- Email: [email protected]
The efficacy and safety of pembrolizumab as a first-line therapy in PD-L1 50% positive advanced NSCLC (HOPE-001)
abstracts
Annals of Oncology
1519P
Patients with metastatic non-small cell lung cancer and PD-L1 expression in Germany: Treatment and first outcome from the prospective German Registry Platform CRISP (AIO-TRK-0315)
M. Sebastian1, W.E.E. Eberhardt2, C. Losem3, C. Bernhardt4, C. Maintz5, N.W. Marschner6, M. J€anicke7, A. Fleitz7, L. Spring7, J. Sahlmann8, A. Karatas9, A. Hipper9, W. Weichert10, P. Hoffknecht11, C. Grah12, A. Rittmeyer13, F. Griesinger14, M. Thomas15 1 Department of Hematology/Medical Oncology, Universit€ atsklinikum Frankfurt, Frankfurt am Main, Germany, 2Department of Medical Oncology, University Hospital 3 Essen, Westdeutsches Tumorzentrum, Essen, Germany, Onkologie, MVZ fu¨r Onkologie und H€amatologie im Rhein-Kreis Neuss, Neuss, Germany, 4Onkologie, Gemeinschaftspraxis fu¨r H€ amatologie und Onkologie, Dortmund, Germany, 5 H€amatologie-Onkologie, MVZ West GmbH Wu¨rselen, Wu¨rselen, Germany, 6Oncology, Praxis fu¨r interdisziplin€are Onkologie & H€ amatologie, Freiburg, Germany, 7Clinical Epidemiology and Health Economics, IOMEDICO, Freiburg, Germany, 8Department of Data Management, Statistics and Medical Informatics, IOMEDICO AG, Freiburg Im Breisgau, Germany, 9AIO, Studien gGmbH, Berlin, Germany, 10Institute of Pathology, Technische Universit€at Mu¨nchen, Munich, Germany, 11Franziskus Hospital Harderberg, Niels Stensen Kliniken, Georgsmarienhu¨tte, Germany, 12Pneumo, Schwerpunkt / Lungenkrebszentrum, Gemeinschaftskrankenhaus Havelho¨he, Berlin, Germany, 13LKI, Lungenfachklinik Immenhausen, Immenhausen, Germany, 14Oncology, Pius Hospital, University of Oldenburg, Oldenburg, Germany, 15Medical Oncology, Thoraxklinik Heidelberg, Heidelberg, Germany Background: Treatment guidelines for metastatic non-small cell lung cancer recommend stratified treatment according to biomarker testing results. Here we used CRISP to evaluate treatment and outcome of patients (pts) with PD-L1-expressing tumors. Methods: Currently 163 centers in Germany have recruited over 3700 pts at start of 1stline who will be followed until death or end of project. Data from 2204 pts recruited by 133 centers between 12/2015 and 06/ 2018 was analyzed regarding PD-L1 testing, treatment and outcome. Progression-free survival (PFS) was determined in patients being 1 year under observation (recruited until June 30th 2017 (n ¼ 906), outcome sample, (ous)). Results: Test rates for PD-L1 increased from 25% (2016) to 75% (2018) in pts with non-squamous tumors (n ¼ 1732), and from 20% (2016) to 62% (2018) in pts with squamous tumors (n ¼ 472). Of pts with test results (n ¼ 1221) PD-L1 antibodies mostly used were Ventana SP263 (19%), DAKO 28-8 or 22-C (8% each) or not known to the documenting site (56%). PD-L1 TPS was 50% in 16% of pts, 1-49% in 18% of pts, and <1% in 7% of pts, while 3%/12% of pts were classified by pathologists as PDL1 positive/negative with TPS not specified. In 9% and 4% an EGFR or ALK alteration was also detected, respectively. Of all pts with PD-L1 TPS50% 70% received pembrolizumab-based 1st-line treatment, 21% chemotherapy and 9% another/targeted therapy. At database cut, 20% had started 2nd-line, 19% had died prior to a 2nd-line and remaining pts were still in 1st-line. In the ous, median PFS of all pts with PD-L1 positive tumors was 4.4 months (62% events, 95%-CI 3.5-5.5 months, n ¼ 185), in pts with PDL1 TPS50% (n ¼ 83) so far 53% had a progression after 1st-line. In total, 49% of pts with PD-L1 positive tumors and 41% of pts with PD-L1 TPS50% had died (ous). Conclusions: CRISP presents current real life data from Germany. Testing for PD-L1 has been quickly integrated into routine care diagnostics. The majority of pts with PDL1 positive tumors and a TPS50% receive an immune-oncology therapy. The impact
Volume 30 | Supplement 5 | October 2019
of these novel targeted treatment approaches on the outcome of pts will be subject of future analyses. Clinical trial identification: NCT02622581. Legal entity responsible for the study: AIO-Studien-gGmbH. Funding: AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, MSD Sharp & Dohme GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, and Takeda Pharma Vertriebs GmbH & Co. KG. Disclosure: M. Sebastian: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: MSD Sharp & Dohme; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim Pharma; Advisory / Consultancy: Celgene; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer. N.W. Marschner: Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Research grant / Funding (institution): MSD Sharp & Dohme; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Leadership role, Shareholder / Stockholder / Stock options, Officer / Board of Directors: iOMEDICO. M. J€anicke: Leadership role, Full / Part-time employment: iOMEDICO. A. Fleitz: Full / Part-time employment: iOMEDICO. L. Spring: Full / Part-time employment: iOMEDICO. J. Sahlmann: Leadership role, Full / Part-time employment: iOMEDICO. A. Karatas: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): MSD Sharp & Dohme; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Takeda. A. Hipper: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): MSD Sharp & Dohme; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Takeda. F. Griesinger: Honoraria (institution), Advisory / Consultancy: Ariad; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myer-Squibb; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Celgene; Honoraria (institution), Advisory / Consultancy: Clovis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): MerckSharp-Dome; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Roche. M. Thomas: Advisory / Consultancy: MSD Sharp & Dohme; Advisory / Consultancy: BristolMyers Squibb; Advisory / Consultancy: Lilly; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Novartis. All other authors have declared no conflicts of interest.
