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1. Preclinical efficacy of the potent, selective menin-KMT2A inhibitor JNJ-75276617 (bleximenib) in KMT2A- and NPM1-altered leukemias

Author

Kwon, Min Chul, Thuring, Jan Willem, Querolle, Olivier, Dai, Xuedong, Verhulst, Tinne, Pande, Vineet, Marien, Ann, Goffin, Dries, Wenge, Daniela V., Yue, Hong, Cutler, Jevon A., Jin, Cyrus, Perner, Florian, Hogeling, Shanna M., Shaffer, Paul L., Jacobs, Frank, Vinken, Petra, Cai, Wei, Keersmaekers, Vikki, Eyassu, Filmon, Bhogal, Balpreet, Verstraeten, Karin, El Ashkar, Sara, Perry, Jennifer A., Jayaguru, Prathiba, Barreyro, Laura, Kuchnio, Anna, Darville, Nicolas, Krosky, Daniel, Urbanietz, Gregor, Verbist, Bie, Edwards, James P., Cowley, Glenn S., Kirkpatrick, Robert, Steele, Ruth, Ferrante, Lucille, Guttke, Christina, Daskalakis, Nikki, Pietsch, E. Christine, Wilson, David M., Attar, Ricardo, Elsayed, Yusri, Fischer, Eric S., Schuringa, Jan Jacob, Armstrong, Scott A., Packman, Kathryn, and Philippar, Ulrike

Published
2024
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3. Teclistamab, a B-cell maturation antigen × CD3 bispecific antibody, in patients with relapsed or refractory multiple myeloma (MajesTEC-1): a multicentre, open-label, single-arm, phase 1 study

Author

Usmani, Saad Z, Garfall, Alfred L, van de Donk, Niels W C J, Nahi, Hareth, San-Miguel, Jesus F, Oriol, Albert, Rosinol, Laura, Chari, Ajai, Bhutani, Manisha, Karlin, Lionel, Benboubker, Lotfi, Pei, Lixia, Verona, Raluca, Girgis, Suzette, Stephenson, Tara, Elsayed, Yusri, Infante, Jeffrey, Goldberg, Jenna D, Banerjee, Arnob, Mateos, María-Victoria, and Krishnan, Amrita

Published
2021
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4. A novel C2 domain binding CD33xCD3 bispecific antibody with potent T-cell redirection activity against acute myeloid leukemia

Author

Nair-Gupta, Priyanka, Diem, Michael, Reeves, Dara, Wang, Weirong, Schulingkamp, Robert, Sproesser, Katrin, Mattson, Bethany, Heidrich, Bradley, Mendonça, Mark, Joseph, Jocelin, Sendecki, Jocelyn, Foulk, Brad, Chu, Gerald, Fink, Damien, Jiao, Qun, Wu, Sheng-Jiun, Packman, Kathryn, Elsayed, Yusri, Attar, Ricardo, and Gaudet, François

Published
2020
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6. Supplementary Table 2 from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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7. Supplementary Figure from A Phase I Study of Quisinostat (JNJ-26481585), an Oral Hydroxamate Histone Deacetylase Inhibitor with Evidence of Target Modulation and Antitumor Activity, in Patients with Advanced Solid Tumors

Author

Venugopal, Balaji, primary, Baird, Richard, primary, Kristeleit, Rebecca S., primary, Plummer, Ruth, primary, Cowan, Richard, primary, Stewart, Adam, primary, Fourneau, Nele, primary, Hellemans, Peter, primary, Elsayed, Yusri, primary, Mcclue, Steve, primary, Smit, Johan W., primary, Forslund, Ann, primary, Phelps, Charles, primary, Camm, John, primary, Evans, T.R. Jeffry, primary, de Bono, Johann S., primary, and Banerji, Udai, primary

Published
2023
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8. Supplementary Figure 3 from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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9. Supplementary Table 1 from A Phase I Study of Quisinostat (JNJ-26481585), an Oral Hydroxamate Histone Deacetylase Inhibitor with Evidence of Target Modulation and Antitumor Activity, in Patients with Advanced Solid Tumors

