AstraZeneca highlights latest advances in lung cancer at the ESMO 2017 Congress

More than 40 presentations, including data from two pivotal trials selected as late-breaking abstracts for oral presentation in the ESMO Presidential Symposia Phase III PACIFIC data reinforce potential of Imfinzi following US FDA breakthrough therapy designation in locally-advanced (Stage III) unresectable NSCLC Phase III FLAURA results highlight superiority of Tagrisso over standard of care in previously-untreated patients with advanced EGFRm NSCLC At the European Society of Medical Oncology (ESMO) 2017 Congress in Madrid, Spain, 8-12 September, AstraZeneca and MedImmune, its global biologics research and development arm, will report results of more than 40 presentations, including two pivotal clinical trial readouts selected for late-breaking abstract presentation at the ESMO Presidential Symposia on Saturday, 9 September, which demonstrate significant improvements over current standard-of-care treatments in lung cancer: Results from the pivotal Phase III PACIFIC trial showing statistically-significant and clinically-meaningful progression-free survival (PFS) benefit with Imfinzi (durvalumab) in patients with locally-advanced (Stage III), unresectable non-small cell lung cancer (NSCLC) following standard chemoradiation therapy, a clinical setting where there are currently no approved treatments. Results of the Phase III FLAURA trial showing statistically-significant and clinically-meaningful PFS with Tagrisso (osimertinib) over current standard-of-care erlotinib or gefitinib as 1st-line treatments in previously-untreated patients with locally-advanced or metastatic epidermal growth factor receptor mutation-positive (EGFRm) NSCLC. Jamie Freedman, Executive Vice President, Head of the Oncology Business Unit at AstraZeneca, said: “The superiority of 1st-line treatment with Tagrisso in the FLAURA trial and the potentially transformative Imfinzi data from the PACIFIC trial reinforce our significant contribution to advancing medicines for patients across multiple stages of lung cancer. We are also proud to share with the medical community our progress towards addressing the needs of patients with other types of difficult-to-treat tumours, including advanced ovarian, breast, and head and neck cancers.” Pushing the boundaries of lung cancer research In addition to the two Presidential Symposia presentations, data being presented at ESMO demonstrate the breadth and depth of AstraZeneca’s commitment to advancing the treatment of lung cancer: Overall survival data on Tagrisso from the Phase II AURA trials in patients with EGFR T790M mutation-positive advanced NSCLC (Abstract #1348P) PFS data and central nervous system (CNS) responses to Tagrisso in patients with EGFR T790M NSCLC in the Asia Pacific region (AURA17) (Abstracts #1331P, 1353P and 1354P) Established expertise in women’s cancers Emerging data from studies of Lynparza , Faslodex , potential new medicines and combinations within women’s cancers will include: Latest Phase III OlympiAD efficacy and health-related quality-of-life data for Lynparza vs. chemotherapy in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation (Abstract #243PD and 290P) Phase III SOLO-2 data for Lynparza maintenance therapy in patients with platinum-sensitive relapsed ovarian cancer (Abstract #932PD) Sustained commitment in head and neck cancer AstraZeneca is presenting additional evidence of the efficacy and safety of Imfinzi and the early potential of its combination strategy in head and neck cancer, including oral presentations on: Preliminary data from the Phase II HAWK study of Imfinzi in recurrent/metastatic head and neck squamous cell carcinoma (HNSCC) (Abstract #1042O) Safety, tolerability and anti-tumour activity in the Phase Ib/II SCORES study of Imfinzi in combination with STAT3 inhibitor AZD9150 or CXCR2 inhibitor AZD5069, in patients with HNSCC (Abstract #1049PD) NOTES TO EDITORS AstraZeneca/MedImmune key presentations at the ESMO 2017 Congress Lead author Abstract title Presentation details Lung cancer Paz-Ares L PACIFIC: A double-blind, placebo-controlled Phase III study of durvalumab after chemoradiation therapy (CRT) in patients with Stage III, locally advanced, unresectable NSCLC Oral Lung Cancer Saturday 9 th September, 16:30-18:10 Presentation Time: 16:30-16:45 Location: Madrid Auditorium Abstract #LBA1 Ramalingam