1520P
The efficacy and safety of pembrolizumab as a first-line therapy in PD-L1 50% positive advanced NSCLC (HOPE-001)
M. Tamiya1, A. Tamiya2, K. Hosoya3, Y. Taniguchi2, T. Yokoyama4, Y. Fukuda4, K. Hirano5, H. Matsumoto5, R. Kominami6, H. Suzuki7, T. Hirashima7, J. Uchida8, M. Morita9, M. Kanazu10, N. Sawa10, S. Hara11, Y. Kinoshita11, T. Kumagai1, D. Fujimoto3 1 Thoracic Oncology, Osaka International Cancer Instisute, Osaka, Japan, 2Internal Medicine, Kinki-chuo Chest Medical Center, Sakai, Japan, 3Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan, 4Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan, 5Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan, 6Respiratory Medicine, Himeji Medical Center, Himeji, Japan, 7Thoracic Oncology, Osaka Habikino Medical Center, Habikino, Japan, 8Respiratory Medicine, Osaka General Medical Center, Osaka, Japan, 9 Respiratory Medicine, Kobe City Medical Center West Hospital, Kobe, Japan, 10Thoracic Oncology, Osaka Toneyama Medical Center, Toyonaka, Japan, 11Respiratory Medicine, Itami City Hospital, Itami, Japan Background: Pembrolizumab (Pem) for NSCLC and PD-L1 TPS 50% as a first-line therapy showed the longer PFS and OS compared with chemotherapy in some clinical trial. However, only limited patients in good general condition without organ failure can participate in them and their outcomes may not be entirely representative of realworld setting. Methods: We conducted a multicenter retrospective study across 11 medical centers (Hanshin Oncology clinical Problem Evaluation group (HOPE)). We analyzed clinical data from NSCLC patients receiving Pem as a first-line therapy between February 1st 2017 and April 30th 2018. We aimed to evaluate the efficacy and safety and to identify which patients will become more suitable candidates for Pem monotherapy. Results: 213 patients were enrolled in this study. The median age was 71 years. Out of 213 patients, 176 (82.6%) were male, 20 (9.4%) were never smokers (Median brinkman index: 900), 172 (80.8%) had ECOG PS of 0-1, 55 (25.8%) had SQ, and PD-L1 TPS were 50-74%: 97 (45.5%), 75-89%: 55 (22.1%), and 90-100%: 69 (32.4%). 39 (18.3%) of all had AEs of grades 3. The most frequently severe AEs was pneumonitis (10 (4.7%) including in 1 grade 4), and no patient died of severe AEs. The overall RR/DCR were 51.2%/73.2%, the median PFS/OS was 8.3/18.4 months (M). In the univariate analysis, the ECOG PS (0-1 vs. 2: 9.0 vs. 4.0 M, HR: 2.11, p ¼ 0.00061), CRP/ALB (<0.3 vs. 0.3: NA vs. 5.9 M, HR: 1.88, p ¼ 0.00148), and steroid usage (not usage vs. usage: 8.7 vs. 2.0 M, HR: 3.17, p ¼ 0.00034) were significantly correlated with PFS of
doi:10.1093/annonc/mdz260 | v623
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Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Ipsen. A. Christopoulou: Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: PFIZER; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: NOVARTIS. H. Linardou: Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): Boehringer ; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche. A. Calles: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: BMS. A. Addeo: Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Roche ; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy: BMS. P.A. Kosmidis: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy: Leo. M.C. Garassino: Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche ; Honoraria (self), Advisory / Consultancy: PFIZER; Honoraria (self): MEDSCAPE; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD Hellas; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Research grant / Funding (institution): Clovis; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Otsuka; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Boehringer; Research grant / Funding (institution): GSK. All other authors have declared no conflicts of interest.
abstracts
Table: 1521P Clinical outcomes for pts with EGFR T790M advanced NSCLC and CNS metastases at BL Clinical outcomes
FAS Osimertinib 80 mg (N ¼ 3015)
CNS subset Osimertinib 80 mg (N ¼ 882)
Response rate*, % (95% CI) Best overall response†, n (%) Responding
57 (55, 59)
59 (55, 62)
1655 (55)
485 (55)
mony: Taiho Pharmaceutical. A. Tamiya: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Pharmaceutical. Y. Taniguchi: Speaker Bureau / Expert testimony: MSD. T. Yokoyama: Speaker Bureau / Expert testimony: Taiho Phermaceutical. K. Hirano: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Phermaceutical. T. Hirashima: Speaker Bureau / Expert testimony: Taiho Phermaceutical. M. Kanazu: Speaker Bureau / Expert testimony: MSD. T. Kumagai: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Phermaceutical. D. Fujimoto: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Phermaceutical. All other authors have declared no conflicts of interest.
