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1. Supplementary Figure 3 from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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2. Supplementary Figure 6 from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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3. Supplementary Figure 5 from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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4. Supplementary Table 1 from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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5. Supplementary Figure 2 from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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6. Data from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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7. Supplementary Figure 4 from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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8. Supplementary Figure 1 from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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9. Supplementary Materials and Methods, Figure Legends from Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., primary, Bouck, David C., primary, Liu, Xiaozhen J., primary, Sappal, Darshan S., primary, Hather, Greg, primary, Cosmopoulos, Katherine, primary, Thomas, Michael P., primary, Kuranda, Mike, primary, Pickard, Michael D., primary, Liu, Ray, primary, Bandi, Syamala, primary, Smith, Peter G., primary, and Lightcap, Eric S., primary

Published
2023
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10. Supplemental Figure 1 from Phase I Study of the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients with Advanced Solid Tumors

Author

Sarantopoulos, John, primary, Shapiro, Geoffrey I., primary, Cohen, Roger B., primary, Clark, Jeffrey W., primary, Kauh, John S., primary, Weiss, Glen J., primary, Cleary, James M., primary, Mahalingam, Devalingam, primary, Pickard, Michael D., primary, Faessel, Hélène M., primary, Berger, Allison J., primary, Burke, Kristine, primary, Mulligan, George, primary, Dezube, Bruce J., primary, and Harvey, R. Donald, primary

Published
2023
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11. Supplementary Data from A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K-mutant Solid Tumors

Author

Sullivan, Ryan J., primary, Weber, Jeffrey, primary, Patel, Sapna, primary, Dummer, Reinhard, primary, Carlino, Matteo S., primary, Tan, Daniel S.W., primary, Lebbé, Celeste, primary, Siena, Salvatore, primary, Elez, Elena, primary, Wollenberg, Lance, primary, Pickard, Michael D., primary, Sandor, Victor, primary, and Ascierto, Paolo A., primary

Published
2023
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12. Supplementary Tables 1-2, Supplementary Methods, Supplementary Figure Legend from Phase I Study of the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients with Advanced Solid Tumors

Author

Sarantopoulos, John, primary, Shapiro, Geoffrey I., primary, Cohen, Roger B., primary, Clark, Jeffrey W., primary, Kauh, John S., primary, Weiss, Glen J., primary, Cleary, James M., primary, Mahalingam, Devalingam, primary, Pickard, Michael D., primary, Faessel, Hélène M., primary, Berger, Allison J., primary, Burke, Kristine, primary, Mulligan, George, primary, Dezube, Bruce J., primary, and Harvey, R. Donald, primary

Published
2023
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13. Data from Genome-Wide siRNA Screen for Modulators of Cell Death Induced by Proteasome Inhibitor Bortezomib

Author

Chen, Siquan, primary, Blank, Jonathan L., primary, Peters, Theodore, primary, Liu, Xiaozhen J., primary, Rappoli, David M., primary, Pickard, Michael D., primary, Menon, Saurabh, primary, Yu, Jie, primary, Driscoll, Denise L., primary, Lingaraj, Trupti, primary, Burkhardt, Anne L., primary, Chen, Wei, primary, Garcia, Khristofer, primary, Sappal, Darshan S., primary, Gray, Jesse, primary, Hales, Paul, primary, Leroy, Patrick J., primary, Ringeling, John, primary, Rabino, Claudia, primary, Spelman, James J., primary, Morgenstern, Jay P., primary, and Lightcap, Eric S., primary

Published
2023
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14. Supplementary Figures 1-4 from Genome-Wide siRNA Screen for Modulators of Cell Death Induced by Proteasome Inhibitor Bortezomib

Author

Chen, Siquan, primary, Blank, Jonathan L., primary, Peters, Theodore, primary, Liu, Xiaozhen J., primary, Rappoli, David M., primary, Pickard, Michael D., primary, Menon, Saurabh, primary, Yu, Jie, primary, Driscoll, Denise L., primary, Lingaraj, Trupti, primary, Burkhardt, Anne L., primary, Chen, Wei, primary, Garcia, Khristofer, primary, Sappal, Darshan S., primary, Gray, Jesse, primary, Hales, Paul, primary, Leroy, Patrick J., primary, Ringeling, John, primary, Rabino, Claudia, primary, Spelman, James J., primary, Morgenstern, Jay P., primary, and Lightcap, Eric S., primary

