Talquetamab improves patient-reported symptoms and health-related quality of life in relapsed or refractory multiple myeloma: Results from the phase 1/2 MonumenTAL-1 study.

Background: Talquetamab is the first approved G protein-coupled receptor family C group 5 member D-targeting bispecific antibody for the treatment of triple-class exposed relapsed/refractory multiple myeloma (RRMM) on the basis of results from the phase 1/2 MonumenTAL-1 study (ClinicalTrials.gov identifiers NCT03399799 and NCT04634552). This study describes patient-reported outcomes (PROs) among patients who received talquetamab in MonumenTAL-1.

Methods: PROs were assessed in phase 2 of MonumenTAL-1. Patients had RRMM with ≥3 prior lines of therapy (proteasome inhibitors, immunomodulatory drugs, and anti-CD38 antibodies). Patients included in these analyses received talquetamab 0.8 mg/kg every other week. PRO assessments included European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30), EuroQol 5-Dimension 5-Level Visual Analogue Scale (EQ-5D-5L VAS), and Patient Global Impression of Severity (PGIS).

Results: As of January 29, 2024, PRO data were available for 118 patients who received ≥1 dose of talquetamab. Compliance for completion was >95% of patients at baseline and >80% at most posttreatment visits. After an initial worsening in most PROs from baseline through cycle 1, patients reported improvements with continued treatment. At cycle 21, least-squares mean change from baseline showed improvements in global health status (4.9 points) and emotional functioning (12.5 points), along with reductions in pain (11.4 points) and fatigue (4.0 points). The proportion of patients with clinically meaningful improvements or no change from baseline increased throughout treatment. EQ-5D-5L VAS and PGIS scores demonstrated improvement in health-related quality of life.

Conclusions: These PRO results complement the efficacy and safety profile of talquetamab, which highlights talquetamab as a viable treatment option for patients with triple-class exposed RRMM.