Citations 3
Efficacy and Safety of Anselamimab in Immunoglobulin Light Chain Amyloidosis: Results From the Randomized CARES Trials
Wechalekar, Ashutosh , Sanchorawala, Vaishali , Zepeda, Victor H. Jimenez-, Suzuki, Kenshi, Lentzsch, Suzanne , Huart, Antoine , Carpinteiro, Alexander , Swenson, Eugene , Khan, Zilehuma, Catini, Julia, Kulkarni, Hrishikesh, Meltzer, Brian, Lake, Stephen, Liedtke, Michaela , Investigators, for the CARES, Ting, Stephen Bek Ngie, Mollee, Peter Norman, Meuleman, Nathalie, Delforge, Michel, Zepeda, Victor Jimenez, Zhang, Shuyang, Du, Xin, Wang, Jianan, Qian, Honglan, Sun, Chunyan, Belhadj, Karim , Arnulf, Bertrand, Karlin, Lionel, Macro, Margaret, Colella, Jean-Marc Schiano De, Stoppa, Anne-Marie, Viallard, Jean-Francois, Fenk, Roland, Hansen, Timon, Girke, Vera, Nogai, Axel, Gatt, Moshe, Lavi, Noa, Magen, Hila , Palladini, Giovanni, Pane, Fabrizio, Buda, Gabriele , Ishida, Tadao, Iida, Shinsuke, Jamroziak, Krzysztof, Byun, Jamin, Koh, Youngil, Kim, Kihyun, Villamediana, Ramón Lecumberri, Lopez, Maria Teresa Cibeira, Martínez, Irene Romera, Duarte, Rafael , Castello, Isabel Angela Krsnik, Garcia, Maria Esther Gonzalez , Chacon, Eusebio Narciso Martin, Martínez, Javier Alberto Rojas , Valent, Jason , Rosenzweig, Michael A., Chung, Alfred, Wong, Sandy, Bumma, Naresh , Comenzo, Raymond, Gaballa, Mahmoud, Lee, Hans C., Kaufman, Gregory P., Passero, Frank, Stockerl-Goldstein, Keith, Waxman, Adam, D'Souza, Anita, Cowan, Andrew, Lee, Sarah, Libby, Edward, Godara, Amandeep , Kovacsovics, Tibor, Sengsayadeth, Salyka, Goodman, Stacey , Chaulagain, Chakra, Wechalekar, Ashutosh D. , Dispenzieri, Angela , Sanchorawala, Vaishali , Kastritis, Efstathios , Lentzsch, Suzanne , Meltzer, Brian , Liedtke, Michaela , Dispenzieri, Angela , Kastritis, Efstathios , Bhutani, Divaya , Bianchi, Giada , Suzuki, Kenshi , Khan, Zilehuma, Kulkarni, Hrishikesh, Lake, Stephen, Ting, Stephen B. , Mollee, Peter , Agis, Hermine , Straßl, Irene , Meuleman, Nathalie , Delforge, Michel , Sedlák, František , Jaccard, Arnaud , Arnulf, Bertrand , Karlin, Lionel , Macro, Margaret , Stoppa, Anne‐Marie, Bridoux, Frank , Chalopin, Thomas , Viallard, Jean‐François , Fenk, Roland , Symeonidis, Argiris , Annibali, Ombretta , Iida, Shinsuke, Ikezoe, Takayuki , Jamroziak, Krzysztof , Koh, Youngil, López, Maria Teresa Cibeira, Rios, Rafael, Garcia, Maria Esther Gonzalez, Chacón, Eusebio Martín, Valent, Jason Neil , Rosenzweig, Michael, Comenzo, Raymond L. , Gaballa, Mahmoud , Kaufman, Gregory P., Medvedova, Eva , Passero, Frank Charles , Stockerl-Goldstein, Keith , Chaulagain, Chakra P.