Published
2023
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15. Supplementary Figure 8 from Genome-Wide siRNA Screen for Modulators of Cell Death Induced by Proteasome Inhibitor Bortezomib

Author

Chen, Siquan, primary, Blank, Jonathan L., primary, Peters, Theodore, primary, Liu, Xiaozhen J., primary, Rappoli, David M., primary, Pickard, Michael D., primary, Menon, Saurabh, primary, Yu, Jie, primary, Driscoll, Denise L., primary, Lingaraj, Trupti, primary, Burkhardt, Anne L., primary, Chen, Wei, primary, Garcia, Khristofer, primary, Sappal, Darshan S., primary, Gray, Jesse, primary, Hales, Paul, primary, Leroy, Patrick J., primary, Ringeling, John, primary, Rabino, Claudia, primary, Spelman, James J., primary, Morgenstern, Jay P., primary, and Lightcap, Eric S., primary

Published
2023
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16. Supplementary Methods, Figure and Table Legends from Genome-Wide siRNA Screen for Modulators of Cell Death Induced by Proteasome Inhibitor Bortezomib

Author

Chen, Siquan, primary, Blank, Jonathan L., primary, Peters, Theodore, primary, Liu, Xiaozhen J., primary, Rappoli, David M., primary, Pickard, Michael D., primary, Menon, Saurabh, primary, Yu, Jie, primary, Driscoll, Denise L., primary, Lingaraj, Trupti, primary, Burkhardt, Anne L., primary, Chen, Wei, primary, Garcia, Khristofer, primary, Sappal, Darshan S., primary, Gray, Jesse, primary, Hales, Paul, primary, Leroy, Patrick J., primary, Ringeling, John, primary, Rabino, Claudia, primary, Spelman, James J., primary, Morgenstern, Jay P., primary, and Lightcap, Eric S., primary

Published
2023
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17. Supplementary Table 3A-F from Genome-Wide siRNA Screen for Modulators of Cell Death Induced by Proteasome Inhibitor Bortezomib

Author

Chen, Siquan, primary, Blank, Jonathan L., primary, Peters, Theodore, primary, Liu, Xiaozhen J., primary, Rappoli, David M., primary, Pickard, Michael D., primary, Menon, Saurabh, primary, Yu, Jie, primary, Driscoll, Denise L., primary, Lingaraj, Trupti, primary, Burkhardt, Anne L., primary, Chen, Wei, primary, Garcia, Khristofer, primary, Sappal, Darshan S., primary, Gray, Jesse, primary, Hales, Paul, primary, Leroy, Patrick J., primary, Ringeling, John, primary, Rabino, Claudia, primary, Spelman, James J., primary, Morgenstern, Jay P., primary, and Lightcap, Eric S., primary

Published
2023
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18. Supplementary Figures 5-7 from Genome-Wide siRNA Screen for Modulators of Cell Death Induced by Proteasome Inhibitor Bortezomib

Author

Chen, Siquan, primary, Blank, Jonathan L., primary, Peters, Theodore, primary, Liu, Xiaozhen J., primary, Rappoli, David M., primary, Pickard, Michael D., primary, Menon, Saurabh, primary, Yu, Jie, primary, Driscoll, Denise L., primary, Lingaraj, Trupti, primary, Burkhardt, Anne L., primary, Chen, Wei, primary, Garcia, Khristofer, primary, Sappal, Darshan S., primary, Gray, Jesse, primary, Hales, Paul, primary, Leroy, Patrick J., primary, Ringeling, John, primary, Rabino, Claudia, primary, Spelman, James J., primary, Morgenstern, Jay P., primary, and Lightcap, Eric S., primary

Published
2023
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20. Survie Globale (SG) à cinq ans dans l’étude COLUMBUS : un essai randomisé de phase 3 évaluant encorafénib plus binimétinib versus vémurafenib ou encorafénib chez les patients atteints d’un mélanome muté BRAF V600