1521P
Osimertinib in epidermal growth factor receptor (EGFR) T790M advanced non-small cell lung cancer (NSCLC): Analysis of patients with central nervous system (CNS) metastases in a real-world study (ASTRIS)
G. Metro1, M. Provencio2, D-W. Kim3, B.C. Cho4, K. Park5, Y. Pan6, Y. Shi7, R. Migliorino8, M. Tiseo9, J. Yu10, Q. Zhou11, A. Santo12, A. Ardizzoni13, Y. Hu14, Y-L. Wu11, S-W. Kim15, M. Miranda16, A. Fernandes17, F. de Marinis18 1 Medical Oncology, Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia, Perugia, Italy, 2Medical Oncology Department, Hospital Universitario Puertade de Hierro, Majadahonda, IDHIPSA, Madrid, Spain, 3Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea, 4Oncology, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea, 5 Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 6Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China, 7 Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China, 8Department of Thoracic Oncology, San Camillo-Forlanini Hospitals, Rome, Italy, 9Medical Oncology Unit, University Hospital of Parma, Parma, Italy, 10Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China, 11Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, 12Medical Oncology, University of Verona, Azienda Ospedaliera Universitaria Integra (AOUI) Verona, Verona, Italy, 13Medical Oncology, S.Orsola-Malpighi University Hospital, Bologna, Italy, 14Department of Oncology, Hubei Cancer Hospital, Wuhan, China, 15Department of Oncology, Asan Medical Center, Seoul, Republic of Korea, 16Biometrics and Information Sciences, AstraZeneca, Cambridge, UK, 17Global Medical Affairs, AstraZeneca US, Gaithersburg, MD, USA, 18 Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan, Italy Background: Approximately 20%–30% of patients (pts) with EGFR mutation-positive NSCLC present with CNS metastases at the time of diagnosis of advanced disease. CNS metastases are associated with a poor prognosis. Osimertinib is a third-generation, irreversible, oral EGFR-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitising (EGFRm) and EGFR T790M mutations and in clinical trials has demonstrated efficacy in NSCLC CNS metastases. ASTRIS is the largest ongoing, international, real-world study of osimertinib in EGFR T790M positive advanced NSCLC (NCT02474355). We report a subset analysis of pts with CNS metastases. Methods: Eligible pts with stage IIIB/IV EGFR T790M positive NSCLC previously treated with an EGFR-TKI received osimertinib 80 mg once-daily. Investigator-assessed (IA) progression-free survival (PFS), clinical response and time to treatment discontinuation (TTD) were analysed in a subset of pts with CNS (leptomeningeal and/or brain) metastases at baseline (BL). Follow-up brain imaging was not mandatory. Results: From 18 September 2015 to 15 October 2018, 3015 pts across 16 countries had received 1 dose of osimertinib (full analysis set [FAS]); 882 (29%) pts presented with CNS metastases at BL. BL demographics were similar between this subset and the FAS (female: 63%/64%; Asian: 69%/69%; median age (range): 61 (27–88) years/62 (27–92); WHO performance status 2: 15%/11%). IA response rates were consistent across the two groups, while median PFS and TTD appeared to be slightly lower in the CNS subset (Table). Overall survival data are immature. Conclusions: In a real-world setting, over half of pts with EGFR T790M positive advanced NSCLC and CNS metastases responded to treatment with osimertinib 80 mg. These findings support previous clinical research showing clinically meaningful CNS efficacy with osimertinib in advanced NSCLC.
v624 | NSCLC, Metastatic
Legal entity responsible for the study: AstraZeneca. Funding: AstraZeneca. Disclosure: M. Provencio: Advisory / Consultancy: BMS, MSD, AstraZeneca, BI; Travel / Accommodation / Expenses: MSD, AstraZeneca. D. Kim: Research grant / Funding (institution): Alpha Biopharma, AstraZeneca/MedImmune, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan. B.C. Cho: Honoraria (institution): Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, Boehringer Ingelheim, Roche, BMS, Pfizer, Eli Lilly, Takeda, TheraCanVac Inc.; Advisory / Consultancy: Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, Boehringer Ingelheim, Roche, BMS, Pfizer, Eli Lilly, Takeda, TheraCanVac Inc.; Speaker Bureau / Expert testimony: Novartis; Research grant / Funding (institution): Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD; Shareholder / Stockholder / Stock options: TheraCanVac Inc.; Licensing / Royalties: Champions Oncology. K. Park: Advisory / Consultancy: AMGEN, AstraZeneca, Astellas, BluePrint, Eli Lilly, Hanmi, KHK, MSD, Boehringer Ingelheim, Roche, Merck KGaA, Ono; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Research grant / Funding (self): AstraZeneca. R. Migliorino: Advisory / Consultancy: AstraZeneca, MSD, BI, Pfizer, Roche, BMS; Speaker Bureau / Expert testimony: AstraZeneca, MSD, BI, Pfizer, Roche, BMS; Travel / Accommodation / Expenses: AstraZeneca, MSD, BI, Pfizer, Roche, BMS. M. Tiseo: Advisory / Consultancy: AstraZeneca, BMS, MSD, Boehringer Ingelheim, Takeda; Research grant / Funding (institution): AstraZeneca. Q. Zhou: Honoraria (self): AstraZeneca, Roche. A. Santo: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca, Roche. A. Ardizzoni: Honoraria (self): MSD, BMS, Pfizer, Eli Lilly; Advisory / Consultancy: MSD, Roche; Research grant / Funding (institution): BMS, Celgene, Roche. Y. Wu: Honoraria (self): AstraZeneca, Roche, Eli Lilly, Pfizer, MSD, BMS, Boehringer Ingelheim; Advisory / Consultancy: AstraZeneca, Roche, Boehringer Ingelheim; Research grant / Funding (institution): AstraZeneca, Roche. S. Kim: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca. M. Miranda: Shareholder / Stockholder / Stock options, Full / Parttime employment: AstraZeneca PLC. A. Fernandes: Shareholder / Stockholder / Stock options, Full / Parttime employment: AstraZeneca. F. de Marinis: Honoraria (self), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Roche, Celgene, MSD, BMS, AstraZeneca, Takeda, Pfizer; Research grant / Funding (self): Boehringer Ingelheim, MSD. All other authors have declared no conflicts of interest.