S Osimertinib vs SoC EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA) Oral Lung Cancer Saturday 9 th September, 16:30-18:10 Presentation Time: 17:30-17:45 Location: Madrid Auditorium Abstract #LBA2 Zhou C Detection of EGFR T790M in Asia-Pacific patients (pts) with EGFR mutation-positive advanced non-small cell lung cancer (NSCLC): circulating tumour (ct) DNA analysis across 3 platforms Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1331P Zhou C Osimertinib in Asia-Pacific patients (pts) with EGFR T790M-positive advanced NSCLC: updated Phase II study results including progression-free survival (PFS) Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #135P Zhou C CNS response to osimertinib in Asian-Pacific patients (pts) with T790M-positive advanced NSCLC: data from an open-label Phase II trial (AURA17) Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1353P Mitsudomi T Overall survival (OS) in patients (pts) with EGFR T790M-positive advanced non-small cell lung cancer (NSCLC) treated with osimertinib: results from two Phase II studies Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1348P Pinotti G EGFR T790M detection in TKI-naïve NSCLCs carrying sensitive EGFR mutations Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1335P Postel-Vinay S A randomized double-blind Phase II trial evaluating maintenance PARP inhibitor Olaparib versus placebo in patients with platinum-sensitive advanced non-small cell lung cancer: PIPSeN trial Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1381TiP Kim Y C Phase II Trial of AZD9291 in Second Line Treatment after Acquired Resistance with T790M Mutation Detected From Circulating Tumor DNA (LiquidLung-O-Cohort 2) Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1360P Calabuig-Farinas S Clinical value of cfDNA and CTCs in EGFR mutations detected in advanced NSCLC Poster Lung Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #1638P Leduc C Ultrasensitive detection of EGFR T790M mutation by droplet digital PCR (ddPCR) in TKI naïve non-small cell lung cancer (NSCLC) harboring EGFR mutation: results of the nationwide program Biomarkers France of the French Cooperative Thoracic Intergroup (IFCT) Poster Discussion Lung Cancer Saturday 9 th September, 9:00-10:45 Presentation Time: 10:16 Location: Pamplona Auditorium Abstract #85PD Wu Y-L A Phase 3 study of first-line durvalumab vs platinum-based chemotherapy in patients with advanced NSCLC and high PD-L1 expression: PEARL Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1378TiP Zhang X Prediction of survival with durvalumab in locally advanced or metastatic NSCLC using early tumor assessments Poster Lung Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #1312P Women’s cancers Martinez Bueno A Disruptive mutations in TP53 associate with survival benefit in a PARPi trial in Ovarian Cancer Oral Ovarian Cancer Saturday 9 th September, 09:15-10:45 Presentation Time: 09:15 Location: Cartagena Auditorium Abstract #LBA42 Ruiz-Borrego M Phase III evaluating the addition of fulvestrant (F) to Anastrozol (A) as adjuvant therapy in postmenopausal women with hormone receptor positive HER2 negative (HR+/HER2-) early breast cancer (EBC): results from the GEICAM/2006-10 study Oral Breast Cancer Friday 8 th September, 14:00-15:30 Presentation Time: 14:24-14:36 Location: Pamplona Auditorium Abstract #148O Delaloge, S. OlympiAD: Further efficacy outcomes in patients with HER2-negative metastatic breast cancer and a germline BRCA mutation receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice Poster Discussion Breast Cancer Sunday 10 th September, 09:15-10:45 Presentation Time: 09:45 Location: Sevilla Auditorium Abstract #243PD Wang J FRIEND: A randomized pilot study to compare the efficacy and tolerability of fulvestrant 500mg with exemestane as first line endocrine therapy for post-m ER positive HER2 negative ABC patients relapse after adjuvant non-steroidal aromatase inhibitors (NSAI) Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #311TiP Kawaguchi H Factors associated with prolonged time to treatment failure with fulvestrant 500 mg in patients with postmenopausal estrogen receptor-positive advanced/metastatic breast cancer (JBCRG-C06; Safari): A subgroup analysis Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #302P Kaufman P Abemaciclib plus fulvestrant in patients (pts) with HR+/HER2- endocrine therapy naïve (EN) advanced breast cancer - an exploratory analysis of MONARCH 2 Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #235P Zimmer A A Phase I PK/PD study of durvalumab (D) in combination with olaparib (O) and cediranib (C) in recurrent women’s cancers Poster Ovarian Cancer, Cervical, Breast, Endometrial Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #390P Westin S Phase I Expansion of olaparib (PARP inhibitor) and AZD5363 (AKT inhibitor) in recurrent ovarian, endometrial and triple negative breast cancer Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #391P Turner N BEECH: A randomised Phase 2 study assessing the efficacy of AKT inhibitor AZD5363 combined with paclitaxel in patients with ER+ve advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population Poster Discussion Breast Cancer Sunday 10 th September, 09:15-10:45 Presentation Time: 09:55 Location: Sevilla Auditorium Abstract #241PD Lui JF A pilot study to evaluate the feasibility, usability, and perceived satisfaction with eCO (eCediranib-Olaparib), a mobile application for side effect monitoring and reporting, in women with recurrent ovarian cancer Poster Ovarian Cancer Sunday 10 th September, 13:15-14:15 Location: Hall 8 Abstract #1560P Nicum S OCTOVA: A randomised Phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with BRCA-mutated platinum-resistant ovarian cancer Poster Ovarian Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #989TiP Taylor J N-DUR: Matched Pair Pharmacodynamics Study of Neoadjuvant Durvalumab in Combination with Chemotherapy in Frontline Ovarian Cancer Poster Ovarian Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #992TiP Penson R Efficacy of olaparib maintenance therapy in patients (pts) with platinum-sensitive relapsed ovarian cancer (PSROC) by lines of prior chemotherapy: Phase III SOLO2 trial (ENGOT Ov-21) Poster Discussion Ovarian Cancer Saturday 9 th September, 09:15-10:45 Presentation Time: 09:15 Location: Cartagena Auditorium Abstract #932PD Dalvi T BREAKOUT: a cross-sectional, prospective, observational study of germline BRCA mutation (gBRCAm) prevalence and real-world outcomes among patients (pts) with HER2-negative (HER2-ve) metastatic breast cancer (mBC) Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #316TiP Shimomura A Gene alteration in triple negative breast cancer patients in a phase I/II study of combination therapy with eribulin and olaparib Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #282P Aogi K Efficacy and safety of olaparib combined with eribulin in patients with advanced or metastatic triple negative breast cancer (TNBC) previously treated with anthracyclines and taxanes: the final analysis of a Japanese Phase I/II trial Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #251P Robson ME OlympiAD: Health-related quality of life (HRQoL) in patients with HER2-negative metastatic breast cancer (mBC) and a germline BRCA mutation (gBRCAm) receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice (TPC) Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #290P O’Connor M Generation of a novel preclinical PK/PD model provides insights into PARP inhibitor clinical monotherapy activity Poster Women’s Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #393P Tutt A OlympiA: a randomized Phase III trial of olaparib as adjuvant therapy in patients with high-risk HER2-negative breast cancer (BC) and a germline BRCA1/2 mutation (gBRCAm) Poster Breast Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #216TiP Sugiyama T Japan CHARLOTTE: Characterizing the cross-sectional approach to ovarian cancer: Genetic testing of BRCA Poster Ovarian Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #984TiP Oza A Evaluation of tumour responses and olaparib efficacy in platinum-sensitive relapsed ovarian cancer (PSROC) patients (pts) with or without measurable disease in the SOLO2 trial (ENGOT Ov-21) Poster Ovarian Cancer Saturday 9 th September, 13:15-14:15 Location: Hall 8 Abstract #965P Callens C BRCA1&2 tumoral and germline status for ovarian cancer patients in first line setting within the PAOLA-01 trial Poster Discussion Ovarian Cancer Saturday 9 th September, 09:15-10:45 Location: Cartagena Auditorium Abstract #935PD Moore K A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Poster Ovarian Cancer Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #990TiP Pjuade-Lauraine E OReO/ENGOT Ov-38: A Phase IIIb trial of olaparib maintenance