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2. Addition of elotuzumab to lenalidomide and dexamethasone for patients with newly diagnosed, transplantation ineligible multiple myeloma (ELOQUENT-1): an open-label, multicentre, randomised, phase 3 trial

Author

Dimopoulos, Meletios A, Richardson, Paul G, Bahlis, Nizar J, Grosicki, Sebastian, Cavo, Michele, Beksaç, Meral, Legieć, Wojciech, Liberati, Anna M, Goldschmidt, Hartmut, Belch, Andrew, Magen, Hila, Larocca, Alessandra, Laubach, Jacob P, Petrucci, Maria T, Reece, Donna, White, Darrell, Mateos, María-Victoria, Špička, Ivan, Lazaroiu, Mihaela, Berdeja, Jesús, Kaufman, Jonathan L, Jou, Ying-Ming, Ganetsky, Alex, Popa McKiver, Mihaela, Lonial, Sagar, Weisel, Katja, Sandhu, Irwindeep, Podhorecka, Monika, Palumbo, Antonio, Shacham-Abulafia, Adi, Vaxman, Iuliana, Shpilberg, Ofer, Besemer, Britta, Martelli, Maurizio, Foà, Roberto, De Fabritiis, Paolo, Caravita di Toritto, Tommaso, Gheorghita, Emanuil, Oriol, Albert, Rowlings, Philip, Emanuele, Angelucci, Carella, Angelo M, Offidani, Massimo, Bladé, Joan, Casado, Luis F, Oakervee, Heather, Panelli, Victoria, Meza, Luis, Kühr, Thomas, Granell, Miguel, Benson, Don, Nair, Rajesh, Holden, Viran, Reeves, James, Jr., Eek, Richard W, Walker, Patricia A, Catalano, John, Rosta, András, Lech-Marańda, Ewa, Samaras, Christy, Reiman, Anthony, Weaver, Robert, Acs, Peter, Grigg, Andrew, De Prijck, Bernard, Louzada, Martha, Minuk, Leonard, Sebag, Michael, Klausmann, Martine, Welslau, Manfred, Hellmann, Andrzej, Danaila, Catalin, Becker, Pamela, Bensinger, William, Porterfield, Bruce, Modiano, Manuel, Schultz, Stephen M, Manges, Robert, Lee, Huey-Shin Cindy, Gray, James X, Wright, Matthew P, Vekemans, Marie-Christine, Hamed, Aryan, Gasztonyi, Zoltán, Mikala, Gábor, Masszi, Tamás, Gamberi, Barbara, Kuliczkowski, Kazimierz, Usnarska-Zubkiewicz, Lidia, Bengoechea, Enrique, Gutiérrez, María AE, García, Miguel TH, San-Miguel, Jesús, Driessen, Christoph, Behl, Rajesh, Brenner, Warren, Gray, Carl, Hansen, Vincent, Moezi, Mehdi, Cortes, Hector V, Yen, Charles, Gressot, Laurent, Horvath, Noemi, D'Rozario, James M, Latimer, Maya, Kyrtsonis, Maria-Christine, Chubar, Evgeni, Mittelman, Moshe, Baldini, Luca, Tosi, Patrizia, Vacca, Angelo, Jędrzejczak, Wiesław W, Robak, Tadeusz, Lahuerta, Juan J, Carney, Jennifer, Chen, Franklin, Hirsch, Robert, Ruiz, Marco, Alencar, Alvaro, Jagasia, Madan, Kasbari, Samer, Kuriakose, Philip, Mahmood, Aftab, Chaudhry, Madhu, Cohen, Gary, Noga, Stephen, Roa, Sch, Jakubowiak, Andrzej, Rosenbaum, Cara, Delforge, Michel, Delrieu, Vanessa, Doyen, Chantal, Dries, Deeren, Demuynck, Hilde, Schots, Rik, Maisnar, Vladimir, Blau, Igor W, Dürk, Heinz A, Kerkhoff, Andrea, Kropff, Martin, Munder, Markus, Röllig, Christoph, Scheid, Christof, Symeonidis, Argiris S, Illés, Árpád, Coyne, Mark, O'Gorman, Peter, Hayden, Patrick, O'Dwyer, Michael, Ben-Yehuda, Dina, Braester, Andrei, Nemets, Anatoly, Lugassy, Gilles, Cohen, Yossi, Rahimi-Levene, Naomi, Bosi, Alberto, Pezzatti, Sara, Rossini, Fausto, Pogliani, Enrico M, Pinto, Antonello, Komarnicki, Mieczysław, Borsaru, Gabriela, Stoia, Razvan, Afanasyev, Boris, Goñi, María A, Carboneras, Ana V, Ali, Sarah, Rubenstein, S. Eric, Caputto, Salvador, Cosgriff, Thomas, Fanning, Suzanne, Khojasteh, Ali, Liman, Andrew, Malcolm, Albert, Vrindavanam, Nandagopal, Patel, Ravindranath, Belani, Rajesh, Shieh, Marie, Stockerl-Goldstein, Keith, Strnad, Charles, Stuart, Robert, Chhabra, Saurabh, Costa, Luciano, Jhangiani, Haresh, Augustson, Bradley, Filshie, Robin, Johnston, Amanda, Hertzberg, Mark S, Mineur, Philippe, Fox, Susan, Kotb, Rami, Dao, Vi, LeBlanc, Richard, Gregora, Evzen, Brioli, Annamaria, Mügge, Lars-Olof, Hänel, Mathias, Langer, Christian, Kapsali, Eleni, Briasoulis, Evangelos, Kyriakou, Despoina, Hardan, Izhar, Horowitz, Netanel A, Clotilde, Cangialosi, Fabbiano, Francesco, Castagnari, Barbara, Ciceri, Fabio, Musuraca, Gerardo, Deptała, Andrzej, Kłoczko, Janusz, Balea, Marius, Vladareanu, Ana-Maria, Rossiev, Victor, Alegre, Adrián, Encinas, Cristina, Gayoso, Jorge, Pabst, Thomas, Rabin, Neil, Arledge, Sherri, Cabanillas, Fernando, Catlett, Joseph, Chidiac, Tarek, Clarkson, David, Dhodapkar, Madhav, Geils, George, Jr., Khan, Cyrus MA, Sahovic, Entezam, Khasawneh, Mohamad, Sehgal, Rajesh, Ballester, Oscar, Levy, Moshe, Fay, Joseph, Liem, Kiem, Lunning, Matthew, Vose, Julie, Faber, Edward, Jr., MacFarlane, Donald, Hohl, Raymond, Mahmood, Tariq, Bhaskar, Birbal, Mims, Martha, Oliff, Ira, Paner, Agne, Maciejewski, John, Padmanabhan, Arvinda, Richard, Robert, Sanyal, Amit, Schiller, Gary, Staszewski, Harry, Stevens, Don, Vaughn, Christopher, and Windsor, Kevin

Published
2022
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3. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors

Author

Le Gouill, Steven, Długosz-Danecka, Monika, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Smith, Stephen D., Doorduijn, Jeanette K., Panizo, Carlos, Shah, Bijal D., Davies, Andrew J., Eek, Richard, Jacobsen, Eric, Kater, Arnon P., Robak, Tadeusz, Jain, Preetesh, Calvo, Roser, Tao, Lin, Wang, Michael, Le Gouill, Steven, Długosz-Danecka, Monika, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Smith, Stephen D., Doorduijn, Jeanette K., Panizo, Carlos, Shah, Bijal D., Davies, Andrew J., Eek, Richard, Jacobsen, Eric, Kater, Arnon P., Robak, Tadeusz, Jain, Preetesh, Calvo, Roser, Tao, Lin, and Wang, Michael

Published
2024

4. Dual CTLA‐4 and PD‐1 checkpoint blockade using CS1002 and CS1003 (nofazinlimab) in patients with advanced solid tumors: A first‐in‐human, dose‐escalation, and dose‐expansion study.

Author

Bishnoi, Sarwan, Kotasek, Dusan, Aghmesheh, Morteza, Yau, Thomas, Cosman, Rasha, Prawira, Amy, Moore, Maggie, Chan, Stephen L., Mant, Andrew, Eek, Richard, Zielinski, Robert, Su, Rila, Pan, Zhaoxuan, Ma, Yiding, Li, Fei, Li, Peiqi, and Tse, Archie N.

