REG - AstraZeneca PLC - AstraZeneca: Q1 2017 Results <Origin Href="QuoteRef">AZN.L</Origin> - Part 2
27/04/2017 07:08
- Part 2: For the preceding part double click ID:nRSa4739Da
of lower respiratory tract illness (LRTI) caused by respiratory syncytial
virus (RSV), the most prevalent cause of LRTI among infants and young children. MEDI8897 is currently in a Phase IIb
clinical trial.
Under the global agreement that closed in March 2017, Sanofi Pasteur made an upfront payment of E120m and will pay up to
E495m upon achievement of certain development and sales-related milestones. The two companies will share all costs and
profits equally. MedImmune and AstraZeneca will continue to lead all development activity through initial approvals and
AstraZeneca will retain MEDI8897 manufacturing activities. Sanofi Pasteur will lead commercialisation activities for
MEDI8897. As AstraZeneca will maintain a significant ongoing interest in MEDI8897, the payment was reported as
Externalisation Revenue in the Company's financial statements.
c) Tudorza And Duaklir In The US
On 17 March 2017, AstraZeneca announced that it had entered a strategic collaboration with Circassia Pharmaceuticals plc
(Circassia) for the development and commercialisation of Tudorza and Duaklir in the US. Tudorza was approved and launched
in the US in 2012. Duaklir is expected to be submitted for US regulatory review in 2018. The transaction closed on 12 April
2017.
Under the terms of the agreement, AstraZeneca received $50m in Ordinary Shares in Circassia on completion and will receive
$100m at the earlier of approval of Duaklir in the US or 30 June 2019. Should Circassia decide to exercise an option to
sub-license the commercial rights to Tudorza in the US, it will pay up to a further $80m.
The two companies will share US profits from Tudorza equally. AstraZeneca will continue to book US Product Sales of Tudorza
until Circassia's potential exercise of the option. Circassia will pay AstraZeneca tiered percentage royalties on potential
future US sales of Duaklir. In addition, Circassia will contribute up to $62.5m towards the development activities for the
medicines. As AstraZeneca will retain a significant, ongoing interest in the medicines, income will be reported as
Externalisation Revenue. This includes approximately $60m at closing, as well as any potential future royalties, deferred
income and any future payment for the option to gain the US commercial rights to Tudorza. Any potential future supply of
the medicines to Circassia will be reported as Product Sales.
d) Benralizumab Rights In Asia
On 24 March 2017, it was announced that AstraZeneca had entered an agreement with Kyowa Hakko Kirin Co., Ltd. (Kyowa) for
the exclusive rights to benralizumab for the treatment of severe, uncontrolled asthma and COPD in Asia.
Under the terms of the agreement, AstraZeneca will pay Kyowa $15m upfront and subsequent payments for regulatory and
commercial milestones, as well as low double-digit percentage sales royalties. As a result of the agreement, AstraZeneca
will be responsible for the development, sales and marketing of benralizumab in 13 Asian countries and regions, except
Japan, where AstraZeneca already holds the commercialisation rights to benralizumab.
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 2 February 2017 (the period):
Regulatory Approvals 6 - Tagrisso - lung cancer (US, EU; full approval) - Tagrisso - lung cancer (CN)- Forxiga - type-2 diabetes (CN)- Qtern - type-2 diabetes (US)- Siliq -
psoriasis (US; by partner)
Regulatory Submission Acceptances 4 - Lynparza - ovarian cancer (2nd line) (US) (Priority Review) - Bydureon - type-2 diabetes (autoinjector) (US) - Symbicort - COPD exacerbations (US)-
benralizumab - severe, uncontrolled asthma (JP)
Phase III or Major Data Readouts 2 - Lynparza - breast cancer- Farxiga - type-2 diabetes (CVD-REAL real-world study)
Other Key Developments 3 - Orphan Designation: Lynparza - ovarian cancer (JP)- Complete Response Letter: ZS-9 (sodium zirconium cyclosilicate) - hyperkalaemia (US)- Orphan
designation: inebilizumab - neuromyelitis optica spectrum disorder (EU)
New Molecular Entities 12 Oncology- durvalumab* - multiple cancers- durva + treme - multiple cancers- acalabrutinib - blood cancers- moxetumomab pasudotox - leukaemia-
(NMEs) In Phase III Trials selumetinib - thyroid cancer Cardiovascular & Metabolic Diseases- ZS-9 (sodium zirconium cyclosilicate)* - hyperkalaemia- roxadustat* - anaemia Respiratory-
Or Under Regulatory Review benralizumab* - severe, uncontrolled asthma, COPD- tralokinumab - severe, uncontrolled asthma- PT010 - COPD Other- anifrolumab - lupus- lanabecestat
(formerly AZD3293) - Alzheimer's disease
Projects in clinical pipeline 124
*Under Regulatory Review
The table as at 27 April 2017
ONCOLOGY
AstraZeneca has a deep-rooted heritage in Oncology and offers a growing portfolio of new medicines that has the potential
to transform patients' lives and the Company's future. At least six new Oncology medicines are expected to be launched
between 2014 and 2020, of which Lynparza and Tagrisso are already benefitting patients. An extensive pipeline of
small-molecule and biologic medicines is in development and the Company is committed to advancing Oncology, primarily
focused on lung, ovarian, breast and blood cancers, as one of AstraZeneca's Growth Platforms.
