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1. Phase 1 study of JNJ-64619178, a protein arginine methyltransferase 5 inhibitor, in patients with lower-risk myelodysplastic syndromes

Author

Haque, Tamanna, Cadenas, Felix López, Xicoy, Blanca, Alfonso-Pierola, Ana, Platzbecker, Uwe, Avivi, Irit, Brunner, Andrew M., Chromik, Jöerg, Morillo, Daniel, Patel, Manish R., Falantes, Jose, Leitch, Heather A., Germing, Ulrich, Preis, Meir, Lenox, Laurie, Lauring, Josh, Brown, Regina J., Kalota, Anna, Mehta, Jaydeep, Pastore, Friederike, Gu, Junchen, Mistry, Pankaj, and Valcárcel, David

Published
2023
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2. The application of adaptive designs in phase III randomised controlled trials in cancer

Author

Mistry, Pankaj

Subjects
R Medicine (General), RC0254 Neoplasms. Tumors. Oncology (including Cancer)
Abstract

The research conducted within this thesis investigated the application of adaptive designs within phase III cancer trials, in particular, the use of multi-arm multi-stage designs (MAMS) were investigated. The application of adaptive designs in phase III randomised controlled trials are becoming common. These designs have the ability to reduce the number of patients required, be efficient in reducing the time needed and effective in having the ability to answer many questions within one trial. A literature review found that adaptive designs were regularly implemented but the reporting of these methods were poor. I proposed there should be an adaptive design extension to the CONSORT 2010 guidelines and subsequently this has been published. A scoping exercise of cancer trials conducted within the Warwick Clinical Trials Unit found that adaptive methods were regularly implemented without classifying them as adaptive designs. This scoping exercise was extended to identify exemplar trials that have implemented adaptive design methodology and to understand the design, conduct and reporting of these trials. MAMS designs within three common cancer sites (breast, colon and lung) were investigated using a superiority hypothesis, primarily focusing on the longer term outcome of overall survival. Simulations were used to demonstrate how MAMS designs can be extended for use with a non-inferiority (NI) hypothesis. A MAMS design was then applied to a trial investigating the optimal duration of Herceptin therapy for patients diagnosed with early breast cancer. A MAMS design with a NI hypothesis appeared feasible from a statistical viewpoint however the operational aspects must be considered to ensure the trials' success. My research showed that implementing a MAMS design within cancer trials can be more efficient and effective. It is anticipated that the use of adaptive designs within phase III randomised trials will continue to increase and are now required to be fully reported.

Published
2020

3. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to other BCMA-targeting agents

Author

Cohen, Adam D., Mateos, María-Victoria, Cohen, Yael C., Rodriguez-Otero, Paula, Paiva, Bruno, van de Donk, Niels W. C. J., Martin, Thomas, Suvannasankha, Attaya, De Braganca, Kevin C., Corsale, Christina, Schecter, Jordan M., Varsos, Helen, Deraedt, William, Wang, Liwei, Vogel, Martin, Roccia, Tito, Xu, Xiaoying, Mistry, Pankaj, Zudaire, Enrique, Akram, Muhammad, Nesheiwat, Tonia, Pacaud, Lida, Avivi, Irit, and San-Miguel, Jesus

Published
2023
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4. Ciltacabtagene autoleucel in patients with lenalidomide-refractory multiple myeloma: CARTITUDE-2 cohort A expansion subgroup.

Author

Cohen, Adam D., primary, Voorhees, Peter M., additional, Martin, Thomas G., additional, Lesokhin, Alexander M., additional, Hillengass, Jens, additional, Kaufman, Jonathan L., additional, Schecter, Jordan Mark, additional, De Braganca, Kevin C., additional, Varsos, Helen, additional, Corsale, Christina, additional, Mistry, Pankaj, additional, Song, Qingxuan, additional, Koneru, Mythili, additional, Akram, Muhammad, additional, Costa Filho, Octavio, additional, and Einsele, Hermann, additional

Published
2024
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6. The Phase 2 Cartitude-2 Trial: Updated Efficacy and Safety of Ciltacabtagene Autoleucel in Patients with Multiple Myeloma and 1–3 Prior Lines of Therapy (Cohort A) and with Early Relapse after First Line Treatment (Cohort B)

Author

Hillengass, Jens, primary, Cohen, Adam D., additional, Agha, Mounzer, additional, Delforge, Michel, additional, Kerre, Tessa, additional, Roeloffzen, Wilfried, additional, Einsele, Hermann, additional, Goldschmidt, Hartmut, additional, Weisel, Katja, additional, Raab, Marc-Steffen, additional, Scheid, Christoph, additional, Anguille, Sébastien, additional, Sonneveld, Pieter, additional, Zweegman, Sonja, additional, Schecter, Jordan M, additional, De Braganca, Kevin C., additional, Jackson, Carolyn C, additional, Vlummens, Philip, additional, Varsos, Helen, additional, Corsale, Christina, additional, Madduri, Deepu, additional, Yeh, Tzu-min, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Song, Qingxuan, additional, Akram, Muhammad, additional, Filho, Octavio Costa, additional, Geng, Dong, additional, Cohen, Yael C, additional, and van de Donk, Niels W.C.J., additional

Published
2024
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7. Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial

Author

Moleron, Rafael, McArdle, Orla, Dyker, Karen, Al Booz, Hoda, O'Toole, Lorcan, Cook, Audrey, Husband, David, Loo, Vivienne, Soe, Win, Aynsley, Eleanor, Sridhar, Thiagarajan, Jankowska, Petra, Joseph, Mano, Geropantas, Konstantinos, Vaidya, Deepali, Griffin, Matthew, Hartley, Andrew, Vijayan, Rengarajan, Hwang, David, Harrington, Kevin, Pettit, Laura, Whitaker, Stephen, De Winton, Emma, Rolles, Martin, Brennan, Sinéad, Sen, Mehmet, Mendes, Ruheena, Forster, Martin, Chan, Andrew, Evans, Mererid, Buter, Jan, Srinivasan, Devraj, Foran, Bernie, Nankivell, Paul, Bryant, Jennifer, Sharma, Neil, Spruce, Rachel, Brooks, Jill, Batis, Nikos, Roques, Tom, Bidmead, Margaret, Yang, Huiqi, Nutting, Christopher, Tyler, Justine, Henderson, Julia, Baines, Helen, Gasnier, Anne, Miles, Elizabeth, Clark, Catharine, Mehanna, Hisham, Robinson, Max, Kong, Anthony, Foran, Bernadette, Fulton-Lieuw, Tessa, Dalby, Matthew, Mistry, Pankaj, Brennan, Sinead, Nixon, Ioanna, Grumett, Joanne, Leemans, C René, McConkey, Christopher, Gray, Alastair, and Dunn, Janet

