REAL-WORLD SAFETY AND OUTCOMES OF BISPECIFIC ANTIBODIES IN OLDER ADULTS
Author(s)
Onur Baser, MA, MS, PhD1, Xianxin Zhu, MS2, Yuanqing Lu, MS2, Nehir Yapar, BS2, Lixuan Wu, MS2, Wanlin Guo, MS2;
1City University of New York (CUNY), Graduate School of Public Health, New York, NY, USA, 2Columbia Data Analytics, New York, NY, USA
1City University of New York (CUNY), Graduate School of Public Health, New York, NY, USA, 2Columbia Data Analytics, New York, NY, USA
OBJECTIVES: This study characterized treatment patterns, laboratory toxicities, and short‑term outcomes of bispecific antibodies in older adults with hematologic malignancies.
METHODS: Medicare-Enhanced Lab and Demographics (MELDTM) dataset (deterministically linked 100% Medicare fee‑for‑service [FFS] claims with electronic medical records [EMR] and patient‑reported outcome [PRO] measures) was used to assemble a retrospective cohort of beneficiaries ≥65 years initiating an approved bispecific antibody 2021-2025 was assembled. Baseline and on‑treatment laboratory tests (−7 to +30 days from first full dose) included complete blood count, comprehensive metabolic panel, liver tests, C‑reactive protein, ferritin, and selected cytokine and cardiac markers. Outcomes: Overall response rate (ORR), 6‑month overall survival (OS), incidence, grade of cytokine‑release syndrome (CRS), ICANS (lab‑anchored algorithms), severe cytopenias and infections, and changes in fatigue and physical function from PROs.
RESULTS: The cohort included 5,200 bispecific‑treated patients (median age:73 years; 31% ≥80), MM:3,400; B‑cell lymphomas:1,800; prior CAR‑T exposure:27%. Myeloma: ORR=58%; CR‑like responses:24%; lymphoma: ORR=46%; 22% complete responses, consistent with contemporary real‑world series. CRS occurred in 38% (grade ≥2:14%); ICANS‑like events:5% (grade ≥2:2%), mostly low‑grade and manageable with standard step‑up dosing and supportive care. Grade 4 neutropenia occurred in 22%; grade ≥3 infections in 24% over 6 months. Six‑month OS: myeloma:78%; lymphoma:72%, but ~60-65% in patients treated after early CAR‑T failure or with elevated LDH. PRO subcohort: Fatigue worsened during step‑up dosing then improved by 3-4 points at 3 months in responders; physical function remained stable vs declines in non‑responders.
CONCLUSIONS: Use of MELDTM enabled an integrated claims-labs-EMR-PRO assessment of bispecific antibody therapy. Bispecifics produced response and survival outcomes comparable to trial and other real‑world data, with predominantly low‑grade CRS and infrequent higher‑grade ICANS but frequent cytopenias and infections, supporting the benefit of these agents in older, heavily pretreated patients, underscoring the need for structured toxicity mitigation and thoughtful integration with checkpoint inhibitors and cellular therapies.
METHODS: Medicare-Enhanced Lab and Demographics (MELDTM) dataset (deterministically linked 100% Medicare fee‑for‑service [FFS] claims with electronic medical records [EMR] and patient‑reported outcome [PRO] measures) was used to assemble a retrospective cohort of beneficiaries ≥65 years initiating an approved bispecific antibody 2021-2025 was assembled. Baseline and on‑treatment laboratory tests (−7 to +30 days from first full dose) included complete blood count, comprehensive metabolic panel, liver tests, C‑reactive protein, ferritin, and selected cytokine and cardiac markers. Outcomes: Overall response rate (ORR), 6‑month overall survival (OS), incidence, grade of cytokine‑release syndrome (CRS), ICANS (lab‑anchored algorithms), severe cytopenias and infections, and changes in fatigue and physical function from PROs.
RESULTS: The cohort included 5,200 bispecific‑treated patients (median age:73 years; 31% ≥80), MM:3,400; B‑cell lymphomas:1,800; prior CAR‑T exposure:27%. Myeloma: ORR=58%; CR‑like responses:24%; lymphoma: ORR=46%; 22% complete responses, consistent with contemporary real‑world series. CRS occurred in 38% (grade ≥2:14%); ICANS‑like events:5% (grade ≥2:2%), mostly low‑grade and manageable with standard step‑up dosing and supportive care. Grade 4 neutropenia occurred in 22%; grade ≥3 infections in 24% over 6 months. Six‑month OS: myeloma:78%; lymphoma:72%, but ~60-65% in patients treated after early CAR‑T failure or with elevated LDH. PRO subcohort: Fatigue worsened during step‑up dosing then improved by 3-4 points at 3 months in responders; physical function remained stable vs declines in non‑responders.
CONCLUSIONS: Use of MELDTM enabled an integrated claims-labs-EMR-PRO assessment of bispecific antibody therapy. Bispecifics produced response and survival outcomes comparable to trial and other real‑world data, with predominantly low‑grade CRS and infrequent higher‑grade ICANS but frequent cytopenias and infections, supporting the benefit of these agents in older, heavily pretreated patients, underscoring the need for structured toxicity mitigation and thoughtful integration with checkpoint inhibitors and cellular therapies.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
CO106
Topic
Clinical Outcomes
Topic Subcategory
Clinical Outcomes Assessment
Disease
SDC: Oncology