At the 2017 American Association for Cancer Research meeting in Washington D.C., 60 abstracts, including seven oral
presentations, were published. These covered, inter alia, tumour drivers and resistance, immuno-oncology (IO),
antibody-drug conjugates and DNA damage response.
a) Lynparza (multiple cancers)
During the period, the Company presented data from the Phase III SOLO-2 trial, in which women with germline BRCA-mutated,
platinum-sensitive, relapsed ovarian cancer were treated with Lynparza tablets (300mg twice daily) or placebo, in the
maintenance setting. The trial met its primary endpoint of investigator-assessed progression-free survival (PFS) with a
hazard ratio of 0.30 (equal to a 70% reduction in the risk of disease progression) and a median survival of 19.1 months vs
5.5 months with placebo. PFS, as measured by Blinded Independent Central Review, demonstrated a hazard ratio of 0.25 (75%
risk reduction), with a median PFS of 30.2 months vs 5.5 months for placebo, representing an improvement of over two years.
Lynparza tablets demonstrated a safety profile generally consistent with previous trials, including a low incidence of
haematological adverse events. The 300mg twice daily tablet dose used in SOLO-2 reduces the pill burden for patients from
16 capsules to 4 tablets per day.
During the period, the Company achieved regulatory submission acceptance for a New Drug Application (NDA) for Lynparza
tablets for use in platinum-sensitive, relapsed ovarian cancer patients in the maintenance setting. Priority Review status
was granted, with an anticipated Prescription Drug User Fee Act (PDUFA) date during Q3 2017.The regulatory submission
included data from the aforementioned SOLO-2 trial, as well as a prior Lynparza trial in ovarian cancer, Study 19.
In the period, the Company received an Orphan Drug Designation for Lynparza in Japan. Presently, there are no approved
medicines in Japan to treat BRCA-mutated ovarian cancer, which affects an estimated 3,500 women every year.
In breast cancer, Lynparza met the primary endpoint in the Phase III OlympiAD trial, comparing Lynparza tablets to standard
of care (SoC) chemotherapy in the treatment of patients with HER2-negative metastatic breast cancer harbouring germline
BRCA1 or BRCA2 mutations. Patients treated with Lynparza showed a statistically-significant and clinically-meaningful
improvement in PFS, compared with those who received SoC chemotherapy. This was the first positive randomised Phase III
trial to demonstrate the efficacy and safety of a poly ADP ribose polymerase (PARP) inhibitor beyond ovarian cancer. The
Company anticipates presenting the data at the forthcoming American Society of Clinical Oncology Annual Meeting in Chicago,
US in June 2017.
PROfound, a Phase III trial in metastatic, castrate-resistant prostate cancer patients, who have previously received a new
hormonal agent, actively started recruitment in the period. This trial is based on early clinical data published in TheNew
England Journal of Medicine. The prostate cancer indication received US Breakthrough Therapy Designation in 2016 and
PROfound is the first pivotal trial for Lynparza in prostate cancer and the first to utilise a new 15-gene homologous
recombination repair panel.
b) Tagrisso (lung cancer)
On 27 March 2017, the Company announced that it had received marketing authorisation by the China FDA for Tagrisso 40mg and
80mg once-daily oral tablets. These tablets are a treatment for adult patients with locally-advanced or metastatic
epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC), whose disease has
progressed on or after EGFR tyrosine kinase inhibitor (TKI) therapy.
This early approval followed the China FDA's Priority Review in recognition of the submitted data from the AURA17 and
AURA18 trials. Tagrisso is the first AstraZeneca medicine approved under the China FDA's Priority Review pathway, using an
accelerated timeline for an innovative medicine. Presently, lung cancer is the most common form of cancer and the leading
cause of cancer-related deaths in China. Approximately 30-40% of Chinese patients with NSCLC have the EGFR mutation at
diagnosis and around half of patients with NSCLC, whose disease progresses after treatment with an EGFR-TKI-based medicine,
develop the T790M mutation.
On 31 March 2017, the Company announced that the US FDA had granted full approval for Tagrisso 80mg once-daily tablets.
