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114 results on '"Rooney, Isabelle"'

1. Genomic Features of Exceptional Response in Vemurafenib ± Cobimetinib–treated Patients with BRAFV600-mutated Metastatic Melanoma

Author

Yan, Yibing, Wongchenko, Matthew J, Robert, Caroline, Larkin, James, Ascierto, Paolo A, Dréno, Brigitte, Maio, Michele, Garbe, Claus, Chapman, Paul B, Sosman, Jeffrey A, Shi, Zhen, Koeppen, Hartmut, Hsu, Jessie J, Chang, Ilsung, Caro, Ivor, Rooney, Isabelle, McArthur, Grant A, and Ribas, Antoni

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Immunology, Human Genome, Genetics, Biotechnology, Cancer, Aetiology, 2.1 Biological and endogenous factors, Alleles, Antineoplastic Combined Chemotherapy Protocols, Azetidines, Biomarkers, Tumor, Clinical Trials, Phase II as Topic, Clinical Trials, Phase III as Topic, Gene Expression Profiling, Genomics, Humans, Melanoma, Mutation, Piperidines, Proto-Oncogene Proteins B-raf, Randomized Controlled Trials as Topic, Retrospective Studies, Treatment Outcome, Vemurafenib, Exome Sequencing, Oncology & Carcinogenesis, Clinical sciences, Oncology and carcinogenesis
Abstract

PurposePrevious investigations identified transcriptional signatures associated with innate resistance to anti-programmed cell death protein 1 therapy in melanoma. This analysis aimed to increase understanding of the role of baseline genetic features in the variability of response to BRAF and MEK inhibitor therapy for BRAF V600-mutated metastatic melanoma.Patients and methodsThis exploratory analysis compared genomic features, using whole-exome and RNA sequencing, of baseline tumors from patients who had complete response versus rapid progression (disease progression at first postbaseline assessment) on treatment with cobimetinib combined with vemurafenib or vemurafenib alone. Associations of gene expression with progression-free survival or overall survival were assessed by Cox proportional hazards modeling.ResultsWhole-exome sequencing showed that MITF and TP53 alterations were more frequent in tumors from patients with rapid progression, while NF1 alterations were more frequent in tumors from patients with complete response. However, the low frequency of alterations in any one gene precluded their characterization as drivers of response/resistance. Analysis of RNA profiles showed that expression of immune response-related genes was enriched in tumors from patients with complete response, while expression of keratinization-related genes was enriched in tumors from patients who experienced rapid progression.ConclusionsThese findings suggest that enriched immune infiltration might be a shared feature favoring response to both targeted and immune therapies, while features of innate resistance to targeted and immune therapies were distinct.

Published
2019

2. Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation–positive melanoma

Author

Dréno, Brigitte, Ascierto, Paolo A, Atkinson, Victoria, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Bartley, Karen, Karagiannis, Thomas, Chang, Ilsung, Rooney, Isabelle, Koralek, Daniel O, Larkin, James, McArthur, Grant A, and Ribas, Antoni

Subjects
Biomedical and Clinical Sciences, Oncology and Carcinogenesis, Clinical Research, Cancer, Antineoplastic Combined Chemotherapy Protocols, Azetidines, Double-Blind Method, Female, Humans, Longitudinal Studies, Male, Melanoma, Mutation, Piperidines, Placebos, Proto-Oncogene Proteins B-raf, Quality of Life, Vemurafenib, vemurafenib, cobimetinib, MEK inhibitor, BRAF inhibitor, HRQOL, EORTC QLQ-C30, metastatic melanoma, Public Health and Health Services, Oncology & Carcinogenesis, Oncology and carcinogenesis
Abstract

BackgroundIn the coBRIM study, cobimetinib plus vemurafenib (C+V) significantly improved survival outcomes vs placebo and vemurafenib (P+V) in patients with advanced/metastatic BRAFV600-mutated melanoma. An analysis of health-related quality of life (HRQOL) from coBRIM is reported.MethodsPatients completing the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline and ⩾1 time point thereafter constituted the analysis population. Change from baseline ⩾10 points was considered clinically meaningful.ResultsMean baseline scores for all QLQ-C30 domains were similar between arms. Most on-treatment scores for QLQ-C30 domains were also comparable between arms. A transient deterioration in role function in cycle 1 day 15 (C1D15; -14.7 points) in the P+V arm and improvement in insomnia in the C+V arm at C2D15 (-12.4 points) was observed. Among patients who experienced a ⩾10-point change from baseline (responders), between-group differences were greatest for insomnia (16%), social functioning (10%), fatigue (9%) and pain (7%), all favouring C+V. Diarrhoea, photosensitivity reaction, pyrexia, and rash did not meaningfully affect global health status (GHS). Serous retinopathy was associated with a transient decrease in GHS at C1D15 assessment.ConclusionsIn patients with advanced/metastatic BRAFV600-mutated melanoma, treatment with C+V maintained HRQOL compared with P+V, with superior efficacy.

Published
2018

3. Association of body-mass index and outcomes in patients with metastatic melanoma treated with targeted therapy, immunotherapy, or chemotherapy: a retrospective, multicohort analysis

Author

McQuade, Jennifer L, Daniel, Carrie R, Hess, Kenneth R, Mak, Carmen, Wang, Daniel Y, Rai, Rajat R, Park, John J, Haydu, Lauren E, Spencer, Christine, Wongchenko, Matthew, Lane, Stephen, Lee, Dung-Yang, Kaper, Mathilde, McKean, Meredith, Beckermann, Kathryn E, Rubinstein, Samuel M, Rooney, Isabelle, Musib, Luna, Budha, Nageshwar, Hsu, Jessie, Nowicki, Theodore S, Avila, Alexandre, Haas, Tomas, Puligandla, Maneka, Lee, Sandra, Fang, Shenying, Wargo, Jennifer A, Gershenwald, Jeffrey E, Lee, Jeffrey E, Hwu, Patrick, Chapman, Paul B, Sosman, Jeffrey A, Schadendorf, Dirk, Grob, Jean-Jacques, Flaherty, Keith T, Walker, Dana, Yan, Yibing, McKenna, Edward, Legos, Jeffrey J, Carlino, Matteo S, Ribas, Antoni, Kirkwood, John M, Long, Georgina V, Johnson, Douglas B, Menzies, Alexander M, and Davies, Michael A

Subjects
Clinical Research, Obesity, Cancer, Clinical Trials and Supportive Activities, Nutrition, Evaluation of treatments and therapeutic interventions, 6.1 Pharmaceuticals, Good Health and Well Being, Adolescent, Adult, Aged, Aged, 80 and over, Antineoplastic Agents, Immunological, Antineoplastic Combined Chemotherapy Protocols, Body Mass Index, Female, Humans, Male, Melanoma, Middle Aged, Molecular Targeted Therapy, Progression-Free Survival, Protective Factors, Randomized Controlled Trials as Topic, Retrospective Studies, Risk Assessment, Risk Factors, Skin Neoplasms, Time Factors, Treatment Outcome, Young Adult, Oncology and Carcinogenesis, Oncology & Carcinogenesis
Abstract