Author

Venugopal, Balaji, primary, Baird, Richard, primary, Kristeleit, Rebecca S., primary, Plummer, Ruth, primary, Cowan, Richard, primary, Stewart, Adam, primary, Fourneau, Nele, primary, Hellemans, Peter, primary, Elsayed, Yusri, primary, Mcclue, Steve, primary, Smit, Johan W., primary, Forslund, Ann, primary, Phelps, Charles, primary, Camm, John, primary, Evans, T.R. Jeffry, primary, de Bono, Johann S., primary, and Banerji, Udai, primary

Published
2023
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10. Supplementary Table 2 from A Phase I Study of Quisinostat (JNJ-26481585), an Oral Hydroxamate Histone Deacetylase Inhibitor with Evidence of Target Modulation and Antitumor Activity, in Patients with Advanced Solid Tumors

Author

Venugopal, Balaji, primary, Baird, Richard, primary, Kristeleit, Rebecca S., primary, Plummer, Ruth, primary, Cowan, Richard, primary, Stewart, Adam, primary, Fourneau, Nele, primary, Hellemans, Peter, primary, Elsayed, Yusri, primary, Mcclue, Steve, primary, Smit, Johan W., primary, Forslund, Ann, primary, Phelps, Charles, primary, Camm, John, primary, Evans, T.R. Jeffry, primary, de Bono, Johann S., primary, and Banerji, Udai, primary

Published
2023
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11. Supplementary Figure 1 from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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12. Supplementary Table 1 from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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13. Supplementary Figure 2 from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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14. Supplementary Table 3 from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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15. Supplementary Legend from A Phase I Study of Quisinostat (JNJ-26481585), an Oral Hydroxamate Histone Deacetylase Inhibitor with Evidence of Target Modulation and Antitumor Activity, in Patients with Advanced Solid Tumors

Author

Venugopal, Balaji, primary, Baird, Richard, primary, Kristeleit, Rebecca S., primary, Plummer, Ruth, primary, Cowan, Richard, primary, Stewart, Adam, primary, Fourneau, Nele, primary, Hellemans, Peter, primary, Elsayed, Yusri, primary, Mcclue, Steve, primary, Smit, Johan W., primary, Forslund, Ann, primary, Phelps, Charles, primary, Camm, John, primary, Evans, T.R. Jeffry, primary, de Bono, Johann S., primary, and Banerji, Udai, primary

Published
2023
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16. Supplementary Table 4 from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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17. Supplementary Methods from Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, primary, Henitz, Erin D., primary, Karkera, Jayaprakash D., primary, Favis, Reyna, primary, Gaffney, Dana, primary, Shapiro, Alice, primary, Theocharous, Panteli, primary, Elsayed, Yusri A., primary, van de Velde, Helgi, primary, Schaffer, Michael E., primary, Osmanov, Evgenii A., primary, Hong, Xiaonan, primary, Scheliga, Adriana, primary, Mayer, Jiri, primary, Offner, Fritz, primary, Rule, Simon, primary, Teixeira, Adriana, primary, Romejko-Jarosinska, Joanna, primary, de Vos, Sven, primary, Crump, Michael, primary, Shpilberg, Ofer, primary, Zinzani, Pier Luigi, primary, Cakana, Andrew, primary, Esseltine, Dixie-Lee, primary, Mulligan, George, primary, and Ricci, Deborah, primary

Published
2023
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18. Characterization of JNJ-80948543, a Novel CD79bxCD20xCD3 Trispecific T-Cell Redirecting Antibody for the Treatment of B-Cell Non-Hodgkin Lymphoma

Author

Kuchnio, Anna, primary, Yang, Danlin, additional, Vloemans, Nele, additional, Lowenstein, Cassandra, additional, Cornelissen, Ivo, additional, Amorim, Ricardo, additional, Han, Chao, additional, Sukumaran, Siddharth, additional, Janssen, Lut, additional, Suls, Toon, additional, Bekkers, Mariette, additional, Lasorsa, Elena, additional, Fontana, Lorena, additional, Medeiros, Nicole, additional, Wu, Bingyuan, additional, Chen, Jun, additional, Feldkamp, Michael, additional, Wu, Sheng-Jiun, additional, Habte, Habtom, additional, Krayer, John, additional, Holland, Cam, additional, Deyoung, M. Phillip, additional, Elsayed, Yusri A, additional, and Philippar, Ulrike, additional