These tablets are for the aforementioned treatment of patients with metastatic EGFR T790M mutation-positive NSCLC, as
detected by an US FDA-approved test, whose disease has progressed on or after an EGFR-TKI therapy. The approval was based
on the Phase III AURA3 trial data that demonstrated a significant improvement in PFS with Tagrisso, as compared to SoC
chemotherapy. The trial also demonstrated a hazard ratio of 0.30 (equal to a 70% reduction in the risk of disease
progression) and a median PFS of 10.1 months, compared to 4.4 months from chemotherapy. The full approval was converted
from the prior accelerated approval.
On 25 April 2017, AstraZeneca announced that the European Medicines Agency (EMA) had granted full marketing authorisation
for Tagrisso on a similar basis to the aforementioned approval in the US. The full approval was based on the results of the
Phase III AURA3 trial, which were presented in 2016.
c) Durvalumab (multiple cancers)
The Company continues to advance multiple monotherapy trials of durvalumab and combination trials of durvalumab with
tremelimumab and other potential new medicines in IO. The combination of durvalumab and tremelimumab is being assessed in
Phase III trials in metastatic urothelial cancer, NSCLC, small cell lung cancer and head and neck squamous cell carcinoma
(HNSCC) and in Phase I/II trials in gastric cancer, pancreatic cancer, hepatocellular carcinoma and haematological
malignancies.
· BLADDER CANCER
In December 2016, AstraZeneca received US FDA acceptance of the Biologics License Application for durvalumab in patients
with locally-advanced or metastatic urothelial carcinoma, whose disease has progressed during or after one standard
platinum-based regimen. The application was granted Priority Review status. The PDUFA date is anticipated to be in Q2
2017.
In Canada, the New Drug Submission (NDS) for durvalumab was filed with Health Canada, seeking conditional approval in
patients with locally-advanced or metastatic urothelial carcinoma, whose disease has progressed during or after
platinum-based chemotherapy. This NDS was granted advance consideration under Health Canada's Notice of Compliance with
Conditions policy, allowing the submission based on encouraging results from the Phase I/II Study 1108. In Australia, the
Therapeutic Goods Administration accepted a similar submission in the period.
During the period, AstraZeneca announced updated efficacy and safety data for durvalumab in patients with locally-advanced
or metastatic urothelial cancer from the Phase I/II 1108 trial. These data, presented at the 2017 American Society of
Clinical Oncology Genitourinary Cancers Symposium, showed an objective response rate of 20.4% in all evaluable patients
(n=103) and 31.1%, in patients whose tumours express PD-L1. At the time of data cut-off, median overall survival (OS) was
14.1 months. Durvalumab, dosed at a rate of 10mg/kg, was administered intravenously every two weeks for up to 12 months in
this trial and demonstrated a manageable safety profile.
DANUBE III 1st line Cisplatin chemo-therapy- eligible/ineligible bladder cancer durvalumab, durva + treme vs SoC chemotherapy FPCD1 Q4 2015 LPCD2 Q1 20173 First data anticipated 2018 Recruitment completed3
Timelines
Status
DANUBE
III
1st line
Cisplatin chemo-therapy- eligible/ineligible bladder cancer
durvalumab, durva + treme vs SoC chemotherapy
FPCD1 Q4 2015 LPCD2 Q1 20173 First data anticipated 2018
Recruitment completed3
1 First Patient Commenced Dosing
2Last Patient Commenced Dosing
3Global trial, excluding China
· LUNG CANCER
During the period, the Company maintained strong momentum in its immunotherapy efforts in lung cancer, including the
decision to initiate a new trial, POSEIDON, testing the durva + treme combination with chemotherapy. This followed
successful Phase I testing of the Company's triple combination of two immunotherapies combined with chemotherapy.
The Company now expects the first data from the Phase III ARCTIC trial in 3rd-line PDL1-low/negative NSCLC to be available
in H2 2017. The trial results are event-driven; events for the primary endpoints of PFS and OS have occurred more slowly
than originally anticipated in the advanced patient population that the trial is assessing.
As previously communicated, the ongoing Phase III NEPTUNE trial was expanded to include local Chinese patients to support
regulatory submission of the 1st-line NSCLC durva + treme combination data in China. During the period, the first patient
was dosed in the China expansion cohort. This expansion is not expected to impact the anticipated OS data readout in 2018
from the global cohort, which is fast approaching full recruitment. Further, during the period, the NEPTUNE trial was
refined to include a primary OS endpoint for patients with PDL1-expressing tumours.