Subjects
CYTOTOXIC T lymphocyte-associated molecule-4, PROGRAMMED cell death 1 receptors, HEREDITARY nonpolyposis colorectal cancer, ADVERSE health care events, MONOCLONAL antibodies, TUMORS
Abstract

Background: This study investigated the safety and efficacy of an anti–CTLA‐4 monoclonal antibody (CS1002) as monotherapy and in combination with an anti–PD‐1 monoclonal antibody (CS1003) in patients with advanced/metastatic solid tumors. Methods: The phase 1 study involved phase 1a monotherapy dose‐escalation (part 1) and phase 1b combination therapy dose escalation (part 2) and expansion (part 3). Various dosing schedules of CS1002 (0.3, 1, or 3 mg/kg every 3 weeks, or 3 mg/kg every 9 weeks) were evaluated with 200 mg CS1003 every 3 weeks in part 3. Results: Parts 1, 2, and 3 included a total of 13, 18, and 61 patients, respectively. No dose‐limiting toxicities or maximum tolerated doses were observed. Treatment‐related adverse events (TRAEs) were reported in 30.8%, 83.3%, and 75.0% of patients in parts 1, 2, and 3, respectively. Grade ≥3 TRAEs were experienced by 15.4%, 50.0%, and 18.3% of patients in each part. Of 61 patients evaluable for efficacy, 23 (37.7%) achieved objective responses in multiple tumor types. Higher objective response rates were observed with conventional and high‐dose CS1002 regimens (1 mg/kg every 3 weeks or 3 mg/kg every 9 weeks) compared to low‐dose CS1002 (0.3 mg/kg every 3 weeks) in microsatellite instability‐high/mismatch repair‐deficient tumors, melanoma, and hepatocellular carcinoma (50.0% vs. 58.8%, 14.3% vs. 42.9%, and 0% vs. 16.7%). Conclusion: CS1002, as monotherapy, and in combination with CS1003, had a manageable safety profile across a broad dosing range. Promising antitumor activities were observed in patients with immune oncology (IO)‐naive and IO‐refractory tumors across CS1002 dose levels when combined with CS1003, supporting further evaluation of this treatment combination for solid tumors. Plain Language Summary: CS1002 is a human immunoglobulin (Ig) G1 monoclonal antibody that blocks the interaction of CTLA‐4 with its ligands and increases T‐cell activation/proliferation. CS1003, now named nofazinlimab, is a humanized, recombinant IgG4 monoclonal antibody that blocks the interaction between human PD‐1 and its ligands.In this original article, we determined the safety profile of CS1002 as monotherapy and in combination with CS1003. Furthermore, we explored the antitumor activity of the combination in anti–programmed cell death protein (ligand)‐1 (PD‐[L]1)‐naive microsatellite instability‐high/mismatch repair‐deficient (MSI‐H/dMMR) pan tumors, and anti–PD‐(L)1‐refractory melanoma and hepatocellular carcinoma (HCC).CS1002 in combination with CS1003 had manageable safety profile across a broad dosing range and showed promising antitumor activities across CS1002 dose levels when combined with CS1003. This supports further assessment of CS1002 in combination with CS1003 for the treatment of solid tumors. This was a phase 1a/1b, dose‐escalation and dose‐expansion study evaluating the safety and efficacy of an anti–CTLA‐4 monoclonal antibody (CS1002) as monotherapy and in combination with an anti–PD‐1 monoclonal antibody (CS1003/nofazinlimab), in patients with advanced/metastatic solid tumors. Promising antitumor activities were observed in heavily pretreated patients with immune oncology (IO)‐naive and IO‐refractory tumors across CS1002 dose levels when combined with CS1003, which supports further assessment of CS1002 in combination with CS1003 for the treatment of solid tumors. [ABSTRACT FROM AUTHOR]

Published
2024
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6. Carfilzomib, thalidomide, and dexamethasone is safe and effective in relapsed and/or refractory multiple myeloma: final report of the single arm, multicenter phase II ALLG MM018/AMN002 study.

Author

Ninkovic, Slavisa, primary, Harrison, Simon J, additional, Lee, Je-Jung, additional, Murphy, Nick, additional, Lee, Jae Hoon, additional, Estell, Jane, additional, Chen, Vivien M, additional, Horvath, Noemi, additional, Kim, Kihuyn, additional, Eek, Richard, additional, Augustson, Bradley, additional, Bang, Soo-Mee, additional, Huang, Shang-Yi, additional, Rajagopal, Rajeev, additional, Szabo, Ferenc, additional, Engeler, Daniel, additional, Butcher, Belinda E, additional, Mollee, Peter, additional, Durie, Brian, additional, Chng, Wee Joo, additional, and Quach, Hang, additional

Published
2024
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7. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis

Author

Acar, Kadir, Afanasyev, Boris, Alonso Alonso, Aránzazu, Anttila, Veli-Jukka, Barba Suñol, Pere, Blesing, Norbert, Comeau, Terrance, del Campo, Teresa, Disperati, Patricia, Eek, Richard, Eom, HyeonSeok, Gaidano, Gianluca, Grosicki, Sebastian, Guillaume, Thierry, Homenda, Wojciech, Hwang, William, Ilyin, Nikolay, Johnston, Anna, Kim, Seok Jin, Kuo, Ching-Yuan, Kuvshinov, Aleksey, Lee, Dong-Gun, Lee, Jae Hoon, Lee, Je-Jung, Lepretre, Stephane, Lie, Albert Kwok-Wai, Lucchesi, Alessandro, Masood, Ahmed, Mir, Naheed, Miranda Castillo, Anna Carolina, Mullane, Kathleen, Myasnikov, Alexandr, Oña Navarrete, Raquel, Pauksens, Karlis, Peniket, Andrew, Perez de Oteyza, Jaime, Pohlreich, David, Pullon, Humphrey, Quittet, Philippe, Rodon, Philippe, Rombo, Lars, Samoylova, Olga, Sanmartin Berglund, Johan, Schattner, Ariah, Selleslag, Dominik, Sinisalo, Marjatta, Sultan, Faisal, Theunissen, Koen, Turner, Paul, Wang, Po-Nan, Yáñez San Segundo, Lucrecia, Young, Jo-Anne, Zachee, Pierre, Zaja, Francesco, Dagnew, Alemnew F, Ilhan, Osman, Lee, Won-Sik, Woszczyk, Dariusz, Kwak, Jae-Yong, Bowcock, Stella, Sohn, Sang Kyun, Rodriguez Macías, Gabriela, Chiou, Tzeon-Jye, Quiel, Dimas, Aoun, Mickael, Navarro Matilla, Maria Belen, de la Serna, Javier, Milliken, Samuel, Murphy, John, McNeil, Shelly A, Salaun, Bruno, Di Paolo, Emmanuel, Campora, Laura, López-Fauqued, Marta, El Idrissi, Mohamed, Schuind, Anne, Heineman, Thomas C, Van den Steen, Peter, and Oostvogels, Lidia

Published
2019
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8. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial

Author

Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Olivier, Smith, Stephen D, Damaj, Gandhi, Doorduijn, Jeanette, Lamy, Thierry, Morschhauser, Franck, Panizo, Carlos, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P, Le Gouill, Steven, Oberic, Lucie, Robak, Taduesz, Covey, Todd, Dua, Richa, Hamdy, Ahmed, Huang, Xin, Izumi, Raquel, Patel, Priti, Rothbaum, Wayne, Slatter, J Greg, and Jurczak, Wojciech

Published
2018
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9. Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma

Author

Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Olivier, Smith, Stephen D., Damaj, Gandhi, Doorduijn, Jeanette K., Lamy, Thierry, Morschhauser, Franck, Panizo, Carlos, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P., Le Gouill, Steven, Oberic, Lucie, Robak, Tadeusz, Jain, Preetesh, Frigault, Melanie M., Izumi, Raquel, Nguyen, Dorothy, Patel, Priti, Yin, Ming, and Długosz-Danecka, Monika

Published
2019
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10. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors

Author

Le Gouill, Steven, primary, Długosz-Danecka, Monika, additional, Rule, Simon, additional, Zinzani, Pier Luigi, additional, Goy, Andre, additional, Smith, Stephen D., additional, Doorduijn, Jeanette K., additional, Panizo, Carlos, additional, Shah, Bijal D., additional, Davies, Andrew J., additional, Eek, Richard, additional, Jacobsen, Eric, additional, Kater, Arnon P., additional, Robak, Tadeusz, additional, Jain, Preetesh, additional, Calvo, Roser, additional, Tao, Lin, additional, and Wang, Michael, additional

Published
2023
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13. Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer

Author

Fukuoka, Masahiro, primary, Yano, Seiji, additional, Giaccone, Giuseppe, additional, Tamura, Tomohide, additional, Nakagawa, Kazuhiko, additional, Douillard, Jean-Yves, additional, Nishiwaki, Yutaka, additional, Vansteenkiste, Johan, additional, Kudoh, Shinzoh, additional, Rischin, Danny, additional, Eek, Richard, additional, Horai, Takeshi, additional, Noda, Kazumasa, additional, Takata, Ichiro, additional, Smit, Egbert, additional, Averbuch, Steven, additional, Macleod, Angela, additional, Feyereislova, Andrea, additional, Dong, Rui-Ping, additional, and Baselga, José, additional

Published
2023
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14. Risk assessment model potency to detect patients most likely to benefit from thromboprophylaxis: An application of the TARGET-TP score.

