AstraZeneca Oncology Update from European Cancer Congress in Amsterdam

Monday, 30 September 2013

AstraZeneca and its global biologics research and development arm, MedImmune, presented oncology data at the European Cancer Congress (ECC) in Amsterdam this week (27 September – 1 October), a multidisciplinary meeting of the European Cancer Organisation (ECCO), the European Society of Medical Oncology (ESMO) and the European Society for Radiotherapy and Oncology (ESTRO).

Data from a range of studies demonstrated early clinical activity from AZD9291, an irreversible inhibitor of epidermal growth factor receptor (EGFR) (Abstract # 33 LBA); MEDI4736, a PD-L1 monoclonal antibody that is being studied in patients with advanced solid tumours (Abstract # 802), and additional data supporting the company’s accelerated development of olaparib, a poly ADP ribose polymerase (PARP) inhibitor (Abstract # 846 in new tablet formulation in combination with carboplatin and paclitaxel; # 801 in ovarian cancer patients with a germline BRCA1/2 mutation; # 3002 in combination with chemotherapy, followed by maintenance monotherapy, in women with platinum-sensitive recurrent serous ovarian cancer). Additional Phase III data on AstraZeneca’s cediranib, a vascular endothelial growth factor (VEGF) signalling inhibitor, in platinum-sensitive relapsed ovarian cancer will be presented by researchers from the UK Medical Research Council on 30 September (Abstract # 10 LBA).

On 29 September, AstraZeneca presented Phase I data from a global open-label study of AZD9291 (Abstract # 33 LBA), a third-generation oral, selective, irreversible inhibitor of EGFR-activating and resistance mutations in non-small-cell lung cancer (NSCLC). In the study, the compound was clinically active and tolerated as a monotherapy in patients with advanced EGFR mutation positive NSCLC whose tumours have progressed following prior therapy with an EGFR tyrosine kinase inhibitor (TKI).

“Cancer is one of our key therapeutic area priorities and we continue to make progress in our development pipeline,” said Susan Galbraith, Head of Oncology Innovative Medicines Unit, AstraZeneca. “The encouraging results from the Phase I trial on AZD9291 in advanced non-small-cell lung cancer show it is active in patients for whom most therapeutic options have been exhausted. We look forward to seeing further results from this trial and although the compound is still at an early stage, we are now considering accelerating its development.”

On 30 September, MedImmune presented pre-clinical and preliminary clinical data from the Phase I study of MEDI4736 in patients with advanced solid tumours (Abstract # 802). Overall, MEDI4736 shows an encouraging level of clinical activity with a manageable safety profile relative to the small data set. In the dose escalation phase of the study, early tumour shrinkage was observed across a range of doses, including the lowest doses explored. The study is currently ongoing and the complete clinical and safety data will be presented at a future scientific meeting.

“MEDI4736 is off to a good start in the dose escalation Phase I study. The safety profile and observed activity at all doses studied are very encouraging at this early point,” said Edward Bradley, Senior Vice President and Head of MedImmune’s Oncology Innovative Medicines Unit. “MEDI4736 plays an important role in our growing portfolio of immune-mediated cancer therapies, which have the potential to become a cornerstone of future cancer therapy regimens, particularly in combination with other highly-active molecules.”

AstraZeneca also presented data on olaparib (Abstracts # 846, # 801 and # 3002), a PARP inhibitor that recently started Phase III development and that has been accepted for marketing authorisation by the European Medicines Agency (EMA) for the maintenance treatment of patients with platinum-sensitive relapsed serous ovarian cancer who have a BRCA mutation.

Key among these data was Study 24 (Abstract # 801, 30 September) which confirmed 300 mg as the optimal dose for the tablet formulation of olaparib, which is the formulation and dose for the Phase III SOLO (Studies of OLaparib in Ovarian cancer) programme initiated on 4 September. The clinical trial programme will determine the benefit, by progression free survival (PFS), of olaparib as a maintenance monotherapy in ovarian cancer patients who have a BRCA mutation who are in complete or partial response following platinum-based chemotherapy in both the first line setting (SOLO 1), and in the relapsed setting (SOLO 2). 