Author

Robert, Caroline, primary, Dummer, Reinhard, additional, Flaherty, Keith, additional, Arance, Ana Maria, additional, Groot, Jan Willem De, additional, Garbe, Claus, additional, Gogas, Helen, additional, Gutzmer, Ralf, additional, Krajsová, Ivana, additional, Liszkay, Gabriella, additional, Loquai, Carmen, additional, Mandalà, Mario, additional, Schadendorf, Dirk, additional, Yamazaki, Naoya, additional, Pickard, Michael D., additional, Zohren, Fabian, additional, Edwards, Michelle L., additional, and Ascierto, Paolo Antonio, additional

Published
2021
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21. Five-year overall survival (OS) in COLUMBUS: A randomized phase 3 trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients (pts) with BRAF V600-mutant melanoma

Author

Dummer, Reinhard Flaherty, Keith Robert, Caroline Arance, Ana Maria De Groot, Jan Willem Garbe, Claus Gogas, Helen and Gutzmer, Ralf Krajsova, Ivana Liszkay, Gabriella Loquai, Carmen Mandala, Mario Schadendorf, Dirk Yamazaki, Naoya and Pickard, Michael D. Zohren, Fabian Edwards, Michelle L. and Ascierto, Paolo Antonio

Published
2021

23. Five-year overall survival (OS) in COLUMBUS: A randomized phase 3 trial of encorafenib plus binimetinib versus vemurafenib or encorafenib in patients (pts) with BRAF V600-mutant melanoma.

Author

Dummer, Reinhard, primary, Flaherty, Keith, additional, Robert, Caroline, additional, Arance, Ana Maria, additional, de Groot, Jan Willem, additional, Garbe, Claus, additional, Gogas, Helen, additional, Gutzmer, Ralf, additional, Krajsová, Ivana, additional, Liszkay, Gabriella, additional, Loquai, Carmen, additional, Mandalà, Mario, additional, Schadendorf, Dirk, additional, Yamazaki, Naoya, additional, Pickard, Michael D., additional, Zohren, Fabian, additional, Edwards, Michelle L., additional, and Ascierto, Paolo Antonio, additional

Published
2021
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25. Update on Overall Survival in the COLUMBUS Study : A randomized Phase 3 Study of Encorafenib (ENCO) plus Binimetinib (BINI) vs Vemurafenib (VEM) or ENCO in Patients with BRAF V600 mutated Melanoma

Author

Schadendorf, Dirk, Garbe, Carolina, Gutzmer, Ralf, Loquai, Carmen, Fluck, Michael, Kiecker, Felix, Mohr, Peter, Terheyden, Patrick, Gogas, Helen, Ascierto, Paolo A., Flaherty, Keith T., Arance, Antonio, Mandala, Marco, Liszkay, Gabriella, Krajsova, Ivana, de Groot, Jan Willem B., Dutriaux, Caroline, Gollerkeri, Ashwin, Pickard, Michael D., Robert, Chrissy, and Dummer, Reinhard

Subjects
Medizin, ComputingMethodologies_GENERAL
Abstract

Poster Abstract

Published
2020

26. A phase II, multicenter study of encorafenib/binimetinib followed by a rational triple-combination after progression in patients with advanced BRAF V600-mutated melanoma (LOGIC2).

Author

Dummer, Reinhard, Sandhu, Shahneen Kaur, Miller, Wilson H., Butler, Marcus O., Blank, Christian U., Munoz-Couselo, Eva, Burris, Howard A., III, Postow, Michael A., Chmielowski, Bartosz, Middleton, Mark R., Berking, Carola, Hassel, Jessica Cecile, Gesierich, Anja, Mauch, Cornelia, Kleha, Joseph, Gollerkeri, Ashwin, Harney, Allison, Pickard, Michael D., Ascierto, Paolo Antonio, Dummer, Reinhard, Sandhu, Shahneen Kaur, Miller, Wilson H., Butler, Marcus O., Blank, Christian U., Munoz-Couselo, Eva, Burris, Howard A., III, Postow, Michael A., Chmielowski, Bartosz, Middleton, Mark R., Berking, Carola, Hassel, Jessica Cecile, Gesierich, Anja, Mauch, Cornelia, Kleha, Joseph, Gollerkeri, Ashwin, Harney, Allison, Pickard, Michael D., and Ascierto, Paolo Antonio