retreatment in patients with epithelial ovarian cancer Poster Ovarian Cancer Saturday 9 th September; 13:15-14:15 Location: Hall 8 Abstract #987TiP Head and neck cancer Cohen EE Phase Ib/II Study (SCORES) Assessing Safety, Tolerability, and Preliminary Anti-tumor Activity of Durvalumab Plus AZD9150 or AZD5069 in Patients With Advanced Solid Malignancies and Squamous Cell Carcinoma of the Head and Neck (SCCHN) Oral Head and Neck Cancer Monday 11 th September, 11:00-12:30 Presentation Time: 11:15-11:30 Location: Madrid Auditorium Abstract #1135O Zandberg DP Durvalumab for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): preliminary results from a single-arm, Phase II study Oral Head and Neck Cancer Monday 11 th September, 15:00-16:20 Presentation Time: 15:39-15:51 Location: Granada Auditorium Abstract #1042O Stokes M Relationship between PD-L1 expression and survival in head and neck squamous cell carcinoma (HNSCC) patients (pts) Poster Discussion Head and Neck Cancer Saturday 9 th September, 14:45-16:15 Presentation Time: 15:07 Location: Alicante Auditorium Abstract #1049PD Pai S Retrospective cohort study of PD-L1 expression in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SUPREME-HN) Poster Discussion Head and Neck Cancer Saturday 9 th September, 14:45-16:15 Presentation Time: 15:07 Location: Alicante Auditorium Abstract #1048PD Even C MEDINDUCTION: Phase I trial evaluating the safety of durvalumab in combination with Docetaxel, Cisplatin and 5-FU (DCF) in induction for locally advanced squamous cell carcinoma of the head and neck (SCCHN) Poster Head and Neck Cancer Sunday 10 th September, 13:15-14:15 Location: Hall 8 Abstract #1109TiP Other cancers Choueiri T Savolitinib versus sunitinib in patients with MET-driven, unresectable and locally advanced or metastatic papillary renal cell carcinoma: SAVOIR, a randomised, Phase III trial Poster Urothelial Carcinoma (UC) Sunday 10 th September, 13:15-14:15 Location: Hall 8 Abstract #924TiP Zheng Y Modeling of Tumor Kinetics and Overall Survival to Identify Predictive Factors for Efficacy of Durvalumab in Patients with Urothelial Carcinoma (UC) Poster Urothelial Carcinoma (UC) Sunday 10 th September, 13:15-14:15 Location: Hall 8 Abstract #869P Gonzalez-Cao M A Phase II exploratory study of durvalumab (MEDI4736) in HIV-1 patients with advanced solid tumors Poster HIV Sunday 10 th September, 13:15-14:15 Location: Hall 8 Abstract #1208TiP Wiester T Comparison of continuous measures across diagnostic PD-L1 assays using image analysis Poster Biomarker Testing Monday 11 th September, 13:15-14:15 Location: Hall 8 Abstract #103P Chen R Efficacy and safety in first-line combined androgen blockade in advanced prostate cancer; a systematic review and meta-analysis Poster Prostate Cancer Sunday 10 th September, 13:15-14:15 Location: Hall 8 Abstract #805P 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 New Oncology as one of AstraZeneca’s five 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, 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 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 commercialisation of small molecule and biologic prescription medicines. MedImmune is pioneering innovative research and exploring novel pathways across Oncology; Respiratory, Cardiovascular & 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 Mountain View, CA. For more information, please visit www.medimmune.com . 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 main therapy areas - Oncology, Cardiovascular & Metabolic Diseases and Respiratory. The Company also is selectively active in the areas of autoimmunity, neuroscience and infection. 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. CONTACTS Media Enquiries Esra Erkal-Paler UK/Global +44 203 749 5638 Rob Skelding UK/Global +44 203 749 5821 Karen Birmingham UK/Global +44 203 749 5634 Matt Kent UK/Global +44 203 749 5906 Jacob Lund Sweden +46 8 553 260 20 Michele Meixell US +1 302 885 2677 Investor Enquiries Thomas Kudsk Larsen +44 203 749 5712 Craig Marks Finance, Fixed Income, M&A +44 7881 615 764 Henry Wheeler Oncology +44 203 749 5797 Mitchell Chan Oncology +1 240 477 3771 Christer Gruvris Diabetes; Autoimmunity, Neuroscience & Infection +44 203 749 5711 Nick Stone Respiratory, Brilinta +44 203 749 5716 US Toll-Free +1 866 381 7277 tags Partnering Corporate and financial

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