1522P
Real-world (RW) treatment patterns and outcomes for second-line (2L) therapy and beyond in patients (pts) with epidermal growth factor receptor-mutated (EGFRm) advanced NSCLC receiving a firstline (1L) first- or second-generation (1G/2G) EGFR tyrosine kinase inhibitor (TKI)
R. Shah1, N. Girard2, S.P. Nagar3, F. Griesinger4, J. Roeper4, K. Davis3, N. Bakker5, B. Thakrar5, A. Taylor5, J. Feliciano6 1 Oncology, Kent Oncology Centre, Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK, 2Thorax Institute Curie Montsouris, Institut Curie, Paris, France, 3Health Economics Group, RTI Health Solutions, Research Triangle Park, Durham, NC, USA, 4Department of Hematology and Oncology, Pius Hospital, University of Oldenburg, Oldenburg, Germany, 5Oncology Business Unit, AstraZeneca, Cambridge, UK, 6Thoracic Oncology Program, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA Background: EGFR-TKIs are the preferred 1L therapy for pts with EGFRm metastatic NSCLC. However, treatment and survival in this population with 2L therapy and
Volume 30 | Supplement 5 | October 2019
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Pem. In the multivariate analysis, ECOG PS (0-1 vs. 2: HR: 1.69, p ¼ 0.03138), CRP/ ALB (<0.3 vs. 0.3: HR: 1.92, p ¼ 0.00153), steroid usage (not usage vs. usage: HR: 2.94, p ¼ 0.00267), and PD-L1 TPS (50-89% vs. 90-100%: HR: 0.65, p ¼ 0.04984) were significantly and independently correlated with PFS of Pem. Conclusions: Our results was consistent with the efficacy and safety of previous key clinical trials, although our study had various backgrounds. Furthermore, poor PS, high inflammatory state (CRP/ALB0.3), and steroid usage at the time of Pem treatment commencement were independently correlated with a shorter PFS of Pem. On the other hands, higher PD-L1 TPS (90-100%) was independently correlated with a longer PFS of Pem. Clinical trial identification: UMIN (University Hospital Medical Information Network in Japan; number 000032470). Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: M. Tamiya: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testi-
Annals of Oncology
Annals of Oncology
1519P
Patients with metastatic non-small cell lung cancer and PD-L1 expression in Germany: Treatment and first outcome from the prospective German Registry Platform CRISP (AIO-TRK-0315)
M. Sebastian1, W.E.E. Eberhardt2, C. Losem3, C. Bernhardt4, C. Maintz5, N.W. Marschner6, M. J€anicke7, A. Fleitz7, L. Spring7, J. Sahlmann8, A. Karatas9, A. Hipper9, W. Weichert10, P. Hoffknecht11, C. Grah12, A. Rittmeyer13, F. Griesinger14, M. Thomas15 1 Department of Hematology/Medical Oncology, Universit€ atsklinikum Frankfurt, Frankfurt am Main, Germany, 2Department of Medical Oncology, University Hospital 3 Essen, Westdeutsches Tumorzentrum, Essen, Germany, Onkologie, MVZ fu¨r Onkologie und H€amatologie im Rhein-Kreis Neuss, Neuss, Germany, 4Onkologie, Gemeinschaftspraxis fu¨r H€ amatologie und Onkologie, Dortmund, Germany, 5 H€amatologie-Onkologie, MVZ West GmbH Wu¨rselen, Wu¨rselen, Germany, 6Oncology, Praxis fu¨r interdisziplin€are Onkologie & H€ amatologie, Freiburg, Germany, 7Clinical Epidemiology and Health Economics, IOMEDICO, Freiburg, Germany, 8Department of Data Management, Statistics and Medical Informatics, IOMEDICO AG, Freiburg Im Breisgau, Germany, 9AIO, Studien gGmbH, Berlin, Germany, 10Institute of Pathology, Technische Universit€at Mu¨nchen, Munich, Germany, 11Franziskus Hospital Harderberg, Niels Stensen Kliniken, Georgsmarienhu¨tte, Germany, 12Pneumo, Schwerpunkt / Lungenkrebszentrum, Gemeinschaftskrankenhaus Havelho¨he, Berlin, Germany, 13LKI, Lungenfachklinik Immenhausen, Immenhausen, Germany, 14Oncology, Pius Hospital, University of Oldenburg, Oldenburg, Germany, 15Medical Oncology, Thoraxklinik Heidelberg, Heidelberg, Germany Background: Treatment guidelines for metastatic non-small cell lung cancer recommend stratified treatment according to biomarker testing results. Here we used CRISP to evaluate treatment and outcome of patients (pts) with PD-L1-expressing tumors. Methods: Currently 163 centers in Germany have recruited over 3700 pts at start of 1stline who will be followed until death or end of project. Data from 2204 pts recruited by 133 centers between 12/2015 and 06/ 2018 was analyzed regarding PD-L1 testing, treatment and outcome. Progression-free survival (PFS) was determined in patients being 1 year under observation (recruited until June 30th 2017 (n ¼ 906), outcome sample, (ous)). Results: Test rates for PD-L1 increased from 25% (2016) to 75% (2018) in pts with non-squamous tumors (n ¼ 1732), and from 20% (2016) to 62% (2018) in pts with squamous tumors (n ¼ 472). Of pts with test results (n ¼ 1221) PD-L1 antibodies mostly used were Ventana SP263 (19%), DAKO 28-8 or 22-C (8% each) or not known to the documenting site (56%). PD-L1 TPS was 50% in 16% of pts, 1-49% in 18% of pts, and <1% in 7% of pts, while 3%/12% of pts were classified by pathologists as PDL1 positive/negative with TPS not specified. In 9% and 4% an EGFR or ALK alteration was also detected, respectively. Of all pts with PD-L1 TPS50% 70% received pembrolizumab-based 1st-line treatment, 21% chemotherapy and 9% another/targeted therapy. At database cut, 20% had started 2nd-line, 19% had died prior to a 2nd-line and remaining pts were still in 1st-line. In the ous, median PFS of all pts with PD-L1 positive tumors was 4.4 months (62% events, 95%-CI 3.5-5.5 months, n ¼ 185), in pts with PDL1 TPS50% (n ¼ 83) so far 53% had a progression after 1st-line. In total, 49% of pts with PD-L1 positive tumors and 41% of pts with PD-L1 TPS50% had died (ous). Conclusions: CRISP presents current real life data from Germany. Testing for PD-L1 has been quickly integrated into routine care diagnostics. The majority of pts with PDL1 positive tumors and a TPS50% receive an immune-oncology therapy. The impact
Volume 30 | Supplement 5 | October 2019
of these novel targeted treatment approaches on the outcome of pts will be subject of future analyses. Clinical trial identification: NCT02622581. Legal entity responsible for the study: AIO-Studien-gGmbH. Funding: AstraZeneca GmbH, Boehringer Ingelheim Pharma GmbH & Co. KG, Bristol-Myers Squibb GmbH & Co. KGaA, Celgene GmbH, MSD Sharp & Dohme GmbH, Lilly Deutschland GmbH, Novartis Pharma GmbH, Pfizer Pharma GmbH, Roche Pharma AG, and Takeda Pharma Vertriebs GmbH & Co. KG. Disclosure: M. Sebastian: Advisory / Consultancy: Bristol-Myers Squibb; Advisory / Consultancy: MSD Sharp & Dohme; Advisory / Consultancy: Roche; Advisory / Consultancy: Novartis; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Boehringer Ingelheim Pharma; Advisory / Consultancy: Celgene; Advisory / Consultancy: Lilly; Advisory / Consultancy: Pfizer. N.W. Marschner: Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Celgene; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Lilly; Advisory / Consultancy, Research grant / Funding (institution): MSD Sharp & Dohme; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution), Travel / Accommodation / Expenses: Novartis; Research grant / Funding (institution), Travel / Accommodation / Expenses: Pfizer; Leadership role, Shareholder / Stockholder / Stock options, Officer / Board of Directors: iOMEDICO. M. J€anicke: Leadership role, Full / Part-time employment: iOMEDICO. A. Fleitz: Full / Part-time employment: iOMEDICO. L. Spring: Full / Part-time employment: iOMEDICO. J. Sahlmann: Leadership role, Full / Part-time employment: iOMEDICO. A. Karatas: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): MSD Sharp & Dohme; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Takeda. A. Hipper: Research grant / Funding (institution): AstraZeneca; Research grant / Funding (institution): Boehringer Ingelheim; Research grant / Funding (institution): Bristol-Myers Squibb; Research grant / Funding (institution): Celgene; Research grant / Funding (institution): MSD Sharp & Dohme; Research grant / Funding (institution): Lilly; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Pfizer; Research grant / Funding (institution): Roche; Research grant / Funding (institution): Takeda. F. Griesinger: Honoraria (institution), Advisory / Consultancy: Ariad; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Boehringer Ingelheim; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Bristol-Myer-Squibb; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Celgene; Honoraria (institution), Advisory / Consultancy: Clovis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Lilly; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): MerckSharp-Dome; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Novartis; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Pfizer; Honoraria (institution), Advisory / Consultancy, Research grant / Funding (institution): Roche. M. Thomas: Advisory / Consultancy: MSD Sharp & Dohme; Advisory / Consultancy: BristolMyers Squibb; Advisory / Consultancy: Lilly; Advisory / Consultancy: AstraZeneca; Advisory / Consultancy: Roche; Advisory / Consultancy: Pfizer; Advisory / Consultancy: Celgene; Advisory / Consultancy: Novartis. All other authors have declared no conflicts of interest.