Published
2020

27. Update on tolerability and overall survival in COLUMBUS: landmark analysis of a randomised phase 3 trial of encorafenib plus binimetinib vs vemurafenib or encorafenib in patients with BRAF V600-mutant melanoma

Author

Ascierto, Paolo A, Dummer, Reinhard, Gogas, Helen J, Flaherty, Keith T, Arance, Ana, Mandala, Mario, Liszkay, Gabriella, Garbe, Claus, Schadendorf, Dirk, Krajsova, Ivana, Gutzmer, Ralf, de Groot, Jan Willem B, Loquai, Carmen, Gollerkeri, Ashwin, Pickard, Michael D, Robert, Caroline, Ascierto, Paolo A, Dummer, Reinhard, Gogas, Helen J, Flaherty, Keith T, Arance, Ana, Mandala, Mario, Liszkay, Gabriella, Garbe, Claus, Schadendorf, Dirk, Krajsova, Ivana, Gutzmer, Ralf, de Groot, Jan Willem B, Loquai, Carmen, Gollerkeri, Ashwin, Pickard, Michael D, and Robert, Caroline

Abstract

BACKGROUND BRAF/MEK inhibitor combinations are established treatments for BRAF V600-mutant melanoma based on demonstrated benefits on progression-free survival (PFS) and overall survival (OS). Here, we report an updated analysis of the COLUMBUS (COmbined LGX818 [encorafenib] Used with MEK162 [binimetinib] in BRAF mutant Unresectable Skin cancer) trial with long-term follow-up. METHODS In part 1 of the COLUMBUS trial, 577 patients with advanced/metastatic BRAF V600-mutant melanoma, untreated or progressed after first-line immunotherapy, were randomised 1:1:1 to 450 mg of encorafenib QD + 45 mg of binimetinib BID (COMBO450) vs 960 mg of vemurafenib BID (VEM) or 300 mg of encorafenib ENCO QD (ENCO300). An updated analysis was conducted that included PFS, OS, objective response rate, safety and tolerability and analyses of results by prognostic subgroups. RESULTS At data cutoff, there were 116, 113 and 138 deaths in the COMBO450, ENCO300 and VEM treatment arms, respectively. The median OS was 33.6 months (95% confidence interval [CI], 24.4-39.2) for COMBO450, 23.5 months (95% CI, 19.6-33.6) for ENCO300 and 16.9 months (95% CI, 14.0-24.5) for VEM. Compared with VEM, COMBO450 decreased the risk of death by 39% (hazard ratio [HR], 0.61; 95% CI, 0.48-0.79). The updated median PFS for COMBO450 was 14.9 months (95% CI, 11.0-20.2), ENCO300 was 9.6 months (95% CI, 7.4-14.8) and VEM was 7.3 months (95% CI, 5.6-7.9). PFS was longer for COMBO450 vs VEM (HR, 0.51; 95% CI, 0.39-0.67). Landmark OS and PFS results show consistent results for each year analysed. Subgroups all favoured COMBO450 vs VEM. CONCLUSIONS Updated PFS and OS results for COMBO450 from the COLUMBUS trial demonstrate a long-term benefit in patients with advanced BRAF V600-mutated melanoma.

Published
2020

28. A Phase Ib/II Study of the BRAF Inhibitor Encorafenib Plus the MEK Inhibitor Binimetinib in Patients with BRAFV600E/K-mutant Solid Tumors

Author

Sullivan, Ryan J., primary, Weber, Jeffrey, additional, Patel, Sapna, additional, Dummer, Reinhard, additional, Carlino, Matteo S., additional, Tan, Daniel S.W., additional, Lebbé, Celeste, additional, Siena, Salvatore, additional, Elez, Elena, additional, Wollenberg, Lance, additional, Pickard, Michael D., additional, Sandor, Victor, additional, and Ascierto, Paolo A., additional

Published
2020
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29. A phase II, multicenter study of encorafenib/binimetinib followed by a rational triple-combination after progression in patients with advanced BRAF V600-mutated melanoma (LOGIC2).

