EFFICACY AND SAFETY OF BISPECIFIC ANTIBODIES IN RELAPSED/REFRACTORY MULTIPLE MYELOMA: A REAL-WORLD STUDY FROM BRAZIL
- 1A. C. Camargo Cancer Center, São Paulo, SP, Brasil
Abstract
Background: Bispecific antibodies (BsAbs) have been commercially available in Brazil since 2023 for the treatment of relapsed/refractory multiple myeloma (R/R MM). Because Brazilian regulatory approval allows their use in triple-class–exposed patients regardless of prior lines of therapy, real-world treatment patterns may differ from those observed in pivotal trials. Aim: To evaluate the efficacy and safety of commercially available BsAbs in patients with R/R MM treated at a Brazilian cancer center. Materials and methods: We retrospectively reviewed patients with R/R MM treated with BsAbs at A.C.Camargo Cancer Center (São Paulo, Brazil) between September 2023 and February 2026. Baseline characteristics, efficacy, and toxicity were collected. PFS and OS were calculated from the first BsAb infusion. ORR was defined as partial response (PR) or better. Patients receiving talquetamab (TAL) as bridging therapy to CAR-T were excluded from survival analyses. Results: Twenty-five patients contributed 30 BsAb treatment episodes (teclistamab [TEC], n=12; talquetamab [TAL], n=14; elranatamab [ELRA], n=4), including five patients subsequently treated with TAL after TEC. Median age was 66 years (43–86), 60% were male, all patients were triple-class exposed, and the median number of prior LoTs was 3 (2–6). ISS III and extramedullary disease were each present in 36.7% of treatment episodes, while 56.7% were at least triple-class refractory. High-risk cytogenetics were identified in 40% of evaluable patients. Median follow-up was 22.2, 15.1, and 9.3 months for TEC, TAL, and ELRA, respectively. ORR was 66.7%, 50.0%, and 100%, with ≥VGPR rates of 58.3%, 42.9%, and 100%, respectively. Median PFS was 9.5 months with TEC and 8.2 months with TAL, whereas it was not reached (NR) with ELRA (P=0.42). Median OS was 24.3 months for TEC, 15.3 months for TAL, and NR for ELRA (P=0.68). CRS occurred in 83.3%, 85.7%, and 100% of TEC-, TAL-, and ELRA-treated patients, respectively; grade ≥3 CRS occurred only with TEC (16.7%). ICANS occurred in 16.7%, 14.3%, and 0%, respectively; only one grade 3 event occurred (TAL). Infections occurred in 91.7%, 92.9%, and 75.0% of patients, with grade 3–4 infections in 66.7%, 71.4%, and 25.0%, respectively. Among TAL-treated patients, oral (85.7%), skin (78.6%), and nail toxicity (64.3%) were common. Dizziness/ataxia occurred in 3/14 patients (21.4%); only one patient experienced grade 1 ataxia, and no patient discontinued TAL because of neurologic toxicity. Discussion: This study provides real-world data on commercially available BsAbs in Brazil and demonstrates meaningful responses despite the high-risk clinical characteristics of the treated population. Shorter survival than reported in pivotal trials likely reflects preferential use in patients with rapidly progressive and clinically high-risk disease. As our institution is a CAR-T referral center, selection of patients with more favorable disease for CAR-T may have further enriched the BsAb cohort with aggressive disease. Infection rates with talquetamab were unexpectedly high and may partly reflect prior BCMA-targeted therapy in nearly one-third of patients. Conclusion: Commercially available BsAbs demonstrated meaningful clinical activity and a manageable safety profile in Brazilian patients with R/R MM.