BackgroundObesity has been linked to increased mortality in several cancer types; however, the relation between obesity and survival outcomes in metastatic melanoma is unknown. The aim of this study was to examine the association between body-mass index (BMI) and progression-free survival or overall survival in patients with metastatic melanoma who received targeted therapy, immunotherapy, or chemotherapy.MethodsThis retrospective study analysed independent cohorts of patients with metastatic melanoma assigned to treatment with targeted therapy, immunotherapy, or chemotherapy in randomised clinical trials and one retrospective study of patients treated with immunotherapy. Patients were classified according to BMI, following the WHO definitions, as underweight, normal, overweight, or obese. Patients without BMI and underweight patients were excluded. The primary outcomes were the associations between BMI and progression-free survival or overall survival, stratified by treatment type and sex. We did multivariable analyses in the independent cohorts, and combined adjusted hazard ratios in a mixed-effects meta-analysis to provide a precise estimate of the association between BMI and survival outcomes; heterogeneity was assessed with meta-regression analyses. Analyses were done on the predefined intention-to-treat population in the randomised controlled trials and on all patients included in the retrospective study.FindingsThe six cohorts consisted of a total of 2046 patients with metastatic melanoma treated with targeted therapy, immunotherapy, or chemotherapy between Aug 8, 2006, and Jan 15, 2016. 1918 patients were included in the analysis. Two cohorts containing patients from randomised controlled trials treated with targeted therapy (dabrafenib plus trametinib [n=599] and vemurafenib plus cobimetinib [n=240]), two cohorts containing patients treated with immunotherapy (one randomised controlled trial of ipilimumab plus dacarbazine [n=207] and a retrospective cohort treated with pembrolizumab, nivolumab, or atezolizumab [n=331]), and two cohorts containing patients treated with chemotherapy (two randomised controlled trials of dacarbazine [n=320 and n=221]) were classified according to BMI as normal (694 [36%] patients), overweight (711 [37%]), or obese (513 [27%]). In the pooled analysis, obesity, compared with normal BMI, was associated with improved survival in patients with metastatic melanoma (average adjusted hazard ratio [HR] 0·77 [95% CI 0·66-0·90] for progression-free survival and 0·74 [0·58-0·95] for overall survival). The survival benefit associated with obesity was restricted to patients treated with targeted therapy (HR 0·72 [0·57-0·91] for progression-free survival and 0·60 [0·45-0·79] for overall survival) and immunotherapy (HR 0·75 [0·56-1·00] and 0·64 [0·47-0·86]). No associations were observed with chemotherapy (HR 0·87 [0·65-1·17, pinteraction=0·61] for progression-free survival and 1·03 [0·80-1·34, pinteraction=0·01] for overall survival). The association of BMI with overall survival for patients treated with targeted and immune therapies differed by sex, with inverse associations in men (HR 0·53 [0·40-0·70]), but no associations observed in women (HR 0·85 [0·61-1·18, pinteraction=0·03]).InterpretationOur results suggest that in patients with metastatic melanoma, obesity is associated with improved progression-free survival and overall survival compared with those outcomes in patients with normal BMI, and that this association is mainly seen in male patients treated with targeted or immune therapy. These results have implications for the design of future clinical trials for patients with metastatic melanoma and the magnitude of the benefit found supports further investigation of the underlying mechanism of these associations.FundingASCO/CCF Young Investigator Award, ASCO/CCF Career Development Award, MD Anderson Cancer Center (MDACC) Melanoma Moonshot Program, MDACC Melanoma SPORE, and the Dr Miriam and Sheldon G Adelson Medical Research Foundation.

Published
2018

4. Figure S3D from Gene Expression Profiling in BRAF-Mutated Melanoma Reveals Patient Subgroups with Poor Outcomes to Vemurafenib That May Be Overcome by Cobimetinib Plus Vemurafenib

Author

Wongchenko, Matthew J., primary, McArthur, Grant A., primary, Dréno, Brigitte, primary, Larkin, James, primary, Ascierto, Paolo A., primary, Sosman, Jeffrey, primary, Andries, Luc, primary, Kockx, Mark, primary, Hurst, Stephen D., primary, Caro, Ivor, primary, Rooney, Isabelle, primary, Hegde, Priti S., primary, Molinero, Luciana, primary, Yue, Huibin, primary, Chang, Ilsung, primary, Amler, Lukas, primary, Yan, Yibing, primary, and Ribas, Antoni, primary

Published
2023
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5. Supplementary Tables from Extended 5-Year Follow-up Results of a Phase Ib Study (BRIM7) of Vemurafenib and Cobimetinib in BRAF-Mutant Melanoma

Author

Ribas, Antoni, primary, Daud, Adil, primary, Pavlick, Anna C., primary, Gonzalez, Rene, primary, Lewis, Karl D., primary, Hamid, Omid, primary, Gajewski, Thomas F., primary, Puzanov, Igor, primary, Wongchenko, Matthew, primary, Rooney, Isabelle, primary, Hsu, Jessie J., primary, Yan, Yibing, primary, Park, Erica, primary, and McArthur, Grant A., primary

Published
2023
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6. Supplementary Figure 1 from SGX523 is an exquisitely selective, ATP-competitive inhibitor of the MET receptor tyrosine kinase with antitumor activity in vivo

Author

Buchanan, Sean G., primary, Hendle, Jorg, primary, Lee, Patrick S., primary, Smith, Christopher R., primary, Bounaud, Pierre-Yves, primary, Jessen, Katti A., primary, Tang, Crystal M., primary, Huser, Nanni H., primary, Felce, Jeremy D., primary, Froning, Karen J., primary, Peterman, Marshall C., primary, Aubol, Brandon E., primary, Gessert, Steve F., primary, Sauder, J. Michael, primary, Schwinn, Kenneth D., primary, Russell, Marijane, primary, Rooney, Isabelle A., primary, Adams, Jason, primary, Leon, Barbara C., primary, Do, Tuan H., primary, Blaney, Jeff M., primary, Sprengeler, Paul A., primary, Thompson, Devon A., primary, Smyth, Lydia, primary, Pelletier, Laura A., primary, Atwell, Shane, primary, Holme, Kevin, primary, Wasserman, Stephen R., primary, Emtage, Spencer, primary, Burley, Stephen K., primary, and Reich, Siegfried H., primary

Published
2023
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7. Supplementary Figure 1 from Extended 5-Year Follow-up Results of a Phase Ib Study (BRIM7) of Vemurafenib and Cobimetinib in BRAF-Mutant Melanoma

Author

Ribas, Antoni, primary, Daud, Adil, primary, Pavlick, Anna C., primary, Gonzalez, Rene, primary, Lewis, Karl D., primary, Hamid, Omid, primary, Gajewski, Thomas F., primary, Puzanov, Igor, primary, Wongchenko, Matthew, primary, Rooney, Isabelle, primary, Hsu, Jessie J., primary, Yan, Yibing, primary, Park, Erica, primary, and McArthur, Grant A., primary

Published
2023
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8. Supplementary Table S6 from Genomic Features of Exceptional Response in Vemurafenib ± Cobimetinib–treated Patients with BRAFV600-mutated Metastatic Melanoma

Author

Yan, Yibing, primary, Wongchenko, Matthew J., primary, Robert, Caroline, primary, Larkin, James, primary, Ascierto, Paolo A., primary, Dréno, Brigitte, primary, Maio, Michele, primary, Garbe, Claus, primary, Chapman, Paul B., primary, Sosman, Jeffrey A., primary, Shi, Zhen, primary, Koeppen, Hartmut, primary, Hsu, Jessie J., primary, Chang, Ilsung, primary, Caro, Ivor, primary, Rooney, Isabelle, primary, McArthur, Grant A., primary, and Ribas, Antoni, primary

Published
2023
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9. Supplementary Data from Genomic Features of Exceptional Response in Vemurafenib ± Cobimetinib–treated Patients with BRAFV600-mutated Metastatic Melanoma

Author

Yan, Yibing, primary, Wongchenko, Matthew J., primary, Robert, Caroline, primary, Larkin, James, primary, Ascierto, Paolo A., primary, Dréno, Brigitte, primary, Maio, Michele, primary, Garbe, Claus, primary, Chapman, Paul B., primary, Sosman, Jeffrey A., primary, Shi, Zhen, primary, Koeppen, Hartmut, primary, Hsu, Jessie J., primary, Chang, Ilsung, primary, Caro, Ivor, primary, Rooney, Isabelle, primary, McArthur, Grant A., primary, and Ribas, Antoni, primary

Published
2023
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10. Supplementary Tables 1-3, Figures 1-4 from SGX523 is an exquisitely selective, ATP-competitive inhibitor of the MET receptor tyrosine kinase with antitumor activity in vivo

Author

Buchanan, Sean G., primary, Hendle, Jorg, primary, Lee, Patrick S., primary, Smith, Christopher R., primary, Bounaud, Pierre-Yves, primary, Jessen, Katti A., primary, Tang, Crystal M., primary, Huser, Nanni H., primary, Felce, Jeremy D., primary, Froning, Karen J., primary, Peterman, Marshall C., primary, Aubol, Brandon E., primary, Gessert, Steve F., primary, Sauder, J. Michael, primary, Schwinn, Kenneth D., primary, Russell, Marijane, primary, Rooney, Isabelle A., primary, Adams, Jason, primary, Leon, Barbara C., primary, Do, Tuan H., primary, Blaney, Jeff M., primary, Sprengeler, Paul A., primary, Thompson, Devon A., primary, Smyth, Lydia, primary, Pelletier, Laura A., primary, Atwell, Shane, primary, Holme, Kevin, primary, Wasserman, Stephen R., primary, Emtage, Spencer, primary, Burley, Stephen K., primary, and Reich, Siegfried H., primary

