Principales presentaciones de AstraZeneca/MedImmune en el congreso de ESMO 2017

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2 Principales presentaciones de AstraZeneca/MedImmune en el congreso de ESMO 2017 Autor principal Título del abstract Detalles de la presentación Cáncer de pulmón Paz-Ares L Ramalingam S Zhou C PACIFIC: A double-blind, placebo-controlled Phase III study of durvalumab after chemoradiation therapy (CRT) in patients with Stage III, locally advanced, unresectable NSCLC Osimertinib vs SoC EGFR-TKI as first-line treatment in patients with EGFRm advanced NSCLC (FLAURA) Detection of EGFR T790M in Asia-Pacific patients (pts) with EGFR mutationpositive advanced nonsmall cell lung cancer (NSCLC): circulating tumour (ct) DNA analysis across 3 platforms 16:30-18:10 Presentation Time: 16:30-16:45 Location: Madrid Abstract #LBA1 16:30-18:10 Presentation Time: 17:30-17:45 Location: Madrid Abstract #LBA2 Abstract #1331P

3 Zhou C Osimertinib in Asia-Pacific patients (pts) with EGFR T790M-positive advanced NSCLC: updated Phase II study results including progression-free survival (PFS) Abstract #135P Zhou C Mitsudomi T Pinotti G Postel-Vinay S Kim Y C CNS response to osimertinib in Asian- Pacific patients (pts) with T790M-positive advanced NSCLC: data from an open-label Phase II trial (AURA17) 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 EGFR T790M detection in TKI-naïve NSCLCs carrying sensitive EGFR mutations A randomized doubleblind Phase II trial evaluating maintenance PARP inhibitor Olaparib versus placebo in patients with platinum-sensitive advanced non-small cell lung cancer: PIPSeN trial Phase II Trial of AZD9291 in Second Line Treatment after Acquired Resistance with T790M Mutation Detected From Circulating Abstract #1353P Abstract #1348P Abstract #1335P Abstract #1381TiP

4 Calabuig-Farinas S Leduc C Wu Y-L Tumor DNA (LiquidLung- O-Cohort 2) Clinical value of cfdna and CTCs in EGFR mutations detected in advanced NSCLC Ultrasensitive detection of EGFR T790M mutation by droplet digital PCR (ddpcr) in TKI naïve nonsmall cell lung cancer (NSCLC) harboring EGFR mutation: results of the nationwide program Biomarkers France of the French Cooperative Thoracic Intergroup (IFCT) A Phase 3 study of firstline durvalumab vs platinum-based chemotherapy in patients with advanced NSCLC and high PD-L1 expression: PEARL Abstract #1360P Abstract #1638P Discussion 9:00-10:45 Presentation Time: 10:16 Location: Pamplona Abstract #85PD Abstract #1378TiP Zhang X Tumores femeninos Martinez Bueno A Prediction of survival with durvalumab in locally advanced or metastatic NSCLC using early tumor assessments Disruptive mutations in TP53 associate with survival benefit in a PARPi trial in Abstract #1312P 09:15-10:45 Presentation Time: 09:15 Location: Cartagena Abstract #LBA42

5 Ruiz-Borrego M Delaloge, S. Wang J Kawaguchi H Kaufman P 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/ study 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 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) 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 Abemaciclib plus fulvestrant in patients (pts) with HR+/HER2- endocrine therapy naïve (EN) advanced breast Friday 8 th September, 14:00-15:30 Presentation Time: 14:24-14:36 Location: Pamplona Abstract #148O Discussion 09:15-10:45 Presentation Time: 09:45 Location: Sevilla Abstract #243PD Abstract #311TiP Abstract #302P

6 Zimmer A Westin S Turner N Lui JF Nicum S cancer - an exploratory analysis of MONARCH 2 A Phase I PK/PD study of durvalumab (D) in combination with olaparib (O) and cediranib (C) in recurrent women s cancers Phase I Expansion of olaparib (PARP inhibitor) and AZD5363 (AKT inhibitor) in recurrent ovarian, endometrial and triple negative breast cancer 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 subpopulation 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 OCTOVA: A randomised Phase II trial of olaparib, chemotherapy, or olaparib and cediranib in patients with BRCA-mutated platinum-resistant ovarian cancer Abstract #235P, Cervical, Breast, Endometrial Abstract #390P Abstract #391P Discussion 09:15-10:45 Presentation Time: 09:55 Location: Sevilla Abstract #241PD Abstract #1560P Abstract #989TiP