Published
2019
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8. MM-183 CARTITUDE-2 Cohort A: Updated Clinical Data and Biological Correlative Analyses of Ciltacabtagene Autoleucel (cilta-cel) in Lenalidomide-Refractory Patients With Progressive Multiple Myeloma (MM) After 1–3 Prior Lines of Therapy (LOT)

Author

Hillengass, Jens, Cohen, Adam D, Delforge, Michel, Einsele, Hermann, Goldschmidt, Hartmut, Weisel, Katja, Raab, Marc-Steffen, Scheid, Christof, Schecter, Jordan M, de Braganca, Kevin C, Varsos, Helen, Yeh, Tzu-min, Mistry, Pankaj, Roccia, Tito, Corsale, Christina, Akram, Muhammad, Pacaud, Lida, Nesheiwat, Tonia, Agha, Mounzer, and Cohen, Yael C

Published
2022
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9. MM-153 Phase 2 CARTITUDE-2 Study (Cohort B): Updated Clinical Data and Biological Correlative Analyses of Ciltacabtagene Autoleucel (cilta-cel), a BCMA-Directed CAR-T Cell Therapy, in Patients With Multiple Myeloma (MM) and Early Relapse After Initial Therapy

Author

Agha, Mounzer, Van de Donk, Niels WCJ, Cohen, Adam D, Cohen, Yael C, Anguille, Sébastien, Kerre, Tessa, Roeloffzen, Wilfried, Schecter, Jordan M, de Braganca, Kevin C, Varsos, Helen, Mistry, Pankaj, Roccia, Tito, Zudaire, Enrique, Corsale, Christina, Akram, Muhammed, Geng, Dong, Nesheiwat, Tonia, Pacaud, Lida, Sonneveld, Pieter, and Zweegman, Sonja

Published
2022
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10. Supplementary Figure 1 from Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors

Author

Vieito, Maria, primary, Moreno, Victor, primary, Spreafico, Anna, primary, Brana, Irene, primary, Wang, Judy S., primary, Preis, Meir, primary, Hernández, Tatiana, primary, Genta, Sofia, primary, Hansen, Aaron R., primary, Doger, Bernard, primary, Galvao, Vladimir, primary, Lenox, Laurie, primary, Brown, Regina J., primary, Kalota, Anna, primary, Mehta, Jaydeep, primary, Pastore, Friederike, primary, Patel, Bharvin, primary, Mistry, Pankaj, primary, Gu, Junchen, primary, Lauring, Josh, primary, and Patel, Manish R., primary

Published
2023
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11. Supplementary Tables 1-3 from Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors

Author

Vieito, Maria, primary, Moreno, Victor, primary, Spreafico, Anna, primary, Brana, Irene, primary, Wang, Judy S., primary, Preis, Meir, primary, Hernández, Tatiana, primary, Genta, Sofia, primary, Hansen, Aaron R., primary, Doger, Bernard, primary, Galvao, Vladimir, primary, Lenox, Laurie, primary, Brown, Regina J., primary, Kalota, Anna, primary, Mehta, Jaydeep, primary, Pastore, Friederike, primary, Patel, Bharvin, primary, Mistry, Pankaj, primary, Gu, Junchen, primary, Lauring, Josh, primary, and Patel, Manish R., primary

Published
2023
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12. Data from Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors

Author

Vieito, Maria, primary, Moreno, Victor, primary, Spreafico, Anna, primary, Brana, Irene, primary, Wang, Judy S., primary, Preis, Meir, primary, Hernández, Tatiana, primary, Genta, Sofia, primary, Hansen, Aaron R., primary, Doger, Bernard, primary, Galvao, Vladimir, primary, Lenox, Laurie, primary, Brown, Regina J., primary, Kalota, Anna, primary, Mehta, Jaydeep, primary, Pastore, Friederike, primary, Patel, Bharvin, primary, Mistry, Pankaj, primary, Gu, Junchen, primary, Lauring, Josh, primary, and Patel, Manish R., primary

Published
2023
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13. P-240 Efficacy and safety of ciltacabtagene autoleucel in patients with relapsed/refractory multiple myeloma and prior noncellular anti-BCMA therapy: CARTITUDE-2 cohort C

Author

Cohen, Adam, primary, Cohen, Yaël, additional, Suvannasankha, Attaya, additional, van de Donk, Niels, additional, San-Miguel, Jesús, additional, De Braganca, Kevin, additional, Jackson, Carolyn, additional, Schecter, Jordan, additional, Vlummens, Philip, additional, Varsos, Helen, additional, Corsale, Christina, additional, Mistry, Pankaj, additional, Song, Qingxuan, additional, Roccia, Tito, additional, Geng, Dong, additional, Zhu, Jieqing, additional, Akram, Muhammad, additional, and Mateos, Maria-Victoria, additional

Published
2023
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14. Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Advanced Solid Tumors

Author

Vieito, Maria, primary, Moreno, Victor, additional, Spreafico, Anna, additional, Brana, Irene, additional, Wang, Judy S., additional, Preis, Meir, additional, Hernandez-Guerrero, Tatiana, additional, Genta, Sofia, additional, Hansen, Aaron R., additional, Doger, Bernard, additional, Galvao, Vladimir, additional, Lenox, Laurie, additional, Brown, Regina J., additional, Kalota, Anna, additional, Mehta, Jaydeep, additional, Pastore, Friederike, additional, Patel, Bharvin, additional, Mistry, Pankaj, additional, Gu, Junchen, additional, Lauring, Josh, additional, and Patel, Manish R., additional