Published
2022
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19. Pharmacological Characterization of JNJ-75276617, a Menin-KMT2A Inhibitor, As Targeted Treatment for KMT2A-Altered and NPM1-Mutant Acute Leukemia

Author

Kwon, Min Chul, primary, Querolle, Olivier, additional, Dai, Xuedong, additional, Thuring, Jan Willem, additional, Verhulst, Tinne, additional, Marien, Ann, additional, Goffin, Dries, additional, Cai, Wei, additional, Keersmaekers, Vikki, additional, Eyassu, Filmon, additional, Verstraeten, Karin, additional, El Ashkar, Sara, additional, Hogeling, Shanna M, additional, Jacob, Frank, additional, Vinken, Petra, additional, Darville, Nicolas, additional, Pande, Vineet, additional, Krosky, Daniel, additional, Urbanietz, Gregor, additional, Verbist, Bie, additional, Ferrante, Lucille A., additional, Drenberg, Christina Diane, additional, Wilson, David, additional, Attar, Ricardo M., additional, Schuringa, Jan Jacob, additional, Daskalakis, Nikki, additional, Packman, Kathryn, additional, Pietsch, Christine, additional, Elsayed, Yusri, additional, and Philippar, Ulrike, additional

Published
2022
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21. Effects of teclistamab and talquetamab on soluble BCMA levels in patients with relapsed/refractory multiple myeloma

Author

Girgis, Suzette, primary, Wang Lin, Shun Xin, additional, Pillarisetti, Kodandaram, additional, Verona, Raluca, additional, Vieyra, Diego, additional, Casneuf, Tineke, additional, Fink, Damien, additional, Miao, Xin, additional, Chen, Yang, additional, Stephenson, Tara, additional, Banerjee, Arnob, additional, Hilder, Brandi W., additional, Russell, Jeffery, additional, Infante, Jeffrey roger, additional, Elsayed, Yusri A, additional, Smit, Jennifer, additional, and Goldberg, Jenna D., additional

Published
2022
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23. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial

Author

Coiffier, Bertrand, Osmanov, Evgenii A, Hong, Xiaonan, Scheliga, Adriana, Mayer, Jiri, Offner, Fritz, Rule, Simon, Teixeira, Adriana, Walewski, Jan, de Vos, Sven, Crump, Michael, Shpilberg, Ofer, Esseltine, Dixie-Lee, Zhu, Eugene, Enny, Christopher, Theocharous, Panteli, van de Velde, Helgi, Elsayed, Yusri A, and Zinzani, Pier Luigi

Published
2011
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28. Abstract 1267: Combination therapy of JNJ-67856633, a novel, first-in-class MALT1 protease inhibitor, and JNJ-64264681, a novel BTK inhibitor, for the treatment of B-cell lymphomas

Author

Philippar, Ulrike, primary, Fontan, Lorena, additional, Cornelissen, Ivo, additional, Rui, Haopeng, additional, Balasubramanian, Sriram, additional, Gaudiano, Marcello, additional, Bekkers, Mariette, additional, Van Nuffel, Luc, additional, Lu, Tianbao, additional, Wiener, John, additional, Tichenor, Mark, additional, Greway, Tony, additional, Packman, Kathryn, additional, Verbist, Bie, additional, Elsayed, Yusri, additional, Attar, Ricardo, additional, Bussolari, Jacqueline, additional, and Gerecitano, John, additional

Published
2021
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30. Translational Approach of Using Ex Vivo Cytotoxicity and Early Clinical Data to Predict Teclistamab Efficacious Therapeutic Range in Multiple Myeloma Patients

