On 29 March 2016 the Japanese Ministry of Health, Labour and Welfare approved Tagrisso 80mg once-daily tablets for the
treatment of patients with EGFR T790M mutation-positive inoperable or recurrent NSCLC that is resistant to EGFR tyrosine
kinase inhibitor therapy. The approval follows the EU and US approvals in late 2015. Given the high prevalence of EGFR
mutations (30-40% of lung cancer patients) and, subsequently, T790M mutations in Asia, Japan is anticipated to be a
proportionally significant market for Tagrisso.
During the period, the Company decided not to restart enrolment of patients into CAURAL, a Phase III trial assessing
Tagrisso in combination with durvalumab as a potential second and later-line treatment for patients with EGFRm T790M NSCLC.
The decision not to restart enrolment reflects the view that the trial design no longer offers the best setting to assess
this combination. There has been no change in the safety or data findings following the suspension of enrolment into the
trial in October 2015.
On 2 March 2016, the National Comprehensive Cancer Network, a US guideline-setting organisation, included Tagrisso in its
guidelines for the treatment of patients with brain metastasises who have progressed on 1st-line therapies. This important
recommendation will expand the utilisation of Tagrisso to patients with limited treatment options.
c) Tremelimumab (mesothelioma)
On 29 February 2016, the Company announced that DETERMINE, a Phase IIb clinical trial of 10mg/kg tremelimumab monotherapy
in 2nd or 3rd-line treatment of unresectable malignant mesothelioma, did not meet its primary endpoint of overall survival.
It was encouraging however that the safety profile of this potential medicine was consistent with expectations.
The results did not have an impact on ongoing combination trials with tremelimumab at the ten-fold lower dose of 1mg/kg
every four weeks. Mesothelioma remains a difficult-to-treat disease with no approved medicine beyond 1st-line treatment.
d) Durvalumab (multiple cancers)
Monotherapy
Durvalumab continues to be the cornerstone in the IO pipeline and is currently being tested in monotherapy, combination
therapy and through numerous collaborations. Current combination trials include both large and small molecules, as well as
chemotherapy. Through a broad and diverse development programme, the Company is committed to finding the patients who
benefit most from unique combinations and targeted approaches using multiple biomarkers.
In the period, Breakthrough Therapy Designation was granted for durvalumab for the treatment of patients with programmed
death-ligand 1 (PD-L1) positive inoperable or metastatic urothelial bladder cancer, whose tumour has progressed during or
after the current standard of care. This designation was based on early clinical data from a large cohort Phase I/II trial
(Study 1108), which has now enrolled more than 1,000 patients with various cancers.
Combination therapy
Pre-clinical data have suggested that targeting both PD-L1 and cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) may
have additive or synergistic effects and, to date, data from the combination treatment with durvalumab and tremelimumab
have demonstrated anti-tumour activity in patients with locally advanced or metastatic NSCLC, irrespective of PD-L1 status.
New data from the Phase Ib durvalumab + tremelimumab (durva + treme) combination trial in NSCLC (Study 006) were published
on 5 February 2016 in TheLancet Oncology. The data cut-off of 1 June 2015 was the same date as per the Society for
Immunotherapy of Cancer publication on 6 November 2015. This was, however, a more mature and robust data set of confirmed
responses, with a longer follow-up period.
In patients receiving the combination at the dose chosen for Phase III (durvalumab 20mg/kg Q4W equivalent + tremelimumab
1mg/kg Q4W), the overall response rate was 29% in patients with PD-L1 negative tumours (<25% tumour staining) and 40% in
patients with zero tumour staining. Disease control was 43% and 50% respectively, with a manageable safety profile, given
the advanced disease setting.