7 Taylor J Penson R Dalvi T Shimomura A Aogi K Robson ME N-DUR: Matched Pair Pharmacodynamics Study of Neoadjuvant Durvalumab in Combination with Chemotherapy in Frontline 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) BREAKOUT: a crosssectional, 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) Gene alteration in triple negative breast cancer patients in a phase I/II study of combination therapy with eribulin and olaparib 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 OlympiAD: Health-related quality of life (HRQoL) in Abstract #992TiP Discussion 09:15-10:45 Presentation Time: 09:15 Location: Cartagena Abstract #932PD Abstract #316TiP Abstract #282P Abstract #251P

8 O Connor M Tutt A Sugiyama T Oza A Callens C 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) Generation of a novel preclinical PK/PD model provides insights into PARP inhibitor clinical monotherapy activity 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) Japan CHARLOTTE: Characterizing the crosssectional approach to ovarian cancer: Genetic testing of BRCA Evaluation of tumour responses and olaparib efficacy in platinumsensitive relapsed ovarian cancer (PSROC) patients (pts) with or without measurable disease in the SOLO2 trial (ENGOT Ov- 21) BRCA1&2 tumoral and germline status for ovarian cancer patients in first line setting within the PAOLA- 01 trial Abstract #290P Women s Cancer Abstract #393P Abstract #216TiP Abstract #984TiP Abstract #965P Discussion 09:15-10:45

9 Moore K Pjuade-Lauraine E A Multicentre Phase II Study of AZD1775 plus Chemotherapy in Patients with Platinum-Resistant Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer OReO/ENGOT Ov-38: A Phase IIIb trial of olaparib maintenance retreatment in patients with epithelial ovarian cancer Location: Cartagena Abstract #935PD Abstract #990TiP Saturday 9 th September; Abstract #987TiP Cáncer de cabeza y cuello 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) Head and Neck Cancer 11:00-12:30 Presentation Time: 11:15-11:30 Location: Madrid Abstract #1135O Zandberg DP Stokes M Durvalumab for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): preliminary results from a single-arm, Phase II study Relationship between PD- L1 expression and survival in head and neck Head and Neck Cancer 15:00-16:20 Presentation Time: 15:39-15:51 Location: Granada Abstract #1042O Discussion Head and Neck Cancer

10 Pai S Even C squamous cell carcinoma (HNSCC) patients (pts) Retrospective cohort study of PD-L1 expression in recurrent and/or metastatic squamous cell carcinoma of the head and neck (SUPREME-HN) 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) 14:45-16:15 Presentation Time: 15:07 Location: Alicante Abstract #1049PD Discussion Head and Neck Cancer 14:45-16:15 Presentation Time: 15:07 Location: Alicante Abstract #1048PD Head and Neck Cancer Abstract #1109TiP Otros tipos de cáncer Choueiri T Savolitinib versus sunitinib in patients with METdriven, unresectable and locally advanced or metastatic papillary renal cell carcinoma: SAVOIR, a randomised, Phase III trial Urothelial Carcinoma (UC) Abstract #924TiP Zheng Y Gonzalez-Cao M Modeling of Tumor Kinetics and Overall Survival to Identify Predictive Factors for Efficacy of Durvalumab in Patients with Urothelial Carcinoma (UC) A Phase II exploratory study of durvalumab (MEDI4736) in HIV-1 Urothelial Carcinoma (UC) Abstract #869P HIV

11 Wiester T Chen R patients with advanced solid tumors Comparison of continuous measures across diagnostic PD-L1 assays using image analysis Efficacy and safety in firstline combined androgen blockade in advanced prostate cancer; a systematic review and meta-analysis Abstract #1208TiP Biomarker Testing Abstract #103P Prostate Cancer Abstract #805P