An overview of key AstraZeneca-sponsored ongoing Phase III trials in lung cancer is provided below:
Monotherapy
ADJUVANT* III N/A Stage Ib-IIIa NSCLC durvalumab vs placebo FPCD Q1 2015 First data anticipated 2020 Recruitment ongoing
PACIFIC III N/A Stage III unresectable NSCLC durvalumab vs placebo FPCD Q2 2014 LPCD Q2 2016 First data anticipated H2 2017 Recruitment completed
PEARL III 1st line NSCLC (Asia) durvalumab vs SoC chemotherapy FPCD Q1 2017 First data anticipated 2020 Recruitment ongoing
Combination therapy
MYSTIC III 1st line NSCLC durvalumab, durva + treme vs SoC chemotherapy FPCD Q3 2015 LPCD Q3 2016 First data anticipated mid-2017 Recruitment completed
NEPTUNE III 1st line NSCLC durva + treme vs SoC chemotherapy FPCD Q4 2015 First data anticipated 2018 Recruitment ongoing
POSEIDON III 1st line NSCLC durvalumab + SoC, durva + treme + SoC vs SoC chemotherapy - Recruitment initiating
ARCTIC III 3rd line PDL1- low/neg. NSCLC durvalumab, tremelimumab, durva + treme vs SoC chemotherapy FPCD Q2 2015 LPCD Q3 2016 First data anticipated H2 2017 Recruitment completed
CASPIAN III 1st line Small-cell lung cancer (SCLC) durvalumab + SoC, durva + treme + SoC vs SoC chemotherapy FPCD Q1 2017 First data anticipated 2020 Recruitment ongoing
CASPIAN
III
1st line
Small-cell lung cancer (SCLC)
durvalumab + SoC, durva + treme + SoC vs SoC chemotherapy
FPCD Q1 2017 First data anticipated 2020
Recruitment ongoing
*Conducted by the National Cancer Institute of Canada
· HEAD AND NECK CANCER
During the period, the Phase III KESTREL trial completed patient recruitment ahead of schedule, despite a delay from a
partial clinical hold on recruitment in 2016. Additionally, the trial was refined to include a primary OS endpoint for
patients with PDL1-expressing tumours. At this stage, the Company continues to anticipate data availability in H2 2017.
An overview of key AstraZeneca-sponsored ongoing Phase III trials in head and neck cancer is provided below:
Name Phase Line of Treatment Population Design Timelines Status Combination therapy KESTREL III 1st line HNSCC durvalumab, durva + treme vs SoC FPCD Q4 2015 LPCD Q1 2017 First data anticipated H2 2017 Recruitment completed EAGLE III 2nd line HNSCC durvalumab, durva + treme vs SoC FPCD Q4 2015 First data anticipated 2018 Recruitment ongoing
Name
Phase
Line of Treatment
Population
Design
Timelines
Status
Combination therapy
KESTREL
III
1st line
HNSCC
durvalumab, durva + treme vs SoC
FPCD Q4 2015 LPCD Q1 2017 First data anticipated H2 2017
Recruitment completed
EAGLE
III
2nd line
HNSCC
durvalumab, durva + treme vs SoC
FPCD Q4 2015 First data anticipated 2018
Recruitment ongoing
CARDIOVASCULAR & METABOLIC DISEASES
This therapy area includes a broad type-2 diabetes portfolio, differentiated devices and unique small and large-molecule
programmes to reduce morbidity, mortality and organ damage across CV disease, diabetes and chronic kidney disease (CKD)
indications.
a
) Forxiga
(
type
-2
diabetes
)
In March 2017, the Company received marketing authorisation from
the China FDA for Forxiga 5mg and 10mg once-daily oral tablets. These tablets are indicated as an adjunct to diet and
exercise to improve glycaemic control (blood sugar level) in adults with type-2 diabetes. Forxiga was the first SGLT2
inhibitor to be approved in China and belongs to a newer class of oral diabetes medicines that works independently from
insulin to help remove excess glucose from the body. The prevalence of diabetes is escalating rapidly in China, now
impacting 114 million patients, representing almost one-third of diabetes cases worldwide.
b) Qtern (type-2 diabetes)
On 28 February 2017, AstraZeneca announced that once-daily Qtern tablets (Farxiga 10mg and Onglyza 5mg fixed-dose
combination) had been approved by the US FDA as an adjunct to diet and exercise to improve glycaemic control in adults with
type-2 diabetes who have inadequate control with Farxiga (10mg) or who are already treated with Farxiga and Onglyza.
c) Bydureon (type-2 diabetes)
During the period, the new Bydureon autoinjector regulatory submission was accepted for review by the US FDA. The
autoinjector is designed to provide patients with a convenient, easy-to-use device for administration of Bydureon as a
once-weekly treatment for type-2 diabetes patients.
In addition to the autoinjector, the regulatory submission of the DURATION-8 combination trial results (Farxiga plus
Bydureon) was also accepted by the US FDA in the period. In parallel, an EU regulatory submission was accepted by the EMA.
The DURATION-8 Phase III trial demonstrated that the addition of Bydureon to Farxiga provides benefits to patients above
and beyond what is observed with the individual medicines, including reduced blood sugar, weight and systolic blood
pressure. The Company anticipates a response from the regulatory agencies on the potential label additions for Bydureon and
Farxiga in 2018 at the earliest.
d) Type-2 diabetes medicines in CV outcomes trials
As the field of type-2 diabetes medicines evolves, with multiple outcomes trials producing data, AstraZeneca continues to
assess both Farxiga and Bydureon for potential long-term CV benefits.