Author

Girgis, Suzette, primary, Wang Lin, Shun Xin, additional, Pillarisetti, Kodandaram, additional, Banerjee, Arnob, additional, Goldberg, Jenna D., additional, Shetty, Shoba, additional, Stephenson, Tara, additional, Hilder, Brandi W., additional, Hanna, Brett, additional, Smit, Jennifer, additional, Adams III, Homer, additional, Sun, Yu-Nien (Tom), additional, Infante, Jeffrey R., additional, Elsayed, Yusri A, additional, and Sharma, Amarnath, additional

Published
2020
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31. Teclistamab is an active T cell–redirecting bispecific antibody against B-cell maturation antigen for multiple myeloma

Author

Pillarisetti, Kodandaram, primary, Powers, Gordon, additional, Luistro, Leopoldo, additional, Babich, Alexander, additional, Baldwin, Eric, additional, Li, Yingzhe, additional, Zhang, Xiaochun, additional, Mendonça, Mark, additional, Majewski, Nate, additional, Nanjunda, Rupesh, additional, Chin, Diana, additional, Packman, Kathryn, additional, Elsayed, Yusri, additional, Attar, Ricardo, additional, and Gaudet, François, additional

Published
2020
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32. Abstract 5690: Discovery of JNJ-67856633: A novel, first-in-class MALT1 protease inhibitor for the treatment of B cell lymphomas

Author

Philippar, Ulrike, primary, Lu, Tianbao, additional, Vloemans, Nele, additional, Bekkers, Mariette, additional, Van Nuffel, Luc, additional, Gaudiano, Marcello, additional, Wnuk-Lipinska, Katarzyna, additional, Van Der Leede, Bas-jan, additional, Amssoms, Katie, additional, Kimpe, Kristof, additional, Medaer, Bart, additional, Greway, Tony, additional, Abraham, Yann, additional, Cummings, Max, additional, Trella, Emanuele, additional, Vanhoof, Greet, additional, Sun, Weimei, additional, Thuring, Jan Willem, additional, Connolly, Peter, additional, Linders, Jan, additional, Rui, Haopeng, additional, Balasubramanian, Sriram, additional, Johnson, Amy, additional, Gerecitano, John, additional, Goldberg, Jenna, additional, Edwards, James P., additional, Elsayed, Yusri, additional, Smit, Jennifer, additional, Bussolari, Jaqueline, additional, and Attar, Ricardo, additional

Published
2020
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33. Abstract 5662: JNJ-67571244: A novel anti-CD33 C2 domain binding bispecific antibody with potent T cell redirection activity

Author

Nair-Gupta, Priyanka, primary, Diem, Michael, additional, Reeves, Dara, additional, Wang, Weirong, additional, Schulingkamp, Robert, additional, Sproesser, Katrin, additional, Mattson, Bethany, additional, Heidrich, Bradley, additional, Joseph, Jocelin, additional, Sendecki, Jocelyn, additional, Foulk, Brad, additional, Chu, Gerald, additional, Fink, Damien, additional, Jiao, Qun, additional, Wu, Sheng-Jiun, additional, Packman, Kathryn, additional, Elsayed, Yusri, additional, Attar, Ricardo, additional, and Gaudet, Francois, additional

Published
2020
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34. Phase I study of teclistamab, a humanized B-cell maturation antigen (BCMA) x CD3 bispecific antibody, in relapsed/refractory multiple myeloma (R/R MM).

Author

Usmani, Saad Zafar, primary, Mateos, Maria-Victoria, additional, Nahi, Hareth, additional, Krishnan, Amrita Y., additional, van de Donk, Niels W.C.J., additional, San Miguel, Jesus, additional, Oriol, Albert, additional, Rosiñol, Laura, additional, Chari, Ajai, additional, Adams, Homer, additional, Girgis, Suzette, additional, Wang Lin, Shun Xin, additional, Stephenson, Tara, additional, Kemmerer, Kristy, additional, Smit, Jennifer, additional, Elsayed, Yusri A., additional, Infante, Jeffrey R., additional, Goldberg, Jenna D., additional, Banerjee, Arnob, additional, and Garfall, Alfred L., additional

