AstraZeneca to showcase clinical and scientific leadership in lung cancer at ELCC 2016

Tagrisso™ late-breaker presentations provide updated data in first-line EGFRm and second-line EGFRm T790M lung cancer

Studies demonstrate use of blood based testing to identify patients for treatment with Iressa and Tagrisso

Data from exploratory immuno-oncology and small molecule combination studies to be presented during the conference

06 April 2016

AstraZeneca and its global biologics research and development arm, MedImmune, will report new clinical trial and scientific data from their industry-leading lung cancer franchise of marketed and pipeline medicines at the European Lung Cancer Conference (ELCC) in Geneva, Switzerland, 13 -16 April, 2016.

Fifteen abstracts will be presented at the meeting including eight oral presentations, two “best abstracts” and two “late-breakers”. Five abstracts have been selected for the official press programme. Highlights will reinforce the potential of Tagrisso (osimertinib) for the treatment of specific types of advanced non-small cell lung cancer (NSCLC), compare plasma testing and tumour tissue biopsy for treatment decisions in advanced NSCLC, and demonstrate the progress of combination therapy in immuno-oncology.

Tagrisso in first- and second-line lung cancer treatment

Two oral, late-breaker presentations share data from the Tagrisso AURA studies. They build on evidence that supported the accelerated approval of Tagrisso as the first indicated treatment for epidermal growth factor receptor (EGFR) T790M mutation-positive metastatic NSCLC in the US, EU and Japan.

On Thursday 14 April, updated efficacy and safety data will be presented from two Phase I expansion cohorts exploring Tagrisso as first-line treatment for patients with EGFRm advanced NSCLC (Abstract #LBA1_PR). Phase I/II data in pre-treated patients with EGFR T790M advanced NSCLC (Abstract #LBA2_PR) will also be presented. Both presentations will feature in the ELCC press programme on Thursday 14 April.

Mondher Mahjoubi, Senior Vice President, Head of Oncology, Global Product and Portfolio Strategy at AstraZeneca, said: “ELCC’s recognition of the importance of our data for the lung cancer community is very encouraging and we are excited to present more mature data from the AURA programme for our new, first-in-class lung cancer medicine, Tagrisso. We are also reaffirming our commitment to deliver the right treatment to the right patient based on scientific research, with updates from our pioneering plasma circulating tumour DNA trials.”

Plasma ctDNA testing: Delivering the right treatment to the right patient

Accurate identification of patients with tumours carrying key molecular mutations is essential for delivering next-generation targeted therapies to those most likely to benefit. Detection of plasma circulating tumour-derived DNA (ctDNA) in a simple blood test offers a minimally invasive alternative to tumour tissue biopsy, and is already available for identifying patients suitable for treatment with AstraZeneca’s Iressa.

Building on this work, the latest results from innovative research in minimally invasive plasma ctDNA analysis to identify patients with EGFRm T790M NSCLC and predict response to Tagrisso will be reported (Abstract #134O_PR and #135O_PR). Further data from the ASSESS study for EGFR mutation detection in plasma from this patient group will also be presented (Abstract #58O_PR). ASSESS is the first largescale “real-world” study comparing tumour biopsy with ctDNA testing for EGFRm in advanced NSCLC. These studies are highlighted in the ELCC press programme on Friday 15 April.

Marc Denis, Professor of Biochemistry and Molecular Biology at Nantes University Hospital, Nantes, France, said: “Plasma ctDNA testing has the potential to rapidly identify patients suitable for targeted therapy not just for lung cancer but across a wide range of tumour types. Availability of these simple blood tests may streamline diagnosis, including for patients where tumour samples are unavailable.”

Immuno-oncology (IO): Combination focus

AstraZeneca has a broad programme of combination clinical trials underway in oncology and continues to explore novel combination therapies addressing the needs of difficult-to-treat patients with lung cancer. Safety and efficacy data from two exploratory trials combining immunotherapies and small-molecules will be reported at ELCC. These presentations have been designated “best abstracts” (Abstracts #57O and #136O) by the conference.

Robert Iannone, Head of Immuno-Oncology, Global Medicines Development, at AstraZeneca, said: “Durvalumab is the cornerstone of our IO portfolio and we have a rapidly-advancing development programme focused primarily on novel combinations. At ELCC, we are presenting the exceptional science behind our combination approach with abstracts describing the ongoing MYSTIC and NEPTUNE studies combining durvalumab with tremelimumab. These build on recent data showing the anti-tumour activity of this combination in patients with metastatic NSCLC irrespective of PD-L1 status, as published in The Lancet Oncology.”