At the 2017 American College of Cardiology Session and Expo, AstraZeneca shared results of the CVD-REAL real-world evidence
study. The study showed that treatment with SGLT2 inhibitors, versus other type-2 diabetes medicines, significantly reduced
rates of hospitalisation due to heart failure (HF) and all-cause mortality.
The study assessed more than 300,000 patients across Europe and the US, approximately 87% of whom did not have existing CV
disease. It demonstrated that treatment with SGLT2 inhibitor medicines, including Farxiga (dapagliflozin), canagliflozin,
and empagliflozin reduced the rate of hospitalisation for HF by 39% and death from any cause by 51%. For the composite
endpoint of hospitalisation for HF and death from any cause, the reduction was 46%.
Patients with type-2 diabetes have a two to three times greater risk of HF and are at an increased risk of having a heart
attack or stroke, when compared to the overall population. Around half of deaths of patients with type-2 diabetes are
caused by CV disease. Two significant type-2 diabetes outcomes trials are highlighted below:
Bydureon EXSCEL GLP-1 agonist ~14,000 Time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke H2 2017
Farxiga DECLARE SGLT2 inhibitor ~17,000* Time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke 2019 at the latest(final analysis)
Farxiga
DECLARE
SGLT2 inhibitor
~17,000*
Time to first occurrence of CV death, non-fatal myocardial infarction or non-fatal stroke
2019 at the latest(final 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)
During the period, the first patients were dosed in the Farxiga HF and CKD Phase III trials. These two extensive outcomes
trials are designed to help define the potential role of Farxiga in the management of HF and CKD respectively, in patients
with and without type-2 diabetes. HF and CKD are common, disabling, costly and deadly conditions that continue to increase
in prevalence and for which new and effective medicines are needed.
c) ZS-9 (sodium zirconium cyclosilicate) (hyperkalaemia)
On 17 March 2017, the Company announced that the US FDA had issued a second Complete Response Letter (CRL) regarding the
NDA for ZS-9, which is being developed for the treatment of hyperkalaemia by ZS Pharma, a wholly-owned subsidiary of
AstraZeneca. Hyperkalaemia is a serious condition characterised by high potassium levels in the blood serum caused by CV,
renal and metabolic diseases.
The second CRL followed an inspection by the US FDA of the dedicated manufacturing facility. The second CRL did not require
the generation of any new clinical data. AstraZeneca and ZS Pharma are actively working with the US FDA to resolve the
remaining matters as soon as possible.
In the EU, the Company announced on 24 February 2017 that the Committee for Medicinal Products for Human Use (CHMP) of the
EMA had issued a positive opinion recommending the approval of ZS-9 for the treatment of hyperkalaemia. Following the
second CRL in the US, the CHMP will consider the potential impact of this new information on the adopted opinion.
RESPIRATORY
AstraZeneca's Respiratory portfolio is aimed at transforming the treatment of asthma and COPD through combination inhaled
therapies, biologics for the unmet medical needs of specific patient populations and an early pipeline focused on disease
modification.
The growing range of medicines includes up to four anticipated launches between 2017 and 2020. The capability in inhalation
technology spans both pressurised metered dose inhalers and dry-powder inhalers to serve patient needs, as well as the
innovative Aerosphere CO-SUSPENSIONTM Delivery Technology, a focus of AstraZeneca's future-platform development for
respiratory-disease combination therapies.
a) Symbicort (COPD)
During the period, the US FDA accepted for review a supplemental NDA proposing an additional indication for Symbicort to
reduce exacerbations in patients with COPD and a history of exacerbations. The PDUFA date for this additional indication is
anticipated to be in Q3 2017.
b) Benralizumab (asthma)
During the period, the Pharmaceuticals and Medical Devices Agency in Japan accepted a regulatory submission for
benralizumab. The submission, for the treatment of patients with severe, uncontrolled asthma with an eosinophilic
phenotype, was based on the results of the Phase III trials, CALIMA, SIROCCO and ZONDA.
c) Tezepelumab (asthma)
In February 2017, tezepelumab, a first-in-class monoclonal antibody that targets thymic stromal lymphopoietin (TSLP) met
its primary endpoint in a Phase IIb trial (PATHWAY) in patients with severe asthma. Tezepelumab, which is being developed
in collaboration with Amgen Inc. (Amgen), demonstrated a significant reduction in the rate of asthma exacerbations,
compared to placebo, over the 52-week treatment period.
TSLP is thought to play a critical role in the activation of the immune system in response to allergens, viruses and other
pathogens in the lung, all of which are known triggers for asthma exacerbations. Blocking TSLP with tezepelumab may
uniquely prevent exacerbations across a broad population of patients with severe asthma. The Phase IIb data will be
presented at a forthcoming medical meeting.
