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 #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 chemoradiationtherapy (CRT) in patients with Stage III, locally advanced, unresectable NSCLC OralLung CancerSaturday 9th September, 16:30-18:10
Presentation Time: 16:30-16:45 Location: Madrid AuditoriumAbstract #LBA1
Ramalingam S Osimertinib vs SoC EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA) OralLung CancerSaturday 9th September, 16:30-18:10
Presentation Time: 17:30-17:45 Location: Madrid AuditoriumAbstract #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 PosterLung CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #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) PosterLung CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #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 CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #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 PosterLung CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #1348P
Pinotti G EGFR T790M detection in TKI-naïve NSCLCs carrying sensitive EGFR mutations PosterLung CancerSaturday 9th September, 13:15-14:15Location: Hall 8Abstract #1335P
Postel-Vinay S A randomized double-blind Phase II trial evaluating maintenance PARP inhibitor Olaparibversus placebo in patients with platinum-sensitive advanced non-small cell lung cancer: PIPSeN trial PosterLung CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #1381TiP
Kim Y C Phase II Trial of AZD9291 in Second Line Treatment after Acquired Resistance with T790MMutation Detected From Circulating Tumor DNA (LiquidLung-O-Cohort 2) PosterLung CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #1360P
Calabuig-Farinas S Clinical value of cfDNA and CTCs in EGFR mutations detected in advanced NSCLC PosterLung CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #1638P
Leduc C Ultrasensitive detection of EGFR T790M mutation by droplet digital PCR (ddPCR) in TKI naïvenon-small cell lung cancer (NSCLC) harboring EGFR mutation: results of the nationwide programBiomarkers France of the French Cooperative Thoracic Intergroup (IFCT) Poster DiscussionLung CancerSaturday 9th September, 9:00-10:45Presentation Time: 10:16Location: Pamplona AuditoriumAbstract #85PD
Wu Y-L A Phase 3 study of first-line durvalumab vs platinum-based chemotherapy in patients withadvanced NSCLC and high PD-L1 expression: PEARL PosterLung CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #1378TiP
Zhang X Prediction of survival with durvalumab in locally advanced or metastatic NSCLC using earlytumor assessments PosterLung CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #1312P

Women’s cancers

Martinez Bueno A Disruptive mutations in TP53 associate with survival benefit in a PARPi trial in Ovarian Cancer OralOvarian Cancer Saturday 9th September, 09:15-10:45
Presentation Time: 09:15 Location: Cartagena AuditoriumAbstract #LBA42
Ruiz-Borrego M Phase III evaluating the addition of fulvestrant (F) to Anastrozol (A) as adjuvant therapy inpostmenopausal women with hormone receptor positive HER2 negative (HR+/HER2-) early breastcancer (EBC): results from the GEICAM/2006-10 study OralBreast CancerFriday 8th September, 14:00-15:30
Presentation Time: 14:24-14:36 Location: Pamplona AuditoriumAbstract #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 DiscussionBreast CancerSunday 10th September, 09:15-10:45
Presentation Time: 09:45 Location: Sevilla AuditoriumAbstract #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) PosterBreast CancerMonday 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 PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #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 PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #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 PosterOvarian Cancer, Cervical, Breast, EndometrialMonday 11th September, 13:15-14:15Location: Hall 8Abstract #390P
Westin S Phase I Expansion of olaparib (PARP inhibitor) and AZD5363 (AKT inhibitor) in recurrent ovarian, endometrial and triple negative breast cancer PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #391P
Turner N BEECH: A randomised Phase 2 study assessing the efficacy of AKT inhibitor AZD5363combined with paclitaxel in patients with ER+ve advanced or metastatic breast cancer, and in a PIK3CA mutant sub-population Poster DiscussionBreast CancerSunday 10th September, 09:15-10:45Presentation Time: 09:55 Location: Sevilla AuditoriumAbstract #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 PosterOvarian CancerSunday 10th September, 13:15-14:15 Location: Hall 8Abstract #1560P
Nicum S OCTOVA: A randomised Phase II trial of olaparib, chemotherapy, or olaparib and cediranib inpatients with BRCA-mutated platinum-resistant ovarian cancer PosterOvarian CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #989TiP
Taylor J N-DUR: Matched Pair Pharmacodynamics Study of Neoadjuvant Durvalumab in Combination with Chemotherapy in Frontline Ovarian Cancer PosterOvarian CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #992TiP
Penson R Efficacy of olaparib maintenance therapy in patients (pts) with platinum-sensitive relapsedovarian cancer (PSROC) by lines of prior chemotherapy: Phase III SOLO2 trial (ENGOT Ov-21) Poster DiscussionOvarian CancerSaturday 9th September, 09:15-10:45
Presentation Time: 09:15 Location: Cartagena AuditoriumAbstract #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) PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #316TiP
Shimomura A Gene alteration in triple negative breast cancer patients in a phase I/II study of combination therapy with eribulin and olaparib PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #282P
Aogi K Efficacy and safety of olaparib combined with eribulin in patients with advanced or metastatictriple negative breast cancer (TNBC) previously treated with anthracyclines and taxanes: the final analysis of a Japanese Phase I/II trial PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #251P
Robson ME OlympiAD: Health-related quality of life (HRQoL) in patients with HER2-negative metastatic breastcancer (mBC) and a germline BRCA mutation (gBRCAm) receiving olaparib monotherapy vs standard single-agent chemotherapy treatment of physician’s choice (TPC) PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #290P
O’Connor M Generation of a novel preclinical PK/PD model provides insights into PARP inhibitor clinical monotherapy activity PosterWomen’s CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #393P
Tutt A OlympiA: a randomized Phase III trial of olaparib as adjuvant therapy in patients with high-riskHER2-negative breast cancer (BC) and a germline BRCA1/2 mutation (gBRCAm) PosterBreast CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #216TiP
Sugiyama T Japan CHARLOTTE: Characterizing the cross-sectional approach to ovarian cancer: Genetic testing of BRCA PosterOvarian CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #984TiP
Oza A Evaluation of tumour responses and olaparib efficacy in platinum-sensitive relapsed ovariancancer (PSROC) patients (pts) with or without measurable disease in the SOLO2 trial (ENGOT Ov-21) PosterOvarian CancerSaturday 9th September, 13:15-14:15 Location: Hall 8Abstract #965P
Callens C BRCA1&2 tumoral and germline status for ovarian cancer patients in first line setting within thePAOLA-01 trial Poster DiscussionOvarian CancerSaturday 9th September, 09:15-10:45 Location: Cartagena AuditoriumAbstract #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 PosterOvarian CancerMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #990TiP
Pjuade-Lauraine E OReO/ENGOT Ov-38: A Phase IIIb trial of olaparib maintenance retreatment in patients with epithelial ovarian cancer Poster Ovarian CancerSaturday 9th September; 13:15-14:15 Location: Hall 8Abstract #987TiP