Published
2023
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16. Phase 1 study of JNJ-64619178, a protein arginine methyltransferase 5 inhibitor, in patients with lower-risk myelodysplastic syndromes

Author

Janssen Research and Development, Haque, Tamanna, López-Cadenas, Félix, Xicoy, Blanca, Alfonso-Pierola, Ana, Platzbecker, Uwe, Avivi, Irit, Brunner, Andrew M., Chromik, Jöerg, Morillo, Daniel, Patel, Manish R., Falantes-González, José Francisco, Leitch, Heather A., Germing, Ulrich, Preis, Meir, Lenox, Laurie, Lauring, Josh, Brown, Regina J., Kalota, Anna, Mehta, Jaydeep, Pastore, Friederike, Gu, Junchen, Mistry, Pankaj, Valcárcel, David, Janssen Research and Development, Haque, Tamanna, López-Cadenas, Félix, Xicoy, Blanca, Alfonso-Pierola, Ana, Platzbecker, Uwe, Avivi, Irit, Brunner, Andrew M., Chromik, Jöerg, Morillo, Daniel, Patel, Manish R., Falantes-González, José Francisco, Leitch, Heather A., Germing, Ulrich, Preis, Meir, Lenox, Laurie, Lauring, Josh, Brown, Regina J., Kalota, Anna, Mehta, Jaydeep, Pastore, Friederike, Gu, Junchen, Mistry, Pankaj, and Valcárcel, David

Abstract

Splicing factor (SF) gene mutations are frequent in myelodysplastic syndromes (MDS), and agents that modulate RNA splicing are hypothesized to provide clinical benefit. JNJ-64619178, a protein arginine methyltransferase 5 (PRMT5) inhibitor, was evaluated in patients with lower-risk (LR) MDS in a multi-part, Phase 1, multicenter study. The objectives were to determine a tolerable dose and to characterize safety, pharmacokinetics, pharmacodynamics, and preliminary clinical activity. JNJ-64619178 was administered on a 14 days on/7 days off schedule or every day on a 21-day cycle to patients with International Prognostic Scoring System (IPSS) Low or Intermediate-1 risk MDS who were red blood cell transfusion-dependent. Twenty-four patients were enrolled; 15 (62.5 %) patients had low IPSS risk score, while 18 (75.0 %) had an SF3B1 mutation. Median duration of treatment was 3.45 months (range: 0.03–6.93). No dose limiting toxicities were observed. The 0.5 mg once daily dose was considered better tolerated and chosen for dose expansion. Twenty-three (95.8 %) patients experienced treatment-emergent adverse events (TEAE). The most common TEAEs were neutropenia (15 [62.5 %]) and thrombocytopenia (14 [58.3 %]). JNJ-64619178 pharmacokinetics was dose-dependent. Target engagement as measured by plasma symmetric di-methylarginine was observed across all dose levels; however, variant allele frequency of clonal mutations in bone marrow or blood did not show sustained reductions from baseline. No patient achieved objective response or hematologic improvement per International Working Group 2006 criteria, or transfusion independence. A tolerable dose of JNJ-64619178 was identified in patients with LR MDS. However, no evidence of clinical benefit was observed.

Published
2023

17. Cilta-Cel Efficacy and Safety in Patients with Progressive Multiple Myeloma after Exposure to Non-Cellular Anti-BCMA Immunotherapy

Author

Suvannasankha, Attaya, primary, Mateos, Maria-Victoria, additional, Cohen, Yael C, additional, Rodriguez-Otero, Paula, additional, Paiva, Bruno, additional, van de Donk, Niels W.C.J., additional, Martin, Thomas, additional, Cohen, Adam D., additional, Corsale, Christina, additional, Schecter, Jordan M, additional, De Braganca, Kevin C., additional, Jackson, Carolyn C, additional, Varsos, Helen, additional, Deraedt, William, additional, Roccia, Tito, additional, Mistry, Pankaj, additional, Xu, Xiaoying, additional, Li, Katherine, additional, Zudaire, Enrique, additional, Akram, Muhammad, additional, Pacaud, Lida, additional, Avivi, Irit, additional, and San-Miguel, Jesús, additional

Published
2023
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18. Efficacy and Safety of Cilta-Cel in Patients with Progressive Multiple Myeloma after Exposure to Non-Cellular Anti-BCMA Immunotherapy

Author

Cohen, Adam D., primary, Mateos, María-Victoria, additional, Cohen, Yael C., additional, Rodriguez Otero, Paula, additional, Paiva, Bruno, additional, Van De Donk, Niels W.C.J., additional, Martin, Thomas, additional, Suvannasankha, Attaya, additional, Corsale, Christina, additional, Schecter, Jordan M., additional, De Braganca, Kevin C., additional, Jackson, Carolyn C., additional, Varsos, Helen, additional, Deraedt, William, additional, Roccia, Tito, additional, Mistry, Pankaj, additional, Xu, Xiaoying, additional, Li, Katherine, additional, Zudaire, Enrique, additional, Akram, Muhammad, additional, Pacaud, Lida, additional, Avivi, Irit, additional, and San-Miguel, Jesús, additional

Published
2022
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19. Ciltacabtagene Autoleucel (Cilta-cel), a BCMA-Directed CAR-T Cell Therapy, in Patients with Multiple Myeloma (MM) and Early Relapse after Initial Therapy: CARTITUDE-2 Cohort B 18-Month Follow-up

Author

Van De Donk, Niels WCJ, primary, Agha, Mounzer, additional, Cohen, Adam D, additional, Cohen, Yael C, additional, Anguille, Sébastien, additional, Kerre, Tessa, additional, Roeloffzen, Wilfried W.H., additional, Schecter, Jordan M, additional, De Braganca, Kevin C, additional, Jackson, Carolyn C, additional, Varsos, Helen, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Xu, Xiaoying, additional, Li, Katherine, additional, Zudaire, Enrique, additional, Corsale, Christina, additional, Akram, Muhammad, additional, Geng, Dong, additional, Pacaud, Lida, additional, Sonneveld, Pieter, additional, and Zweegman, Sonja, additional