OTHER
a) Brodalumab (psoriasis)
On 16 February 2017, the Company announced that the US FDA had approved brodalumab (Siliq in the US) for the treatment of
adult patients with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and have
failed to respond or no longer respond to other systemic therapies.
Through a collaboration agreement, AstraZeneca granted Valeant, an expert in dermatology, the exclusive license to develop
and commercialise brodalumab globally, except in Japan and certain other Asian countries where rights are held by Kyowa
Hakko Kirin Co., Ltd through an agreement with Amgen and in Europe, where LEO Pharma holds exclusive rights to develop and
commercialise brodalumab.
b) Inebilizumab (neuromyelitis optica spectrum disorder)
On 29 March 2017, the EMA granted Orphan designation to inebilizumab (formerly MEDI-551) for the treatment of neuromyelitis
optica spectrum disorder (NMOSD). NMOSD is a rare and life-threatening autoimmune disease of the central nervous system in
which the body's immune system attacks healthy cells, most commonly in the optic nerve and spinal cord. NMOSD may cause
severe muscle weakness and paralysis, loss of vision, respiratory failure, problems with bowel and bladder function and
neuropathic pain. There is currently no cure or approved medicine for this rare disease.
Developed by MedImmune, inebilizumab is currently in Phase IIb clinical development for NMOSD and received Orphan Drug
Designation by the US FDA in early 2016.
ASTRAZENECA DEVELOPMENT PIPELINE 31 March 2017
AstraZeneca-sponsored or -directed trials
Phase III / Pivotal Phase II / Registration
New Molecular Entities (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.
Oncology
durvalumab# PD-L1 mAb ≥2nd-line advanced bladder cancer Accepted(Breakthrough Therapy & Priority Review)
acalabrutinib# BTK inhibitor B-cell malignancy Q1 2015 H1 2017(Orphan drug)
acalabrutinib# BTK inhibitor 1st-line CLL Q3 2015 2020(Orphan drug) 2020(Orphan drug)
acalabrutinib# BTK inhibitor r/r CLL, high risk Q4 2015 2020(Orphan drug) 2020(Orphan drug)
selumetinib MEK inhibitor differentiated thyroid cancer Q3 2013 2018(Orphan drug) 2018
ASTRA
moxetumomab pasudotox#PLAIT anti-CD22 recombinant hairy cell leukaemia Q2 2013 2018 (Orphan drug)
immunotoxin
durvalumab#PACIFIC PD-L1 mAb stage III NSCLC Q2 2014 H2 2017 H2 2017 H2 2017
durvalumab#PEARL PD-L1 mAb 1st-line NSCLC Q1 2017 2019
durvalumab# +tremelimumab PD-L1 mAb + CTLA-4 mAb 3rd-line NSCLC Q2 2015 H2 2017 H2 2017 H2 2017
ARCTIC
durvalumab# + tremelimumabMYSTIC PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q3 2015 H2 2017 H2 2017 H2 2017
durvalumab# + tremelimumabNEPTUNE PD-L1 mAb + CTLA-4 mAb 1st-line NSCLC Q4 2015 2019 2019 2019 2020
durvalumab# + tremelimumab + SoCCASPIAN PD-L1 mAb + CTLA-4 mAb + SoC 1st-line SCLC Q1 2017
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 1st-line HNSCC Q4 2015 2018 2018 2018
KESTREL
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb 2nd-line HNSCC Q4 2015 2018 2018 2018
EAGLE
durvalumab# + tremelimumabDANUBE PD-L1 mAb + CTLA-4 mAb 1st-line bladder cancer Q4 2015 2018 2018 2018
Lynparza¶ + cediranibCONCERTO PARP inhibitor + VEGF inhibitor recurrent platinum-resistant ovarian cancer Q1 2017 2020
Cardiovascular & Metabolic Diseases
Farxiga2 SGLT2 inhibitor type-2 diabetes Launched Launched Launched Approved
Epanova omega-3 carboxylic acids severe hypertriglyceridemia Approved 2018
ZS-9 (sodium zirconium cyclosilicate) potassium binder hyperkalaemia - Accepted 2019
roxadustat# OLYMPUS (US) ROCKIES (US) hypoxia-inducible factor prolyl hydroxylase inhibitor anaemia in CKD/ESRD Q3 2014 2018 Initiated3