An update on key AstraZeneca-sponsored ongoing trials with durvalumab is provided below:
OTHER METASTATIC CANCERs Name Phase Line of treatment Population Design Timelines Status Combination therapy DANUBE III 1st line Cisplatin chemo-therapy- eligible/ineligible bladder cancer durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 Recruiting ALPS II 2nd line Pancreatic ductal carcinoma durva + treme (single arm) FPD Q4 2015 Data expected 2017 Recruiting - II 2nd line Unresectable liver cancer durvalumab vs tremelimumab vs durva + treme FPD Q1 2016 Recruiting - II 2nd/3rd line
Metastatic gastric cancer durvalumab vs tremelimumab vs durva + treme - In preparation
Early disease Monotherapy
ADJUVANT1 III N/A Stage Ib-IIIa NSCLC durvalumab vs placebo FPD2 Q1 2015 Data expected 2020 Recruiting
PACIFIC III N/A Stage III unresectable NSCLC durvalumab vs placebo FPD Q2 2014 LPCD3 Q2 2016 Data expected H1 2017 Recruitment completed
Advanced/metastatic disease Combination therapy
ARCTIC III 3rd line PD-L1 neg.4NSCLC durvalumab vs tremelimumab vs durva + treme vs SoC5 FPD Q2 2015 Data expected H1 2017 Recruiting
MYSTIC III 1st line NSCLC durvalumab vs durva + treme vs SoC FPD Q3 2015 Data expected H1 2017 Recruiting
NEPTUNE III 1st line NSCLC durva + treme vs SoC FPD Q4 2015 Data expected 2018 Recruiting
- III 1st line NSCLC durvalumab + chemotherapy +/- tremelimumab - Recruiting in safety lead-in
- III 1st line SCLC6 durva + treme + chemotherapy vs SoC - Awaiting first patient dosed
-
III
1st line
SCLC6
durva + treme + chemotherapy vs SoC
-
Awaiting first patient dosed
1 Conducted by the National Cancer Institute of Canada2 FPD = First Patient Dosed3LPCD = Last Patient Commenced Dosing4
PD-L1 negativity cut-off measured at <25% of tumour-cell staining5 SoC = Standard of Care6 SCLC = Small Cell Lung Cancer
METASTATIC OR RECURRENT HEAD AND NECK CANCER
Name Phase Line of treatment Population Design Timelines Status
Monotherapy
HAWK II 2nd line PD-L1 pos. SCCHN1 durvalumab (single arm) FPD Q1 2015 LPCD Q2 2016 Data expected H2 2016 Recruitment completed Indication granted FDA Fast Track Designation
Combination therapy
CONDOR II 2nd line PD-L1 neg. SCCHN durvalumab vs tremelimumab vs durva + treme FPD Q2 2015 LPCD Q2 2016 Data expected H1 2017 Recruitment completed
EAGLE III 2nd line SCCHN durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 Recruiting
KESTREL III 1st line SCCHN durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 Recruiting
1SCCHN = Squamous Cell Carcinoma of the Head and Neck
OTHER METASTATIC CANCERs
Name Phase Line of treatment Population Design Timelines Status
Combination therapy
DANUBE III 1st line Cisplatin chemo-therapy- eligible/ineligible bladder cancer durvalumab vs durva + treme vs SoC FPD Q4 2015 Data expected 2018 Recruiting
ALPS II 2nd line Pancreatic ductal carcinoma durva + treme (single arm) FPD Q4 2015 Data expected 2017 Recruiting
- II 2nd line Unresectable liver cancer durvalumab vs tremelimumab vs durva + treme FPD Q1 2016 Recruiting
- II 2nd/3rd line Metastatic gastric cancer durvalumab vs tremelimumab vs durva + treme - In preparation
e) Acalabrutinib (blood cancers)
On 25 February 2016, the European Medicines Agency adopted and approved three positive opinions recommending acalabrutinib
for Orphan Drug Designation in chronic lymphocytic leukaemia (CLL)/small lymphotytic lymphoma (SLL), mantle cell lymphoma
(MCL) and lymphoplasmacytic lymphoma (Waldenström's macroglobulinaemia, WM).
Acalabrutinib has the potential for regulatory submission in the second half of the year in one type of blood cancer, for
which it is currently being assessed in Phase II/III trials.
f) Early-stage pipeline
During the period, the Company initiated a Phase I trial for monalizumab, a humanised, monoclonal antibody targeting
natural-killer cell NKG2A. This potential medicine is being developed with Innate Pharma SA under a co-development and
commercialisation agreement. The trial is a combination with durvalumab and will explore the medicine's safety,
tolerability and anti-tumour activity in solid tumours.