Author

Burbury, Kate, primary, Alexander, Marliese, additional, Harris, Samuel J., additional, Underhill, Craig, additional, Torres, Javier, additional, Sharma, Sharad, additional, Lee, Nora, additional, Wong, Hui-Li, additional, Eek, Richard Wilhelm, additional, Michael, Michael, additional, Tie, Jeanne, additional, Rogers, Jennifer, additional, Heriot, Alexander Graham, additional, Ball, David, additional, MacManus, Michael Patrick, additional, Wolfe, Rory, additional, and Solomon, Benjamin J., additional

Published
2022
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15. Targeting HER2-positive metastatic breast cancer with ARX788, a novel anti-HER2 antibody-drug conjugate in patients whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens.

Author

Lu, Janice M., primary, Kalinsky, Kevin, additional, Tripathy, Debu, additional, Sledge, George W., additional, Gradishar, William John, additional, O'Regan, Ruth, additional, O'Shaughnessy, Joyce, additional, Modi, Shanu, additional, Park, Haeseong, additional, McCartney, Amelia, additional, Frentzas, Sophia, additional, Shannon, Catherine M., additional, Eek, Richard Wilhelm, additional, Martin, Miguel, additional, Curigliano, Giuseppe, additional, Jerusalem, Guy Heinrich Maria, additional, Huang, Chiun-Sheng, additional, Press, Michael F., additional, Tolaney, Sara M., additional, and Hurvitz, Sara A., additional

Published
2022
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16. Abstract OT1-02-02: A global, phase 2 study of ARX788 in patients with HER2-positive metastatic breast cancer whose disease is resistant or refractory to T-DM1, and/or T-DXd, and/or tucatinib-containing regimens

Author

Lu, Janice, primary, Kalinsky, Kevin M, additional, Tripathy, Debu, additional, Sledge, George W, additional, Gradishar, William, additional, O’Regan, Ruth, additional, O’Shaughnessy, Joyce, additional, Modi, Shanu, additional, Drago, Joshua, additional, Park, Haeseong, additional, McCartney, Amelia, additional, Frentzas, Sophia, additional, Shannon, Catherine, additional, Cuff, Katharine, additional, Eek, Richard, additional, Martin, Miguel Idzwan, additional, Curigliano, Giuseppe, additional, Jerusalem, Guy, additional, Huang, Chiun-Sheng, additional, Press, Michael, additional, Li, Matt, additional, Xu, Dong, additional, Song, Cynthia, additional, Huhn, Richard, additional, Yan, Jinchun, additional, and Hurvitz, Sara, additional

Published
2022
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18. Lenalidomide Consolidation Improves Measurable Residual Disease (MRD) Rates and Progression Free Survival in Patients with Chronic Lymphocytic Leukemia Following Initial FCR Chemotherapy - Final Analysis of CLL6 Residuum Study of the Australian Leukaemia and Lymphoma Group (ALLG) and the French Innovative Leukemia Organization (FILO)

Author

Aurran-Schleinitz, Therese, Mulligan, Stephen P, Letestu, Remi, Bene, Marie Christine, Cull, Gavin, Vilque, Jean Pierre, Tam, Constantine S., De Guibert, Sophie, Harrup, Rosemary Anne, Drenou, Bernard, Grigg, Andrew P, Voillat, Laurent, Butcher, Belinda E, Dartigeas, Caroline, Eek, Richard, Daguindau, Nicolas, Forsyth, Cecily, Tiab, Mourad, Smith, Delaine, Curnow, Jennifer, Leblond, Veronique, Larsen, Stephen Robert, Cymbalista, Florence, and Gottlieb, David

Published
2023
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19. Planned Interim Safety Analysis of the Phase 3 Randomized Trial of Selinexor and Lenalidomide Versus Lenalidomide Maintenance Post Autologous Stem Cell Transplant for Patients with Newly Diagnosed Multiple Myeloma (ALLG MM23; Sealand)

Author

Quach, Hang, Lasica, Masa, Low, Michael, Mollee, Peter, Lai, Hock Choong, Wong Doo, Nicole, Hocking, Jay, Campbell, Philip, Murphy, Nicholas E., Sidiqi, M Hasib, Routledge, David, Heenan, Jessica, Horvath, Noemi, Eek, Richard, Renwick, William E. P., Lenton, Douglas Stuart, Child, Lauren J, McCaughan, Georgia, Butcher, Belinda E, Mazumdar, Deepmala, and Kalff, Anna

Published
2023
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20. Safety and unique pharmacokinetic profile of ARX788, a site-specific ADC, in heavily pretreated patients with HER2-overexpresing solid tumors: Results from two phase 1 clinical trials.

Author

Hurvitz, Sara A., primary, Park, Haeseong, additional, Frentzas, Sophia, additional, Shannon, Catherine M., additional, Cuff, Katharine, additional, Eek, Richard Wilhelm, additional, Budd, George Thomas, additional, McCartney, Amelia, additional, O'Shaughnessy, Joyce, additional, Lu, Janice M., additional, Zhang, Jian, additional, Ji, Dongmei, additional, Shen, Weina, additional, Li, Matt, additional, Yan, Jinchun, additional, Xia, Gang, additional, Ji, Yanping, additional, Yao, Sulan, additional, Xiong, Gaozhun, additional, and Hu, Xichun, additional

Published
2021
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21. A randomized, open-label, phase 3 study of low-dose selinexor and lenalidomide (Len) versus len maintenance post autologous stem cell transplant (ASCT) for newly diagnosed multiple myeloma (NDMM): ALLG MM23, Sealand.

Author

Quach, Hang, primary, Lasica, Masa, additional, Routledge, David, additional, Kalff, Anna, additional, Lim, Andrew, additional, Low, Michael, additional, Estell, Jane A., additional, Sidiqi, M Hasib, additional, Campbell, Philip, additional, Eek, Richard Wilhelm, additional, Lai, Hock C., additional, McCaughan, Georgia J., additional, D'Rozario, James, additional, Browlett, Peter, additional, Rajagopal, Rajeev, additional, Heenan, Jessica, additional, Murphy, Nicholas E, additional, Renwick, William, additional, Huan, Georgina, additional, and Mollee, Peter, additional

Published
2021
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22. Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Mantle Cell Lymphoma: Long-Term Efficacy and Safety Results from a Phase 2 Study

Author

Wang, Michael, primary, Rule, Simon, additional, Zinzani, Pier Luigi, additional, Goy, Andre H., additional, Casasnovas, Rene-Olivier, additional, Smith, Stephen D., additional, Damaj, Gandhi Laurent, additional, Doorduijn, Jeanette K., additional, Lamy, Thierry, additional, Morschhauser, Franck, additional, Panizo, Carlos, additional, Shah, Bijal, additional, Davies, Andrew, additional, Eek, Richard, additional, Dupuis, Jehan, additional, Jacobsen, Eric, additional, Kater, Arnon P., additional, Le Gouill, Steven, additional, Oberic, Lucie, additional, Robak, Tadeusz, additional, Jain, Preetesh, additional, Brock, Graham, additional, Patel, Priti, additional, Tao, Lin, additional, and Dlugosz-Danecka, Monika, additional