Published
2022
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20. DVRd Followed By Ciltacabtagene Autoleucel Versus DVRd Followed By ASCT in Patients with Newly Diagnosed Multiple Myeloma Who Are Transplant Eligible: A Randomized Phase 3 Study (EMagine/CARTITUDE-6)

Author

Boccadoro, Mario, primary, San-Miguel, Jesús, additional, Suzuki, Kenshi, additional, Van De Donk, Niels W.C.J., additional, Cook, Gordon, additional, Jakubowiak, Andrzej, additional, Madduri, Deepu, additional, Afifi, Salma, additional, Stevens, An-Sofie, additional, Schecter, Jordan M., additional, Deraedt, William, additional, Kuppens, Steven, additional, Mistry, Pankaj, additional, Pacaud, Lida, additional, Florendo, Erika, additional, Broijl, Annemiek, additional, Gay, Francesca, additional, Mina, Roberto, additional, Rasche, Leo, additional, Moreau, Philippe, additional, Mateos, María-Victoria, additional, Einsele, Hermann, additional, and Sonneveld, Pieter, additional

Published
2022
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21. Poster: MM-183 CARTITUDE-2 Cohort A: Updated Clinical Data and Biological Correlative Analyses of Ciltacabtagene Autoleucel (cilta-cel) in Lenalidomide-Refractory Patients With Progressive Multiple Myeloma (MM) After 1–3 Prior Lines of Therapy (LOT)

Author

Hillengass, Jens, primary, Cohen, Adam D, additional, Delforge, Michel, additional, Einsele, Hermann, additional, Goldschmidt, Hartmut, additional, Weisel, Katja, additional, Raab, Marc-Steffen, additional, Scheid, Christof, additional, Schecter, Jordan M, additional, de Braganca, Kevin C, additional, Varsos, Helen, additional, Yeh, Tzu-min, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Corsale, Christina, additional, Akram, Muhammad, additional, Pacaud, Lida, additional, Nesheiwat, Tonia, additional, Agha, Mounzer, additional, and Cohen, Yael C, additional

Published
2022
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22. Poster: MM-153 Phase 2 CARTITUDE-2 Study (Cohort B): Updated Clinical Data and Biological Correlative Analyses of Ciltacabtagene Autoleucel (cilta-cel), a BCMA-Directed CAR-T Cell Therapy, in Patients With Multiple Myeloma (MM) and Early Relapse After Initial Therapy

Author

Agha, Mounzer, primary, Van de Donk, Niels WCJ, additional, Cohen, Adam D, additional, Cohen, Yael C, additional, Anguille, Sébastien, additional, Kerre, Tessa, additional, Roeloffzen, Wilfried, additional, Schecter, Jordan M, additional, de Braganca, Kevin C, additional, Varsos, Helen, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Zudaire, Enrique, additional, Corsale, Christina, additional, Akram, Muhammed, additional, Geng, Dong, additional, Nesheiwat, Tonia, additional, Pacaud, Lida, additional, Sonneveld, Pieter, additional, and Zweegman, Sonja, additional

Published
2022
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23. OAB-044: Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to BCMA-targeting antibody-drug conjugate treatment

Author

Cohen, Adam, primary, Mateos, María-Victoria, additional, Cohen, Yael, additional, Rodriguez-Otero, Paula, additional, Paiva, Bruno, additional, van de Donk, Niels W.C.J., additional, Martin, Thomas, additional, Abu-Zaid, Mohammad, additional, Corsale, Christina, additional, Schecter, Jordan, additional, De Braganca, Kevin, additional, Varsos, Helen, additional, Deraedt, William, additional, Wang, Liwei, additional, Roccia, Tito, additional, Li, Claire, additional, Mistry, Pankaj, additional, Xu, Xiaoying, additional, Zudaire, Enrique, additional, Akram, Muhammad, additional, Nesheiwat, Tonia, additional, Pacaud, Lida, additional, Avivi, Irit, additional, and San-Miguel, Jesus, additional

Published
2022
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24. OAB-043: Ciltacabtagene autoleucel (cilta-cel) in patients with multiple myeloma and early relapse after initial therapy: biological correlative analyses and updated clinical results from CARTITUDE-2 Cohort B

Author

Agha, Mounzer, primary, van de Donk, Niels W.C.J., additional, Cohen, Adam, additional, Cohen, Yael, additional, Anguille, Sébastien, additional, Kerre, Tessa, additional, Roeloffzen, Wilfried, additional, Schecter, Jordan, additional, De Braganca, Kevin, additional, Varsos, Helen, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Zudaire, Enrique, additional, Corsale, Christina, additional, Akram, Muhammad, additional, Geng, Dong, additional, Nesheiwat, Tonia, additional, Pacaud, Lida, additional, Sonneveld, Pieter, additional, and Zweegman, Sonja, additional

Published
2022
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25. OAB-045: Updated clinical data and biological correlative analyses of ciltacabtagene autoleucel (cilta-cel) in lenalidomide-refractory multiple myeloma after 1–3 prior lines of therapy: CARTITUDE-2 Cohort A

Author

Cohen, Adam, primary, Einsele, Hermann, additional, Delforge, Michel, additional, Hillengass, Jens, additional, Goldschmidt, Hartmut, additional, Weisel, Katja, additional, Raab, Marc-Steffen, additional, Scheid, Christof, additional, Schecter, Jordan, additional, De Braganca, Kevin, additional, Varsos, Helen, additional, Yeh, Tzu-min, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Corsale, Christina, additional, Akram, Muhammad, additional, Pacaud, Lida, additional, Nesheiwat, Tonia, additional, Agha, Mounzer, additional, and Cohen, Yael, additional

Published
2022
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26. OAB-062: Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to BCMA-targeting bispecific antibody treatment

