Health-related quality of life in patients with relapsed/refractory multiple myeloma (RRMM) treated with teclistamab, a B-cell maturation antigen (BCMA) x CD3 bispecific antibody: Patient-reported outcomes in MajesTEC-1.

Thomas G. Martin UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA info_outline Thomas G. Martin, Philippe Moreau, Saad Zafar Usmani, Alfred L. Garfall, Maria-Victoria Mateos, Jesús F. San-Miguel, Albert Oriol Rocafiguera, Ajay K. Nooka, Laura Rosiñol, Ajai Chari, Lionel Karlin, Amrita Y. Krishnan, Nizar J. Bahlis, Rakesh Popat, Britta Besemer, Joaquin Martinez, Michel Delforge, John Fastenau, Katharine S. Gries, Niels W.C.J. van de Donk

Authors Thomas G. Martin UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA info_outline Thomas G. Martin, Philippe Moreau, Saad Zafar Usmani, Alfred L. Garfall, Maria-Victoria Mateos, Jesús F. San-Miguel, Albert Oriol Rocafiguera, Ajay K. Nooka, Laura Rosiñol, Ajai Chari, Lionel Karlin, Amrita Y. Krishnan, Nizar J. Bahlis, Rakesh Popat, Britta Besemer, Joaquin Martinez, Michel Delforge, John Fastenau, Katharine S. Gries, Niels W.C.J. van de Donk Organizations UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, Hematology Clinic, University Hospital Hôtel-Dieu, Nantes, France, Levine Cancer Institute/Atrium Health, Charlotte, NC, Abramson Cancer Center, Perelman School of Medicine, University of Pennsylvania, Philadelphia, PA, University Hospital of Salamanca/IBSAL/CIC/CIBERONC, Salamanca, Spain, Clínica Universidad de Navarra, CCUN, CIMA, CIBERONC, IDISNA, Pamplona, Spain, Institut Català d’Oncologia and Institut Josep Carreras, Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain, Winship Cancer Institute, Emory University, Atlanta, GA, Hospital Clínic, IDIBAPS, University of Barcelona, Barcelona, Spain, Mount Sinai School of Medicine, New York, NY, Service d’Hématologie Clinique, Centre Hospitalier Lyon Sud, Pierre-Bénite, France, City of Hope Comprehensive Cancer Center, Duarte, CA, Arnie Charbonneau Cancer Institute, University of Calgary, Calgary, AB, Canada, University College London Hospitals, NHS Foundation Trust, London, United Kingdom, University of Tuebingen, Tuebingen, Germany, Haematological Malignancies Clinical Research Unit, Hospital 12 de Octubre Universidad Complutense, CNIO, CIBERONC, Madrid, Spain, University of Leuven, Leuven, Belgium, Janssen Research & Development, Raritan, NJ, Amsterdam University Medical Center, Vrije Universiteit Amsterdam, Amsterdam, Netherlands Abstract Disclosures Research Funding Pharmaceutical/Biotech Company Background: As multiple myeloma (MM) negatively affects patients’ (pts) health-related quality of life (HRQoL), assessment of patient-reported outcomes (PROs) in addition to clinical outcomes is important. Teclistamab (tec; JNJ-64007957) is an off-the-shelf bispecific antibody that redirects CD3+ T cells to mediate T-cell activation and subsequent lysis of BCMA-expressing MM cells. Initial results from the pivotal cohort of the phase 1/2 MajesTEC-1 study demonstrated that tec was well tolerated with encouraging efficacy in pts who received ≥3 prior lines of treatment (LOT; including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 antibody). Here we report PROs from this cohort. Methods: Pts (aged ≥18 years) had documented RRMM (International Myeloma Working Group criteria), progressive/measurable disease, and had previously received ≥3 prior LOT; prior anti-BCMA treatment (tx) was not allowed. Pts received weekly subcutaneous tec at the recommended phase 2 dose (1.5 mg/kg with step-up doses of 0.06 and 0.3 mg/kg). PROs were assessed at screening and every even cycle (cycles 2–8 reported here) using the EORTC QLQ-C30 (range: 0–100; higher scores indicate better global health status [GHS] but greater symptom severity [symptom scales]) and the EuroQol 5-dimensional descriptive system (visual analog scale [VAS] range: 0 [worst imaginable health state] to 100 [best imaginable]). Tx effect was assessed by a mixed-effects model with repeated measures; the proportion of pts with meaningful improvement was defined as a change ≥10 points. Time to worsening was determined using the Kaplan-Meier estimate. Results: A total of 110 pts were included (median follow-up: 7.8 mos). Overall PRO compliance rates were high (baseline [BL]: 85–90%; cycles 2–8: 80–94%). Tec improved overall HRQoL as evidenced by improvements in GHS scores (cycles 2–8) and reduction in pain (-4.2 [cycle 2] to -15.1 [cycle 8]; Table), with no overall change in physical functioning and fatigue. The proportions of pts with meaningful improvements from BL at cycle 8 were GHS: 50%; physical functioning: 35%; pain: 65%; fatigue: 73%; 50% of pts reported meaningful improvement in their overall health (VAS). Median time to improvement from baseline was ̃1.5 months (with nausea/vomiting and fatigue taking longer to improve), while median time to worsening (all symptoms) ranged from 2 months to not estimable. Conclusions: Consistent with clinical outcomes, pts treated with tec reported rapid, clinically meaningful improvements in HRQoL. Clinical trial information: NCT04557098. BL and least squares (LS) mean change from baseline in PRO measures. GHS Physical functioning Pain Fatigue VAS BL (mean) 58.0 71.3 43.6 39.6 61.2 LS mean change Cycle 2 0.6 −6.7 −4.2 6.9 0 Cycle 4 6.6 0.4 −9.6 −0.6 7.9 Cycle 6 6.8 0.6 −10.7 0.8 8.9 Cycle 8 11.3 5.3 −15.1 −0.4 10.7