Published
2020
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23. Carfilzomib Thalidomide and Dexamethasone Is Safe and Effective in the Treatment of Relapsed/Refractory Multiple Myeloma: An Open Label Phase II Australasian Leukaemia and Lymphoma Group (ALLG) MM 018/ Asian Myeloma Network (AMN) 002 Study

Author

Quach, Hang, primary, Harrison, Simon J, additional, Lee, Je-Jung, additional, Murphy, Nichloas, additional, Lee, Jae Hoon, additional, Kihyun, Kim, additional, Estell, Jane, additional, Horvath, Noemi, additional, Eek, Richard, additional, Augustson, Bradley, additional, Campbell, Philip, additional, Rajagopal, Rajeev, additional, Bang, Soo-Mee, additional, Huang, Jeffrey SY, additional, Soo, Yoon Sung, additional, Butcher, Belinda, additional, Durie, Brian G.M., additional, and Chng, Wee Joo, additional

Published
2020
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25. Multi-Institutional Randomized Phase II Trial of Gefitinib for Previously Treated Patients With Advanced Non–Small-Cell Lung Cancer

Author

Fukuoka, Masahiro, Yano, Seiji, Giaccone, Giuseppe, Tamura, Tomohide, Nakagawa, Kazuhiko, Douillard, Jean-Yves, Nishiwaki, Yutaka, Vansteenkiste, Johan, Kudoh, Shinzoh, Rischin, Danny, Eek, Richard, Horai, Takeshi, Noda, Kazumasa, Takata, Ichiro, Smit, Egbert, Averbuch, Steven, Macleod, Angela, Feyereislova, Andrea, Dong, Rui-Ping, and Baselga, José

Published
2003

28. Pro-Active Dasatinib Dose Reduction Based on Trough Levels May Minimise Toxicity and Preserve Efficacy - Interim Analysis of the ALLG CML 12 Direct Study

Author

Yeung, David T, primary, Grigg, Andrew, additional, Shanmuganathan, Naranie, additional, Solterbeck, Ann Christine, additional, White, Deborah L., additional, Branford, Susan, additional, Viiala, Nicholas, additional, Rowlings, Philip Arthur, additional, Mills, Anthony K, additional, Shortt, Jake, additional, Tiley, Campbell, additional, Ross, David M, additional, Kipp, David, additional, Harrup, Rosemary Anne, additional, Cunningham, Ilona, additional, Kwan, John, additional, Eek, Richard, additional, Mutsando, Howard, additional, Tan, Ken-Soon, additional, Burbury, Kate, additional, Wright, Matthew P.F., additional, Hughes, Timothy P., additional, and ALLG, On Behalf of the, additional

Published
2019
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29. Carfilzomib, Thalidomide and Dexamethasone (KTd) is safe and effective in RRMM: interim analysis of the single arm, multicentre phase II ALLG MM018/AMN002 study

Author

Ninkovic, Slavisa, primary, Chng, Wee Joo, additional, Harrison, Simon J., additional, Murphy, Nick, additional, Lee, Jae Hoon, additional, Estell, Jane, additional, Horvath, Noemi, additional, Eek, Richard, additional, Augustson, Bradley, additional, Kalro, Akash, additional, Rajagopal, Rajeev, additional, Kim, Kihyun, additional, Bang, Soo-Mee, additional, Huang, Shang-Yi, additional, Butcher, Belinda, additional, Durie, Brian, additional, Mollee, Peter, additional, and Quach, Hang, additional

Published
2019
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30. Long-Term Follow-Up of Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Mantle Cell Lymphoma

Author

Wang, Michael, primary, Rule, Simon, additional, Zinzani, Pier Luigi, additional, Goy, Andre, additional, Casasnovas, Oliver, additional, Smith, Stephen, additional, Damaj, Gandhi, additional, Doorduijn, Jeanette K., additional, Lamy, Thierry, additional, Morschhauser, Franck, additional, Panizo, Carlos, additional, Shah, Bijal, additional, Davies, Andrew, additional, Eek, Richard, additional, Dupuis, Jehan, additional, Jacobsen, Eric, additional, Kater, Arnon P., additional, Le Gouill, Steven, additional, Oberic, Lucie, additional, Robak, Tadeusz, additional, Dua, Richa, additional, Frigault, Melanie M., additional, Izumi, Raquel, additional, Nguyen, Dorothy, additional, Patel, Priti, additional, Yin, Ming, additional, and Jurczak, Wojciech, additional

Published
2019
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31. Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical trial and post-hoc efficacy analysis

Author

Dagnew, Alemnew F, primary, Ilhan, Osman, additional, Lee, Won-Sik, additional, Woszczyk, Dariusz, additional, Kwak, Jae-Yong, additional, Bowcock, Stella, additional, Sohn, Sang Kyun, additional, Rodriguez Macías, Gabriela, additional, Chiou, Tzeon-Jye, additional, Quiel, Dimas, additional, Aoun, Mickael, additional, Navarro Matilla, Maria Belen, additional, de la Serna, Javier, additional, Milliken, Samuel, additional, Murphy, John, additional, McNeil, Shelly A, additional, Salaun, Bruno, additional, Di Paolo, Emmanuel, additional, Campora, Laura, additional, López-Fauqued, Marta, additional, El Idrissi, Mohamed, additional, Schuind, Anne, additional, Heineman, Thomas C, additional, Van den Steen, Peter, additional, Oostvogels, Lidia, additional, Acar, Kadir, additional, Afanasyev, Boris, additional, Alonso Alonso, Aránzazu, additional, Anttila, Veli-Jukka, additional, Barba Suñol, Pere, additional, Blesing, Norbert, additional, Comeau, Terrance, additional, del Campo, Teresa, additional, Disperati, Patricia, additional, Eek, Richard, additional, Eom, HyeonSeok, additional, Gaidano, Gianluca, additional, Grosicki, Sebastian, additional, Guillaume, Thierry, additional, Homenda, Wojciech, additional, Hwang, William, additional, Ilyin, Nikolay, additional, Johnston, Anna, additional, Kim, Seok Jin, additional, Kuo, Ching-Yuan, additional, Kuvshinov, Aleksey, additional, Lee, Dong-Gun, additional, Lee, Jae Hoon, additional, Lee, Je-Jung, additional, Lepretre, Stephane, additional, Lie, Albert Kwok-Wai, additional, Lucchesi, Alessandro, additional, Masood, Ahmed, additional, Mir, Naheed, additional, Miranda Castillo, Anna Carolina, additional, Mullane, Kathleen, additional, Myasnikov, Alexandr, additional, Oña Navarrete, Raquel, additional, Pauksens, Karlis, additional, Peniket, Andrew, additional, Perez de Oteyza, Jaime, additional, Pohlreich, David, additional, Pullon, Humphrey, additional, Quittet, Philippe, additional, Rodon, Philippe, additional, Rombo, Lars, additional, Samoylova, Olga, additional, Sanmartin Berglund, Johan, additional, Schattner, Ariah, additional, Selleslag, Dominik, additional, Sinisalo, Marjatta, additional, Sultan, Faisal, additional, Theunissen, Koen, additional, Turner, Paul, additional, Wang, Po-Nan, additional, Yáñez San Segundo, Lucrecia, additional, Young, Jo-Anne, additional, Zachee, Pierre, additional, and Zaja, Francesco, additional

Published
2019
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32. Azacitidine with or without lenalidomide in higher risk myelodysplastic syndrome & low blast acute myeloid leukemia

Author

Kenealy, Melita, primary, Hertzberg, Mark, additional, Benson, Warwick, additional, Taylor, Kerry, additional, Cunningham, Ilona, additional, Stevenson, Will, additional, Hiwase, Devendra, additional, Eek, Richard, additional, Zantomio, Daniela, additional, Jong, Steve, additional, Wall, Meaghan, additional, Blombery, Piers, additional, Gerber, Tracey, additional, Debrincat, Marlyse, additional, Zannino, Diana, additional, and Seymour, John F., additional

Published
2018
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33. Long-Term Follow-up of Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Mantle Cell Lymphoma

Author

Wang, Michael, primary, Rule, Simon, additional, Zinzani, Pier Luigi, additional, Goy, Andre, additional, Casasnovas, Olivier, additional, Smith, Stephen D., additional, Damaj, Gandhi, additional, Doorduijn, Jeanette K., additional, Lamy, Thierry, additional, Morschhauser, Franck, additional, Panizo, Carlos, additional, Shah, Bijal D., additional, Davies, Andrew, additional, Eek, Richard, additional, Dupuis, Jehan, additional, Jacobsen, Eric, additional, Kater, Arnon P., additional, LE Gouill, Steven, additional, Oberic, Lucie, additional, Robak, Tadeusz, additional, Dua, Richa, additional, Frigault, Melanie M., additional, Izumi, Raquel, additional, Nguyen, Dorothy, additional, Patel, Priti, additional, Yin, Ming, additional, and Jurczak, Wojciech, additional