Published
2023
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12. Supplementary Figure Legends from Gene Expression Profiling in BRAF-Mutated Melanoma Reveals Patient Subgroups with Poor Outcomes to Vemurafenib That May Be Overcome by Cobimetinib Plus Vemurafenib

Author

Wongchenko, Matthew J., primary, McArthur, Grant A., primary, Dréno, Brigitte, primary, Larkin, James, primary, Ascierto, Paolo A., primary, Sosman, Jeffrey, primary, Andries, Luc, primary, Kockx, Mark, primary, Hurst, Stephen D., primary, Caro, Ivor, primary, Rooney, Isabelle, primary, Hegde, Priti S., primary, Molinero, Luciana, primary, Yue, Huibin, primary, Chang, Ilsung, primary, Amler, Lukas, primary, Yan, Yibing, primary, and Ribas, Antoni, primary

Published
2023
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13. Cobimetinib combined with vemurafenib in advanced BRAFV600-mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

Author

Ascierto, Paolo A, McArthur, Grant A, Dréno, Brigitte, Atkinson, Victoria, Liszkay, Gabrielle, Di Giacomo, Anna Maria, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Yan, Yibing, Wongchenko, Matthew, Chang, Ilsung, Hsu, Jessie J, Koralek, Daniel O, Rooney, Isabelle, Ribas, Antoni, and Larkin, James

Published
2016
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18. Extended 5-Year Follow-up Results of a Phase Ib Study (BRIM7) of Vemurafenib and Cobimetinib in BRAF-Mutant Melanoma

Author

Ribas, Antoni, primary, Daud, Adil, additional, Pavlick, Anna C., additional, Gonzalez, Rene, additional, Lewis, Karl D., additional, Hamid, Omid, additional, Gajewski, Thomas F., additional, Puzanov, Igor, additional, Wongchenko, Matthew, additional, Rooney, Isabelle, additional, Hsu, Jessie J., additional, Yan, Yibing, additional, Park, Erica, additional, and McArthur, Grant A., additional

Published
2020
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22. Genomic Features of Exceptional Response in Vemurafenib ± Cobimetinib-treated Patients with BRAF V600-mutated Metastatic Melanoma.

Author

Yan, Yibing, Yan, Yibing, Wongchenko, Matthew J, Robert, Caroline, Larkin, James, Ascierto, Paolo A, Dréno, Brigitte, Maio, Michele, Garbe, Claus, Chapman, Paul B, Sosman, Jeffrey A, Shi, Zhen, Koeppen, Hartmut, Hsu, Jessie J, Chang, Ilsung, Caro, Ivor, Rooney, Isabelle, McArthur, Grant A, Ribas, Antoni, Yan, Yibing, Yan, Yibing, Wongchenko, Matthew J, Robert, Caroline, Larkin, James, Ascierto, Paolo A, Dréno, Brigitte, Maio, Michele, Garbe, Claus, Chapman, Paul B, Sosman, Jeffrey A, Shi, Zhen, Koeppen, Hartmut, Hsu, Jessie J, Chang, Ilsung, Caro, Ivor, Rooney, Isabelle, McArthur, Grant A, and Ribas, Antoni

Abstract

PurposePrevious investigations identified transcriptional signatures associated with innate resistance to anti-programmed cell death protein 1 therapy in melanoma. This analysis aimed to increase understanding of the role of baseline genetic features in the variability of response to BRAF and MEK inhibitor therapy for BRAF V600-mutated metastatic melanoma.Patients and methodsThis exploratory analysis compared genomic features, using whole-exome and RNA sequencing, of baseline tumors from patients who had complete response versus rapid progression (disease progression at first postbaseline assessment) on treatment with cobimetinib combined with vemurafenib or vemurafenib alone. Associations of gene expression with progression-free survival or overall survival were assessed by Cox proportional hazards modeling.ResultsWhole-exome sequencing showed that MITF and TP53 alterations were more frequent in tumors from patients with rapid progression, while NF1 alterations were more frequent in tumors from patients with complete response. However, the low frequency of alterations in any one gene precluded their characterization as drivers of response/resistance. Analysis of RNA profiles showed that expression of immune response-related genes was enriched in tumors from patients with complete response, while expression of keratinization-related genes was enriched in tumors from patients who experienced rapid progression.ConclusionsThese findings suggest that enriched immune infiltration might be a shared feature favoring response to both targeted and immune therapies, while features of innate resistance to targeted and immune therapies were distinct.

Published
2019

23. Control of the Complement System

Author

Uszewski, M. Kathryn, primary, Farries, Timothy C., additional, Lublin, Douglas M., additional, Rooney, Isabelle A., additional, and Atkinson, John P., additional

Published
1996
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24. Additional file 1: of A phase Ib study of pictilisib (GDC-0941) in combination with paclitaxel, with and without bevacizumab or trastuzumab, and with letrozole in advanced breast cancer

Author

Schöffski, Patrick, Cresta, Sara, Mayer, Ingrid, Wildiers, Hans, Damian, Silvia, Gendreau, Steven, Rooney, Isabelle, Morrissey, Kari, Spoerke, Jill, Ng, Vivian, Singel, Stina, and Winer, Eric

Abstract

Table S1. All-grade AEs related to any study drug occurring in ≥ 15% of all patients and corresponding grade ≥ 3 AEs. Table S2. SAEs related to any study drug (regardless of causality). Table S3. AEs and grade ≥ 3 AEs of special interest (regardless of causality). Table S4. Summary of DLTs observed during the study. (DOCX 66 kb)

Published
2018
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27. Effects of Molecular Heterogeneity on Survival of Patients With BRAFV600-Mutated Melanoma Treated With Vemurafenib With or Without Cobimetinib in the coBRIM Study

Author

Wongchenko, Matthew J., primary, Ribas, Antoni, additional, Ascierto, Paolo A., additional, Dréno, Brigitte, additional, Maria di Giacomo, Anna, additional, Garbe, Claus, additional, Chang, Ilsung, additional, Hsu, Jessie, additional, Rooney, Isabelle, additional, Lu, William, additional, Koeppen, Hartmut, additional, Larkin, James, additional, Yan, Yibing, additional, and McArthur, Grant A., additional

Published
2018
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28. Efficacy and safety of cobimetinib (C) combined with vemurafenib (V) in patients (pts) with BRAFV600 mutation–positive metastatic melanoma: analysis from the 4-year extended follow-up of the phase 3 coBRIM study.

Author

Dreno, Brigitte, primary, Ascierto, Paolo Antonio, additional, McArthur, Grant A., additional, Atkinson, Victoria, additional, Liszkay, Gabriella, additional, Di Giacomo, Anna Maria, additional, Mandalà, Mario, additional, Demidov, Lev V., additional, Stroyakovskiy, Daniil, additional, Thomas, Luc, additional, De la Cruz-Merino, Luis, additional, Dutriaux, Caroline, additional, Garbe, Claus, additional, Rooney, Isabelle Anne, additional, Hsu, Jessie J., additional, Park, Erica, additional, Ribas, Antoni, additional, and Larkin, James M. G., additional

Published
2018
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29. Association of programmed death ligand-1 (PD-L1) expression with treatment outcomes in patients with BRAF mutation-positive melanoma treated with vemurafenib or cobimetinib combined with vemurafenib

Author

Wongchenko, Matthew J., primary, Ribas, Antoni, additional, Dréno, Brigitte, additional, Ascierto, Paolo A., additional, McArthur, Grant A., additional, Gallo, Jorge D., additional, Rooney, Isabelle A., additional, Hsu, Jessie, additional, Koeppen, Hartmut, additional, Yan, Yibing, additional, and Larkin, James, additional

Published
2017
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30. Melanoma and immunotherapy bridge 2015