1520P
The efficacy and safety of pembrolizumab as a first-line therapy in PD-L1 50% positive advanced NSCLC (HOPE-001)
M. Tamiya1, A. Tamiya2, K. Hosoya3, Y. Taniguchi2, T. Yokoyama4, Y. Fukuda4, K. Hirano5, H. Matsumoto5, R. Kominami6, H. Suzuki7, T. Hirashima7, J. Uchida8, M. Morita9, M. Kanazu10, N. Sawa10, S. Hara11, Y. Kinoshita11, T. Kumagai1, D. Fujimoto3 1 Thoracic Oncology, Osaka International Cancer Instisute, Osaka, Japan, 2Internal Medicine, Kinki-chuo Chest Medical Center, Sakai, Japan, 3Respiratory Medicine, Kobe City Medical Center General Hospital, Kobe, Japan, 4Respiratory Medicine, Kurashiki Central Hospital, Kurashiki, Japan, 5Respiratory Medicine, Hyogo Prefectural Amagasaki General Medical Center, Amagasaki, Japan, 6Respiratory Medicine, Himeji Medical Center, Himeji, Japan, 7Thoracic Oncology, Osaka Habikino Medical Center, Habikino, Japan, 8Respiratory Medicine, Osaka General Medical Center, Osaka, Japan, 9 Respiratory Medicine, Kobe City Medical Center West Hospital, Kobe, Japan, 10Thoracic Oncology, Osaka Toneyama Medical Center, Toyonaka, Japan, 11Respiratory Medicine, Itami City Hospital, Itami, Japan Background: Pembrolizumab (Pem) for NSCLC and PD-L1 TPS 50% as a first-line therapy showed the longer PFS and OS compared with chemotherapy in some clinical trial. However, only limited patients in good general condition without organ failure can participate in them and their outcomes may not be entirely representative of realworld setting. Methods: We conducted a multicenter retrospective study across 11 medical centers (Hanshin Oncology clinical Problem Evaluation group (HOPE)). We analyzed clinical data from NSCLC patients receiving Pem as a first-line therapy between February 1st 2017 and April 30th 2018. We aimed to evaluate the efficacy and safety and to identify which patients will become more suitable candidates for Pem monotherapy. Results: 213 patients were enrolled in this study. The median age was 71 years. Out of 213 patients, 176 (82.6%) were male, 20 (9.4%) were never smokers (Median brinkman index: 900), 172 (80.8%) had ECOG PS of 0-1, 55 (25.8%) had SQ, and PD-L1 TPS were 50-74%: 97 (45.5%), 75-89%: 55 (22.1%), and 90-100%: 69 (32.4%). 39 (18.3%) of all had AEs of grades 3. The most frequently severe AEs was pneumonitis (10 (4.7%) including in 1 grade 4), and no patient died of severe AEs. The overall RR/DCR were 51.2%/73.2%, the median PFS/OS was 8.3/18.4 months (M). In the univariate analysis, the ECOG PS (0-1 vs. 2: 9.0 vs. 4.0 M, HR: 2.11, p ¼ 0.00061), CRP/ALB (<0.3 vs. 0.3: NA vs. 5.9 M, HR: 1.88, p ¼ 0.00148), and steroid usage (not usage vs. usage: 8.7 vs. 2.0 M, HR: 3.17, p ¼ 0.00034) were significantly correlated with PFS of
doi:10.1093/annonc/mdz260 | v623
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Accommodation / Expenses: Pierre Fabre; Travel / Accommodation / Expenses: Ipsen. A. Christopoulou: Honoraria (institution), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: PFIZER; Honoraria (self), Advisory / Consultancy: Sanofi; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: NOVARTIS. H. Linardou: Honoraria (self), Speaker Bureau / Expert testimony, Travel / Accommodation / Expenses: AstraZeneca; Honoraria (self): Boehringer ; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Travel / Accommodation / Expenses: Merck; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Roche. A. Calles: Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Boehringer; Honoraria (self), Advisory / Consultancy: Pfizer; Honoraria (self), Advisory / Consultancy: Roche; Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy: Novartis; Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: BMS. A. Addeo: Honoraria (self), Advisory / Consultancy: MSD; Honoraria (self), Advisory / Consultancy: Roche ; Honoraria (self), Advisory / Consultancy: AstraZeneca; Honoraria (self), Advisory / Consultancy: Takeda; Honoraria (self), Advisory / Consultancy: BMS. P.A. Kosmidis: Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Pfizer; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: MSD; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: BMS; Honoraria (self), Advisory / Consultancy, Travel / Accommodation / Expenses: Novartis; Honoraria (self), Advisory / Consultancy: Leo. M.C. Garassino: Honoraria (self), Advisory / Consultancy: Lilly; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): Roche ; Honoraria (self), Advisory / Consultancy: PFIZER; Honoraria (self): MEDSCAPE; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): MSD Hellas; Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): BMS; Research grant / Funding (institution): Clovis; Research grant / Funding (institution): Merck; Research grant / Funding (institution): Otsuka; Research grant / Funding (institution): Bayer; Research grant / Funding (institution): Novartis; Research grant / Funding (institution): Boehringer; Research grant / Funding (institution): GSK. All other authors have declared no conflicts of interest.
abstracts
Table: 1521P Clinical outcomes for pts with EGFR T790M advanced NSCLC and CNS metastases at BL Clinical outcomes
FAS Osimertinib 80 mg (N ¼ 3015)
CNS subset Osimertinib 80 mg (N ¼ 882)
Response rate*, % (95% CI) Best overall response†, n (%) Responding
57 (55, 59)
59 (55, 62)
1655 (55)
485 (55)
mony: Taiho Pharmaceutical. A. Tamiya: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Pharmaceutical. Y. Taniguchi: Speaker Bureau / Expert testimony: MSD. T. Yokoyama: Speaker Bureau / Expert testimony: Taiho Phermaceutical. K. Hirano: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Phermaceutical. T. Hirashima: Speaker Bureau / Expert testimony: Taiho Phermaceutical. M. Kanazu: Speaker Bureau / Expert testimony: MSD. T. Kumagai: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Phermaceutical. D. Fujimoto: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testimony: Taiho Phermaceutical. All other authors have declared no conflicts of interest.