Published
2018
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34. Carfilzomib Thalidomide and Dexamethasone Is Safe and Effective in the Treatment of Relapsed/Refractory Multiple Myeloma: Preliminary Outcome from the Open Label Phase II ALLGMM018/AMN003 Study

Author

Quach, Hang, primary, Harrison, Simon J., additional, Ninkovic, Slavisa, additional, Estell, Jane, additional, Horvath, Noemi, additional, Murphy, Nick, additional, Eek, Richard, additional, Augustson, Bradley, additional, Campbell, Philip, additional, Rajagopal, Rajeev, additional, Kalro, Akash, additional, Hemme, Robyn, additional, Butcher, Belinda, additional, Gerber, Tracey, additional, Mollee, Peter, additional, Durie, Brian GM, additional, and Chng, Wee-Joo, additional

Published
2018
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35. Randomized Trial in Unfit, Elderly Chronic Lymphocytic Leukemia (CLL) Patients with Comorbidities of Dose-Reduced Oral Fludarabine and Cyclophosphamide Plus Obinutuzumab (FC+G) Versus Chlorambucil Plus Obinutuzumab (Cbl+G) As Front-Line Therapy

Author

Mulligan, Stephen P., primary, Freeman, Jane A., additional, Badoux, Xavier, additional, Eek, Richard, additional, Cull, Gavin, additional, Mackinlay, Naomi J., additional, Murphy, Nicholas E., additional, Carradice, Duncan P., additional, Solterbeck, Ann C., additional, Best, Oliver Giles, additional, Tam, Constantine S., additional, and Kuss, Bryone J., additional

Published
2018
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36. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial.

Author

UCL - (MGD) Service d'hématologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, Hulin, Cyrille, Belch, Andrew, Shustik, Chaim, Petrucci, Maria Teresa, Dührsen, Ulrich, Lu, Jin, Song, Kevin, Rodon, Philippe, Pégourié, Brigitte, Garderet, Laurent, Hunter, Hannah, Azais, Isabelle, Eek, Richard, Gisslinger, Heinz, Macro, Margaret, Dakhil, Shaker, Goncalves, Cristina, LeBlanc, Richard, Romeril, Ken, Royer, Bruno, Doyen, Chantal, Leleu, Xavier, Offner, Fritz, Leupin, Nicolas, Houck, Vanessa, Chen, Guang, Ervin-Haynes, Annette, Dimopoulos, Meletios A, Facon, Thierry, UCL - (MGD) Service d'hématologie, UCL - SSS/IREC/MONT - Pôle Mont Godinne, Hulin, Cyrille, Belch, Andrew, Shustik, Chaim, Petrucci, Maria Teresa, Dührsen, Ulrich, Lu, Jin, Song, Kevin, Rodon, Philippe, Pégourié, Brigitte, Garderet, Laurent, Hunter, Hannah, Azais, Isabelle, Eek, Richard, Gisslinger, Heinz, Macro, Margaret, Dakhil, Shaker, Goncalves, Cristina, LeBlanc, Richard, Romeril, Ken, Royer, Bruno, Doyen, Chantal, Leleu, Xavier, Offner, Fritz, Leupin, Nicolas, Houck, Vanessa, Chen, Guang, Ervin-Haynes, Annette, Dimopoulos, Meletios A, and Facon, Thierry

Abstract

Purpose This analysis of the FIRST trial in patients with newly diagnosed multiple myeloma (MM) ineligible for stem-cell transplantation examined updated outcomes and impact of patient age. Patients and Methods Patients with untreated symptomatic MM were randomly assigned at a one-to-one-to-one ratio to lenalidomide plus low-dose dexamethasone until disease progression (Rd continuous), Rd for 72 weeks (18 cycles; Rd18), or melphalan, prednisone, and thalidomide (MPT; 72 weeks), stratified by age (≤ 75 v > 75 years), disease stage (International Staging System stage I/II v III), and country. The primary end point was progression-free survival. Rd continuous and MPT were primary comparators. Results Between August 21, 2008, and March 7, 2011, 1,623 patients were enrolled (Rd continuous, n = 535; Rd18, n = 541; MPT, n = 547), including 567 (35%) age older than 75 years. Higher rates of advanced-stage disease and renal impairment were observed in patients older than 75 versus 75 years of age or younger. Rd continuous reduced the risk of progression or death compared with MPT by 31% (hazard ratio [HR], 0.69; 95% CI, 0.59 to 0.80; P < .001) overall, 36% (HR, 0.64; 95% CI, 0.53 to 0.77; P < .001) in patients age 75 years or younger, and 20% (HR, 0.80; 95% CI, 0.62 to 1.03; P = .084) in those age older than 75 years. Median overall survival was longer with Rd continuous than with MPT, including a 14-month difference in patients age older than 75 years. Progression-free survival with Rd18 was similar to that with MPT, and overall survival with Rd18 was marginally inferior to that with Rd continuous. Rates of grade 3 to 4 treatment-emergent adverse events were similar for Rd continuous-treated patients age 75 years or older and those age older than 75 years; however, older patients had more frequent lenalidomide dose reductions. Conclusion Results support Rd continuous treatment as a new standard of care for stem-cell transplantation-ineligible patients with newly diagnosed M

Published
2016

37. Updated Outcomes and Impact of Age With Lenalidomide and Low-Dose Dexamethasone or Melphalan, Prednisone, and Thalidomide in the Randomized, Phase III FIRST Trial

Author

Hulin, Cyrille, primary, Belch, Andrew, additional, Shustik, Chaim, additional, Petrucci, Maria Teresa, additional, Dührsen, Ulrich, additional, Lu, Jin, additional, Song, Kevin, additional, Rodon, Philippe, additional, Pégourié, Brigitte, additional, Garderet, Laurent, additional, Hunter, Hannah, additional, Azais, Isabelle, additional, Eek, Richard, additional, Gisslinger, Heinz, additional, Macro, Margaret, additional, Dakhil, Shaker, additional, Goncalves, Cristina, additional, LeBlanc, Richard, additional, Romeril, Ken, additional, Royer, Bruno, additional, Doyen, Chantal, additional, Leleu, Xavier, additional, Offner, Fritz, additional, Leupin, Nicolas, additional, Houck, Vanessa, additional, Chen, Guang, additional, Ervin-Haynes, Annette, additional, Dimopoulos, Meletios A., additional, and Facon, Thierry, additional

Published
2016
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38. Reporäntans påverkan på svenska branschindex

Author

Klarin, Martin, Eek, Richard, Karlsson, Christofer, Klarin, Martin, Eek, Richard, and Karlsson, Christofer

Abstract

Examensarbetets titel: Reporäntans påverkan på svenska branschindex Seminariedatum: 2015-01-15 Ämne/kurs: FEKH89 Examensarbete i finansiering på kandidatnivå, 15 HP Författare: Richard Eek, Martin Klarin, Christofer Karlsson Handledare: Erling Green Fem nyckelord: Reporänta, onormal avkastning, händelsestudie, branschindex, ränteförändring. Syfte: Syftet med den här uppsatsen är att utreda marknadseffektiviteten samt vilken inverkan en justering av reporäntan har på olika branschindex på den svenska aktiemarknaden. Metod: Vi har genomfört en kvantitativ studie och genom en händelsestudie undersökt den onormala avkastningen för 8 olika branschindex på Nasdaq Stockholm. Teoretiska perspektiv: Uppsatsen utgår från tidigare forskning om hur en ränteförändring påverkar aktiemarknaden. Vi har utgått från studier som har gjorts på den svenska och amerikanska aktiemarknaden. Empiri: Vi har valt ut 8 olika branschindex på Nasdaq Stockholm. De indexen vi har valt ger ett bra urval av olika delar av aktiemarknaden. Indexen är Oil & gas, Basic materials, Industrials, Consumer goods, Consumer service, Health care, Technology och Financials. Resultat: Våra resultat visar att marknaden är inte är effektiv. Marknaden prisar inte in en ränteförändring direkt, utan det finns tecken både på att det sker en fördröjd reaktion från marknaden och att marknaden prisar in ränteförändringen redan innan den har skett. Vi har även sett att det förekommer skillnader i den kumulativa avkastningen mellan olika branschindex.