Author

Dummer, Reinhard, primary, Sandhu, Shahneen Kaur, additional, Miller, Wilson H., additional, Butler, Marcus O., additional, Blank, Christian U., additional, Muñoz-Couselo, Eva, additional, Burris III, Howard A., additional, Postow, Michael A., additional, Chmielowski, Bartosz, additional, Middleton, Mark R., additional, Berking, Carola, additional, Hassel, Jessica Cecile, additional, Gesierich, Anja, additional, Mauch, Cornelia, additional, Kleha, Joseph, additional, Gollerkeri, Ashwin, additional, Harney, Allison, additional, Pickard, Michael D, additional, and Ascierto, Paolo Antonio, additional

Published
2020
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30. Encorafenib plus cetuximab with or without binimetinib for BRAF V600E-mutant metastatic colorectal cancer: Quality-of-life results from a randomized, three-arm, phase III study versus the choice of either irinotecan or FOLFIRI plus cetuximab (BEACON CRC).

Author

Kopetz, Scott, primary, Grothey, Axel, additional, Van Cutsem, Eric, additional, Yaeger, Rona, additional, Wasan, Harpreet Singh, additional, Yoshino, Takayuki, additional, Desai, Jayesh, additional, Ciardiello, Fortunato, additional, Loupakis, Fotios, additional, Hong, Yong Sang, additional, Steeghs, Neeltje, additional, Guren, Tormod Kyrre, additional, Arkenau, Hendrik-Tobias, additional, Garcia-Alfonso, Pilar, additional, Gollerkeri, Ashwin, additional, Maharry, Kati, additional, Christy-Bittel, Janna, additional, Keir, Christopher Hunt, additional, Pickard, Michael D, additional, and Tabernero, Josep, additional

Published
2020
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31. Update on overall survival in COLUMBUS: A randomized phase III trial of encorafenib (ENCO) plus binimetinib (BINI) versus vemurafenib (VEM) or ENCO in patients with BRAF V600-mutant melanoma.

Author

Gogas, Helen, primary, Ascierto, Paolo Antonio, additional, Flaherty, Keith, additional, Arance, Ana, additional, Mandalà, Mario, additional, Liszkay, Gabriella, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Krajsova, Ivana, additional, Gutzmer, Ralf, additional, de Groot, Jan Willem, additional, Dutriaux, Caroline, additional, Loquai, Carmen, additional, Gollerkeri, Ashwin, additional, Pickard, Michael D, additional, Robert, Caroline, additional, and Dummer, Reinhard, additional

Published
2020
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32. Update on tolerability and overall survival in COLUMBUS: landmark analysis of a randomised phase 3 trial of encorafenib plus binimetinib vs vemurafenib or encorafenib in patients with BRAF V600–mutant melanoma

Author

Ascierto, Paolo A., primary, Dummer, Reinhard, additional, Gogas, Helen J., additional, Flaherty, Keith T., additional, Arance, Ana, additional, Mandala, Mario, additional, Liszkay, Gabriella, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Krajsova, Ivana, additional, Gutzmer, Ralf, additional, de Groot, Jan Willem B., additional, Loquai, Carmen, additional, Gollerkeri, Ashwin, additional, Pickard, Michael D., additional, and Robert, Caroline, additional

Published
2020
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33. Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management

Author

Gogas, Helen J, Flaherty, Keith T, Dummer, Reinhard, Ascierto, Paolo A, Arance, Ana, Mandala, Mario, Liszkay, Gabriella, Garbe, Claus, Schadendorf, Dirk, Krajsova, Ivana, Gutzmer, Ralf, Sileni, Vanna Chiarion, Dutriaux, Caroline, de Groot, Jan Willem B, Yamazaki, Naoya, Loquai, Carmen, Gollerkeri, Ashwin, Pickard, Michael D, Robert, Caroline, Gogas, Helen J, Flaherty, Keith T, Dummer, Reinhard, Ascierto, Paolo A, Arance, Ana, Mandala, Mario, Liszkay, Gabriella, Garbe, Claus, Schadendorf, Dirk, Krajsova, Ivana, Gutzmer, Ralf, Sileni, Vanna Chiarion, Dutriaux, Caroline, de Groot, Jan Willem B, Yamazaki, Naoya, Loquai, Carmen, Gollerkeri, Ashwin, Pickard, Michael D, and Robert, Caroline