1521P
Osimertinib in epidermal growth factor receptor (EGFR) T790M advanced non-small cell lung cancer (NSCLC): Analysis of patients with central nervous system (CNS) metastases in a real-world study (ASTRIS)
G. Metro1, M. Provencio2, D-W. Kim3, B.C. Cho4, K. Park5, Y. Pan6, Y. Shi7, R. Migliorino8, M. Tiseo9, J. Yu10, Q. Zhou11, A. Santo12, A. Ardizzoni13, Y. Hu14, Y-L. Wu11, S-W. Kim15, M. Miranda16, A. Fernandes17, F. de Marinis18 1 Medical Oncology, Santa Maria della Misericordia Hospital, Azienda Ospedaliera di Perugia, Perugia, Italy, 2Medical Oncology Department, Hospital Universitario Puertade de Hierro, Majadahonda, IDHIPSA, Madrid, Spain, 3Department of Internal Medicine, Seoul National University Hospital, Seoul, Republic of Korea, 4Oncology, Yonsei Cancer Research Institute, Yonsei University College of Medicine, Seoul, Republic of Korea, 5 Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea, 6Department of Medical Oncology, The First Affiliated Hospital of Anhui Medical University, Hefei, China, 7 Department of Medical Oncology, Beijing Key Laboratory of Clinical Study on Anticancer Molecular Targeted Drugs, National Cancer Center, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, China, 8Department of Thoracic Oncology, San Camillo-Forlanini Hospitals, Rome, Italy, 9Medical Oncology Unit, University Hospital of Parma, Parma, Italy, 10Department of Radiation Oncology, Shandong Cancer Hospital and Institute, Jinan, China, 11Guangdong Lung Cancer Institute, Guangdong Provincial People’s Hospital and Guangdong Academy of Medical Sciences, Guangzhou, China, 12Medical Oncology, University of Verona, Azienda Ospedaliera Universitaria Integra (AOUI) Verona, Verona, Italy, 13Medical Oncology, S.Orsola-Malpighi University Hospital, Bologna, Italy, 14Department of Oncology, Hubei Cancer Hospital, Wuhan, China, 15Department of Oncology, Asan Medical Center, Seoul, Republic of Korea, 16Biometrics and Information Sciences, AstraZeneca, Cambridge, UK, 17Global Medical Affairs, AstraZeneca US, Gaithersburg, MD, USA, 18 Division of Thoracic Oncology, European Institute of Oncology IRCCS, Milan, Italy Background: Approximately 20%–30% of patients (pts) with EGFR mutation-positive NSCLC present with CNS metastases at the time of diagnosis of advanced disease. CNS metastases are associated with a poor prognosis. Osimertinib is a third-generation, irreversible, oral EGFR-tyrosine kinase inhibitor (TKI) that potently and selectively inhibits both EGFR-TKI sensitising (EGFRm) and EGFR T790M mutations and in clinical trials has demonstrated efficacy in NSCLC CNS metastases. ASTRIS is the largest ongoing, international, real-world study of osimertinib in EGFR T790M positive advanced NSCLC (NCT02474355). We report a subset analysis of pts with CNS metastases. Methods: Eligible pts with stage IIIB/IV EGFR T790M positive NSCLC previously treated with an EGFR-TKI received osimertinib 80 mg once-daily. Investigator-assessed (IA) progression-free survival (PFS), clinical response and time to treatment discontinuation (TTD) were analysed in a subset of pts with CNS (leptomeningeal and/or brain) metastases at baseline (BL). Follow-up brain imaging was not mandatory. Results: From 18 September 2015 to 15 October 2018, 3015 pts across 16 countries had received 1 dose of osimertinib (full analysis set [FAS]); 882 (29%) pts presented with CNS metastases at BL. BL demographics were similar between this subset and the FAS (female: 63%/64%; Asian: 69%/69%; median age (range): 61 (27–88) years/62 (27–92); WHO performance status 2: 15%/11%). IA response rates were consistent across the two groups, while median PFS and TTD appeared to be slightly lower in the CNS subset (Table). Overall survival data are immature. Conclusions: In a real-world setting, over half of pts with EGFR T790M positive advanced NSCLC and CNS metastases responded to treatment with osimertinib 80 mg. These findings support previous clinical research showing clinically meaningful CNS efficacy with osimertinib in advanced NSCLC.