4. Infection, Neuroscience and Gastrointestinal
a) MEDI8852 (hospitalised influenza)
On 7 March 2016, AstraZeneca's global biologics research and development arm, MedImmune, received Fast Track Designation
from the FDA for its potential new medicine MEDI8852, a human, monoclonal antibody for the treatment of patients
hospitalised with type-A strain influenza. MEDI8852 is currently being evaluated in a Phase Ib/IIa clinical trial to assess
the safety and efficacy of a single intravenous dose in combination with oseltamivir and as a monotherapy in adult patients
with confirmed acute, uncomplicated influenza caused by type-A strains.
b) AZD3293 (Alzheimer's disease)
On 8 April 2016, AstraZeneca announced that AMARANTH, a Phase II/III trial of AZD3293, an oral BACE inhibitor in
development as a potential treatment for early Alzheimer's disease, will move into the Phase III portion of the trial.
The transition into Phase III will also trigger the start of an additional Phase III trial with AZD3293. DAYBREAK will
focus on patients with mild Alzheimer's disease and is scheduled to begin enrolling patients in the second half of the
year. Emerging evidence suggests that cognitive decline precedes and predicts a functional decline in Alzheimer's disease,
particularly during earlier stages of the disease. Accordingly, AMARANTH will be amended and DAYBREAK will use a single,
cognitive endpoint, ADAS-cog13.
ASTRAZENECA DEVELOPMENT PIPELINE 31 MARCH 2016
Includes AstraZeneca-sponsored or -directed studies only
Phase III / Pivotal Phase II / Registration
NMEs and significant additional indications
Regulatory submission dates shown for assets in Phase III and beyond. As disclosure of compound information is balanced by
the business need to maintain confidentiality, information in relation to some compounds listed here has not been disclosed
at this time.
† US and EU dates correspond to anticipated acceptance of the regulatory submission.
# Collaboration.
Respiratory, Inflammation and Autoimmunity
Zurampic#(lesinurad) selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of hyperuricemia in patients with gout Q4 2011 Approved Approved1 N/A N/A
CLEAR 1,2
CRYSTAL
Bevespi Aerosphere (PT003) LABA/LAMA COPD Q2 2013 Approved H2 2016 2017 2017
brodalumab#AMAGINE-1,2,3 IL-17R mAb psoriasis Q3 2012 Accepted Accepted N/A N/A
benralizumab#CALIMA SIROCCO ZONDA BISE BORAGREGALE IL-5R mAb severe asthma Q4 2013 H2 2016 H2 2016 N/A N/A
benralizumab#TERRANOVA GALATHEA IL-5R mAb COPD Q3 2014 2018 2018 N/A N/A
PT010 LABA/LAMA/ ICS COPD Q3 2015 2018 2018 2017 2019
tralokinumabSTRATOS 1,2TROPOSMESOS IL-13 mAb severe asthma Q3 2014 2018 2018 2018
anifrolumab# TULIP IFN-alphaR mAb systemic lupus erythematosus Q3 2015 2019(Fast Track) 2019 2019
Cardiovascular and Metabolic Diseases
Brilinta/Brilique2 P2Y12 receptor antagonist arterial thrombosis Launched Launched Accepted Launched
Farxiga/Forxiga3 SGLT2 inhibitor type-2 diabetes Launched Launched Launched Accepted
Epanova# omega-3 carboxylic acids severe hypertrigly-ceridemia Approved 2018
ZS-9 (sodium zirconium cyclosilicate) potassium binder hyperkalaemia Accepted Accepted
roxadustat# OLYMPUS ROCKIES hypoxia-inducible factor prolyl hydroxylase inhibitor anaemia in CKD/ESRD Q3 2014 2018 N/A N/A H2 20164