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BibTeX
@article{villefort2026efficacy,
title = {{EFFICACY AND SAFETY OF BISPECIFIC ANTIBODIES IN RELAPSED/REFRACTORY MULTIPLE MYELOMA: A REAL-WORLD STUDY FROM BRAZIL}},
author = {Humberto Humberto VILLEFORT and Giovanna Alves PERUZINI and Julia Curi AMARANTE and Vanessa dos Anjos BOVOLENTA and Jayr SCHMIDT-FILHO and Bianca Batista CAL},
journal = {Hematology, Transfusion and Cell Therapy},
year = {2026},
month = oct,
doi = {10.1016/j.htct.2026.107868},
url = {https://doi.org/10.1016/j.htct.2026.107868},
note = {CC BY},
}
RIS
TY - JOUR
TI - EFFICACY AND SAFETY OF BISPECIFIC ANTIBODIES IN RELAPSED/REFRACTORY MULTIPLE MYELOMA: A REAL-WORLD STUDY FROM BRAZIL
AU - Humberto Humberto VILLEFORT
AU - Giovanna Alves PERUZINI
AU - Julia Curi AMARANTE
AU - Vanessa dos Anjos BOVOLENTA
AU - Jayr SCHMIDT-FILHO
AU - Bianca Batista CAL
PY - 2026
DA - 2026/10/23
JO - Hematology, Transfusion and Cell Therapy
DO - 10.1016/j.htct.2026.107868
UR - https://doi.org/10.1016/j.htct.2026.107868
AB - Background: Bispecific antibodies (BsAbs) have been commercially available in Brazil since 2023 for the treatment of relapsed/refractory multiple myeloma (R/R MM). Because Brazilian regulatory approval allows their use in triple-class–exposed patients regardless of prior lines of therapy, real-world treatment patterns may differ from those observed in pivotal trials. Aim: To evaluate the efficacy and safety of commercially available BsAbs in patients with R/R MM treated at a Brazilian cancer center. Materials and methods: We retrospectively reviewed patients with R/R MM treated with BsAbs at A.C.Camargo Cancer Center (São Paulo, Brazil) between September 2023 and February 2026. Baseline characteristics, efficacy, and toxicity were collected. PFS and OS were calculated from the first BsAb infusion. ORR was defined as partial response (PR) or better. Patients receiving talquetamab (TAL) as bridging therapy to CAR-T were excluded from survival analyses. Results: Twenty-five patients contributed 30 BsAb treatment episodes (teclistamab [TEC], n=12; talquetamab [TAL], n=14; elranatamab [ELRA], n=4), including five patients subsequently treated with TAL after TEC. Median age was 66 years (43–86), 60% were male, all patients were triple-class exposed, and the median number of prior LoTs was 3 (2–6). ISS III and extramedullary disease were each present in 36.7% of treatment episodes, while 56.7% were at least triple-class refractory. High-risk cytogenetics were identified in 40% of evaluable patients. Median follow-up was 22.2, 15.1, and 9.3 months for TEC, TAL, and ELRA, respectively. ORR was 66.7%, 50.0%, and 100%, with ≥VGPR rates of 58.3%, 42.9%, and 100%, respectively. Median PFS was 9.5 months with TEC and 8.2 months with TAL, whereas it was not reached (NR) with ELRA (P=0.42). Median OS was 24.3 months for TEC, 15.3 months for TAL, and NR for ELRA (P=0.68). CRS occurred in 83.3%, 85.7%, and 100% of TEC-, TAL-, and ELRA-treated patients, respectively; grade ≥3 CRS occurred only with TEC (16.7%). ICANS occurred in 16.7%, 14.3%, and 0%, respectively; only one grade 3 event occurred (TAL). Infections occurred in 91.7%, 92.9%, and 75.0% of patients, with grade 3–4 infections in 66.7%, 71.4%, and 25.0%, respectively. Among TAL-treated patients, oral (85.7%), skin (78.6%), and nail toxicity (64.3%) were common. Dizziness/ataxia occurred in 3/14 patients (21.4%); only one patient experienced grade 1 ataxia, and no patient discontinued TAL because of neurologic toxicity. Discussion: This study provides real-world data on commercially available BsAbs in Brazil and demonstrates meaningful responses despite the high-risk clinical characteristics of the treated population. Shorter survival than reported in pivotal trials likely reflects preferential use in patients with rapidly progressive and clinically high-risk disease. As our institution is a CAR-T referral center, selection of patients with more favorable disease for CAR-T may have further enriched the BsAb cohort with aggressive disease. Infection rates with talquetamab were unexpectedly high and may partly reflect prior BCMA-targeted therapy in nearly one-third of patients. Conclusion: Commercially available BsAbs demonstrated meaningful clinical activity and a manageable safety profile in Brazilian patients with R/R MM.
SN - 2531-1379
SN - 2531-1387
ER -