Author

San-Miguel, Jesus, primary, Mateos, María-Victoria, additional, Cohen, Yael C., additional, Rodriguez-Otero, Paula, additional, Paiva, Bruno, additional, van de Donk, Niels W.C.J., additional, Martin, Thomas, additional, Abu-Zaid, Mohammad, additional, Corsale, Christina, additional, Schecter, Jordan M., additional, De Braganca, Kevin C., additional, Varsos, Helen, additional, Deraedt, William, additional, Wang, Liwei, additional, Roccia, Tito, additional, Li, Claire, additional, Mistry, Pankaj, additional, Xu, Xiaoying, additional, Zudaire, Enrique, additional, Akram, Muhammad, additional, Nesheiwat, Tonia, additional, Pacaud, Lida, additional, Avivi, Irit, additional, and Cohen, Adam D., additional

Published
2022
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27. MM-505 Efficacy and Safety of Ciltacabtagene Autoleucel ± Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma With Suboptimal Response to Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort D

Author

Arnulf, Bertrand, Kerre, Tessa, Agha, Mounzer, Delforge, Michel, Braunschweig, Ira, Shah, Nishi, Richard, Shambavi, Alsina, Melissa, Einsele, Hermann, Mistry, Pankaj, Varsos, Helen, Corsale, Christina, Schecter, Jordan, De Braganca, Kevin, Jethava, Yogesh, Song, Qingxuan, Koneru, Mythili, Akram, Muhammad, Cohen, Yaël, and Roeloffzen, Wilfried

Published
2024
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28. Efficacy and Safety of Ciltacabtagene Autoleucel ± Lenalidomide Maintenance in Newly Diagnosed Multiple Myeloma With Suboptimal Response to Frontline Autologous Stem Cell Transplant: CARTITUDE-2 Cohort D

Author

Arnulf, Bertrand, Kerre, Tessa, Agha, Mounzer, Delforge, Michel, Braunschweig, Ira, Shah, Nishi, Richard, Shambavi, Alsina, Melissa, Einsele, Hermann, Mistry, Pankaj, Varsos, Helen, Corsale, Christina, Schecter, Jordan, De Braganca, Kevin, Jethava, Yogesh, Song, Qingxuan, Koneru, Mythili, Akram, Muhammad, Cohen, Yaël, and Roeloffzen, Wilfried

Published
2024
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29. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in patients with multiple myeloma (MM) and early relapse after initial therapy: CARTITUDE-2, cohort B.

Author

van de Donk, Niels W.C.J., primary, Agha, Mounzer E., additional, Cohen, Adam D., additional, Cohen, Yael C., additional, Anguille, Sébastien, additional, Kerre, Tessa, additional, Roeloffzen, Wilfried, additional, Schecter, Jordan Mark, additional, De Braganca, Kevin C., additional, Varsos, Helen, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Zudaire, Enrique, additional, Corsale, Christina, additional, Akram, Muhammad, additional, Geng, Dong, additional, Nesheiwat, Tonia, additional, Bubuteishvili-Pacaud, Lida, additional, Sonneveld, Pieter, additional, and Zweegman, Sonja, additional

Published
2022
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30. Biological correlative analyses and updated clinical data of ciltacabtagene autoleucel (cilta-cel), a BCMA-directed CAR-T cell therapy, in lenalidomide (len)-refractory patients (pts) with progressive multiple myeloma (MM) after 1–3 prior lines of therapy (LOT): CARTITUDE-2, cohort A.

Author

Einsele, Hermann, primary, Cohen, Adam D., additional, Delforge, Michel, additional, Hillengass, Jens, additional, Goldschmidt, Hartmut, additional, Weisel, Katja, additional, Raab, Marc-Steffen, additional, Scheid, Christof, additional, Schecter, Jordan Mark, additional, De Braganca, Kevin C., additional, Varsos, Helen, additional, Yeh, Tzu-min, additional, Mistry, Pankaj, additional, Roccia, Tito, additional, Corsale, Christina, additional, Akram, Muhammad, additional, Bubuteishvili-Pacaud, Lida, additional, Nesheiwat, Tonia, additional, Agha, Mounzer E., additional, and Cohen, Yael C., additional

Published
2022
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31. Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT

Author

Bruce, Julie, primary, Mazuquin, Bruno, additional, Mistry, Pankaj, additional, Rees, Sophie, additional, Canaway, Alastair, additional, Hossain, Anower, additional, Williamson, Esther, additional, Padfield, Emma J, additional, Lall, Ranjit, additional, Richmond, Helen, additional, Chowdhury, Loraine, additional, Lait, Clare, additional, Petrou, Stavros, additional, Booth, Katie, additional, Lamb, Sarah E, additional, Vidya, Raghavan, additional, and Thompson, Alastair M, additional

Published
2022
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32. Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation

Author

Bruce, Julie, primary, Mazuquin, Bruno, additional, Canaway, Alastair, additional, Hossain, Anower, additional, Williamson, Esther, additional, Mistry, Pankaj, additional, Lall, Ranjit, additional, Petrou, Stavros, additional, Lamb, Sarah E, additional, Rees, Sophie, additional, Padfield, Emma, additional, Vidya, Raghavan, additional, and Thompson, Alastair M, additional

Published
2021
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33. Sustained Improvement in Health-Related Quality of Life in Transplant-Ineligible Patients with Newly Diagnosed Multiple Myeloma Treated with Daratumumab, Lenalidomide, and Dexamethasone Versus Lenalidomide and Dexamethasone: Update of the Phase 3 MAIA Trial

Author

Perrot, Aurore, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Moreau, Philippe, additional, Bahlis, Nizar J., additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O'Dwyer, Michael E., additional, Venner, Chris P., additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur S., additional, Tiab, Mourad, additional, Macro, Magaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Liu, Kevin, additional, Fastenau, John, additional, Gries, Katharine S., additional, Ho, Kai Fai, additional, Mistry, Pankaj, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad Z., additional

Published
2021
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34. Phase 1 Study of JNJ-64619178, a Protein Arginine Methyltransferase 5 Inhibitor, in Patients with Lower-Risk Myelodysplastic Syndromes