Journal of Clinical Oncology | May 29, 2026 | Volume: 44 | Issue: 20 | Pages: 1899-1910
PURPOSE In immunoglobulin light chain (AL) amyloidosis, amyloid fibrils cause organ dysfunction. Anselamimab, a monoclonal antibody, selectively binds to amyloid fibrils, accelerating their clearance. METHODS Newly diagnosed patients with European modification of Mayo 2004 stage IIIa or IIIb AL amyloidosis were randomly assigned to receive anselamimab or placebo with cyclophosphamide, bortezomib, and dexamethasone (with or without daratumumab). The primary end point was a hierarchical composite of time to all-cause mortality (ACM) and frequency of cardiovascular hospitalizations (CVHs), analyzed using the Finkelstein-Schoenfeld test and win ratio estimation. RESULTS Among 406 randomly assigned patients, the primary end point win ratio for anselamimab versus placebo was 1.11 (95% CI, 0.83, 1.50; P = .332) and the hazard ratio (HR) for ACM was 0.80 (95% CI, 0.57, 1.13; P = .290). CVH rates in the anselamimab and placebo groups were 0.59 (95% CI, 0.42, 0.83) and 0.89 (95% CI, 0.55, 1.43), respectively ( P = .145). Among patients with kappa isotype (n = 72), the win ratio was 2.06 (95% CI, 0.98, 4.31; P = .100) and anselamimab reduced ACM by 62% versus placebo (HR, 0.38; 95% CI, 0.17 to 0.86; nominal P = .012), and CVH by 71% (IRR, 0.29; 95% CI, 0.10 to 0.87; nominal P = .028) with improvements in Kansas City Cardiomyopathy Questionnaire-Overall Score. There was no clinical benefit observed in the lambda population. Anselamimab was generally well-tolerated; safety data were comparable between treatment arms overall. CONCLUSION Treatment with anselamimab, an antifibril antibody used alongside antiplasma cell dyscrasia therapy, while not meeting the primary end point in the overall population, significantly improved ACM and CVH in patients with kappa AL, potentially offering a new therapeutic option for this isotype.
Optimal Sequencing Determination in Relapsed Multiple Myeloma
Sengsayadeth, Salyka, Fitzgerald, Bridget, Nandakumar, Bharat , Schmidt, Timothy M. , Silbermann, Rebecca , Chen, Heidi , Kumar, Shaji , Thapa, Bicky , Chhabra, Saurabh , Callander, Natalie S. , Costa, Luciano J.
Blood | November 28, 2022 | Volume: 140 | Issue: Supplement 1 | Pages: 10033-10035
Does FLT3 mutation impact survival after hematopoietic stem cell transplantation for acute myeloid leukemia? A Center for International Blood and Marrow Transplant Research (CIBMTR) analysis
Deol, Abhinav , Sengsayadeth, Salyka, Ahn, Kwang Woo , Wang, Hailin , Aljurf, Mahmoud , Antin, Joseph H. , Cahn, Jean‐Yves , Camitta, Bruce, Chen, Yi‐Bin , Ganguly, Siddhartha , Inamoto, Yoshihiro , Jagasia, Madan , Kamble, Rammurti T., Koreth, John , Litzow, Mark R. , Marks, David I. , Olsson, Richard F. , Rowe, Jacob M. , Saad, Ayman , Sabloff, Mitchell , Schouten, Harry C. , Shea, Thomas C., Soiffer, Robert J. , Uy, Geoffrey L. , Waller, Edmund K. , Wiernik, Peter H. , Wirk, Baldeep , Woolfrey, Ann E. , Bunjes, Donald , Weisdorf, Dan, Khoury, H. Jean , Saber, Wael , Weisdorf, Daniel J. , Battiwalla, Minoo , Bornhäuser, Martin , Camitta, Bruce M., Cutler, Corey S. , Gale, Robert Peter , Hamadani, Mehdi , Lazarus, Hillard M. , Liesveld, Jane L. , Nishihori, Taiga , Reshef, Ran , Devine, Steven M. , Lima, Marcos de , Sandmaier, Brenda M , Saad, Ayman , Olsson, Richard F , Waller, Edmund K , Weisdorf, Dan , Uy, Geoffrey , Sabloff, Mitchell
Cancer | June 17, 2016 | Volume: 122 | Issue: 19 | Pages: 3005-3014
BACKGROUNDPatients with FMS like tyrosine kinase 3 (FLT3)‐mutated acute myeloid leukemia (AML) have a poor prognosis and are referred for early allogeneic hematopoietic stem cell transplantation (HCT).METHODSData from the Center for International Blood and Marrow Transplant Research (CIBMTR) were used to evaluate 511 adult patients with de novo AML who underwent HCT during 2008 through 2011 to determine whether FLT3 mutations had an impact on HCT outcomes.RESULTSIn total, 158 patients (31%) had FLT3 mutations. Univariate and multivariate analyses revealed an increased risk of relapse at 3 years in the FLT3 mutated group compared with the wild‐type (WT) group (38% [95% confidence interval (CI), 30%‐45%] vs 28% [95% CI, 24%‐33%]; P = .04; relative risk, 1.60 [95% CI, 1.15‐2.22]; P = .0048). However, FLT3 mutation status was not significantly associated with nonrelapse mortality, leukemia‐free survival, or overall survival. Although more patients in the FLT3 mutated group died from relapsed primary disease compared with those in the WT group (60% vs 46%), the 3‐year overall survival rate was comparable for the 2 groups (mutated group: 49%; 95% CI, 40%‐57%; WT group: 55%, 95% CI, 50%‐60%; P = .20).CONCLUSIONSThe current data indicate that FLT3 mutation status did not adversely impact overall survival after HCT, and about 50% of patients with this mutation who underwent HCT were long‐term survivors. Cancer 2016;122:3005‐3014. © 2016 American Cancer Society.