Published
2020
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35. A T-cell–redirecting bispecific G-protein–coupled receptor class 5 member D x CD3 antibody to treat multiple myeloma

Author

Pillarisetti, Kodandaram, primary, Edavettal, Suzanne, primary, Mendonça, Mark, primary, Li, Yingzhe, primary, Tornetta, Mark, primary, Babich, Alexander, primary, Majewski, Nate, primary, Husovsky, Matt, primary, Reeves, Dara, primary, Walsh, Eileen, primary, Chin, Diana, primary, Luistro, Leopoldo, primary, Joseph, Jocelin, primary, Chu, Gerald, primary, Packman, Kathryn, primary, Shetty, Shoba, primary, Elsayed, Yusri, primary, Attar, Ricardo, primary, and Gaudet, François, primary

Published
2020
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37. Bortezomib plus rituximab versus rituximab in patients with high-risk, relapsed, rituximab-naïve or rituximab-sensitive follicular lymphoma: subgroup analysis of a randomized phase 3 trial

Author

Zinzani Pier, Khuageva Nuriet K, Wang Huaqing, Garicochea Bernardo, Walewski Jan, Van Hoof Achiel, Soubeyran Pierre, Caballero Dolores, Buckstein Rena, Esseltine Dixie-Lee, Theocharous Panteli, Enny Christopher, Zhu Eugene, Elsayed Yusri A, and Coiffier Bertrand

Subjects
Bortezomib, Follicular, High risk, Lymphoma, Rituximab, Diseases of the blood and blood-forming organs, RC633-647.5, Neoplasms. Tumors. Oncology. Including cancer and carcinogens, RC254-282
Abstract

Abstract Background The randomized phase 3 LYM3001 trial in relapsed follicular lymphoma (FL) demonstrated higher overall (ORR) and complete response (CR) rates and prolonged progression-free survival (PFS) with bortezomib-rituximab versus rituximab. We report findings in high-risk patients (FL International Prognostic Index [FLIPI] score ≥3, and high tumor burden by modified Groupe d’Etude des Lymphomas Folliculaires [GELF] criteria). Methods Patients aged ≥18 years with grade 1/2 FL, ≥1 measurable lesion, and documented relapse or progression following prior therapy, rituximab-naïve or rituximab-sensitive, were enrolled at 164 centers in 29 countries across Europe, the Americas, and Asia-Pacific. Patients were randomized (1:1) to five 5-week cycles of bortezomib-rituximab (bortezomib 1.6 mg/m2, days 1, 8, 15, and 22, all cycles; rituximab 375 mg/m2, days 1, 8, 15, and 22, cycle 1, and day 1, cycles 2–5; N=336) or rituximab alone (N=340). Randomization was stratified by FLIPI score, prior rituximab, time since last dose of anti-lymphoma therapy, and geographical region. The primary endpoint of the study was PFS. Results 103 bortezomib-rituximab and 98 rituximab patients had high-risk FL. The ORR was 59% versus 37% (p=0.002), the CR/CRu rate was 13% versus 6% (p=0.145), and the durable response rate was 45% versus 26% (p=0.008) with bortezomib-rituximab versus rituximab. Median PFS was 9.5 versus 6.7 months (hazard ratio [HR] 0.667, p=0.012) with bortezomib-rituximab versus rituximab; median time to progression was 10.9 versus 6.8 months (HR 0.656, p=0.009); median time to next anti-lymphoma treatment was 14.8 versus 9.1 months (HR 0.762, p=0.103); and the 1-year Overall Survival rate was 83.1% versus 76.6%. Overall, 51% of bortezomib-rituximab and 32% of rituximab patients reported grade ≥3 adverse events, including neutropenia (18%, 6%), anemia (4%, 5%), diarrhea (8%, 0%), thrombocytopenia (5%, 2%), and sensory neuropathy (1%, 0%). Conclusions High-risk FL patients treated with bortezomib-rituximab had significantly higher ORR and longer PFS than patients receiving rituximab alone, with greater clinical benefit than in the overall study population; additional toxicity was acceptable and did not affect treatment feasibility. Trial registration The phase 3 LYM3001 trial is registered with ClinicalTrials.gov, with the identifier NCT00312845.