Author

Haque, Tamanna, primary, Cadenas, Felix López, additional, Xicoy, Blanca, additional, Alfonso, Ana, additional, Platzbecker, Uwe, additional, Avivi, Irit, additional, Brunner, Andrew M., additional, Chromik, Jörg, additional, Morillo, Daniel, additional, Patel, Manish R., additional, Falantes, José F., additional, Leitch, Heather A., additional, Germing, Ulrich, additional, Preis, Meir, additional, Lavie, David, additional, Lenox, Laurie, additional, Lauring, Josh, additional, Kalota, Anna, additional, Brown, Regina, additional, Mehta, Jaydeep, additional, Pastore, Friederike, additional, Mistry, Pankaj, additional, and Valcarcel, David, additional

Published
2021
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35. Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post Hoc Analyses from MAIA

Author

Perrot, Aurore, primary, Facon, Thierry, additional, Kumar, Shaji, additional, Plesner, Torben, additional, Orlowski, Robert Z., additional, Moreau, Philippe, additional, Bahlis, Nizar J., additional, Basu, Supratik, additional, Nahi, Hareth, additional, Hulin, Cyrille, additional, Quach, Hang, additional, Goldschmidt, Hartmut, additional, O'Dwyer, Michael E., additional, Venner, Chris P., additional, Weisel, Katja, additional, Mace, Joseph R., additional, Raje, Noopur S., additional, Tiab, Mourad, additional, Macro, Magaret, additional, Frenzel, Laurent, additional, Leleu, Xavier, additional, Liu, Kevin, additional, Fastenau, John, additional, Gries, Katharine S., additional, Ho, Kai Fai, additional, Mistry, Pankaj, additional, Tromp, Brenda, additional, Delioukina, Maria, additional, Vermeulen, Jessica, additional, and Usmani, Saad Z., additional

Published
2021
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36. Development and validation of an improved classification and risk stratification system for carotid body tumors: Multinational collaborative cohort study

Author

Mehanna, Hisham, primary, Mistry, Pankaj, additional, Golusinski, Pawel, additional, Di Maio, Pasquale, additional, Nankivell, Paul, additional, Snider, Francesco, additional, Ferrante, Angela M. R., additional, Montalto, Nausica, additional, Nicolai, Piero, additional, Marcantoni, Alessandra, additional, Grandi, Cesare, additional, Zavatta, Marco, additional, Grego, Franco, additional, Malec, Kataryna, additional, Hosal, Sefik, additional, Suslu, Nilda, additional, Kuscu, Oguz, additional, Torrealba, Ignacio, additional, Valdes, Francisco, additional, Sharma, Neil, additional, Ayuk, John, additional, Monksfield, Peter, additional, Irving, Richard, additional, Dunn, Janet A., additional, Kay, Mark, additional, and Borsetto, Daniele, additional

Published
2021
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37. Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation

Author

Bruce, Julie, Mazuquin, Bruno, Canaway, Alastair, Hossain, Anower, Williamson, Esther, Mistry, Pankaj, Lall, Ranjit, Petrou, Stavros, Lamb, Sarah E, Rees, Sophie, Padfield, Emma, Vidya, Raghavan, Thompson, Alastair M, Bruce, Julie, Mazuquin, Bruno, Canaway, Alastair, Hossain, Anower, Williamson, Esther, Mistry, Pankaj, Lall, Ranjit, Petrou, Stavros, Lamb, Sarah E, Rees, Sophie, Padfield, Emma, Vidya, Raghavan, and Thompson, Alastair M

Abstract

Objective To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. Design Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. Setting 17 UK National Health Service cancer centres. Participants 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). Interventions Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. Main outcome measures Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. Results Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale −0.68, −1.23 to −0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer T

Published
2021

38. The Phase 2 CARTITUDE-2 Trial: Updated Efficacy and Safety of Ciltacabtagene Autoleucel in Patients with Multiple Myeloma and 1-3 Prior Lines of Therapy (Cohort A) and with Early Relapse after First Line Treatment (Cohort B)

Author

Hillengass, Jens, Cohen, Adam D., Agha, Mounzer E, Delforge, Michel, Kerre, Tessa, Roeloffzen, Wilfried, Einsele, Hermann, Goldschmidt, Hartmut, Weisel, Katja, Raab, Marc S., Scheid, Christof, Anguille, Sebastien, Sonneveld, Pieter, Zweegman, Sonja, Schecter, Jordan M., De Braganca, Kevin C, Jackson, Carolyn Chang, Vlummens, Philip, Varsos, Helen, Corsale, Christina, Madduri, Deepu, Yeh, Tzu-min, Mistry, Pankaj, Roccia, Tito, Song, Qingxuan, Akram, Muhammad, Costa Filho, Octavio, Geng, Dong, Cohen, Yael C., and Van De Donk, Niels W.C.J.

Published
2023
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42. Abstract P1-13-04: Prevention of shoulder problems trial (UK-PROSPER): Exercise to prevent shoulder problems in patients undergoing breast cancer treatment

Author

Bruce, Julie, primary, Mazuquin, Bruno, additional, Mistry, Pankaj, additional, Williamson, Esther, additional, Lall, Ranjit, additional, Vidya, Raghavan, additional, Withers, Emma, additional, Rees, Sophie, additional, Canaway, Alastair, additional, Petrou, Stavros, additional, Lamb, Sarah E, additional, and Thompson, Alastair M, additional

Published
2020
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43. Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV):an open-label randomised controlled phase 3 trial

Author

Mehanna, Hesham, Robinson, Max, Hartley, Andrew, Kong, Anthony, Foran, Bernadette, Fulton-Lieuw, Marissa, Dalby, Matthew, Mistry, Pankaj, and Sen, Mehmet

Abstract

Background The incidence of human papillomavirus (HPV)-positive oropharyngeal cancer, a disease affecting younger patients, is rapidly increasing. Cetuximab, an epidermal growth factor receptor inhibitor, has been proposed for treatment de-escalation in this setting to reduce the toxicity of standard cisplatin treatment, but no randomised evidence exists for the efficacy of this strategy. Methods We did an open-label randomised controlled phase 3 trial at 32 head and neck treatment centres in Ireland, the Netherlands, and the UK, in patients aged 18 years or older with HPV-positive low-risk oropharyngeal cancer (non-smokers or lifetime smokers with a smoking history of