Abstract

BACKGROUND Dual inhibition of the mitogen-activated protein kinase pathway with BRAF/MEK inhibitor (BRAFi/MEKi) therapy is a standard treatment for BRAFV600-mutant metastatic melanoma and has historically been associated with grade III pyrexia or photosensitivity depending on the combination used. The objective of this study was to fully describe adverse events from the COLUMBUS study evaluating the most recent BRAF/MEK inhibitor combination encorafenib+binimetinib. PATIENTS AND METHODS Patients with locally advanced, unresectable or metastatic BRAFV600-mutant melanoma were randomised to receive encorafenib 450 mg once daily plus binimetinib 45 mg twice daily, encorafenib 300 mg once daily or vemurafenib 960 mg twice daily. Adverse events that represent known effects of available BRAFi and/or MEKi were evaluated. RESULTS The safety population included a total of 570 patients (encorafenib+binimetinib = 192; encorafenib = 192; vemurafenib = 186). Median duration of exposure was longer with encorafenib+binimetinib (51 weeks) than with encorafenib (31 weeks) or vemurafenib (27 weeks). Common BRAFi/MEKi toxicities with encorafenib+binimetinib were generally manageable, reversible and infrequently associated with discontinuation. Pyrexia was less frequent with encorafenib+binimetinib (18%) and encorafenib (16%) than with vemurafenib (30%) and occurred later in the course of therapy with encorafenib+binimetinib (median time to first onset: 85 days versus 2.5 days and 19 days, respectively). The incidence of photosensitivity was lower with encorafenib+binimetinib (5%) and encorafenib (4%) than with vemurafenib (30%). The incidence of serous retinopathy was higher with encorafenib+binimetinib (20%) than with encorafenib (2%) or vemurafenib (2%), but no patients discontinued encorafenib+binimetinib because of this event. CONCLUSION Encorafenib+binimetinib is generally well tolerated and has a low discontinuation rate in patients with BRAFV600-mutant melanoma, with a distinct

Published
2019

36. Overall survival in COLUMBUS: A phase 3 trial of encorafenib (ENCO) plus binimetinib (BINI) vs vemurafenib (VEM) or enco in BRAF-mutant melanoma

Author

Dummer, Reinhard Ascierto, Paolo Antonio Gogas, Helen and Arance, Ana M. Mandala, Mario Liszkay, Gabriella Garbe, Claus Schadendorf, Dirk Krajsova, Ivana Gutzmer, Ralf and Chiarion-Sileni, Vanna Dutriaux, Caroline de Groot, Jan Willem and Yamazaki, Naoya Loquai, Carmen De Parseval, Laure A. and Pickard, Michael D. Sandor, Victor Robert, Caroline and Flaherty, Keith

Published
2018

37. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF-mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial

Author

Dummer, Reinhard, Ascierto, Paolo A, Gogas, Helen J, Arance, Ana, Mandala, Mario, Liszkay, Gabriella, Garbe, Claus, Schadendorf, Dirk, Krajsova, Ivana, Gutzmer, Ralf, Chiarion-Sileni, Vanna, Dutriaux, Caroline, de Groot, Jan Willem B, Yamazaki, Naoya, Loquai, Carmen, Moutouh-de Parseval, Laure A, Pickard, Michael D, Sandor, Victor, Robert, Caroline, Flaherty, Keith T, University of Zurich, and Dummer, Reinhard

Subjects
Medizin, 10177 Dermatology Clinic, 610 Medicine & health, 2730 Oncology
Published
2018

38. Adverse events associated with encorafenib plus binimetinib in the COLUMBUS study: incidence, course and management

Author

Gogas, Helen J., primary, Flaherty, Keith T., additional, Dummer, Reinhard, additional, Ascierto, Paolo A., additional, Arance, Ana, additional, Mandala, Mario, additional, Liszkay, Gabriella, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Krajsova, Ivana, additional, Gutzmer, Ralf, additional, Sileni, Vanna Chiarion, additional, Dutriaux, Caroline, additional, de Groot, Jan Willem B., additional, Yamazaki, Naoya, additional, Loquai, Carmen, additional, Gollerkeri, Ashwin, additional, Pickard, Michael D., additional, and Robert, Caroline, additional

Published
2019
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39. Update on overall survival in COLUMBUS: A randomized phase III trial of encorafenib (ENCO) plus binimetinib (BINI) versus vemurafenib (VEM) or ENCO in patients with BRAF V600–mutant melanoma.