Published
2012
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39. Development of a New BCMAxCD3 Duobody® Antibody for Multiple Myeloma

Author

Pillarisetti, Kodandaram, primary, Baldwin, Eric, additional, Babich, Alexander, additional, Majewski, Nate, additional, Barone, Linda, additional, Li, Yingzhe, additional, Zhang, Xiaochun, additional, Chin, Diana, additional, Luistro, Leopoldo, additional, Mendonça, Mark, additional, Nanjunda, Rupesh, additional, Rudnick, Stephen, additional, Bellew, Kevin, additional, Elsayed, Yusri, additional, Attar, Ricardo M., additional, and Gaudet, François, additional

Published
2016
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40. The Impact of the Bone Marrow Microenvironment on T Cell Redirection Therapeutics

Author

Nair-Gupta, Priyanka, primary, Rudnick, Stephen, additional, Luistro, Leopoldo, additional, Chin, Diana, additional, Smith, Melissa, additional, McDaid, Ronan, additional, Li, Yingzhe, additional, Pillarisetti, Kodandaram, additional, Baldwin, Eric, additional, Packman, Kathryn, additional, Elsayed, Yusri, additional, Attar, Ricardo M., additional, and Gaudet, François, additional

Published
2016
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41. Development of a CD123xCD3 Bispecific Antibody (JNJ-63709178) for the Treatment of Acute Myeloid Leukemia (AML)

Author

Gaudet, François, primary, Nemeth, Jennifer F, additional, McDaid, Ronan, additional, Li, Yingzhe, additional, Harman, Benjamin, additional, Millar, Hillary, additional, Teplyakov, Alexey, additional, Wheeler, John, additional, Luo, Jinquan, additional, Tam, Susan, additional, Wu, Sheng-Jiun, additional, Chen, Emily, additional, Rudnick, Stephen, additional, Chu, Gerald, additional, Hughes, Anna, additional, Luistro, Leopoldo, additional, Chin, Diana, additional, Babich, Alexander, additional, Kalota, Anna, additional, Singh, Indrajeet, additional, Salvati, Mark, additional, Elsayed, Yusri, additional, and Attar, Ricardo M., additional

Published
2016
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42. Discovery of a Novel, First-in-Class Bfl-1 BH3 Mimetic with Pro-Apoptotic Activity

Author

Derks, Maarten, Bryan, Marian C., Rockx, Cindy, Schults, Tamara, Verhulst, Tinne, Pietrak, Beth, Maehigashi, Tatsuya, Robertson, James C., DeMaria, Andrew H., Holt, Kimberly, Ji, Shaofei, Wong, Victoria, Bueters, Ruud, Koo, Seong Joo, Masure, Stefan, Bhogal, Balpreet, Kelly, Christopher B., Mitra, Kaushik, Luistro, Leopoldo, Shaffer, Paul L., Szewczuk, Lawrence, Elsayed, Yusri, and Philippar, Ulrike

Abstract

Background: Intrinsic apoptosis is regulated by the B Cell lymphoma 2 (BCL-2) protein family. Anti-apoptotic family members, such as BCL-2, MCL-1 and BFL-1, sequester their pro-apoptotic counterparts through a highly conserved BH3 binding groove. Disruption of this balance leads to mitochondrial pore formation and subsequent cell death. To evade apoptosis, tumors often upregulate the expression of one or more anti-apoptotic family members and as such they have become attractive targets for anti-cancer drug development. BFL-1 (‘Bcl-2 related gene expressed in fetal liver’, gene name BCL2A1) is a lesser-known anti-apoptotic family member, physiologically mainly expressed in the hematopoietic system.