Published
2015

39. Awareness, preferences, and experiences of thrombosis and thromboprophylaxis in adults commencing systemic anticancer therapies: TARGET-TP trial.

Author

Alexander, Marliese, Harris, Samuel John, Torres, Javier, Underhill, Craig, Sharma, Sharad, Lee, Nora, Wong, Hui-Li, Eek, Richard Wilhelm, Michael, Michael, Tie, Jeanne, Rogers, Jennifer, Patrick, Rachael, Heriot, Alexander Graham, Ball, David, MacManus, Michael Patrick, Wolfe, Rory, Solomon, Benjamin J., and Burbury, Kate

Published
2023
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41. Efficacy and Safety of Acalabrutinib Monotherapy in Patients with Relapsed/Refractory Mantle Cell Lymphoma in the Phase 2 ACE-LY-004 Study

Author

Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Rene-Olivier, Smith, Stephen D., Damaj, Gandhi, Doorduijn, Jeanette K., Lamy, Thierry, Morschhauser, Franck, Panizo, Carlos, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P., Le Gouill, Steven, Oberic, Lucie, Robak, Tadeusz, Covey, Todd, Dua, Richa, Hamdy, Ahmed, Huang, Xin, Izumi, Raquel, Patel, Priti, Slatter, J. Greg, and Jurczak, Wojciech

Published
2017
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43. Effect of Age on Efficacy and Safety Outcomes in Patients (Pts) with Newly Diagnosed Multiple Myeloma (NDMM) Receiving Lenalidomide and Low-Dose Dexamethasone (Rd): The First Trial

Author

Hulin, Cyrille, primary, Facon, Thierry, additional, Shustik, Chaim, additional, Belch, Andrew, additional, Petrucci, Maria Teresa, additional, Dührsen, Ulrich, additional, Lu, Jin, additional, Song, Kevin, additional, Rodon, Philippe, additional, Pegourie, Brigitte, additional, Garderet, Laurent, additional, Hunter, Hannah, additional, Azais, Isabelle, additional, Eek, Richard, additional, Macro, Margaret, additional, Dakhil, Shaker, additional, Houck, Vanessa, additional, Chen, Guang, additional, Ervin-Haynes, Annette, additional, and Offner, Fritz, additional

Published
2014
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44. Patients’ and health care professionals’ evaluation of health-related quality of life issues in bone metastases

Author

Harris, Kristin, primary, Chow, Edward, additional, Zhang, Liying, additional, Velikova, Galina, additional, Bezjak, Andrea, additional, Wu, Jackson, additional, Barton, Michael, additional, Sezer, Orhan, additional, Eek, Richard, additional, Shafiq, Jesmin, additional, Yee, Albert, additional, Clemons, Mark, additional, Brundage, Michael, additional, Hoskin, Peter, additional, van der Linden, Yvette, additional, Johnson, Colin D., additional, and Bottomley, Andrew, additional

Published
2009
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46. Durable response with single-agent acalabrutinib in patients with relapsed or refractory mantle cell lymphoma

Author

Pier Luigi Zinzani, Michael Wang, Andre Goy, Stephen D. Smith, Bijal D. Shah, Steven Le Gouill, Thierry Lamy, Priti Patel, Raquel Izumi, Arnon P. Kater, Monika Długosz-Danecka, Lucie Oberic, Andrew Davies, Jehan Dupuis, Tadeusz Robak, Simon Rule, Richard Eek, Jeanette K. Doorduijn, Melanie M. Frigault, Gandhi Damaj, Ming Yin, Carlos Panizo, Olivier Casasnovas, Eric D. Jacobsen, Preetesh Jain, Franck Morschhauser, Dorothy Nguyen, CHU Lille, Université de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - EA 7365, MD Anderson Cancer Center [Houston], Plymouth University, University of Bologna/Università di Bologna, Hackensack University Medical Center [Hackensack], CHU Dijon, University of Washington [Seattle], Institut d'Hématologie de Basse-Normandie [IHBN], CHU Pontchaillou [Rennes], Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA], Universidad de Navarra [Pamplona] [UNAV], H. Lee Moffitt Cancer Center and Research Institute, University of Southampton, CHU Henri Mondor [Créteil], Harvard Medical School [Boston] [HMS], University of Amsterdam [Amsterdam] [UvA], Centre hospitalier universitaire de Nantes [CHU Nantes], Centre de Recherches en Cancérologie de Toulouse [CRCT], Medical University of Łódź [MUL], The University of Texas M.D. Anderson Cancer Center [Houston], Acerta Pharma (Redwood City, CA), Brown University, Uniwersytet Jagielloński w Krakowie = Jagiellonian University [UJ], The University of Texas Health Science Center at Houston (UTHealth), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Institut d'Hématologie de Basse-Normandie (IHBN), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER, Erasmus University Medical Center [Rotterdam] (Erasmus MC), Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Universidad de Navarra [Pamplona] (UNAV), Border Medical Oncology [Wodonga, VIC, Australia], CHU Henri Mondor, Harvard Medical School [Boston] (HMS), University of Amsterdam [Amsterdam] (UvA), Centre hospitalier universitaire de Nantes (CHU Nantes), Centre de Recherches en Cancérologie de Toulouse (CRCT), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Medical University of Łódź (MUL), Uniwersytet Jagielloński w Krakowie = Jagiellonian University (UJ), Université de Lille, LillOA, Université de Toulouse (UT)-Université de Toulouse (UT)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS), Clinical Haematology, CCA - Cancer Treatment and Quality of Life, Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Olivier, Smith, Stephen D, Damaj, Gandhi, Doorduijn, Jeanette K, Lamy, Thierry, Morschhauser, Franck, Panizo, Carlo, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P, Le Gouill, Steven, Oberic, Lucie, Robak, Tadeusz, Jain, Preetesh, Frigault, Melanie M, Izumi, Raquel, Nguyen, Dorothy, Patel, Priti, Yin, Ming, Długosz-Danecka, Monika, and Hematology

Subjects
Cancer Research, Acalabrutinib, business.industry, Durable response, single-agent, acalabrutinib, relapsed, refractory, mantle cell lymphoma, [SDV]Life Sciences [q-bio], Mantle cell lymphoma (MCL), Bruton tyrosine kinase (BTK), Follow up studies, Hematology, medicine.disease, Lymphoma, [SDV] Life Sciences [q-bio], Oncology, hemic and lymphatic diseases, medicine, Cancer research, Refractory Mantle Cell Lymphoma, Clinical data, Neoplasm, In patient, Single agent, business, B-cell lymphoma, ComputingMilieux_MISCELLANEOUS
Abstract

Bruton tyrosine kinase (BTK) inhibitors have greatly improved the spectrum of treatment options in mantle cell lymphoma (MCL) [1–4]. Acalabrutinib is a highly selective, orally administered, and potent BTK inhibitor with limited off-target activity [5]. Acalabrutinib was approved in 2017 by the US Food and Drug Administration for the treatment of relapsed/refractory MCL based on clinical data from the open-label, multicenter, phase 2 ACE-LY-004 study of acalabrutinib 100 mg twice daily [1]. Here, we present updated results from the ACE-LY-004 study after a median 26-month follow-up. Eligibility criteria and study design were published previously (Supplementary methods) [1]. Analysis of minimal residual disease (MRD) was conducted after complete response (CR) or partial response (PR) was achieved using the quantitative ClonoSEQ next-generation sequencing (5 × 10−6 ) assay (Adpative Biotechnologies, Seattle, WA, USA) in consenting patients with available paired archival tumor and whole blood samples. Data are updated as of February 12, 2018.

