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

Pressmeddelande   •   Aug 31, 2017 08:11 CEST

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 showingstatistically-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 #10420)
  • 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)

– ENDS –

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 9th 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 9th 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 9th 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 9th 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 9th 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 9th 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 9th 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 9th 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 9th 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 11th 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 9th 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 9th 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 9th 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 9th 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 8th 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 10th 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 11th 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 11th 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 11th 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 11th 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 11th 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 10th 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 10th 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 9th 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 9th 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 9th 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 11th 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 11th 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 11th 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 11th 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 11th 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 11th 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 9th 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 9th 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 9th 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 11th 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 9th 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 11th 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 11th 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 9th 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 9th 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 10th 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 10th 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 10th 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 10th 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 11th 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 10th 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.

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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.comand follow us on Twitter @AstraZeneca.

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