Author

Nanda, Vashisht G. Y., Peng, Weiyi, Hwu, Patrick, Davies, Michael A., Ciliberto, Gennaro, Fattore, Luigi, Malpicci, Debora, Aurisicchio, Luigi, Ascierto, Paolo Antonio, Croce, Carlo M., Mancini, Rita, Spranger, Stefani, Gajewski, Thomas F., Wang, Yangyang, Ferrone, Soldano, Vanpouille-Box, Claire, Wennerberg, Erik, Pilones, Karsten A., Formenti, Silvia C., Demaria, Sandra, Tang, Haidong, Wang, Yang, Fu, Yang-Xin, Dummer, Reinhard, Puzanov, Igor, Tarhini, Ahmad, Chauvin, Joe-Marc, Pagliano, Ornella, Fourcade, Julien, Sun, Zhaojun, Wang, Hong, Sanders, Cindy, Kirkwood, John M., Chen, Tseng-hui Timothy, Maurer, Mark, Korman, Alan J., Zarour, Hassane M., Stroncek, David F., Huber, Veronica, Rivoltini, Licia, Thurin, Magdalena, Rau, Tilman, Lugli, Alessandro, Pagès, Franck, Camarero, Jorge, Sancho, Arantxa, Jommi, Claudio, de Coaña, Yago Pico, Wolodarski, Maria, Yoshimoto, Yuya, Gentilcore, Giusy, Poschke, Isabel, Masucci, Giuseppe V., Hansson, Johan, Kiessling, Rolf, Scognamiglio, Giosuè, Sabbatino, Francesco, Marino, Federica Zito, Anniciello, Anna Maria, Cantile, Monica, Cerrone, Margherita, Scala, Stefania, D’alterio, Crescenzo, Ianaro, Angela, Cirin, Giuseppe, Liguori, Giuseppina, Bott, Gerardo, Chapman, Paul B., Robert, Caroline, Larkin, James, Haanen, John B., Ribas, Antoni, Hogg, David, Hamid, Omid, Testori, Alessandro, Lorigan, Paul, Sosman, Jeffrey A., Flaherty, Keith T., Yue, Huibin, Coleman, Shelley, Caro, Ivor, Hauschild, Axel, McArthur, Grant A., Sznol, Mario, Callahan, Margaret K., Kluger, Harriet, Postow, Michael A., Gordan, RuthAnn, Segal, Neil H., Rizvi, Naiyer A., Lesokhin, Alexander, Atkins, Michael B., Burke, Matthew M., Ralabate, Amanda, Rivera, Angel, Kronenberg, Stephanie A., Agunwamba, Blessing, Ruisi, Mary, Horak, Christine, Jiang, Joel, Wolchok, Jedd, Ascierto, Paolo A., Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stoyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Atkinson, Victoria, Dutriaux, Caroline, Garbe, Claus, Wongchenko, Matthew, Chang, Ilsung, Koralek, Daniel O., Rooney, Isabelle, Yan, Yibing, Dréno, Brigitte, Sullivan, Ryan, Patel, Manish, Hodi, Stephen, Amaria, Rodabe, Boasberg, Peter, Wallin, Jeffrey, He, Xian, Cha, Edward, Richie, Nicole, Ballinger, Marcus, Smith, David C., Bauer, Todd M., Wasser, Jeffrey S., Luke, Jason J., Balmanoukian, Ani S., Kaufman, David R., Zhao, Yufan, Maleski, Janet, Leopold, Lance, Gangadhar, Tara C., Long, Georgina V., Michielin, Olivier, VanderWalde, Ari, Andtbacka, Robert H. I., Cebon, Jonathan, Fernandez, Eugenio, Malvehy, Josep, Olszanski, Anthony J., Gause, Christine, Chen, Lisa, Chou, Jeffrey, Stephen Hodi, F., Brady, Benjamin, Mortier, Laurent, Hassel, Jessica C., Rutkowski, Piotr, McNeil, Catriona, Kalinka-Warzocha, Ewa, Lebbé, Celeste, Ny, Lars, Chacon, Matias, Queirolo, Paola, Loquai, Carmen, Cheema, Parneet, Berrocal, Alfonso, Eizmendi, Karmele Mujika, Bar-Sela, Gil, Hardy, Helene, Weber, Jeffrey S., Grob, Jean-Jacques, Marquez-Rodas, Ivan, Schmidt, Henrik, Briscoe, Karen, Baurain, Jean-François, Wolchok, Jedd D., Pinto, Rosamaria, De Summa, Simona, Garrisi, Vito Michele, Strippoli, Sabino, Azzariti, Amalia, Guida, Gabriella, Guida, Michele, Tommasi, Stefania, Jacquelot, Nicolas, Enot, David, Flament, Caroline, Pitt, Jonathan M., Vimond, Nadège, Blattner, Carolin, Yamazaki, Takahiro, Roberti, Maria-Paula, Vetizou, Marie, Daillere, Romain, Poirier-Colame, Vichnou, la Semeraro, Michaë, Caignard, Anne, Slingluff, Craig L, Sallusto, Federica, Rusakiewicz, Sylvie, Weide, Benjamin, Marabelle, Aurélien, Kohrt, Holbrook, Dalle, Stéphane, Cavalcanti, Andréa, Kroemer, Guido, Di Giacomo, Anna Maria, Maio, Michaele, Wong, Phillip, Yuan, Jianda, Umansky, Viktor, Eggermont, Alexander, Zitvogel, Laurence, Anna, Passarelli, Marco, Tucci, Stefania, Stucci, Francesco, Mannavola, Mariaelena, Capone, Gabriele, Madonna, Antonio, Ascierto Paolo, Franco, Silvestris, Roberti, María Paula, Enot, David P., Semeraro, Michaela, Jégou, Sarah, Flores, Camila, Kwon, Byoung S., Anderson, Ana Carrizossa, Borg, Christophe, Aubin, François, Ayyoub, Maha, De Presbiteris, Anna Lisa, Cordaro, Fabiola Gilda, Camerlingo, Rosa, Fratangelo, Federica, Mozzillo, Nicola, Pirozzi, Giuseppe, Patriarca, Eduardo J., Caputo, Emilia, Motti, Maria Letizia, Falcon, Rosaria, Miceli, Roberta, Capone, Mariaelena, Madonna, Gabriele, Mallardo, Domenico, Carrier, Maria Vincenza, Panza, Elisabetta, De Cicco, Paola, Armogida, Chiara, Ercolano, Giuseppe, Botti, Gerardo, Cirino, Giuseppe, Sandru, Angela, Blank, Miri, Balatoni, Timea, Olasz, Judit, Farkas, Emil, Szollar, Andras, Savolt, Akos, Godeny, Maria, Csuka, Orsolya, Horvath, Szabolcs, Eles, Klara, Shoenfeld, Yehuda, Kasler, Miklos, Costantini, Susan, Capone, Francesca, Moradi, Farnaz, Berglund, Pontus, Leandersson, Karin, Linnskog, Rickard, Andersson, Tommy, Prasad, Chandra Prakash, Nigro, Cristiana Lo, Lattanzio, Laura, Wang, Hexiao, Proby, Charlotte, Syed, Nelofer, Occelli, Marcella, Cauchi, Carolina, Merlano, Marco, Harwood, Catherine, Thompson, Alastair, Crook, Tim, Bifulco, Katia, Ingangi, Vincenzo, Minopoli, Michele, Ragone, Concetta, Pessi, Antonello, Mannavola, Francesco, D’Oronzo, Stella, Felici, Claudia, Tucci, Marco, Doronzo, Antonio, Silvestris, Franco, Ferretta, Anna, Guida, Stefania, Maida, Imma, Cocco, Tiziana, Passarelli, Anna, Quaresmini, Davide, Franzese, Ornella, Palermo, Belinda, Di Donna, Cosmo, Sperduti, Isabella, Foddai, MariaLaura, Stabile, Helena, Gismondi, Angela, Santoni, Angela, Nisticò, Paola, Sponghini, Andrea P., Platini, Francesca, Marra, Elena, Rondonotti, David, Alabiso, Oscar, Fierro, Maria T., Savoia, Paola, Stratica, Florian, Quaglino, Pietro, Di Monta, Gianluca, Corrado, Caracò, Di Marzo, Massimiliano, Ugo, Marone, Di Cecilia, Maria Luisa, Nicola, Mozzillo, Fusciello, Celeste, Marra, Antonio, Guarrasi, Rosario, Baldi, Carlo, Russo, Rosa, Di Giulio, Giovanni, Faiola, Vincenzo, Zeppa, Pio, Pepe, Stefano, Gambale, Elisabetta, Carella, Consiglia, Di Paolo, Alessandra, De Tursi, Michele, Marra, Laura, De Murtas, Fara, Sorrentino, Valeria, Voinea, Silviu, Panaitescu, Eugenia, Bolovan, Madalina, Stanciu, Adina, Cinca, Sabin, Botti, Chiara, Aquino, Gabriella, Anniciello, Annamaria, Fortes, Cristina, Mastroeni, Simona, Caggiati, Alessio, Passarelli, Francesca, Zappalà, Alba, Capuano, Maria, Bono, Riccardo, Nudo, Maurizio, Marino, Claudia, Michelozzi, Paola, De Biasio, Valeria, Battarra, Vincenzo C., Formenti, Silvia, Ascierto, Maria Libera, McMiller, Tracee L., Berger, Alan E., Danilova, Ludmila, Anders, Robert A., Netto, George J., Xu, Haiying, Pritchard, Theresa S., Fan, Jinshui, Cheadle, Chris, Cope, Leslie, Drake, Charles G., Pardoll, Drew M., Taube, Janis M., Topalian, Suzanne L., Gnjatic, Sacha, Nataraj, Sarah, Imai, Naoko, Rahman, Adeeb, Jungbluth, Achim A., Pan, Linda, Venhaus, Ralph, Park, Andrew, Lehmann, Frédéric F., Lendvai, Nikoletta, Cohen, Adam D., Cho, Hearn J., Daniel, Speiser, and Hirsh, Vera