NOTES TO EDITORS

AstraZeneca/MedImmune key presentations at ELCC

Lead author

Abstract title

Presentation details

Osimertinib

AURA

Ramalingam S

Osimertinib as first-line treatment for EGFR mutation-positive advanced NSCLC: updated efficacy and safety results from two Phase I expansion cohorts

Oral

Proffered papers – New strategies for EGFR

addicted NSCLC

Thursday 14 Apr 14:45-16:15
Room B

Abstract # LBA1_PR

Late Breaker

Press Programme

AURA & AURA 2

Yang J

Osimertinib (AZD9291) in pre-treated pts with T790M-positive advanced NSCLC: updated Phase 1 (P1) and

pooled Phase 2 (P2) results

Oral
Proffered papers – New strategies for EGFR

addicted NSCLC

Thursday 14 Apr 14:45-16:15
Room B

Abstract # LBA2_PR

Late Breaker

Press Programme

TATTON

Ahn M-J

Osimertinib combined with durvalumab in EGFR-mutant non-small cell lung cancer: results from the TATTON Phase Ib trial

Oral
Proffered papers – Best abstracts: the evolving landscape of immunotherapy
Friday 15 Apr 16:45-18:30
Room B

Abstract # 136O

AURA

Jenkins S

Yang J to present

Plasma ctDNA analysis for detection of EGFR T790M mutation in patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (aNSCLC)

Oral

Proffered papers – NSCLC targeted therapy and circulating biomarkers

Friday 15 Apr 09:00-10:40
Room C

Abstract # 134O

Press Programme

AURA
Oxnard G

Plasma genotyping for predicting benefit from osimertinib in patients (pts) with advanced NSCLC

Oral

Proffered papers – NSCLC targeted therapy and circulating biomarkers

Fri 15 Apr 09:00-10:40
Room C

Abstract # 135O

Press Programme

Gefitinib

Gibbons D

Efficacy, safety and tolerability of MEDl4736 (durvalumab [DJ), a human lgG1 anti-programmed cell death ­ligand-1 (PD-L 1) antibody, combined with gefitinib (G): a Phase I expansion in TKl-naïve patients (pts) with EGFR mutant NSCLC

Oral
Proffered papers – Best abstracts: the evolving landscape of immunotherapy
Friday 15 Apr 16:45-18:30
Room B

Abstract # 57O

Yeh T

Inhibition of pEGFR in paired tumour biopsies from TKI treatment-naïve EGFR mutant NSCLC patients

treated with gefitinib (EGFR inhibitor) or gefitinib in combination with durvalumab (anti-PD-L1)

Poster discussion
Targeting EGFR and ALK driven tumours

Thursday 14 Apr 14:45-16:00
Room W

Abstract # 60PD

Normanno N

Clinical and demographic features that influence EGFR mutation detection in plasma from patients (pts) with aNSCLC: the ASSESS experience

Oral
Proffered papers – NSCLC targeted therapy and circulating biomarkers

Friday 15 Apr 09:00-10:40
Room C

Abstract # 58O_PR

Press programme

Han B

Efficacy, safety and tolerability of MEDl4736 (durvalumab [DJ), a human lgG1 anti-programmed cell death ­ligand-1 (PD-L 1) antibody, combined with gefitinib (G): a Phase I expansion in TKl-naïve patients (pts) with EGFR mutant NSCLC

Poster discussion
Targeting EGFR and ALK driven tumours

Thursday 14 Apr 14:45-16:00
Room W

Abstract #59PD

Aperribay E

Level of concordance between EGFR mutation status obtained from tissue/cytology and blood (plasma) for advanced non‐small‐cell lung cancer in Spain: ASSESS study

Poster

Tumour biology and pathology

Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 147TiP

Cadranel J

Real life practice of gefitinib in patients (pts) with non-small-cell lung cancer (NSCLC) depending on epidermal growth factor receptor (EGFR) mutation status: results from the prospective EPIDAURE study

Poster

Tumour biology and pathology

Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 168P

Jin B

Combination of chemotherapy and gefitinib as first-line treatment of patients with advanced lung adenocarcinoma and sensitive EGFR mutations: a randomised controlled trial

Oral

Proffered papers – New strategies for EGFR addicted NSCLC

Thu 14 Apr 14:45-16:15
Room B

Abstract # 131O

 

Durvalumab

NEPTUNE

Mok T

Phase 3, randomised, open-label study of durvalumab (MEDI4736) in combination with tremelimumab versus platinum-based chemotherapy in first-line treatment of patients with advanced or metastatic NSCLC: NEPTUNE

Poster

Tumour biology and pathology

Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 192TiP

MYSTIC Peters S

Phase 3, randomised, open-label study of durvalumab (MEDI4736) in combination with tremelimumab or durvalumab alone versus platinum-based chemotherapy in first-line treatment of patients with advanced/metastatic NSCLC: MYSTIC

Poster

Tumour biology and pathology

Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 191 TiP

Rothschild S

SAKK 16/14 – Anti-PD-L1 antibody durvalumab (MEDI4736) in addition to neoadjuvant chemotherapy in patients with stage IIIA(N2) non-small cell lung cancer (NSCLC). A multicenter single-arm phase II trial

Poster

Tumour biology and pathology

Thursday April 14th Poster lunch: 12:30-13:00

Hall 1

Abstract # 129TiP

 

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 6 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 New Oncology as one of AstraZeneca’s six Growth Platforms 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 haematology.

By harnessing the power of four scientific platforms -- immuno-oncology, the genetic drivers of cancer and resistance, DNA damage repair 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.

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 diseases in three main therapy areas - respiratory, inflammation, autoimmune disease (RIA), cardiovascular and metabolic disease (CVMD) and oncology – as well as 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.

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Key: RIA - Respiratory, Inflammation and Autoimmunity, CVMD - Cardiovascular and Metabolic Disease, ING - Infection, Neuroscience and Gastrointestinal