Published
2019

47. Acalabrutinib in relapsed or refractory mantle cell lymphoma (ACE-LY-004): a single-arm, multicentre, phase 2 trial

Author

Priti Patel, Raquel Izumi, Richa Dua, Eric D. Jacobsen, Ahmed Hamdy, Stephen D. Smith, Pier Luigi Zinzani, Jeanette K. Doorduijn, Lucie Oberic, Andrew Davies, Andre Goy, Arnon P. Kater, Wayne Rothbaum, Carlos Panizo, Taduesz Robak, Franck Morschhauser, Thierry Lamy, Simon Rule, Todd Covey, Richard Eek, Steven Le Gouill, Jehan Dupuis, J. Greg Slatter, Michael Wang, Xin Huang, Gandhi Damaj, Olivier Casasnovas, Bijal D. Shah, Wojciech Jurczak, Wang, Michael, Rule, Simon, Zinzani, Pier Luigi, Goy, Andre, Casasnovas, Olivier, Smith, Stephen D, Damaj, Gandhi, Doorduijn, Jeanette, Lamy, Thierry, Morschhauser, Franck, Panizo, Carlo, Shah, Bijal, Davies, Andrew, Eek, Richard, Dupuis, Jehan, Jacobsen, Eric, Kater, Arnon P, Le Gouill, Steven, Oberic, Lucie, Robak, Taduesz, Covey, Todd, Dua, Richa, Hamdy, Ahmed, Huang, Xin, Izumi, Raquel, Patel, Priti, Rothbaum, Wayne, Slatter, J. Greg, Jurczak, Wojciech, Hematology, Department of Lymphoma and Myeloma [Houston, TX, USA], The University of Texas M.D. Anderson Cancer Center [Houston], Department of Stem Cell Transplantation and Cellular Therapy [Houston, TX, USA], Plymouth University Medical School [Plymouth, UK], The Institute of Hematology and Oncology L. and A. Seràgnoli [Bologna, Italy], Alma Mater Studiorum Università di Bologna [Bologna] (UNIBO), John Theurer Cancer Center [Hackensack, NJ, USA], Hackensack University Medical Center [Hackensack], Lipides - Nutrition - Cancer [Dijon - U1231] (LNC), Université de Bourgogne (UB)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale (INSERM), Service d'Hématologie Clinique (CHU de Dijon), Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon), Fred Hutchinson Cancer Research Center [Seattle] (FHCRC), Institut d'Hématologie de Basse-Normandie (IHBN), Université de Caen Normandie (UNICAEN), Normandie Université (NU)-Normandie Université (NU)-CHU Caen, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Tumorothèque de Caen Basse-Normandie (TCBN)-Centre Régional de Lutte contre le Cancer François Baclesse [Caen] (UNICANCER/CRLC), UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-UNICANCER, Erasmus Medical Centre [Rotterdam, The Netherlands], HOVON Lunenburg Lymphoma Phase I/II Consortium [Amsterdam, The Netherlands], CHU Pontchaillou [Rennes], Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 (GRITA), Université de Lille-Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Clínica Universidad de Navarra [Pamplona, Spain], H. Lee Moffitt Cancer Center and Research Institute, Cancer Sciences Unit [Southampton, UK] (Cancer Research UK Centre), University of Southampton, Faculty of Medicine [Southampton, UK], Border Medical Oncology [Wodonga, VIC, Australia], Unité des hémopathies lymphoïdes [CHU Henri Mondor], CHU Henri Mondor, Dana-Farber Cancer Institute [Boston], Harvard Medical School [Boston] (HMS), Academic Medical Center [Amsterdam, Netherlands], Hôpital Hôtel-Dieu de Nantes - Centre Hospitalier Universitaire de Nantes (Hôpital Hôtel-Dieu de Nantes - CHU de Nantes), Regulation of Bcl2 and p53 Networks in Multiple Myeloma and Mantle Cell Lymphoma (CRCINA-ÉQUIPE 10), Centre de Recherche en Cancérologie et Immunologie Nantes-Angers (CRCINA), Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Université de Nantes - UFR de Médecine et des Techniques Médicales (UFR MEDECINE), Université de Nantes (UN)-Université de Nantes (UN)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Centre National de la Recherche Scientifique (CNRS)-Université d'Angers (UA), Institut Universitaire du Cancer de Toulouse - Oncopole (IUCT Oncopole - UMR 1037), Université Toulouse III - Paul Sabatier (UT3), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale (INSERM), Medical University of Łódź (MUL), Acerta Pharma (Redwood City, CA), Department of Hematology [Krakow, Poland], Uniwersytet Jagielloński w Krakowie = Jagiellonian University (UJ), Acerta Pharma, a member of the AstraZeneca Group., Department of Haematology, Derriford Hospital, L. and A. Seràgnoli Hospital, University of Bologna, John Theurer Cancer Center - Hackensack University Medical Center, Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand ( CHU Dijon ), Lipides - Nutrition - Cancer [Dijon - U1231] ( LNC ), Université de Bourgogne ( UB ) -AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Fred Hutchinson Cancer Research Center [Seattle] ( FHCRC ), CHU Caen, Erasmus University Medical Centre Rotterdam [Rotterdam], Biophysique, Médecine Nucléaire et Technologies Médicales ( EA 1049 ), Centre Hospitalier Régional Universitaire [Lille] ( CHRU Lille ), Hematology Service, Clínica Universitaria, Universidad de Navarra [Pamplona] ( UNAV ), H. Lee Moffitt Cancer Center & Research Institute, Electrical Engineering University of Leeds, Service d'hématologie clinique, Assistance publique - Hôpitaux de Paris (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 ( UPEC UP12 ), Centre hospitalier universitaire de Nantes ( CHU Nantes ), Centre de Recherche en Cancérologie / Nantes - Angers ( CRCNA ), CHU Angers-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 ), Institut Universitaire du Cancer de Toulouse - Oncopole ( IUCT Oncopole - UMR 1037 ), Université Paul Sabatier - Toulouse 3 ( UPS ) -CHU Toulouse [Toulouse]-Institut National de la Santé et de la Recherche Médicale ( INSERM ), Medical University of Lodz, Copernicus Memorial Hospital, Jagiellonian University [Krakow] ( UJ ), Clinical Haematology, CCA - Cancer Treatment and Quality of Life, Université de Bourgogne (UB)-Institut National de la Santé et de la Recherche Médicale (INSERM)-AgroSup Dijon - Institut National Supérieur des Sciences Agronomiques, de l'Alimentation et de l'Environnement, Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN), Erasmus University Medical Center [Rotterdam] (Erasmus MC), Biophysique, Médecine Nucléaire et Technologies Médicales (EA 1049), Centre Hospitalier Régional Universitaire [Lille] (CHRU Lille), Universidad de Navarra [Pamplona] (UNAV), Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12), Centre hospitalier universitaire de Nantes (CHU Nantes), 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), Jagiellonian University [Krakow] (UJ), Bernardo, Elizabeth, Plymouth University, Normandie Université (NU)-UNICANCER-Tumorothèque de Caen Basse-Normandie (TCBN)-UNICANCER, Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes)-Université d'Angers (UA)-Université de Nantes (UN)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Centre hospitalier universitaire de Nantes (CHU Nantes), Université Fédérale Toulouse Midi-Pyrénées-Université Fédérale Toulouse Midi-Pyrénées-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM), CCA - Cancer Treatment and quality of life, CHU Henri Mondor [Créteil], and Université de Toulouse (UT)-Université de Toulouse (UT)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Institut National de la Santé et de la Recherche Médicale (INSERM)

Subjects
0301 basic medicine, Male, medicine.medical_specialty, Population, Phases of clinical research, [SDV.CAN]Life Sciences [q-bio]/Cancer, Lymphoma, Mantle-Cell, Neutropenia, Gastroenterology, [ SDV.CAN ] Life Sciences [q-bio]/Cancer, 03 medical and health sciences, 0302 clinical medicine, [SDV.CAN] Life Sciences [q-bio]/Cancer, Recurrence, Internal medicine, medicine, Clinical endpoint, Humans, education, Protein Kinase Inhibitors, Survival analysis, Aged, Tyrosine kinase inhibitors, education.field_of_study, Mantle cell lymphoma, Dose-Response Relationship, Drug, business.industry, Acalabrutinib, General Medicine, Middle Aged, medicine.disease, Survival Analysis, 3. Good health, 030104 developmental biology, Treatment Outcome, 030220 oncology & carcinogenesis, Pyrazines, Benzamides, Refractory Mantle Cell Lymphoma, Female, business, Progressive disease
Abstract

