Teclistamab Improves Patient-Reported Symptoms and Health-Related Quality of Life in Relapsed or Refractory Multiple Myeloma: Results From the Phase II MajesTEC-1 Study

被引:4
作者
Martin, Thomas G. [1 ,21 ]
Moreau, Philippe [2 ]
Usmani, Saad Z. [3 ]
Garfall, Alfred [4 ,5 ,19 ]
Mateos, Maria -Victoria [5 ,12 ]
San-Miguel, Jesus F. [6 ]
Oriol, Albert [7 ,8 ]
Nooka, Ajay K. [9 ]
Rosinol, Laura [10 ]
Chari, Ajai [11 ]
Karlin, Lionel [12 ]
Krishnan, Amrita [13 ]
Bahlis, Nizar [14 ]
Popat, Rakesh [15 ]
Besemer, Britta [16 ]
Martinez-Lopez, Joaquin [17 ]
Delforge, Michel [18 ]
Trancucci, Danielle [19 ]
Pei, Lixia [19 ]
Kobos, Rachel [19 ]
Fastenau, John [19 ]
Gries, Katharine S. [19 ]
van de Donk, Niels W. C. J. [20 ]
机构
[1] Univ Calif San Francisco, San Francisco, CA USA
[2] Univ Hosp Hotel Dieu, Hematol Clin, Nantes, France
[3] Levine Canc Inst, Atrium Hlth, Charlotte, NC USA
[4] Univ Penn, Abramson Canc Ctr, Perelman Sch Med, Philadelphia, PA USA
[5] Univ Hosp Salamanca IBSAL CIC CIBERONC, Salamanca, Spain
[6] Clin Univ Navarra CCUN, CIMA, CIBERONC, IDISNA, Pamplona, Spain
[7] Hosp Badalona Germans Trias & Pujol, Inst Catala Oncol, Badalona, Barcelona, Spain
[8] Hosp Badalona Germans Trias & Pujol, Inst Josep Carreras, Badalona, Barcelona, Spain
[9] Emory Univ, Winship Canc Inst, Atlanta, GA USA
[10] Univ Barcelona, Hosp Clin, IDIBAPS, Barcelona, Spain
[11] Mt Sinai Sch Med, New York, NY USA
[12] Ctr Hosp Lyon Sud, Serv Hematol Clin, Pierre Benite, France
[13] City Hope Comprehens Canc Ctr, Duarte, CA USA
[14] Univ Calgary, Arnie Charbonneau Canc Inst, Calgary, AB, Canada
[15] Univ Coll London Hosp, NHS Fdn Trust, London, England
[16] Univ Tubingen, Tubingen, Germany
[17] Univ Complutense, Hosp Octubre 12, CIBERONC,Haematol Malignancies Clin Res Unit, Madrid, Spain
[18] Univ Ziekenhuizen Leuven, Leuven, Belgium
[19] Janssen Res & Dev, Raritan, NJ USA
[20] Amsterdam Univ Med Ctr, Vrije Univ Amsterdam, Amsterdam, Netherlands
[21] Div Hematol Oncol, 400 Parnassus Ave,4th Floor, San Francisco, CA 94143 USA
关键词
B-cell maturation antigen; Bispecific antibody; EORTC QLQ-C30; EQ-5D-5L; Patient-reported outcomes; DIAGNOSIS; ANTIBODY;
D O I
10.1016/j.clml.2023.11.001
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Patients with relapsed/refractory multiple myeloma (RRMM) typically report poor health -related quality of life (HRQoL), which deteriorates as they progress through multiple lines of therapy. This study provides HRQoL data in patients with RRMM who received teclistamab in MajesTEC-1, including improvements in pain, global health status, and emotional functioning. These results support teclistamab as a promising treatment option in this population. Introduction: Patients with relapsed or refractory multiple myeloma (RRMM) report significantly lower HRQoL compared with patients with newly diagnosed MM and experience further deterioration in HRQoL with each relapse and subsequent treatment. Therefore, consideration of the impact of treatment on HRQoL in addition to clinical outcomes is vital. Patients and Methods: In the phase I/II MajesTEC-1 (NCT03145181, NCT04557098) study, patients with RRMM who received teclistamab, an off -the -shelf, T -cell redirecting BCMA x CD3 bispecific antibody, had deep and durable responses with manageable safety. HRQoL was assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire core 30 -item and the EuroQol 5 Dimension 5 Level descriptive questionnaire. Changes over time from baseline were measured with a repeated measures mixed -effects model. Proportions of patients with clinically meaningful improvement after starting treatment and time to clinically meaningful worsening were assessed. Results: Compliance was maintained throughout the study. Compared with baseline, positive changes were observed for pain, global health status, and emotional functioning with treatment; other assessments were largely unchanged from baseline. Post hoc analysis showed patients with deeper clinical response generally reported improved HRQoL outcomes. Following an initial decline in HRQoL in some scales, the proportion of patients reporting clinically meaningful improvements increased, while the proportion reporting clinically meaningful worsening decreased over time. Clinically meaningful improvements in pain were reported in >= 40% of patients at most assessment time points. Conclusions: These results complement previously reported clinical benefits and support teclistamab as a promising therapeutic option for patients with RRMM.
引用
收藏
页码:194 / 202
页数:9
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