Head and neck cancer

Cohen EE Phase Ib/II Study (SCORES) Assessing Safety, Tolerability, and Preliminary Anti-tumor Activityof 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 CancerMonday 11th September, 11:00-12:30
Presentation Time: 11:15-11:30 Location: Madrid AuditoriumAbstract #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 OralHead and Neck CancerMonday 11th September, 15:00-16:20
Presentation Time: 15:39-15:51 Location: Granada AuditoriumAbstract #1042O
Stokes M Relationship between PD-L1 expression and survival in head and neck squamous cellcarcinoma (HNSCC) patients (pts) Poster DiscussionHead and Neck CancerSaturday 9th September, 14:45-16:15
Presentation Time: 15:07 Location: Alicante AuditoriumAbstract #1049PD
Pai S Retrospective cohort study of PD-L1 expression in recurrent and/or metastatic squamous cellcarcinoma of the head and neck (SUPREME-HN) Poster DiscussionHead and Neck CancerSaturday 9th September, 14:45-16:15
Presentation Time: 15:07 Location: Alicante AuditoriumAbstract #1048PD
Even C MEDINDUCTION: Phase I trial evaluating the safety of durvalumab in combination withDocetaxel, Cisplatin and 5-FU (DCF) in induction for locally advanced squamous cell carcinoma of the head and neck (SCCHN) PosterHead and Neck CancerSunday 10th September, 13:15-14:15 Location: Hall 8Abstract #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 PosterUrothelial Carcinoma (UC)Sunday 10th September, 13:15-14:15 Location: Hall 8Abstract #924TiP
Zheng Y Modeling of Tumor Kinetics and Overall Survival to Identify Predictive Factors for Efficacy ofDurvalumab in Patients with Urothelial Carcinoma (UC) PosterUrothelial Carcinoma (UC)Sunday 10th September, 13:15-14:15 Location: Hall 8Abstract #869P
Gonzalez-Cao M A Phase II exploratory study of durvalumab (MEDI4736) in HIV-1 patients with advanced solidtumors PosterHIVSunday 10th September, 13:15-14:15 Location: Hall 8Abstract #1208TiP
Wiester T Comparison of continuous measures across diagnostic PD-L1 assays using image analysis PosterBiomarker TestingMonday 11th September, 13:15-14:15 Location: Hall 8Abstract #103P
Chen R Efficacy and safety in first-line combined androgen blockade in advanced prostate cancer; a systematic review and meta-analysis PosterProstate CancerSunday 10th September, 13:15-14:15 Location: Hall 8Abstract #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.

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