Subjects
Medicine(all), Biochemistry, Genetics and Molecular Biology(all), Meeting Abstracts
Abstract

Table of contents MELANOMA BRIDGE 2015 KEYNOTE SPEAKER PRESENTATIONS Molecular and immuno-advances K1 Immunologic and metabolic consequences of PI3K/AKT/mTOR activation in melanoma Vashisht G. Y. Nanda, Weiyi Peng, Patrick Hwu, Michael A. Davies K2 Non-mutational adaptive changes in melanoma cells exposed to BRAF and MEK inhibitors help the establishment of drug resistance Gennaro Ciliberto, Luigi Fattore, Debora Malpicci, Luigi Aurisicchio, Paolo Antonio Ascierto, Carlo M. Croce, Rita Mancini K3 Tumor-intrinsic beta-catenin signaling mediates tumor-immune avoidance Stefani Spranger, Thomas F. Gajewski K4 Intracellular tumor antigens as a source of targets of antibody-based immunotherapy of melanoma Yangyang Wang, Soldano Ferrone Combination therapies K5 Harnessing radiotherapy to improve responses to immunotherapy in cancer Claire Vanpouille-Box, Erik Wennerberg, Karsten A. Pilones, Silvia C. Formenti, Sandra Demaria K6 Creating a T cell-inflamed tumor microenvironment overcomes resistance to checkpoint blockade Haidong Tang, Yang Wang, Yang-Xin Fu K7 Biomarkers for treatment decisions? Reinhard Dummer K8 Combining oncolytic therapies in the era of checkpoint inhibitors Igor Puzanov K9 Immune checkpoint blockade for melanoma: should we combine or sequence ipilimumab and PD-1 antibody therapy? Michael A. Postow News in immunotherapy K10 An update on adjuvant and neoadjuvant therapy for melanom Ahmad Tarhini K11 Targeting multiple inhibitory receptors in melanoma Joe-Marc Chauvin, Ornella Pagliano, Julien Fourcade, Zhaojun Sun, Hong Wang, Cindy Sanders, John M. Kirkwood, Tseng-hui Timothy Chen, Mark Maurer, Alan J. Korman, Hassane M. Zarour K12 Improving adoptive immune therapy using genetically engineered T cells David F. Stroncek Tumor microenvironment and biomarkers K13 Myeloid cells and tumor exosomes: a crosstalk for assessing immunosuppression? Veronica Huber, Licia Rivoltini K14 Update on the SITC biomarker taskforce: progress and challenges Magdalena Thurin World-wide immunoscore task force: an update K15 The immunoscore in colorectal cancer highlights the importance of digital scoring systems in surgical pathology Tilman Rau, Alessandro Lugli K16 The immunoscore: toward an integrated immunomonitoring from the diagnosis to the follow up of cancer’s patients Franck Pagès Economic sustainability of melanoma treatments: regulatory, health technology assessment and market access issues K17 Nivolumab, the regulatory experience in immunotherapy Jorge Camarero, Arantxa Sancho K18 Evidence to optimize access for immunotherapies Claudio Jommi ORAL PRESENTATIONS Molecular and immuno-advances O1 Ipilimumab treatment results in CD4 T cell activation that is concomitant with a reduction in Tregs and MDSCs Yago Pico de Coaña, Maria Wolodarski, Yuya Yoshimoto, Giusy Gentilcore, Isabel Poschke, Giuseppe V. Masucci, Johan Hansson, Rolf Kiessling O2 Evaluation of prognostic and therapeutic potential of COX-2 and PD-L1 in primary and metastatic melanoma Giosuè Scognamiglio, Francesco Sabbatino, Federica Zito Marino, Anna Maria Anniciello, Monica Cantile, Margherita Cerrone, Stefania Scala, Crescenzo D’alterio, Angela Ianaro, Giuseppe Cirino, Paolo Antonio Ascierto, Giuseppina Liguori, Gerardo Botti O3 Vemurafenib in patients with BRAFV600 mutation–positive metastatic melanoma: final overall survival results of the BRIM-3 study Paul B. Chapman, Caroline Robert, James Larkin, John B. Haanen, Antoni Ribas, David Hogg, Omid Hamid, Paolo Antonio Ascierto, Alessandro Testori, Paul Lorigan, Reinhard Dummer, Jeffrey A. Sosman, Keith T. Flaherty, Huibin Yue, Shelley Coleman, Ivor Caro, Axel Hauschild, Grant A. McArthur O4 Updated survival, response and safety data in a phase 1 dose-finding study (CA209-004) of concurrent nivolumab (NIVO) and ipilimumab (IPI) in advanced melanoma Mario Sznol, Margaret K. Callahan, Harriet Kluger, Michael A. Postow, RuthAnn Gordan, Neil H. Segal, Naiyer A. Rizvi, Alexander Lesokhin, Michael B. Atkins, John M. Kirkwood, Matthew M. Burke, Amanda Ralabate, Angel Rivera, Stephanie A. Kronenberg, Blessing Agunwamba, Mary Ruisi, Christine Horak, Joel Jiang, Jedd Wolchok Combination therapies O5 Efficacy and correlative biomarker analysis of the coBRIM study comparing cobimetinib (COBI) + vemurafenib (VEM) vs placebo (PBO) + VEM in advanced BRAF-mutated melanoma patients (pts) Paolo A. Ascierto, Grant A. McArthur, James Larkin, Gabriella Liszkay, Michele Maio, Mario Mandalà, Lev Demidov, Daniil Stoyakovskiy, Luc Thomas, Luis de la Cruz-Merino, Victoria Atkinson, Caroline Dutriaux, Claus Garbe, Matthew Wongchenko, Ilsung Chang, Daniel O. Koralek, Isabelle Rooney, Yibing Yan, Antoni Ribas, Brigitte Dréno O6 Preliminary clinical safety, tolerability and activity results from a Phase Ib study of atezolizumab (anti-PDL1) combined with vemurafenib in BRAFV600-mutant metastatic melanoma Ryan Sullivan, Omid Hamid, Manish Patel, Stephen Hodi, Rodabe Amaria, Peter Boasberg, Jeffrey Wallin, Xian He, Edward Cha, Nicole Richie, Marcus Ballinger, Patrick Hwu O7 Preliminary safety and efficacy data from a phase 1/2 study of epacadostat (INCB024360) in combination with pembrolizumab in patients with advanced/metastatic melanoma Thomas F. Gajewski, Omid Hamid, David C. Smith, Todd M. Bauer, Jeffrey S. Wasser, Jason J. Luke, Ani S. Balmanoukian, David R. Kaufman, Yufan Zhao, Janet Maleski, Lance Leopold, Tara C. Gangadhar O8 Primary analysis of MASTERKEY-265 phase 1b study of talimogene laherparepvec (T-VEC) and pembrolizumab (pembro) for unresectable stage IIIB-IV melanoma Reinhard Dummer, Georgina V. Long, Antoni Ribas, Igor Puzanov, Olivier Michielin, Ari VanderWalde, Robert H.I. Andtbacka, Jonathan Cebon, Eugenio Fernandez, Josep Malvehy, Anthony J. Olszanski, Thomas F. Gajewski, John M. Kirkwood, Christine Gause, Lisa Chen, David R. Kaufman, Jeffrey Chou, F. Stephen Hodi News in immunotherapy O9 Two-year survival and safety update in patients (pts) with treatment-naïve advanced melanoma (MEL) receiving nivolumab (NIVO) or dacarbazine (DTIC) in CheckMate 066 Victoria Atkinson, Paolo A. Ascierto, Georgina V. Long, Benjamin Brady, Caroline Dutriaux, Michele Maio, Laurent Mortier, Jessica C. Hassel, Piotr Rutkowski, Catriona McNeil, Ewa Kalinka-Warzocha, Celeste Lebbé, Lars Ny, Matias Chacon, Paola Queirolo, Carmen Loquai, Parneet Cheema, Alfonso Berrocal, Karmele Mujika Eizmendi, Luis De La Cruz-Merino, Gil Bar-Sela, Christine Horak, Joel Jiang, Helene Hardy, Caroline Robert O10 Efficacy and safety of nivolumab (NIVO) in patients (pts) with advanced melanoma (MEL) who were treated beyond progression in CheckMate 066/067 Georgina V. Long, Jeffrey S. Weber, James Larkin, Victoria Atkinson, Jean-Jacques Grob, Reinhard Dummer, Caroline Robert, Ivan Marquez-Rodas, Catriona McNeil, Henrik Schmidt, Karen Briscoe, Jean-François Baurain, F. Stephen Hodi, Jedd D. Wolchok Tumor microenvironment and biomarkers O11 New biomarkers for response/resistance to BRAF inhibitor therapy in metastatic melanoma Rosamaria Pinto, Simona De Summa, Vito Michele Garrisi, Sabino Strippoli, Amalia Azzariti, Gabriella Guida, Michele Guida, Stefania Tommasi O12 Chemokine receptor patterns in lymphocytes mirror metastatic spreading in melanoma and response to ipilimumab Nicolas Jacquelot, David Enot, Caroline Flament, Jonathan M. Pitt, Nadège Vimond, Carolin Blattner, Takahiro Yamazaki, Maria-Paula Roberti, Marie Vetizou, Romain Daillere, Vichnou Poirier-Colame, Michaëla Semeraro, Anne Caignard, Craig L Slingluff Jr, Federica Sallusto, Sylvie Rusakiewicz, Benjamin