Author

Liszkay, Gabriella, primary, Gogas, Helen, additional, Mandalà, Mario, additional, Arance Fernandez, ANA Maria, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Dummer, Reinhard, additional, Ascierto, Paolo Antonio, additional, Robert, Caroline, additional, Pickard, Michael D, additional, Sandor, Victor, additional, Gollerkeri, Ashwin, additional, and Flaherty, Keith, additional

Published
2019
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40. Overall survival in patients with BRAF-mutant melanoma receiving encorafenib plus binimetinib versus vemurafenib or encorafenib (COLUMBUS): a multicentre, open-label, randomised, phase 3 trial

Author

Dummer, Reinhard, primary, Ascierto, Paolo A, additional, Gogas, Helen J, additional, Arance, Ana, additional, Mandala, Mario, additional, Liszkay, Gabriella, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Krajsova, Ivana, additional, Gutzmer, Ralf, additional, Chiarion Sileni, Vanna, additional, Dutriaux, Caroline, additional, de Groot, Jan Willem B, additional, Yamazaki, Naoya, additional, Loquai, Carmen, additional, Moutouh-de Parseval, Laure A, additional, Pickard, Michael D, additional, Sandor, Victor, additional, Robert, Caroline, additional, and Flaherty, Keith T, additional

Published
2018
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41. Overall survival in COLUMBUS: A phase 3 trial of encorafenib (ENCO) plus binimetinib (BINI) vs vemurafenib (VEM) or enco in BRAF-mutant melanoma.

Author

Dummer, Reinhard, primary, Ascierto, Paolo Antonio, additional, Gogas, Helen, additional, Arance, Ana M., additional, Mandalà, Mario, additional, Liszkay, Gabriella, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Krajsova, Ivana, additional, Gutzmer, Ralf, additional, Chiarion-Sileni, Vanna, additional, Dutriaux, Caroline, additional, de Groot, Jan Willem, additional, Yamazaki, Naoya, additional, Loquai, Carmen, additional, De Parseval, Laure A., additional, Pickard, Michael D, additional, Sandor, Victor, additional, Robert, Caroline, additional, and Flaherty, Keith, additional

Published
2018
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42. Adverse events of special interest in the phase 3 COLUMBUS study.

Author

Gogas, Helen, primary, Dummer, Reinhard, additional, Ascierto, Paolo Antonio, additional, Arance, Ana M., additional, Mandalà, Mario, additional, Liszkay, Gabriella, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Krajsova, Ivana, additional, Gutzmer, Ralf, additional, Chiarion-Sileni, Vanna, additional, Dutriaux, Caroline, additional, de Groot, Jan Willem, additional, Yamazaki, Naoya, additional, Loquai, Carmen, additional, De Parseval, Laure A., additional, Pickard, Michael D, additional, Gollerkeri, Ashwin, additional, Robert, Caroline, additional, and Flaherty, Keith, additional

Published
2018
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43. Encorafenib plus binimetinib versus vemurafenib or encorafenib in patients with BRAF -mutant melanoma (COLUMBUS): a multicentre, open-label, randomised phase 3 trial

Author

Dummer, Reinhard, primary, Ascierto, Paolo A, additional, Gogas, Helen J, additional, Arance, Ana, additional, Mandala, Mario, additional, Liszkay, Gabriella, additional, Garbe, Claus, additional, Schadendorf, Dirk, additional, Krajsova, Ivana, additional, Gutzmer, Ralf, additional, Chiarion-Sileni, Vanna, additional, Dutriaux, Caroline, additional, de Groot, Jan Willem B, additional, Yamazaki, Naoya, additional, Loquai, Carmen, additional, Moutouh-de Parseval, Laure A, additional, Pickard, Michael D, additional, Sandor, Victor, additional, Robert, Caroline, additional, and Flaherty, Keith T, additional