Published
2019
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44. Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV) : an open-label randomised controlled phase 3 trial

Author

Mehanna, Hisham M., Robinson, Max, Hartley, Andrew, Kong, Anthony, Foran, Bernadette, Fulton-Lieuw, Tessa, Dalby, Matthew, Mistry, Pankaj, Sen, Mehmet, O'Toole, Lorcan, Al Booz, Hoda, Dyker, Karen, Moleron, Rafael, Whitaker, Stephen, Brennan, Sinéad, Cook, Audrey, Griffin, Matthew, Aynsley, Eleanor, Rolles, Martin, De Winton, Emma, Chan, Andrew, Srinivasan, Devraj, Nixon, Ioanna, Grumett, Joanne, Leemans, C René, Buter, Jan, Henderson, Julia, McConkey, Christopher C., Gray, Alastair, Dunn, Janet A., McArdle, Orla, Husband, David, Loo, Vivienne, Soe, Win, Sridhar, Thiagarajan, Jankowska, Petra, Joseph, Mano, Geropantas, Konstantinos, Vaidya, Deepali, Vijayan, Rengarajan, Hwang, David, Harrington, Kevin, Pettit, Laura, Mendes, Ruheena, Forster, Martin, Evans, Mererid, Nankivell, Paul, Bryant, Jennifer, Sharma, Neil, Spruce, Rachel, Brooks, Jill, Batis, Nikos, Roques, Tom, Bidmead, Margaret, Yang, Huiqi, Nutting, Christopher, Tyler, Justine, Baines, Helen, Gasnier, Anne, Miles, Elizabeth, and Clark, Catharine

Subjects
RC0254, RM
Abstract

Background\ud \ud The incidence of human papillomavirus (HPV)-positive oropharyngeal cancer, a disease affecting younger patients, is rapidly increasing. Cetuximab, an epidermal growth factor receptor inhibitor, has been proposed for treatment de-escalation in this setting to reduce the toxicity of standard cisplatin treatment, but no randomised evidence exists for the efficacy of this strategy.\ud \ud Methods\ud \ud We did an open-label randomised controlled phase 3 trial at 32 head and neck treatment centres in Ireland, the Netherlands, and the UK, in patients aged 18 years or older with HPV-positive low-risk oropharyngeal cancer (non-smokers or lifetime smokers with a smoking history of

Published
2018

45. IGC: The Open Source Intel Graphics Compiler

Author

Chandrasekhar, Anupama, primary, Chen, Gang, additional, Chen, Po-Yu, additional, Chen, Wei-Yu, additional, Gu, Junjie, additional, Guo, Peng, additional, Kumar, Shruthi Hebbur Prasanna, additional, Lueh, Guei-Yuan, additional, Mistry, Pankaj, additional, Pan, Wei, additional, Raoux, Thomas, additional, and Trifunovic, Konrad, additional

Published
2019
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46. Radiotherapy plus cisplatin or cetuximab in low-risk human papillomavirus-positive oropharyngeal cancer (De-ESCALaTE HPV): an open-label randomised controlled phase 3 trial

Author

Mehanna, Hisham, primary, Robinson, Max, additional, Hartley, Andrew, additional, Kong, Anthony, additional, Foran, Bernadette, additional, Fulton-Lieuw, Tessa, additional, Dalby, Matthew, additional, Mistry, Pankaj, additional, Sen, Mehmet, additional, O'Toole, Lorcan, additional, Al Booz, Hoda, additional, Dyker, Karen, additional, Moleron, Rafael, additional, Whitaker, Stephen, additional, Brennan, Sinead, additional, Cook, Audrey, additional, Griffin, Matthew, additional, Aynsley, Eleanor, additional, Rolles, Martin, additional, De Winton, Emma, additional, Chan, Andrew, additional, Srinivasan, Devraj, additional, Nixon, Ioanna, additional, Grumett, Joanne, additional, Leemans, C René, additional, Buter, Jan, additional, Henderson, Julia, additional, Harrington, Kevin, additional, McConkey, Christopher, additional, Gray, Alastair, additional, Dunn, Janet, additional, McArdle, Orla, additional, Husband, David, additional, Loo, Vivienne, additional, Soe, Win, additional, Sridhar, Thiagarajan, additional, Jankowska, Petra, additional, Joseph, Mano, additional, Geropantas, Konstantinos, additional, Vaidya, Deepali, additional, Vijayan, Rengarajan, additional, Hwang, David, additional, Pettit, Laura, additional, Brennan, Sinéad, additional, Mendes, Ruheena, additional, Forster, Martin, additional, Evans, Mererid, additional, Foran, Bernie, additional, Nankivell, Paul, additional, Bryant, Jennifer, additional, Sharma, Neil, additional, Spruce, Rachel, additional, Brooks, Jill, additional, Batis, Nikos, additional, Roques, Tom, additional, Bidmead, Margaret, additional, Yang, Huiqi, additional, Nutting, Christopher, additional, Tyler, Justine, additional, Baines, Helen, additional, Gasnier, Anne, additional, Miles, Elizabeth, additional, and Clark, Catharine, additional

Published
2019
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48. Management of hot flushes in UK breast cancer patients: clinician and patient perspectives.

