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AstraZeneca presents advances in improving treatment options for ovarian and lung cancer patients at ESMO 2018

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More than 50 presentations, including data from the pivotal Phase III trial SOLO-1 selected for oral presentation in the ESMO Presidential Symposium

New Lynparza data demonstrate clinically-meaningful improvement for newly-diagnosed, advanced BRCA-mutated ovarian cancer

New data in NSCLC improve understanding of resistance mechanisms after 1st-line Tagrisso and evaluate treatment variations prior to Imfinzi in Stage III disease

AstraZeneca and MedImmune, its global biologics research and development arm, will present 54 abstracts, including eight oral presentations and three late breakers, to the European Society of Medical Oncology (ESMO 2018) Congress in Munich, Germany, 19-23 October.

Data span several tumour types and include full results from the Phase III SOLO-1 ovarian cancer trial to be presented in the Presidential Symposium, along with new research on resistance mechanisms in metastatic epidermal growth factor receptor (EGFR)-mutated non-small cell lung cancer (NSCLC). In addition, MedImmune Senior Vice President, Head of Oncology Innovative Medicines and Professor of Medicine and Medical Oncology at South-Paris University, Jean-Charles Soria, will be recognised for his outstanding contribution to medical oncology by receiving the 2018 ESMO Award.

Dave Fredrickson, Executive Vice President, Head of Oncology Business Unit, said: “Our diversified Oncology portfolio prioritises medicines with the potential to redefine the clinical practice of cancer treatment. We are working to deliver potentially curative approaches earlier in the treatment paradigm across a range of cancers. We are also exploring how to stay a step ahead of disease progression by understanding how tumours become resistant to treatment over time.”

Detailed Lynparza data from the Phase III SOLO-1 trial in women with newly-diagnosed, advanced BRCA-mutated ovarian cancer

SOLO-1 is the only trial of a poly (ADP-ribose) polymerase (PARP) inhibitor, Lynparza, to demonstrate a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) for women with newly-diagnosed, advanced BRCA-mutated ovarian cancer. Data from the trial by AstraZeneca and MSD, known as Merck in the US and Canada, will be featured in an ESMO Presidential Symposium (Presentation #LBA7_PRAbstract). In the 1st-line setting, only 20 percent of women have prolonged, relapse-free periods and are considered cured following surgery and chemotherapy, and 70 percent relapse within three years. These data will provide detailed PFS results for Lynparza, supporting the treatment goal of long-term remission in women with newly-diagnosed disease, where currently-available treatment options aimed at extending time to progression only offer modest improvements.

New understanding of acquired resistance mechanisms in lung cancer from the

Phase III FLAURA trial

Preliminary data on acquired resistance mechanisms seen with 1st-line Tagrisso (osimertinib) use in the Phase III FLAURA trial (Presentation Number #LBA_5005) will be presented as a late-breaker, providing new insights into potential treatment strategies for patients with metastatic EGFR-mutated NSCLC.

Lung cancer Immuno-Oncology (IO): New insights from the Phase III PACIFIC trial

An oral presentation of subgroup analyses will explore the efficacy and safety of the PACIFIC regimen in unresectable, Stage III NSCLC evaluating differences in treatment and timing for chemoradiation therapy before Imfinzi (Abstract #1363O).

Early pipeline explores combinations in difficult-to-treat tumour types

Key presentations from AstraZeneca’s early stage pipeline include insight into novel DNA Damage Response (DDR)-IO combinations. A Phase I clinical and translational evaluation of the ATR inhibitor, AZD6738, in combination with Imfinzi in patients with lung or head and neck cancer will be featured as a poster discussion (Abstract #413PD).

Data from the early-stage IO pipeline, including updated results from the Phase Ib/II multi-indication SCORES trial of Imfinzi plus danvatirsen (AZD9150, STAT3) or AZD5069 (CXCR2), demonstrating the impact of targeting novel pathways, will also be presented (Abstract #1044O).

Additionally, new approaches to patient selection using different methods of detection of homologous recombination repair gene mutations will be highlighted in a Phase II trial of Lynparza plus abiraterone (Study 08) in metastatic castration-resistant prostate cancer (Abstract #97P).

