- Email: [email protected]
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)
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
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz260.041/5577870 by guest on 26 October 2019
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.
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
Downloaded from https://academic.oup.com/annonc/article-abstract/30/Supplement_5/mdz260.041/5577870 by guest on 26 October 2019
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.