Published
2023
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43. Discovery of JNJ-88549968, a Novel, First-in-Class CALRmutxCD3 T-Cell Redirecting Antibody for the Treatment of Myeloproliferative Neoplasms

Author

Kuchnio, Anna, Samakai, Elsie, Hug, Eva, Balmaña, Meritxell, Janssen, Lut, Amorim, Ricardo, Cornelissen, Ivo, Majoros, Andrea, Broux, Michaël, Taneja, Isha, Torti, Vince, Agic, Azra, Moritsch, Stefan, Benedetti, Filippo, Rosebrock, Felix, Packman, Kathryn, Arts, Janine, Patel, Sonal, Lomas, Oliver Christopher, Deyoung, M. Phillip, Zagrijtschuk, Oleh, Elsayed, Yusri, Constantinescu, Stefan, Kralovics, Robert, and Philippar, Ulrike

Abstract

Myeloproliferative neoplasms (MPNs) are clonal malignant disorders of hematopoiesis arising in the hematopoietic stem cell (HSC) compartment that are characterized by excessive production of mature blood cells of the myeloid lineage. Transformation to secondary acute myeloid leukemia (sAML) represents a significant cause of death among MPN patients and this transformation occurs mainly from the clone carrying the disease phenotype driver mutation. Current treatment options for MPN patients are not curative and are limited to symptomatic treatment. Therefore, identification of novel therapeutic approaches with a clear disease-modifying effect for the treatment of MPNs and intercepting their progression to sAML is an unmet medical need. Mutations in JAK2, thrombopoietin receptor (MPL), and calreticulin (CALR) are phenotypic drivers in the pathogenesis of MPN. CALR mutations (CALRmut) are the second most frequent in MPN. CALRmut are insertions or deletions resulting in a frameshift in the last exon of the gene, causing a loss of the KDEL ER-retention motif and generation of a 36 amino acid positively charged C-terminal neoantigen. Due to loss of the KDEL motif, CALRmut are not confined to the ER and through interaction with MPL are trafficked to the cell surface where they induce persistent MPL activation and oncogenicity. Immunotherapies engaging T cells, such as bispecific cluster of differentiation 3 (CD3) redirection antibodies, show promising response rates in the clinic.

Published
2023
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44. Abstract 1492: Development of a CD123xCD3 bispecific antibody to treat acute myeloid leukemia (AML)

Author

Gaudet, Francois, primary, Nemeth, Jennifer F., additional, McDaid, Ronan, additional, Li, Yingzhe, additional, Harman, Benjamin, additional, Millar, Hillary, additional, Teplyakov, Alexey, additional, Wheeler, John, additional, Luo, Jinquan, additional, Tam, Susan, additional, Wu, Sheng-Jiun, additional, Chen, Emily, additional, Babich, Alexander, additional, Elsayed, Yusri, additional, and Attar, Ricardo, additional

Published
2016
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45. Abstract CT325: First in human study of JNJ-42756493, a potent pan fibroblast growth factor receptor (FGFR) inhibitor in patients with advanced solid tumors

Author

Dienstmann, Rodrigo, primary, Bahleda, Rastilav, additional, Adamo, Barbara, additional, Rodon, Jordi, additional, Varga, Andrea, additional, Gazzah, Anas, additional, Platero, Suso, additional, Smit, Hans, additional, Perera, Timothy, additional, Zhong, Bob, additional, Stuyckens, Kim, additional, Elsayed, Yusri, additional, Takimoto, Chris, additional, Peddareddigari, Vijay, additional, Tabernero, Josep, additional, Luo, Feng Roger, additional, and Soria, Jean-Charles, additional

Published
2014
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46. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial.

Author

UCL - (MGD) Service d'hématologie, Coiffier, Bertrand, Osmanov, Evgenii A, Hong, Xiaonan, Scheliga, Adriana, Mayer, Jiri, Offner, Fritz, Rule, Simon, Teixeira, Adriana, Walewski, Jan, de Vos, Sven, Crump, Michael, Shpilberg, Ofer, Esseltine, Dixie-Lee, Zhu, Eugene, Enny, Christopher, Theocharous, Panteli, van de Velde, Helgi, Elsayed, Yusri A, Zinzani, Pier Luigi, André, Marc, UCL - (MGD) Service d'hématologie, Coiffier, Bertrand, Osmanov, Evgenii A, Hong, Xiaonan, Scheliga, Adriana, Mayer, Jiri, Offner, Fritz, Rule, Simon, Teixeira, Adriana, Walewski, Jan, de Vos, Sven, Crump, Michael, Shpilberg, Ofer, Esseltine, Dixie-Lee, Zhu, Eugene, Enny, Christopher, Theocharous, Panteli, van de Velde, Helgi, Elsayed, Yusri A, Zinzani, Pier Luigi, and André, Marc

Abstract

Johnson & Johnson Pharmaceutical Research & Development and Millennium Pharmaceuticals, Inc.