v624 | NSCLC, Metastatic
Legal entity responsible for the study: AstraZeneca. Funding: AstraZeneca. Disclosure: M. Provencio: Advisory / Consultancy: BMS, MSD, AstraZeneca, BI; Travel / Accommodation / Expenses: MSD, AstraZeneca. D. Kim: Research grant / Funding (institution): Alpha Biopharma, AstraZeneca/MedImmune, Hanmi, Janssen, Merus, Mirati Therapeutics, MSD, Novartis, Ono Pharmaceutical, Pfizer, Roche/Genentech, Takeda, TP Therapeutics, Xcovery, Yuhan. B.C. Cho: Honoraria (institution): Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, Boehringer Ingelheim, Roche, BMS, Pfizer, Eli Lilly, Takeda, TheraCanVac Inc.; Advisory / Consultancy: Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD, Boehringer Ingelheim, Roche, BMS, Pfizer, Eli Lilly, Takeda, TheraCanVac Inc.; Speaker Bureau / Expert testimony: Novartis; Research grant / Funding (institution): Novartis, Bayer, AstraZeneca, MOGAM Institute, Dong-A ST, Champions Oncology, Janssen, Yuhan, Ono, Dizal Pharma, MSD; Shareholder / Stockholder / Stock options: TheraCanVac Inc.; Licensing / Royalties: Champions Oncology. K. Park: Advisory / Consultancy: AMGEN, AstraZeneca, Astellas, BluePrint, Eli Lilly, Hanmi, KHK, MSD, Boehringer Ingelheim, Roche, Merck KGaA, Ono; Speaker Bureau / Expert testimony: Boehringer Ingelheim; Research grant / Funding (self): AstraZeneca. R. Migliorino: Advisory / Consultancy: AstraZeneca, MSD, BI, Pfizer, Roche, BMS; Speaker Bureau / Expert testimony: AstraZeneca, MSD, BI, Pfizer, Roche, BMS; Travel / Accommodation / Expenses: AstraZeneca, MSD, BI, Pfizer, Roche, BMS. M. Tiseo: Advisory / Consultancy: AstraZeneca, BMS, MSD, Boehringer Ingelheim, Takeda; Research grant / Funding (institution): AstraZeneca. Q. Zhou: Honoraria (self): AstraZeneca, Roche. A. Santo: Honoraria (self), Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca, Roche. A. Ardizzoni: Honoraria (self): MSD, BMS, Pfizer, Eli Lilly; Advisory / Consultancy: MSD, Roche; Research grant / Funding (institution): BMS, Celgene, Roche. Y. Wu: Honoraria (self): AstraZeneca, Roche, Eli Lilly, Pfizer, MSD, BMS, Boehringer Ingelheim; Advisory / Consultancy: AstraZeneca, Roche, Boehringer Ingelheim; Research grant / Funding (institution): AstraZeneca, Roche. S. Kim: Advisory / Consultancy, Research grant / Funding (institution): AstraZeneca. M. Miranda: Shareholder / Stockholder / Stock options, Full / Parttime employment: AstraZeneca PLC. A. Fernandes: Shareholder / Stockholder / Stock options, Full / Parttime employment: AstraZeneca. F. de Marinis: Honoraria (self), Travel / Accommodation / Expenses: Roche; Advisory / Consultancy: Roche, Celgene, MSD, BMS, AstraZeneca, Takeda, Pfizer; Research grant / Funding (self): Boehringer Ingelheim, MSD. All other authors have declared no conflicts of interest.
1522P
Real-world (RW) treatment patterns and outcomes for second-line (2L) therapy and beyond in patients (pts) with epidermal growth factor receptor-mutated (EGFRm) advanced NSCLC receiving a firstline (1L) first- or second-generation (1G/2G) EGFR tyrosine kinase inhibitor (TKI)
R. Shah1, N. Girard2, S.P. Nagar3, F. Griesinger4, J. Roeper4, K. Davis3, N. Bakker5, B. Thakrar5, A. Taylor5, J. Feliciano6 1 Oncology, Kent Oncology Centre, Maidstone Hospital, Maidstone and Tunbridge Wells NHS Trust, Maidstone, UK, 2Thorax Institute Curie Montsouris, Institut Curie, Paris, France, 3Health Economics Group, RTI Health Solutions, Research Triangle Park, Durham, NC, USA, 4Department of Hematology and Oncology, Pius Hospital, University of Oldenburg, Oldenburg, Germany, 5Oncology Business Unit, AstraZeneca, Cambridge, UK, 6Thoracic Oncology Program, Johns Hopkins Bayview Medical Center, Baltimore, MD, USA Background: EGFR-TKIs are the preferred 1L therapy for pts with EGFRm metastatic NSCLC. However, treatment and survival in this population with 2L therapy and
Volume 30 | Supplement 5 | October 2019
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Pem. In the multivariate analysis, ECOG PS (0-1 vs. 2: HR: 1.69, p ¼ 0.03138), CRP/ ALB (<0.3 vs. 0.3: HR: 1.92, p ¼ 0.00153), steroid usage (not usage vs. usage: HR: 2.94, p ¼ 0.00267), and PD-L1 TPS (50-89% vs. 90-100%: HR: 0.65, p ¼ 0.04984) were significantly and independently correlated with PFS of Pem. Conclusions: Our results was consistent with the efficacy and safety of previous key clinical trials, although our study had various backgrounds. Furthermore, poor PS, high inflammatory state (CRP/ALB0.3), and steroid usage at the time of Pem treatment commencement were independently correlated with a shorter PFS of Pem. On the other hands, higher PD-L1 TPS (90-100%) was independently correlated with a longer PFS of Pem. Clinical trial identification: UMIN (University Hospital Medical Information Network in Japan; number 000032470). Legal entity responsible for the study: The authors. Funding: Has not received any funding. Disclosure: M. Tamiya: Speaker Bureau / Expert testimony: MSD; Speaker Bureau / Expert testi-
Annals of Oncology