Weide, Aurélien Marabelle, Holbrook Kohrt, Stéphane Dalle, Andréa Cavalcanti, Guido Kroemer, Anna Maria Di Giacomo, Michaele Maio, Phillip Wong, Jianda Yuan, Jedd Wolchok, Viktor Umansky, Alexander Eggermont, Laurence Zitvogel O13 Serum levels of PD1- and CD28-positive exosomes before Ipilimumab correlate with therapeutic response in metastatic melanoma patients Passarelli Anna, Tucci Marco, Stucci Stefania, Mannavola Francesco, Capone Mariaelena, Madonna Gabriele, Ascierto Paolo Antonio, Silvestris Franco O14 Immunological prognostic factors in stage III melanomas María Paula Roberti, Nicolas Jacquelot, David P Enot, Sylvie Rusakiewicz, Michaela Semeraro, Sarah Jégou, Camila Flores, Lieping Chen, Byoung S. Kwon, Ana Carrizossa Anderson, Caroline Robert, Christophe Borg, Benjamin Weide, François Aubin, Stéphane Dalle, Michele Maio, Jedd D. Wolchok, Holbrook Kohrt, Maha Ayyoub, Guido Kroemer, Aurélien Marabelle, Andréa Cavalcanti, Alexander Eggermont, Laurence Zitvogel POSTER PRESENTATIONS Molecular and immuno-advances P1 Human melanoma cells resistant to B-RAF and MEK inhibition exhibit mesenchymal-like features Anna Lisa De Presbiteris, Fabiola Gilda Cordaro, Rosa Camerlingo, Federica Fratangelo, Nicola Mozzillo, Giuseppe Pirozzi, Eduardo J. Patriarca, Paolo A. Ascierto, Emilia Caputo P2 Anti-proliferative and pro-apoptotic effect of ABT888 on melanoma cell lines and its potential role in the treatment of melanoma resistant to B-RAF inhibitors Federica Fratangelo, Rosa Camerlingo, Emilia Caputo, Maria Letizia Motti, Rosaria Falcone, Roberta Miceli, Mariaelena Capone, Gabriele Madonna, Domenico Mallardo, Maria Vincenza Carriero, Giuseppe Pirozzi and Paolo Antonio Ascierto P3 Involvement of the L-cysteine/CSE/H2S pathway in human melanoma progression Elisabetta Panza, Paola De Cicco, Chiara Armogida, Giuseppe Ercolano, Rosa Camerlingo, Giuseppe Pirozzi, Giosuè Scognamiglio, Gerardo Botti, Giuseppe Cirino, Angela Ianaro P4 Cancer stem cell antigen revealing pattern of antibody variable region genes were defined by immunoglobulin repertoire analysis in patients with malignant melanoma Beatrix Kotlan, Gabriella Liszkay, Miri Blank, Timea Balatoni, Judit Olasz, Emil Farkas, Andras Szollar, Akos Savolt, Maria Godeny, Orsolya Csuka, Szabolcs Horvath, Klara Eles, Yehuda Shoenfeld and Miklos Kasler P5 Upregulation of Neuregulin-1 expression is a hallmark of adaptive response to BRAF/MEK inhibitors in melanoma Debora Malpicci, Luigi Fattore, Susan Costantini, Francesca Capone, Paolo Antonio Ascierto, Rita Mancini, Gennaro Ciliberto P6 HuR positively regulates migration of HTB63 melanoma cells Farnaz Moradi, Pontus Berglund, Karin Leandersson, Rickard Linnskog, Tommy Andersson, Chandra Prakash Prasad P7 Prolyl 4- (C-P4H) hydroxylases have opposing effects in malignant melanoma: implication in prognosis and therapy Cristiana Lo Nigro, Laura Lattanzio, Hexiao Wang, Charlotte Proby, Nelofer Syed, Marcella Occelli, Carolina Cauchi, Marco Merlano, Catherine Harwood, Alastair Thompson, Tim Crook P8 Urokinase receptor antagonists: novel agents for the treatment of melanoma Maria Letizia Motti, Katia Bifulco, Vincenzo Ingangi, Michele Minopoli, Concetta Ragone, Federica Fratangelo, Antonello Pessi, Gennaro Ciliberto, Paolo Antonio Ascierto, Maria Vincenza Carriero P9 Exosomes released by melanoma cell lines enhance chemotaxis of primary tumor cells Francesco Mannavola, Stella D’Oronzo, Claudia Felici, Marco Tucci, Antonio Doronzo, Franco Silvestris P10 New insights in mitochondrial metabolic reprogramming in melanoma Anna Ferretta, Gabriella Guida, Stefania Guida, Imma Maida, Tiziana Cocco, Sabino Strippoli, Stefania Tommasi, Amalia Azzariti, Michele Guida P11 Lenalidomide restrains the proliferation in melanoma cells through a negative regulation of their cell cycle Stella D’Oronzo, Anna Passarelli, Claudia Felici, Marco Tucci, Davide Quaresmini, Franco Silvestris Combination therapies P12 Chemoimmunotherapy elicits polyfunctional anti-tumor CD8 + T cells depending on the activation of an AKT pathway sustained by ICOS Ornella Franzese, Belinda Palermo, Cosmo Di Donna, Isabella Sperduti, MariaLaura Foddai, Helena Stabile, Angela Gismondi, Angela Santoni, Paola Nisticò P13 Favourable toxicity profile of combined BRAF and MEK inhibitors in metastatic melanoma patients Andrea P. Sponghini, Francesca Platini, Elena Marra, David Rondonotti, Oscar Alabiso, Maria T. Fierro, Paola Savoia, Florian Stratica, Pietro Quaglino P14 Electrothermal bipolar vessel sealing system dissection reduces seroma output or time to drain removal following axillary and ilio-inguinal node dissection in melanoma patients: a pilot study Di Monta Gianluca, Caracò Corrado, Di Marzo Massimiliano, Marone Ugo, Di Cecilia Maria Luisa, Mozzillo Nicola News in immunotherapy P15 Clinical and immunological response to ipilimumab in a metastatic melanoma patient with HIV infection Francesco Sabbatino, Celeste Fusciello1, Antonio Marra, Rosario Guarrasi, Carlo Baldi, Rosa Russo, Di Giulio Giovanni, Vincenzo Faiola, Pio Zeppa, Stefano Pepe P16 Immunotherapy and hypophysitis: a case report Elisabetta Gambale, Consiglia Carella, Alessandra Di Paolo, Michele De Tursi Tumor microenvironment and biomarkers P17 New immuno- histochemical markers for the differential diagnosis of atypical melanocytic lesions with uncertain malignant potential Laura Marra, Giosuè Scognamiglio, Monica Cantile, Margherita Cerrone, Fara De Murtas, Valeria Sorrentino, Anna Maria Anniciello, Gerardo Botti P18 Utility of simultaneous measurement of three serum tumor markers in melanoma patients Angela Sandru, Silviu Voinea, Eugenia Panaitescu, Madalina Bolovan, Adina Stanciu, Sabin Cinca P19 The significance of various cut-off levels of melanoma inhibitory activity in evaluation of cutaneous melanoma patients Angela Sandru, Silviu Voinea, Eugenia Panaitescu, Madalina Bolovan, Adina Stanciu, Sabin Cinca P20 The long noncoding RNA HOTAIR is associated to metastatic progression of melanoma and it can be identified in the blood of patients with advanced disease Chiara Botti, Giosuè Scognamiglio, Laura Marra, Gabriella Aquino, Rosaria Falcone, Annamaria Anniciello, Paolo Antonio Ascierto, Gerardo Botti, Monica Cantile Other P21 The effect of Sentinel Lymph Node Biopsy in melanoma mortality: timing of dissection Cristina Fortes, Simona Mastroeni, Alessio Caggiati, Francesca Passarelli, Alba Zappalà, Maria Capuano, Riccardo Bono, Maurizio Nudo, Claudia Marino, Paola Michelozzi P22 Epidemiological survey on related psychopathology in melanoma Valeria De Biasio, Vincenzo C. Battarra IMMUNOTHERAPY BRIDGE KEYNOTE SPEAKER PRESENTATIONS Immunotherapy beyond melanoma K19 Predictor of response to radiation and immunotherapy Silvia Formenti K20 Response and resistance to PD-1 pathway blockade: clues from the tumor microenvironment Maria Libera Ascierto, Tracee L. McMiller, Alan E. Berger, Ludmila Danilova, Robert A. Anders, George J. Netto, Haiying Xu, Theresa S. Pritchard, Jinshui Fan, Chris Cheadle, Leslie Cope, Charles G. Drake, Drew M. Pardoll, Janis M. Taube and Suzanne L. Topalian K21 Combination immunotherapy with autologous stem cell transplantation, protein immunization, and PBMC reinfusion in myeloma patients Sacha Gnjatic, Sarah Nataraj, Naoko Imai, Adeeb Rahman, Achim A. Jungbluth, Linda Pan, Ralph Venhaus, Andrew Park, Frédéric F. Lehmann, Nikoletta Lendvai, Adam D. Cohen, and Hearn J. Cho K22 Anti-cancer immunity despite T cell “exhaustion” Speiser Daniel Immunotherapy in oncology (I-O): data from clinical trial K23 The Checkpoint Inhibitors for the Treatment of Metastatic Non-small Cell Lung Cancer (NSCLC) Vera Hirsh