Published
2011

47. A Phase I Study of Quisinostat (JNJ-26481585), an Oral Hydroxamate Histone Deacetylase Inhibitor with Evidence of Target Modulation and Antitumor Activity, in Patients with Advanced Solid Tumors

Author

Venugopal, Balaji, primary, Baird, Richard, additional, Kristeleit, Rebecca S., additional, Plummer, Ruth, additional, Cowan, Richard, additional, Stewart, Adam, additional, Fourneau, Nele, additional, Hellemans, Peter, additional, Elsayed, Yusri, additional, Mcclue, Steve, additional, Smit, Johan W., additional, Forslund, Ann, additional, Phelps, Charles, additional, Camm, John, additional, Evans, T.R. Jeffry, additional, de Bono, Johann S., additional, and Banerji, Udai, additional

Published
2013
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48. Prespecified Candidate Biomarkers Identify Follicular Lymphoma Patients Who Achieved Longer Progression-Free Survival with Bortezomib–Rituximab Versus Rituximab

Author

Coiffier, Bertrand, primary, Li, Weimin, additional, Henitz, Erin D., additional, Karkera, Jayaprakash D., additional, Favis, Reyna, additional, Gaffney, Dana, additional, Shapiro, Alice, additional, Theocharous, Panteli, additional, Elsayed, Yusri A., additional, van de Velde, Helgi, additional, Schaffer, Michael E., additional, Osmanov, Evgenii A., additional, Hong, Xiaonan, additional, Scheliga, Adriana, additional, Mayer, Jiri, additional, Offner, Fritz, additional, Rule, Simon, additional, Teixeira, Adriana, additional, Romejko-Jarosinska, Joanna, additional, de Vos, Sven, additional, Crump, Michael, additional, Shpilberg, Ofer, additional, Zinzani, Pier Luigi, additional, Cakana, Andrew, additional, Esseltine, Dixie-Lee, additional, Mulligan, George, additional, and Ricci, Deborah, additional

Published
2013
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49. Phase 2 Multicenter Trial of Oral Quisinostat, a Histone Deacetylase Inhibitor, in Patients with Previously Treated Stage IB-IVA Cutaneous T-Cell Lymphoma

Author

Child, Fiona, primary, Romero, Pablo Ortiz, additional, Alvarez, Rute, additional, Bagot, Martine, additional, Stadler, Rudolf, additional, Weichenthal, Michael, additional, Alves, Rosario, additional, Bernengo, Maria Grazia, additional, Beylot-Barry, Marie, additional, Cowan, Richard, additional, Geskin, Larisa J., additional, Ferriols, Amparo Pérez, additional, Hellemans, Peter, additional, Elsayed, Yusri, additional, Phelps, Charles, additional, Forslund, Ann, additional, Kamida, Makio, additional, and Zinzani, Pier Luigi, additional

Published
2012
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50. Phase 2 study of carlumab (CNTO 888), a human monoclonal antibody against CC-chemokine ligand 2 (CCL2), in metastatic castration-resistant prostate cancer

Author

Pienta, Kenneth J., primary, Machiels, Jean-Pascal, additional, Schrijvers, Dirk, additional, Alekseev, Boris, additional, Shkolnik, Mikhail, additional, Crabb, Simon J., additional, Li, Susan, additional, Seetharam, Shobha, additional, Puchalski, Thomas A., additional, Takimoto, Chris, additional, Elsayed, Yusri, additional, Dawkins, Fitzroy, additional, and de Bono, Johann S., additional

Published
2012
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