Published
2018
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44. Phase I Study of the Investigational NEDD8-Activating Enzyme Inhibitor Pevonedistat (TAK-924/MLN4924) in Patients with Advanced Solid Tumors

Author

Sarantopoulos, John, primary, Shapiro, Geoffrey I., additional, Cohen, Roger B., additional, Clark, Jeffrey W., additional, Kauh, John S., additional, Weiss, Glen J., additional, Cleary, James M., additional, Mahalingam, Devalingam, additional, Pickard, Michael D., additional, Faessel, Hélène M., additional, Berger, Allison J., additional, Burke, Kristine, additional, Mulligan, George, additional, Dezube, Bruce J., additional, and Harvey, R. Donald, additional

Published
2016
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45. Sequence analysis of β-subunit genes of the 20S proteasome in patients with relapsed multiple myeloma treated with bortezomib or dexamethasone

Author

Lichter, David I., Danaee, Hadi, Pickard, Michael D., Tayber, Olga, Sintchak, Michael, Shi, Hongliang, Richardson, Paul G., Cavenagh, Jamie, Bladé, Joan, Façon, Thierry, Niesvizky, Ruben, Alsina, Melissa, Dalton, William, Sonneveld, Pieter, Lonial, Sagar, van de Velde, Helgi, Ricci, Deborah, Esseltine, Dixie-Lee, Trepicchio, William L., Mulligan, George, and Anderson, Kenneth C.

Published
2012
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46. Nedd8-Activating Enzyme Inhibitor MLN4924 Provides Synergy with Mitomycin C through Interactions with ATR, BRCA1/BRCA2, and Chromatin Dynamics Pathways

Author

Garcia, Khristofer, primary, Blank, Jonathan L., additional, Bouck, David C., additional, Liu, Xiaozhen J., additional, Sappal, Darshan S., additional, Hather, Greg, additional, Cosmopoulos, Katherine, additional, Thomas, Michael P., additional, Kuranda, Mike, additional, Pickard, Michael D., additional, Liu, Ray, additional, Bandi, Syamala, additional, Smith, Peter G., additional, and Lightcap, Eric S., additional

Published
2014
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48. Abstract B92: Nedd8-activating enzyme inhibitor MLN4924 provides synergy in nonclinical models with mitomycin C through interactions with ATR, BRCA1/BRCA2 and chromatin dynamics pathways.

Author

Lightcap, Eric S., primary, Garcia, Khristofer, additional, Blank, Jonathan L., additional, Bouck, David C., additional, Liu, Xiaozhen J., additional, Hather, Greg, additional, Berger, Allison, additional, Cosmopoulos, Katherine, additional, Thomas, Michael P., additional, Kuranda, Mike, additional, Pickard, Michael D., additional, Liu, Ray, additional, Bandi, Syamala, additional, and Smith, Peter G., additional

Published
2013
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49. Abstract A38: Development and implementation of immunohistochemistry (IHC)-based pharmacodynamic (PD) biomarkers demonstrate NAE pathway inhibition in MLN4924 solid tumor clinical trials.

Author

McDonald, Alice A., primary, Burke, Kristine, additional, Thomas, Michael, additional, Berger, Alison, additional, Smith, Peter G., additional, Tirrell, Stephen, additional, Blakemore, Stephen J., additional, Mulligan, Geogre, additional, Pickard, Michael D., additional, Fleming, Mark D., additional, Kauh, John S., additional, Sarantopoulos, John, additional, Dezube, Bruce J., additional, and Stringer, Bradley, additional

Published
2011
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50. Abstract A196: Development, validation, and clinical implementation of a peripheral blood RT-PCR pharmacodynamic assay for MLN4924, an investigational small molecule inhibitor of NEDD8-activating enzyme (NAE).

Author

Walker, Russell M., primary, Koenig, Erik, additional, Mulligan, George, additional, Lightcap, Eric, additional, Pickard, Michael D., additional, Smith, Peter G., additional, Berger, Allison J., additional, Tirrell, Stephen M., additional, Dezube, Bruce J., additional, Trepicchio, William L., additional, Izmailova, Elena S., additional, and Blakemore, Stephen J., additional

Published
2011
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