Key AstraZeneca/MedImmune presentations at ESMO 2018:

Lead author Abstract title Presentation details
Ovarian cancer
Moore, K Phase III SOLO1 trial: Maintenance olaparib following platinum-based chemotherapy in newly diagnosed patients (pts) with advanced stage ovarian cancer (OC) and a BRCA1/2 mutation (BRCAm) Oral PresentationPresidential Symposium 2Sunday 21st October, 16:30-18:10Presentation Time: 17:45-18:00Location: Hall A2, Room 18Abstract #LBA7_PR
Penson, RT MEDIOLA: A Phase I/II trial of olaparib (PARP inhibitor) in combination with durvalumab (anti-PD-L1 antibody) in patients with advanced solid tumors – new ovarian cancer cohorts Poster Gynaecological cancersMonday 22nd October, 12:45-13:45Location: Hall A3Abstract #448TiP
Colombo, N BAROCCO: A randomized phase II study of weekly paclitaxel vs. cediranib-olaparib with continuous schedule vs. cediranib-olaparib with intermittent schedule in advanced platinum-resistant ovarian cancer Poster Gynaecological cancersSaturday 20th October, 12:30-13:30Location: Hall A3 Abstract #1002TiP
Lung Cancer
Ramalingam, S Mechanisms of acquired resistance to first-line osimertinib: preliminary data from the phase III FLAURA study Oral PresentationNSCLC, metastaticFriday 19th October, 16:00-17:30Presentation Time: 16:00-16:12 Location: Hall A2, Room 18Abstract #LBA50
Faivre-Finn, C Efficacy and safety evaluation based on time from completion of radiotherapy to randomization with durvalumab or placebo in pts from PACIFIC Oral Presentation​Non-Metastatic NSCLC and Other Thoracic MalignanciesSunday 21th October, 09:15-10:45Presentation Time: 10:15-10:30 Location: Hall A1, Room 17
Abstract #1363O
Kowalski, D ARCTIC: durvalumab + tremelimumab and durvalumab monotherapy vs SoC in ≥3L advanced NSCLC treatment Oral Presentation ​NSCLC, metastaticMonday 22nd October, 09:15-11:00​Presentation Time: 10:15-10:30 Location: Hall A1, Room 17​Abstract #1378O
Bondarenko, I Preliminary efficacy of durvalumab plus tremelimumab in platinum-refractory/resistant ED-SCLC from Arm A of the Phase II BALTIC study Poster DiscussionLung earlySunday 21st October, 14:45-16:00Discussion Time: 15:25-15:35Location: ICM, Room 1Abstract #1665PD
Early pipeline
Cohen, EW Phase 1b/2 Study (SCORES) of Durvalumab (D) Plus AZD9150 or AZD5069 in Advanced Solid Malignancies and Recurrent/Metastatic Squamous Cell Carcinoma of the Head and Neck (R/M-SCCHN): Updated Results Oral Presentation Head & Neck cancer
Monday 22nd October, 14:45-16:15
Presentation Time: 14:45-15:00 Location: ICM, Room 14b
Abstract #1044O
Krebs, MG Phase I clinical and translational evaluation of AZD6738 in combination with durvalumab in patients (pts) with lung or head and neck carcinoma Poster DiscussionDevelopmental therapeuticsSaturday 20th October, 15:00-16:15Discussion Time: 15:00-15:20Location: Hall B3, Room 22Abstract #413PD
Carr, Thomas H Multimodal detection of homologous recombination repair gene mutations (HRRm) in a Phase II trial of olaparib plus abiraterone in metastatic castrate resistant prostate cancer (mCRPC) PosterBiomarkersSaturday 20th October, 12:30-13:30 Location: Hall A3 Abstract #97P

– 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 haematology.

By harnessing the power of four scientific platforms – Immuno-Oncology, Tumour Drivers 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.

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation 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.com and follow us on Twitter @AstraZeneca.

About MedImmune

MedImmune is the global biologics research and development arm of AstraZeneca, a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology, Respiratory, Cardiovascular, Renal and Metabolic Diseases, and Infection and Vaccines. The MedImmune headquarters is located in Gaithersburg, Md., one of AstraZeneca’s three global R&D centres, with additional sites in Cambridge, UK and South San Francisco, CA. For more information, please visit www.medimmune.com.

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