NOTES TO EDITORS

About AZD9291

AZD9291 is an oral, selective, irreversible inhibitor of epidermal growth factor receptor (EGFR) activating and resistance mutations in non-small cell lung cancer (NSCLC) that has been shown in a Phase I study to be clinically active and tolerated as monotherapy.

About MEDI4736

MEDI4736 is a human monoclonal IgG1 antibody directed against a component of tumour cells and immune cells known as the programmed cell death ligand 1 (PD-L1). It is believed that by targeting PD-L1, MEDI4736 may block this ligand from sending out a signal to T cells to ‘ignore’ tumour cells, thereby countering cancer’s immune-evading tactics.

About olaparib

Olaparib is a potential first-in-class oral poly ADP-ribose polymerase (PARP) inhibitor that has been shown in pre-clinical models to exploit DNA repair pathway deficiencies to preferentially kill cancer cells. This mode of action gives olaparib the potential for activity in a range of tumour types with DNA repair deficiencies.

About cediranib

Cediranib is a highly potent VEGF signalling inhibitor that inhibits all three VEGF receptors. It has been shown to inhibit angiogenesis and lymphangiogenesis. In preclinical and clinical studies, cediranib has shown reduction in tumour growth in a range of solid tumour models, consistent with an antiangiogenic mechanism of action.

About MedImmune

MedImmune is the worldwide biologics research and development arm of AstraZeneca. MedImmune is pioneering innovative research and exploring novel pathways across key therapeutic areas, including respiratory, inflammation and autoimmunity; cardiovascular and metabolic disease; oncology; neuroscience; and infection and vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centers. For more information, please visit www.medimmune.com.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

 

Solid Tumors

Metastatic

AZD9291

Ranson M  Preliminary results from a Phase I study with AZD9291: an irreversible inhibitor of epidermal growth factor receptor (EGFR) activating and resistance mutations in non-small-cell lung cancer (NSCLC) Abstract #33LBA
Sunday 29 September 2013
08:50AM - 11:35AM CEST
Location: Elicium 2
Session title: Lung Cancer – Metastatic
 

MEDI4736

Khleif S MEDI4736, an anti-PD-L1 antibody with modified Fc domain: Preclinical evaluation and early clinical results from a phase 1 study in patients with advanced solid tumors Abstract #802
Monday 30 September 2013
08:50AM - 11:35AM CEST
Location: Elicium 2
Session title: Lung Cancer – Metastatic
 

Olaparib

van der Noll R
Study 4
 
Safety results from a Phase I study with a new tablet formulation of olaparib (O) in combination with carboplatin (C) and paclitaxel Abstract #846
Sunday 29 September
09:30 AM-12:00 PM
Location: Hall 4
Session Type: Poster (drug development)
 
Mateo J
Study 24
 
Administration of continuous/intermittent olaparib in ovarian cancer patients with a germline BRCA1/2 mutation to determine an optimal dosing schedule for the tablet formulation Abstract #801
Monday 30 September
09:00AM-11:00 AM
Location: Room G104
Session Type: Oral presentation (drug development)
 
Oza A
Study 41
 
Olaparib plus chemotherapy, followed by maintenance monotherapy, in women with platinum-sensitive recurrent serous ovarian cancer (PSR SOC): BRCA1/2 mutation (BRCAm) and interim overall survival analyses. Abstract #3002
Tuesday 1 October
09:00 AM-11:00 AM
Location: Hall 7.2
Session Type: Oral presentation (gynaecological cancer)
 

Cediranib

   Randomised double-blind Phase III trial of cediranib (AZD2171) in relapsed platinum-sensitive ovarian cancer: Results of the ICON6 trial. Abstract #LBA10
Monday 30 September
12:30 AM
Location: Hall 7.1
Session Type: Oral presentation (Presidential Session III)
 

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