Oncology
TagrissoAURA, AURA 2, (AURA17 Asia regional) EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q2 2014 Launched(Breakthrough designation, Priority Review, Orphan Drug) Launched5 (Accelerated assessment) Approved5 2017
TagrissoAURA 3 EGFR tyrosine kinase inhibitor ≥2nd-line advanced EGFRm T790M NSCLC Q3 2014 2017 2017 2017 2018
cediranibICON 6 VEGFR tyrosine kinase inhibitor PSR ovarian cancer Q2 2007 Accepted (Orphan Drug)
acalabrutinib# (ACP-196) Bruton's tyrosine kinase (BTK) inhibitor B-cell blood cancers Q1 2015 H2 2016(Orphan Drug) (Orphan Drug)
selumetinib# MEK inhibitor 2nd-line KRASm NSCLC Q4 2013 2017 2017
SELECT-1
selumetinib# MEK inhibitor differentiated thyroid cancer Q3 2013 2018 2018
ASTRA
moxetumomab pasudotox#PLAIT anti-CD22 recombinant hairy cell leukaemia Q2 2013 2017(Orphan Drug) 2018
immunotoxin
durvalumab#PACIFIC PD-L1 mAb stage III NSCLC Q2 2014 2017 2020 2020
durvalumab# +tremelimumab PD-L1 mAb + CTLA-4 mAb 3rd-line NSCLC Q2 2015 2017 2017 2017
ARCTIC
durvalumab# + tremelimumabMYSTIC PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q3 2015 2017 2017 2017 2020
durvalumab# + tremelimumabNEPTUNE PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q4 2015 2019 2019 2019
durvalumab# PD-L1 mAb 2nd-line SCCHN (PD-L1 positive) Q1 2015 2017(Fast Track) 2019 2019
HAWK¶
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line SCCHN (PD-L1 negative) Q2 2015 2017 2019 2019
CONDOR¶
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 1st-line SCCHN Q4 2015 2018 2018 2018
KESTREL
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line SCCHN Q4 2015 2019 2019 2019
EAGLE
durvalumab# + tremelimumabALPS¶ PD-L1 mAb + CTLA-4 mAb metastatic pancreatic ductal carcinoma Q4 2015 2017 2017 2017
durvalumab# + tremelimumabDANUBE PD-L1 mAb + CTLA-4 mAb 1st-line bladder Q4 2015 2018 2018 2018
Infection, Neuroscience and Gastrointestinal
Zinforo# extended spectrum cephalosporin with affinity to penicillin-binding proteins pneumonia/skin infections N/A Launched N/A Submitted
CAZ AVI# cephalosporin/ beta lactamase inhibitor hospital-acquired pneumonia/ ventilator-associated pneumonia Q2 2013 N/A Accepted 2017
CAZ AVI# cephalosporin/beta lactamase inhibitor serious infections, complicated intra-abdominal infection, complicated urinary tract infection Q1 2012 N/A Accepted 2017
MEDI-550 pandemic influenza virus vaccine pandemic influenza prophylaxis N/A Q2 20166 N/A N/A
AZD3293#AMARANTH beta-secretase inhibitor Early Alzheimer's disease Q2 20167 2020 2020 2020
N/A
N/A
AZD3293#AMARANTH
beta-secretase inhibitor
Early Alzheimer's disease
Q2 20167
2020
2020
2020
¶ Registrational Phase II/IIItrial
1 Approval received February 2016
2 Brilinta in the US; Brilique in rest of world
3 Farxiga in the US; Forxiga in rest of world
4 Rolling NDA submission to be initiated in H2 2016
5 EU Approval received 3 February 2016; JP approval received 28 March 2016
6 CHMP Positive Opinion received April 2016
7 First patient dosed April 2016
Phases I and II
NMEs and significant additional indications
Respiratory, Inflammation and Autoimmunity
PT010 LABA/LAMA/ICS asthma II Q2 2014
tralokinumab IL-13 mAb atopic dermatitis II Q1 2015
anifrolumab# IFN-alphaR mAb lupus nephritis II Q4 2015