Published
2016

31. Cobimetinib combined with vemurafenib in advanced BRAF V600 -mutant melanoma (coBRIM): updated efficacy results from a randomised, double-blind, phase 3 trial

Author

Ascierto, Paolo, Mcarthur, Grant, Dréno, Brigitte, Atkinson, Victoria, Liszkay, Gabrielle, Di Giacomo, Anna Maria, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, De La Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Yan, Yibing, Wongchenko, Matthew, Chang, Ilsung, Hsu, Jessie, Koralek, Daniel, Rooney, Isabelle, Ribas, Antoni, Larkin, James, Bernardo, Elizabeth, Istituto Nazionale Tumori, Molecular Oncology Laboratory [East Melbourne, Australia], Peter MacCallum Cancer Centre [East Melbourne, Australia], Centre de Recherche en Cancérologie Nantes-Angers (CRCNA), Centre Hospitalier Universitaire d'Angers (CHU Angers), PRES Université Nantes Angers Le Mans (UNAM)-PRES Université Nantes Angers Le Mans (UNAM)-Hôtel-Dieu de Nantes-Institut National de la Santé et de la Recherche Médicale (INSERM)-Hôpital Laennec-Centre National de la Recherche Scientifique (CNRS)-Faculté de Médecine d'Angers-Centre hospitalier universitaire de Nantes (CHU Nantes), Service de dermatologie [Nantes], Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes), Princess Alexandra Hospital, Brisbane, Institute of Oncology, Azienda Ospedaliera Universitaria Senese, Hospital Papa Giovanni XXIII (Hosp P Giovanni XXIII), Russian Cancer Research Centre, Moscow City Oncology Hospital, CHU Lyon, Hospital Universitario Virgen del Rocío [Sevilla], Hôpital Saint-André, University of Tübingen, Genentech, Inc., Genentech, Inc. [San Francisco], and Comprehensive Cancer Center

Subjects
[SDV.CAN] Life Sciences [q-bio]/Cancer, [SDV.CAN]Life Sciences [q-bio]/Cancer
Abstract

International audience; Background The combination of cobimetinib with vemurafenib improves progression-free survival compared with placebo and vemurafenib in previously untreated patients with BRAF V600-mutant advanced melanoma, as previously reported in the coBRIM study. In this Article, we report updated effi cacy results, including overall survival and safety after longer follow-up, and selected biomarker correlative studies.

Published
2016

32. Gene Expression Profiling in BRAF-Mutated Melanoma Reveals Patient Subgroups with Poor Outcomes to Vemurafenib That May Be Overcome by Cobimetinib Plus Vemurafenib

Author

Wongchenko, Matthew J., primary, McArthur, Grant A., additional, Dréno, Brigitte, additional, Larkin, James, additional, Ascierto, Paolo A., additional, Sosman, Jeffrey, additional, Andries, Luc, additional, Kockx, Mark, additional, Hurst, Stephen D., additional, Caro, Ivor, additional, Rooney, Isabelle, additional, Hegde, Priti S., additional, Molinero, Luciana, additional, Yue, Huibin, additional, Chang, Ilsung, additional, Amler, Lukas, additional, Yan, Yibing, additional, and Ribas, Antoni, additional

Published
2017
Full Text
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37. Association of programmed death ligand‐1 (PD‐L1) expression with treatment outcomes in patients with BRAF mutation‐positive melanoma treated with vemurafenib or cobimetinib combined with vemurafenib.

Author

Wongchenko, Matthew J., Ribas, Antoni, Dréno, Brigitte, Ascierto, Paolo A., McArthur, Grant A., Gallo, Jorge D., Rooney, Isabelle A., Hsu, Jessie, Koeppen, Hartmut, Yan, Yibing, and Larkin, James

Subjects
MELANOMA, CANCER, IMMUNOTHERAPY, CLINICAL immunology, THERAPEUTICS, VEMURAFENIB
Abstract

Summary: The prognostic significance of programmed death ligand‐1 (PD‐L1) on treatment outcomes in patients receiving BRAF with or without MEK inhibitors is not well understood. This retrospective exploratory analysis evaluated the association of tumour PD‐L1 expression with progression‐free survival (PFS) and overall survival (OS) among 210 patients in the coBRIM trial treated with cobimetinib plus vemurafenib or placebo plus vemurafenib. In the vemurafenib cohort, there was a trend of increased PFS and OS in those with PD‐L1+ melanoma, with hazard ratios (HRs; PD‐L1+ vs. PD‐L1−) of 0.70 (95% CI, 0.46–1.07) and 0.69 (95% CI, 0.42–1.13) for PFS and OS, respectively. However, in patients treated with cobimetinib plus vemurafenib, a similar trend was not observed with HRs (PD‐L1+ versus PD‐L1−) of 1.04 (95% CI, 0.66–1.68) and 0.94 (95% CI, 0.57–1.57) for PFS and OS, respectively. The combination cobimetinib plus vemurafenib appears to overcome the poor prognosis associated with low PD‐L1 expression. [ABSTRACT FROM AUTHOR]

Published
2018
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38. Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation-positive melanoma.