Author

Fenlon, Deborah, Morgan, Adrienne, Khambaita, Priya, Mistry, Pankaj, Dunn, Janet, Ah-See, Mei-Lin, Pennery, Emma, Hunter, Myra S., and NCRI CSG Breast Cancer Symptom Working Party

Subjects
HOT flashes treatment, BREAST cancer patients, BREAST cancer treatment, MENOPAUSE, NIGHT sweats, PATIENT surveys, DISEASE management, SEROTONIN uptake inhibitors, BREAST tumors, COGNITIVE therapy, PSYCHOLOGICAL stress, SURVEYS, TREATMENT effectiveness, DISEASE complications, HOT flashes, PSYCHOLOGICAL factors, PSYCHOLOGY
Abstract

Introduction: Menopausal problems are among the most prevalent and distressing problems following breast cancer treatment, with 70% women experiencing hot flushes and night sweats (HFNS). A working party was set up to support the development of new research into the management of these problems.Methods: We conducted surveys to explore the need as perceived by women with breast cancer and establish current UK management practices. A patient survey was conducted through a charity, Breast Cancer Care, and a health professional survey via the UK Breast Intergroup. The HFNS Problem Rating Scale was used, as well as specific questions addressing the aims of the study.Results: Six hundred and sixty-five patients responded and 185 health professionals. Twenty-eight percent women had considered stopping adjuvant endocrine treatment because of HFNS, yet 34% had never been asked about HFNS by any health professional. The most commonly offered interventions were SSRIs, such as venlafaxine, yet only 25% patients had been offered these drugs. Cognitive behavioural therapy was rarely suggested (2%) despite good evidence.Discussion: This study shows a lack of coherence in the management of HFNS in breast cancer survivors, which may lead to reduced adherence to adjuvant therapy. There is an urgent need to develop guidelines to support management of HFNS after breast cancer. [ABSTRACT FROM AUTHOR]

Published
2017
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49. Efficacy and safety of cilta-cel in patients with progressive multiple myeloma after exposure to other B-cell maturation antigen−targeting agents

Author

Cohen, Adam D., Mateos, María-Victoria, Cohen, Yael C., Rodriguez-Otero, Paula, Paiva, Bruno, van de Donk, Niels W.C.J., Martin, Thomas, Suvannasankha, Attaya, De Braganca, Kevin C., Corsale, Christina, Schecter, Jordan M., Varsos, Helen, Deraedt, William, Wang, Liwei, Vogel, Martin, Roccia, Tito, Xu, Xiaoying, Mistry, Pankaj, Zudaire, Enrique, Akram, Muhammad, Nesheiwat, Tonia, Pacaud, Lida, Avivi, Irit, and San-Miguel, Jesus

Abstract

B-cell maturation antigen (BCMA)–targeting therapies, including bispecific antibodies (BsAbs) and antibody-drug conjugates (ADCs), are promising treatments for multiple myeloma (MM), but disease may progress after their use. CARTITUDE-2 is a phase 2, multicohort study evaluating the safety and efficacy of cilta-cel, an anti-BCMA chimeric antigen receptor T therapy, in various myeloma patient populations. Patients in cohort C progressed despite treatment with a proteasome inhibitor, immunomodulatory drug, anti-CD38 antibody, and noncellular anti-BCMA immunotherapy. A single cilta-cel infusion was given after lymphodepletion. The primary end point was minimal residual disease (MRD) negativity at 10−5. Overall, 20 patients were treated (13 ADC exposed; 7 BsAb exposed; 1 in the ADC group also had prior BsAb exposure). Sixteen (80%) were refractory to prior anti-BCMA therapy. At a median follow-up of 11.3 months (range, 0.6-16.0), 7 of 20 (35%) patients were MRD negative (7 of 10 [70.0%] in the MRD-evaluable subset). Overall response rate (95% confidence interval [CI]) was 60.0% (36.1-80.9). Median duration of response and progression-free survival (95% CI) were 11.5 (7.9—not estimable) and 9.1 (1.5—not estimable) months, respectively. The most common adverse events were hematologic. Cytokine release syndrome occurred in 12 (60%) patients (all grade 1-2); 4 had immune effector cell-associated neurotoxicity syndrome (2 had grade 3-4); none had parkinsonism. Seven (35%) patients died (3 of progressive disease, 4 of adverse events [1 treatment related, 3 unrelated]). Cilta-cel induced favorable responses in patients with relapsed/refractory MM and prior exposure to anti-BCMA treatment who had exhausted other therapies. This trial was registered at www.clinicaltrials.govas NCT04133636.

Published
2022
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50. Meaningful Changes in Patient-Reported Outcomes in Relation to Best Clinical Response and Disease Progression: Post HocAnalyses from MAIA

Author

Perrot, Aurore, Facon, Thierry, Kumar, Shaji, Plesner, Torben, Orlowski, Robert Z., Moreau, Philippe, Bahlis, Nizar J., Basu, Supratik, Nahi, Hareth, Hulin, Cyrille, Quach, Hang, Goldschmidt, Hartmut, O'Dwyer, Michael E., Venner, Chris P., Weisel, Katja, Mace, Joseph R., Raje, Noopur S., Tiab, Mourad, Macro, Magaret, Frenzel, Laurent, Leleu, Xavier, Liu, Kevin, Fastenau, John, Gries, Katharine S., Ho, Kai Fai, Mistry, Pankaj, Tromp, Brenda, Delioukina, Maria, Vermeulen, Jessica, and Usmani, Saad Z.

Abstract

Introduction:In oncology clinical trials, overall survival (OS) is considered the gold standard efficacy endpoint. However, in multiple myeloma, the prolonged survival times and availability of multiple salvage therapies render it difficult to rely on OS as a primary endpoint. Instead, progression-free survival (PFS) or clinical response can be a relevant biomarker. At the same time, some health technology assessment bodies will only consider evidence based on patient-relevant endpoints, such as morbidity, mortality, and health-related quality of life (HRQoL), within their benefit assessments. Patient-reported outcomes (PROs) provide insights into how a treatment affects HRQoL, including symptoms and functioning. In the phase 3 MAIA trial, daratumumab, lenalidomide, and dexamethasone (D-Rd) demonstrated a significantly prolonged PFS and rapid and sustained improvements in PROs compared with lenalidomide and dexamethasone (Rd) alone at a median follow-up of 28 months. Updated results with longer follow-up confirmed a continued PFS benefit, deepening best clinical responses, and a significant OS benefit with D-Rd. Here, we report the results of analyses exploring the relationship between clinical efficacy endpoints and PROs in the MAIA trial.

Published
2021
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