anifrolumab# IFN-alphaR mAb systemic lupus erythematosus (subcutaneous) I Q4 2015
verinurad (RDEA3170) selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of hyperuricemia in patients with gout II Q3 2013
abediterol (AZD0548) LABA asthma/COPD II Q4 2007
AZD7594 inhaled SGRM asthma/COPD II Q3 2015
AZD7624 inhaled P38 inhibitor COPD II Q4 2014
AZD9412# inhaled interferon beta asthma/COPD II Q3 2015
mavrilimumab# GM-CSFR mAb rheumatoid arthritis II Q1 2010
inebilizumab# (MEDI-551)# CD19 mAb neuromyelitis optica II Q1 2015(Orphan Drug)
MEDI2070# IL-23 mAb Crohn's disease II Q1 2013
tezepelumab# (MEDI9929)# TSLP mAb asthma / atopic dermatitis II Q2 2014
lesinurad + allopurinol FDC selective uric acid reabsorption inhibitor (URAT-1)+xanthine oxidase inhibitor FDC chronic treatment of hyperuricemia in patients with gout I Q4 2015
AZD1419# TLR9 agonist Asthma I Q3 2013
AZD5634 inhaled ENaC cystic fibrosis I Q1 2016
AZD7986 DPP1 COPD I Q4 2014
AZD8871 MABA COPD I Q4 2015
AZD9567 oral SGRM rheumatoid arthritis I Q4 2015
MEDI0700# BAFF/B7RP1 bispecific mAb systemic lupus erythematosus I Q1 2016
MEDI4920 anti-CD40L-Tn3 fusion protein primary Sjögren's syndrome I Q2 2014
MEDI5872# B7RP1 mAb systemic lupus erythematosus I Q4 2008
MEDI7836 IL-13 mAb-YTE asthma I Q1 2015
MEDI9314 IL-4R mAb atopic dermatitis I Q1 2016
Cardiovascular and Metabolic Diseases
MEDI4166 PCSK9/GLP-1 mAb + peptide fusion diabetes / cardiovascular II Q1 2016
MEDI6012 LCAT ACS II Q4 2015
AZD4076 anti-miR103/107 oligonucleotide non-alcoholic fatty liver disease/non-alcoholic steatohepatitis (NASH) I Q4 2015
AZD5718 FLAP CAD I Q1 2016
MEDI0382 GLP-1/glucagon dual agonist diabetes / obesity I Q1 2015
MEDI8111 Rh-factor II trauma / bleeding I Q1 2014
Oncology
durvalumab# PD-L1 mAb bladder cancer II Q1 2016(Breakthrough Therapy Designation)
durvalumab# PD-L1 mAb solid tumours II Q3 2014
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb gastric cancer II Q2 2015
durvalumab# + AZD5069 PD-L1 mAb + CXCR2 SCCHN II Q3 2015
durvalumab# + AZD9150# PD-L1 mAb + STAT3 inhibitor
durvalumab# PD-L1 mAb solid tumours I Q3 2014
durvalumab# + monalizumab1 PD-L1 mAb + NKG2a mAb solid tumours I Q1 2016
durvalumab# + MEDI9447 PD-L1 mAb + CD73 mAb solid tumours I Q1 2016
durvalumab# + MEDI6383# PD-L1 mAb + OX40 agonist solid tumours I Q2 2015
durvalumab#+ Iressa PD-L1 mAb+ EGFR tyrosine kinase inhibitor NSCLC I Q2 2014
durvalumab# + MEDI0680 PD-L1 mAb + PD-1 mAb solid tumours I Q2 2014
durvalumab# + dabrafenib + trametinib2 PD-L1 mAb+ BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb solid tumours I Q4 2013
Tagrisso + (durvalumab# or selumetinib# or savolitinib#)TATTON EGFR tyrosine kinase inhibitor + (PD-L1 mAb or MEK inhibitor or MET tyrosine kinase inhibitor) advanced EGFRm NSCLC I Q3 2014
selumetinib# MEK inhibitor 2nd-line KRAS wt NSCLC II Q1 2013
savolitinib/volitinib# MET tyrosine kinase inhibitor papillary renal cell carcinoma II Q2 2014
AZD1775# WEE-1 inhibitor ovarian cancer II Q4 2012
vistusertib (AZD2014) mTOR serine/ threonine kinase inhibitor solid tumours II Q1 2013
AZD3759 BLOOM EGFR tyrosine kinase inhibitor brain metastases in advanced EGFRm NSCLC II Q4 2015
Tagrisso (AZD9291) BLOOM EGFR tyrosine kinase inhibitor
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