Author

Dréno, Brigitte, Ascierto, Paolo A, Atkinson, Victoria, Liszkay, Gabriella, Maio, Michele, Mandalà, Mario, Demidov, Lev, Stroyakovskiy, Daniil, Thomas, Luc, de la Cruz-Merino, Luis, Dutriaux, Caroline, Garbe, Claus, Bartley, Karen, Karagiannis, Thomas, Chang, Ilsung, Rooney, Isabelle, Koralek, Daniel O, Larkin, James, McArthur, Grant A, and Ribas, Antoni

Abstract

Background: In the coBRIM study, cobimetinib plus vemurafenib (C+V) significantly improved survival outcomes vs placebo and vemurafenib (P+V) in patients with advanced/metastatic BRAFV600-mutated melanoma. An analysis of health-related quality of life (HRQOL) from coBRIM is reported.Methods: Patients completing the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline and ⩾1 time point thereafter constituted the analysis population. Change from baseline ⩾10 points was considered clinically meaningful.Results: Mean baseline scores for all QLQ-C30 domains were similar between arms. Most on-treatment scores for QLQ-C30 domains were also comparable between arms. A transient deterioration in role function in cycle 1 day 15 (C1D15; -14.7 points) in the P+V arm and improvement in insomnia in the C+V arm at C2D15 (-12.4 points) was observed. Among patients who experienced a ⩾10-point change from baseline (responders), between-group differences were greatest for insomnia (16%), social functioning (10%), fatigue (9%) and pain (7%), all favouring C+V. Diarrhoea, photosensitivity reaction, pyrexia, and rash did not meaningfully affect global health status (GHS). Serous retinopathy was associated with a transient decrease in GHS at C1D15 assessment.Conclusions: In patients with advanced/metastatic BRAFV600-mutated melanoma, treatment with C+V maintained HRQOL compared with P+V, with superior efficacy. [ABSTRACT FROM AUTHOR]

Published
2018
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39. TOTABLE TAILGATE.

Author

Schend, James, Rooney, Isabelle, and Hass, Matthew

Published
2019

40. Update of progression-free survival (PFS) and correlative biomarker analysis from coBRIM: Phase III study of cobimetinib (cobi) plus vemurafenib (vem) in advanced BRAF-mutated melanoma.

Author

Larkin, James M. G., primary, Yan, Yibing, additional, McArthur, Grant A., additional, Ascierto, Paolo Antonio, additional, Liszkay, Gabriella, additional, Maio, Michele, additional, Mandalà, Mario, additional, Demidov, Lev V., additional, Stroyakovskiy, Daniil, additional, Thomas, Luc, additional, De La Cruz-Merino, Luis, additional, Atkinson, Victoria, additional, Dutriaux, Caroline, additional, Garbe, Claus, additional, Wongchenko, Matthew, additional, Rooney, Isabelle Anne, additional, Chang, Ilsung, additional, Hack, Stephen Paul, additional, Dréno, Brigitte, additional, and Ribas, Antoni, additional

Published
2015
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41. Abstract P5-19-10: Tolerability and anti-tumor activity of the oral PI3K inhibitor GDC-0941 in combination with paclitaxel, with and without bevacizumab or trastuzumab in patients with locally recurrent or metastatic breast cancer

Author

Schöffski, Patrick, primary, Cresta, Sara, additional, Mayer, Ingrid A, additional, Wildiers, Hans, additional, Rooney, Isabelle, additional, Apt, Doris, additional, Gendreau, Steve, additional, Morrissey, Kari, additional, Lackner, Mark, additional, Spoerke, Jill, additional, and Winer, Eric, additional

Published
2015
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48. SGX523 is an exquisitely selective, ATP-competitive inhibitor of the MET receptor tyrosine kinase with antitumor activity in vivo

Author

Buchanan, Sean G., primary, Hendle, Jorg, additional, Lee, Patrick S., additional, Smith, Christopher R., additional, Bounaud, Pierre-Yves, additional, Jessen, Katti A., additional, Tang, Crystal M., additional, Huser, Nanni H., additional, Felce, Jeremy D., additional, Froning, Karen J., additional, Peterman, Marshall C., additional, Aubol, Brandon E., additional, Gessert, Steve F., additional, Sauder, J. Michael, additional, Schwinn, Kenneth D., additional, Russell, Marijane, additional, Rooney, Isabelle A., additional, Adams, Jason, additional, Leon, Barbara C., additional, Do, Tuan H., additional, Blaney, Jeff M., additional, Sprengeler, Paul A., additional, Thompson, Devon A., additional, Smyth, Lydia, additional, Pelletier, Laura A., additional, Atwell, Shane, additional, Holme, Kevin, additional, Wasserman, Stephen R., additional, Emtage, Spencer, additional, Burley, Stephen K., additional, and Reich, Siegfried H., additional

Published
2009
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49. Impact of the ΔF508 Mutation in First Nucleotide-binding Domain of Human Cystic Fibrosis Transmembrane Conductance Regulator on Domain Folding and Structure

Author

Lewis, Hal A., primary, Zhao, Xun, additional, Wang, Chi, additional, Sauder, J. Michael, additional, Rooney, Isabelle, additional, Noland, Brian W., additional, Lorimer, Don, additional, Kearins, Margaret C., additional, Conners, Kris, additional, Condon, Brad, additional, Maloney, Peter C., additional, Guggino, William B., additional, Hunt, John F., additional, and Emtage, Spencer, additional

Published
2005
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50. Absorption, Metabolism, Excretion, and the Contribution of Intestinal Metabolism to the Oral Disposition of [14C]Cobimetinib, a MEK Inhibitor, in Humans

Author

Takahashi, Ryan H., Choo, Edna F., Ma, Shuguang, Wong, Susan, Halladay, Jason, Deng, Yuzhong, Rooney, Isabelle, Gates, Mary, Hop, Cornelis E.C.A., Khojasteh, S. Cyrus, Dresser, Mark J., and Musib, Luna

Abstract

The pharmacokinetics, metabolism, and excretion of cobimetinib, a MEK inhibitor, were characterized in healthy male subjects (n= 6) following a single 20 mg (200 μCi) oral dose. Unchanged cobimetinib and M16 (glycine conjugate of hydrolyzed cobimetinib) were the major circulating species, accounting for 20.5% and 18.3% of the drug-related material in plasma up to 48 hours postdose, respectively. Other circulating metabolites were minor, accounting for less than 10% of drug-related material in plasma. The total recovery of the administered radioactivity was 94.3% (±1.6%, S.D.) with 76.5% (±2.3%) in feces and 17.8% (±2.5%) in urine. Metabolite profiling indicated that cobimetinib had been extensively metabolized with only 1.6% and 6.6% of the dose remaining as unchanged drug in urine and feces, respectively. In vitro phenotyping experiments indicated that CYP3A4 was predominantly responsible for metabolizing cobimetinib. From this study, we concluded that cobimetinib had been well absorbed (fraction absorbed, Fa= 0.88). Given this good absorption and the previously determined low hepatic clearance, the systemic exposures were lower than expected (bioavailability, F= 0.28). We hypothesized that intestinal metabolism had strongly attenuated the oral bioavailability of cobimetinib. Supporting this hypothesis, the fraction escaping gut wall elimination (Fg) was estimated to be 0.37 based on Fand Fafrom this study and the fraction escaping hepatic elimination (Fh) from the absolute bioavailability study (F= Fa× Fh× Fg). Physiologically based pharmacokinetics modeling also showed that intestinal clearance had to be included to adequately describe the oral profile. These collective data suggested that cobimetinib was well absorbed following oral administration and extensively metabolized with intestinal first-pass metabolism contributing to its disposition.

Published
2016
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