Respiratory
Bevespi Aerosphere (PT003) LABA/LAMA COPD Launched H1 2017 2018 2018
benralizumab#CALIMA SIROCCO ZONDABISEBORAGREGALE IL-5R mAb severe asthma Accepted Accepted Accepted 2020
benralizumab#TERRANOVA GALATHEA IL-5R mAb COPD Q3 2014 2018 2018 2019
PT010 LABA/LAMA/ ICS COPD Q3 2015 2019 2019 2018 2019
tralokinumabSTRATOS 1,2TROPOSMESOS IL-13 mAb severe asthma Q3 2014 2018 2018 2018
Other
anifrolumab# TULIP IFN-alphaR mAb systemic lupus erythematosus Q3 2015 2019(Fast Track) 2019 2019
lanabecestat# (AZD3293)AMARANTH + extension, DAYBREAK-ALZ beta-secretase inhibitor Alzheimer's disease Q2 2016 2020(Fast Track) 2020 2020
2019
2019
lanabecestat# (AZD3293)AMARANTH + extension, DAYBREAK-ALZ
beta-secretase inhibitor
Alzheimer's disease
Q2 2016
2020(Fast Track)
2020
2020
¶ Registrational Phase IItrial
# Collaboration
1 Brilinta in the US and Japan; Brilique in ROW
2 Farxiga in the US; Forxiga in ROW
3 Rolling New Drug Application (NDA) regulatory submission initiated in Q4 2016
Phases I and II
NMEs and significant additional indications
Oncology
durvalumab# PD-L1 mAb solid tumours II Q3 2014
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb hepatocellular carcinoma (liver cancer) II Q4 2016
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb gastric cancer II Q2 2015
durvalumab# + AZD5069 PD-L1 mAb + CXCR2 HNSCC II Q3 2015
durvalumab# + AZD9150# PD-L1 mAb + STAT3 inhibitor
durvalumab# + dabrafenib + trametinib PD-L1 mAb+ BRAF inhibitor + MEK inhibitor melanoma I Q1 2014
durvalumab# + AZD1775# PD-L1 mAb + Wee1 inhibitor solid tumours I Q4 2015
durvalumab# + MEDI0680 PD-L1 mAb + PD-1 mAb solid tumours II Q3 2016
durvalumab# or durvalumab# + (tremelimumab or AZD9150#) PD-L1 mAb or PD-L1 mAb + (CTLA-4 mAb or STAT3 inhibitor) diffuse large B-cell lymphoma I Q3 2016
durvalumab#+ Iressa PD-L1 mAb+ EGFR inhibitor NSCLC I Q2 2014
durvalumab# + MEDI0562# PD-L1 mAb + humanised OX40 agonist solid tumours I Q2 2016
durvalumab# + MEDI9447 PD-L1 mAb + CD73 mAb solid tumours I Q1 2016
durvalumab# + monalizumab PD-L1 mAb + NKG2a mAb solid tumours I Q1 2016
durvalumab# + selumetinib PD-L1 mAb + MEK inhibitor solid tumours I Q4 2015
durvalumab# + tremelimumab PD-L1 mAb + CTLA-4 mAb solid tumours I Q4 2013
tremelimumab + MEDI0562# CTLA-4 mAb + humanised OX40 agonist solid tumours I Q2 2016
Lynparza + AZD6738 PARP inhibitor + ATR inhibitor gastric cancer II Q3 2016
Lynparza + AZD1775# PARP inhibitor + Wee1 inhibitor solid tumours I Q3 2015
savolitinib# MET inhibitor papillary renal cell carcinoma II Q2 2014
Tagrisso + (selumetinib# or savolitinib#)TATTON EGFR inhibitor + (MEK inhibitor or MET inhibitor) advanced EGFRm NSCLC II Q2 2016
Tagrisso BLOOM EGFR inhibitor CNS metastases in advanced EGFRm NSCLC II Q4 2015
AZD1775#+ chemotherapy Wee1 inhibitor + chemotherapy ovarian cancer II Q4 2012
AZD1775# Wee1 inhibitor solid tumours II Q1 2016
vistusertib (AZD2014) mTOR inhibitor solid tumours II Q1 2013
AZD5363# AKT inhibitor breast cancer II Q1 2014
AZD4547 FGFR inhibitor solid tumours II Q4 2011
MEDI-573# IGF mAb metastatic breast cancer II Q2 2012
AZD0156 ATM inhibitor solid tumours I Q4 2015
AZD2811# Aurora B inhibitor solid tumours I Q4 2015
AZD4635 A2aR inhibitor solid tumours I Q2 2016
AZD6738 ATR inhibitor solid tumours I Q4 2013
AZD8186 PI3k inhibitor solid tumours I Q2 2013
AZD9150# STAT3 inhibitor haematological malignancies I Q1 2012
AZD9496 selective oestrogen receptor downregulator (SERD) ER+ breast cancer I Q4 2014
MEDI-565# CEA BiTE mAb solid tumours I Q1 2011
MEDI0562# humanised OX40 agonist solid tumours I Q1 2015
MEDI0680 PD-1 mAb solid tumours I Q4 2013
