SUMMARY  

• No formal studies of TALVEY in patients with renal impairment have been conducted.¹
• Results of population pharmacokinetic analyses indicate that mild (60 mL/min/1.73m² ≤ estimated glomerular filtration rate [eGFR] <90 mL/min/1.73m²) or moderate renal impairment (30 mL/min/1.73m² ≤ eGFR <60 mL/min/1.73m²) did not significantly influence the pharmacokinetics of TALVEY. No data is available in patients with severe renal impairment.¹
• Based on population pharmacokinetic analyses, no dose adjustment is recommended for patients with mild or moderate renal impairment.¹
• MonumenTAL-1 (MMY1001) is an ongoing, open-label, phase 1/2 study evaluating the efficacy and safety of TALVEY in patients with relapsed or refractory multiple myeloma (RRMM) after ≥3 prior lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody.²
  • Per protocol, patients enrolled in the study were required to have adequate renal function during the screening phase described as: creatinine clearance ≥40 mL/min/1.73m² based upon Modified Diet in Renal Disease (MDRD) formula calculation.³
  • Krishnan et al (2023)⁴ presented (at the International Myeloma Society [IMS] Annual Meeting and Exposition) subgroup analyses of the efficacy and safety results from the MonumenTAL-1 study phases 1/2 in patients who received TALVEY at the recommended phase 2 doses (RP2D) of 0.4 mg/kg subcutaneous (SC) weekly (QW) and 0.8 mg/kg SC once every other week (Q2W), including those who were naïve or exposed to T-cell redirection (TCR) therapy. Data was presented from key high-risk subgroups, including patients with renal impairment (baseline function ≤60 mL/min/1.73 m²).

CLINICAL DATA – MONUMENTAL-1 STUDY

Krishnan et al (2023)⁴ evaluated the efficacy and safety of TALVEY in key high-risk subgroups of patients from phases 1/2 of the MonumenTAL-1 study.

Results

Treatment Disposition, Patient Demographics, and Disease/Treatment Characteristics

• The subgroup analysis included 143 patients in the 0.4 mg/kg SC QW cohort and 145 patients in the 0.8 mg/kg SC Q2W cohort.
• A total of 40 patients (28%) in the 0.4 mg/kg SC QW cohort and 45 patients (31%) in the 0.8 mg/kg SC Q2W cohort with renal impairment (baseline function ≤60 mL/min/1.73 m²) were included in the analysis.
• Baseline demographic characteristics overall and in patients with renal impairment are presented in the Table: MonumenTAL-1: Baseline Demographic Characteristics in Patients with Renal Impairment.

Efficacy

• The median follow-up and ORR in the RP2Ds of 0.4 mg/kg QW and 0.8 mg/kg Q2W are summarized in the Table: MonumenTAL-1: ORR in Patients with Renal-Impairment.

Safety

• Adverse events (AEs) observed in the RP2Ds of 0.4 mg/kg QW and 0.8 mg/kg Q2W are summarized in the Table: MonumenTAL-1: Summary of AEs in Patients with Renal Impairment.

literature search

A literature search of MEDLINE^®, Embase^®, BIOSIS Previews^®, and Derwent Drug File databases (and/or other resources, including internal/external databases) was conducted on 12 November 2024.