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SUMMARY
- Janssen does not recommend the use of TALVEY in a manner that is inconsistent with the approved labeling.
- MonumenTAL-1 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 (LOTs), including a proteasome inhibitor (PI), an immunomodulatory drug, and an anti-CD38 monoclonal antibody (mAb).1-3
- Per protocol, patients with central nervous system (CNS) involvement or clinical signs of meningeal involvement of multiple myeloma (MM), were excluded from enrollment.4
- A search of the scientific literature retrieved limited information from 2 congress posters, describing the use of TALVEY in the included patients with MM and CNS involvement:
- Mersi J, Eisele F, Zhou X, et al. The role of bispecific antibodies and CAR T cells in the treatment of multiple myeloma with central nervous system involvement. Poster presented at: European Hematology Association (EHA) 2024 Hybrid Congress; June 13-16, 2024; Madrid, Spain.
- Gill SK, Fleming E, Gebre H, et al. Real world outcomes with talquetamab, a T-cell-redirecting GPRC5D bispecific antibody: A single center experience for relapsed/ refractory multiple myeloma (RRMM). Presented at the 66th American Society for Hematology (ASH) Annual Meeting and Exposition; December 7-10, 2024; San Diego, California.
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 02 June 2025.
1 | Chari A, Touzeau C, Schinke C, et al. Safety and activity of talquetamab in patients with relapsed or refractory multiple myeloma (MonumenTAL-1): a multicentre, open-label, phase 1-2 study. Lancet Haematol. 2025;12(4):e269-e281. |
2 | Chari A, Minnema MC, Berdeja JG, et al. Talquetamab, a T-cell-redirecting GPRC5D bispecific antibody for multiple myeloma. N Engl J Med. 2022;387(24):2232-2244. |
3 | Schinke CD, Touzeau C, Minnema MC, et al. Pivotal phase 2 MonumenTAL-1 results of talquetamab, a GPRC5DxCD3 bispecific antibody, for relapsed/refractory multiple myeloma. Poster presented at: American Society of Clinical Oncology (ASCO) Annual Meeting; June 2-6, 2023; Chicago, IL/Virtual. |
4 | Chari A, Minnema MC, Berdeja JG. Protocol to: Talquetamab, a T-cell–redirecting GPRC5D bispecific antibody for multiple myeloma. N Engl J Med. 2022;387(24):2232-2244. |