MEDI1873 GITR agonist fusion protein solid tumours I Q4 2015
MEDI3726# PSMA antibody drug conjugate prostate cancer I Q1 2017
MEDI4276 HER2 bi-specific antibody drug conjugate solid tumours I Q4 2015
MEDI5083 immune activator solid tumours I Q1 2017
MEDI9197# TLR 7/8 agonist solid tumours I Q4 2015
MEDI9447 CD73 mAb solid tumours I Q3 2015
Cardiovascular & Metabolic Diseases
MEDI0382 GLP-1/glucagon dual agonist diabetes / obesity II Q3 2016
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) II Q4 2016
AZD4831 myeloperoxidase HF with a preserved ejection fraction I Q3 2016
MEDI5884# cholesterol modulation cardiovascular I Q1 2017
AZD5718 FLAP CAD I Q1 2016
AZD8601# VEGF-A cardiovascular I Q1 2017
MEDI8111 Rh-factor II trauma / bleeding I Q1 2014
Respiratory
tezepelumab# TSLP mAb asthma / atopic dermatitis II Q2 2014
abediterol# LABA asthma/COPD II Q4 2007
AZD7594 inhaled SGRM asthma/COPD II Q3 2015
PT010 LABA/LAMA/ICS asthma II Q2 2014
AZD1419# inhaled TLR9 agonist asthma II Q4 2016
AZD8871# MABA COPD II Q1 2017
AZD0284 RORg psoriasis/respiratory I Q4 2016
AZD5634 inhaled ENaC cystic fibrosis I Q1 2016
AZD7594+abediterol# inhaled SGRM+LABA asthma/COPD I Q4 2016
AZD7986# DPP1 COPD I Q4 2014
AZD9567 oral SGRM rheumatoid arthritis/respiratory I Q4 2015
Other
anifrolumab# IFN-alphaR mAb lupus nephritis II Q4 2015
anifrolumab# IFN-alphaR mAb systemic lupus erythematosus (subcutaneous) II Q1 2017
inebilizumab# CD19 mAb neuromyelitis optica II(Orphan drug US, EU) Q1 2015
mavrilimumab# GM-CSFR mAb rheumatoid arthritis II Q1 2010
verinurad selective uric acid reabsorption inhibitor (URAT-1) chronic treatment of hyperuricemia in patients with gout II Q3 2013
MEDI5872# B7RP1 mAb primary Sjögren's syndrome II Q3 2016
MEDI3902 Psl/PcrV bispecific mAb prevention of nosocomial Pseudomonas aeruginosa pneumonia II(Fast Track, US) Q2 2016
MEDI4893 mAb binding to S. aureus toxin prevention of nosocomial Staphylococcus aureuspneumonia II(Fast Track, US) Q4 2014
MEDI8852 influenza A mAb influenza A treatment II(Fast Track, US) Q4 2015
MEDI8897# RSV mAb-YTE passive RSV prophylaxis II(Fast Track, US) Q1 2015
MEDI0700# BAFF/B7RP1 bispecific mAb systemic lupus erythematosus I Q1 2016
MEDI1814# amyloid beta mAb Alzheimer's disease I Q2 2014
MEDI4920 anti-CD40L-Tn3 fusion protein primary Sjögren's syndrome I Q2 2014
MEDI7352 NGF/TNF bispecific mAb osteoarthritis pain I Q1 2016
MEDI7734 ILT7 mAb myositis I Q3 2016
MEDI9314 IL-4R mAb atopic dermatitis I Q1 2016
Q3 2016
MEDI9314
IL-4R mAb
atopic dermatitis
I
Q1 2016
# Collaboration
Significant Lifecycle Management
Oncology
FaslodexFALCON oestrogen receptor antagonist 1st-line hormone receptor +ve advanced breast cancer Accepted Accepted Accepted H2 2017
Lynparza OlympiAD PARP inhibitor gBRCA metastatic breast cancer Q2 2014 H2 2017 2018 H2 2017
Lynparza PARP inhibitor 2nd-line or greater BRCAm PSR ovarian cancer, maintenance monotherapy Q3 2013 Accepted(Priority Review) H1 2017 H2 2017
SOLO-2
Lynparza PARP inhibitor 1st-line BRCAm ovarian cancer Q3 2013 2018 2018 2018
SOLO-1
Lynparza PARP inhibitor gBRCA PSR ovarian cancer Q1 2015 2018
SOLO-3
Lynparza PARP inhibitor pancreatic cancer Q1 2015 2018 2018
POLO
- More to follow, for following part double click ID:nRSa4739DcRecent news on AstraZeneca
See all newsRCS - LHH - LHH, EZRA's AI Leadership Transformation Program
AnnouncementREG - AstraZeneca PLC - Baxdrostat met primary endpoint in Bax24 Ph3 trial
AnnouncementREG - AstraZeneca PLC - Datroway improved OS and PFS in TROPION-Breast02
AnnouncementREG - AstraZeneca PLC - Total Voting Rights
AnnouncementREG - AstraZeneca PLC - Enhertu improved IDFS in early BC in DB-05
Announcement