International audience; BACKGROUND:Bruton tyrosine kinase is a clinically validated target in mantle cell lymphoma. Acalabrutinib (ACP-196) is a highly selective, potent Bruton tyrosine kinase inhibitor developed to minimise off-target activity.METHODS:In this open-label, phase 2 study, oral acalabrutinib (100 mg twice per day) was given to patients with relapsed or refractory mantle cell lymphoma, until disease progression or unacceptable toxicity. The primary endpoint was overall response assessed according to the Lugano classification, and safety analyses were done in all participants. This trial is registered with ClinicalTrials.gov, number NCT02213926.FINDINGS:From March 12, 2015, to Jan 5, 2016, 124 patients with relapsed or refractory mantle cell lymphoma were enrolled and all patients received treatment; median age 68 years. Patients received a median of two (IQR 1-2) previous therapies. At a median follow-up of 15·2 months, 100 (81%) patients achieved an overall response and 49 (40%) patients achieved a complete response. The Kaplan-Meier estimated medians for duration of response, progression-free survival, and overall survival were not reached; the 12-month rates were 72% (95% CI 62-80), 67% (58-75), and 87% (79-92%), respectively. The most common adverse events were primarily grade 1 or 2 and were headache (47 [38%]), diarrhoea (38 [31%]), fatigue (34 [27%]), and myalgia (26 [21%]). The most common grade 3 or worse adverse events were neutropenia (13 [10%]), anaemia (11 [9%]), and pneumonia (six [5%]). There were no cases of atrial fibrillation and one case of grade 3 or worse haemorrhage. The median duration of treatment was 13·8 months. Treatment was discontinued in 54 (44%) patients, primarily due to progressive disease (39 [31%]) and adverse events (seven [6%]).INTERPRETATION:Acalabrutinib treatment provided a high rate of durable responses and a favourable safety profile in patients with relapsed or refractory mantle cell lymphoma. These findings suggest an important role for acalabrutinib in the treatment of this disease population.FUNDING:Acerta Pharma, a member of the AstraZeneca Group.Copyright © 2017 Elsevier Ltd. All rights reserved.

Published
2018

48. Carfilzomib, thalidomide, and dexamethasone are safe and effective in relapsed and/or refractory multiple myeloma: final report of the single-arm, multicenter, phase II ALLG MM018/AMN002 study.

Author

Ninkovic S, Harrison SJ, Lee JJ, Murphy N, Lee JH, Estell J, Chen VM, Horvath N, Kim K, Eek R, Augustson B, Bang SM, Huang SY, Rajagopal R, Szabo F, Engeler D, Butcher BE, Mollee P, Durie B, Chng WJ, and Quach H

Subjects
Humans, Aged, Female, Middle Aged, Male, Aged, 80 and over, Adult, Treatment Outcome, Drug Resistance, Neoplasm drug effects, Recurrence, Multiple Myeloma drug therapy, Multiple Myeloma mortality, Dexamethasone administration & dosage, Dexamethasone therapeutic use, Dexamethasone adverse effects, Oligopeptides administration & dosage, Oligopeptides therapeutic use, Oligopeptides adverse effects, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Antineoplastic Combined Chemotherapy Protocols adverse effects, Thalidomide administration & dosage, Thalidomide therapeutic use
Abstract

This multicenter, phase II study of the Australasian Lymphoma and Leukemia Group and the Asian Myeloma Network investigated fixed-duration (18-month) treatment with carfilzomib (K), thalidomide (T), and dexamethasone (d) (KTd) in patients with relapsed and/or refractory multiple myeloma who had received one to three prior lines of therapy. Patients received induction with up to 12 28-day cycles of carfilzomib (20 mg/m2 intravenously in cycle 1 on days 1 and 2, then 56 mg/m2 [36 mg/m2 for patients ≥75 years] from day 8 onwards), thalidomide 100 mg orally in the evening and weekly dexamethasone 40 mg (20 mg for patients ≥75 years). During maintenance, thalidomide was omitted, while carfilzomib was continued on days 1, 2, 15, and 16 with fortnightly dexamethasone. The primary endpoint was progression-free survival. Secondary endpoints were overall response rate, overall survival, duration of response, safety, and tolerability. Ninety-three patients (median age 66.3 years [range, 41.9-84.5]) were enrolled and followed up for a median of 26.4 months (range, 1.6-54.6). The median progression-free survival was 22.3 months (95% confidence interval: 15.7-25.6) and the 2-year progression-free survival was 46.3% (95% confidence interval: 35.1-52.8). The median overall survival was not reached and the 2-year overall survival was 73.8% (95% confidence interval: 62.9-81.9). The overall response rate was 88% (73% had a very good partial response or better). There was no difference in the depth of response, progression-free survival or overall survival comparing Asian and non-Asian cohorts (P=0.61). The safety profile of KTd was consistent with that of each individual drug. KTd is well tolerated and effective in patients with relapsed and/or refractory multiple myeloma irrespective of Asian or non-Asian ethnicity and provides an alternative treatment option, particularly in circumstances in which the use of carfilzomib, lenalidomide, and dexamethasone (KRd) is limited by access, cost, or renal impairment.

Published
2024
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49. Final results and overall survival data from a phase II study of acalabrutinib monotherapy in patients with relapsed/refractory mantle cell lymphoma, including those with poor prognostic factors.

Author

Le Gouill S, Długosz-Danecka M, Rule S, Zinzani PL, Goy A, Smith SD, Doorduijn JK, Panizo C, Shah BD, Davies AJ, Eek R, Jacobsen E, Kater AP, Robak T, Jain P, Calvo R, Tao L, and Wang M

Subjects
Adult, Humans, Prognosis, Pyrazines therapeutic use, Clinical Trials, Phase II as Topic, Lymphoma, Mantle-Cell drug therapy, Lymphoma, Mantle-Cell pathology
Published
2024
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50. Azacitidine with or without lenalidomide in higher risk myelodysplastic syndrome & low blast acute myeloid leukemia.

Author

Kenealy M, Hertzberg M, Benson W, Taylor K, Cunningham I, Stevenson W, Hiwase D, Eek R, Zantomio D, Jong S, Wall M, Blombery P, Gerber T, Debrincat M, Zannino D, and Seymour JF

Subjects
Aged, Aged, 80 and over, Azacitidine adverse effects, Disease-Free Survival, Female, Follow-Up Studies, Humans, Lenalidomide adverse effects, Male, Middle Aged, Risk Factors, Survival Rate, Azacitidine administration & dosage, Blast Crisis drug therapy, Blast Crisis mortality, Lenalidomide administration & dosage, Leukemia, Myelogenous, Chronic, BCR-ABL Positive drug therapy, Leukemia, Myelogenous, Chronic, BCR-ABL Positive mortality, Leukemia, Myeloid, Acute drug therapy, Leukemia, Myeloid, Acute mortality, Myelodysplastic Syndromes drug therapy, Myelodysplastic Syndromes mortality
Abstract

Standard treatment for higher risk myelodysplastic syndromes, chronic myelomonocytic leukemia and low blast acute myeloid leukemia is azacitidine. In single arm studies, adding lenalidomide had been suggested to improve outcomes. The ALLG MDS4 phase II trial randomized such patients to standard azacitidine or combination azacitidine (75mg/m 2 /d days 1 to 5) with lenalidomide (10mg days 1-21 of 28-day cycle from cycle 3) to assess clinical benefit (alive without progressive disease) at 12 months. A total of 160 patients were enrolled; median age 70.7 years (range 42.5-87.2), 31.3% female with 14% chronic myelomonocytic leukemia, 12% acute myeloid leukemia and 74% myelodysplastic syndromes. Adverse events were similar in both arms. There was excellent delivery of protocol therapy (median azacitidine cycles 11 both arms) with few dose reductions, delays or early cessations. At median follow up 33.1 months (range 0.7-59.5), the rate of clinical benefit at 12 months was 65% azacitidine arm and 54% lenalidomide+azacitidine arm ( P =0.2). There was no difference in clinical benefit between each arm according to WHO diagnostic subgroup or IPSS-R. Overall response rate was 57% in azacitidine arm and 69% in lenalidomide+azacitidine ( P =0.14). There was no difference in progression- free or overall survival between the arms (each P >0.12). Although the combination of lenalidomide and azacitidine was tolerable, there was no improvement in clinical benefit, response rates or overall survival in higher risk myelodysplastic syndrome, chronic myelomonocytic leukemia or low blast acute myeloid leukemia patients compared to treatment with azacitidine alone. This trial was registered at www.anzc-tr.org.au as ACTRN12610000271000 ., (Copyright© 2019 Ferrata Storti Foundation.)

Published
2019
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