Real-World Data Support Efficacy of Talquetamab for RRMM

Talquetamab-tgvs (Talvey; Johnson & Johnson) established its efficacy for heavily pretreated patients with relapsed/refractory multiple myeloma (RRMM) in a multi-institutional real-world study. The data, published in Blood Cancer Journal, support clinical trial outcomes and talquetamab’s place in this treatment setting.¹

“This multicenter, retrospective analysis provides important [real-world evidence] on the effectiveness and safety of talquetamab in heavily pretreated patients with RRMM,” the researchers wrote. “The observed [overall response rate (ORR)] of 64% to 73%, including 23% [complete response (CR)] rate, aligns with the findings reported in the pivotal MonumenTAL-1 trial.”¹

Talquetamab is a GPRC5D-targeting bispecific antibody approved by the FDA in 2023 for treatment of patients with RRMM who have received at least 4 prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. The decision was based off data from the MonumenTAL-1 trial (NCT03399799, NCT4634552) where talquetamab yielded ORRs over 73%.^1-4

In a multicenter retrospective analysis, talquetamab continues to demonstrate its efficacy. The study included a total of 114 heavily pretreated patients with RRMM with a median prior line of therapy of 6. Of the population, all were triple-class refractory, 79% were penta-refractory, and 65% had received prior BCMA-targeted therapy.¹

The primary outcomes measured were ORR—including CR and very good partial response (VGPR)—and progression-free survival (PFS). The data showed an ORR of 73%, with a CR of 26% and VGPR of 26%.¹

“In this highly refractory population, survival outcomes were favorable, with 6-month and PFS rates of 86 and 56%, respectively, and a median PFS of 10 months, suggesting clinically meaningful and durable responses in a real-world setting.”¹

The most common adverse events (AEs) were cytokine release syndrome (CRS; 54%, with 7.3% grade ≥2), infections (27%), and immune effector cell–associated neurotoxicity syndrome (ICANS; 9.8%).¹

At 3 months, infections occurred in 14% of patients, divided between viral (59%) and bacterial (41%) causes. Severe (grade ≥3) infections were reported in 18% of cases, and 61% of patients required intravenous immunoglobulin therapy. Additionally, patients experienced notable weight loss, averaging an 8.8% reduction at 6 months.¹

“While the cumulative incidence of infections was lower than those observed with use of that reported with teclistamab, over half required hospitalization, underscoring the need for vigilant monitoring and prophylactic strategies for infection prevention,” the researchers wrote. “Weight loss was both substantial and worsened over time, highlighting the importance of nutritional assessment, proactive talquetamab dosing adjustment, and empiric use of supportive care.”¹

The real-world data build on clinical trial evidence showing talquetamab’s safety and efficacy for heavily pretreated patients with RRMM.

REFERENCES

1. Hadidi S, Szabo A, Lal B, et al. Talquetamab in relapsed refractory multiple myeloma: multi-institutional real-world study. Blood Cancer Journal. November 7, 2025. Accessed November 11, 2025. https://www.nature.com/articles/s41408-025-01386-7#Sec14

2. FDA grants accelerated approval to talquetamab-tgvs for relapsed or refractory multiple myeloma. FDA. August 9, 2025. Accessed November 11, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-talquetamab-tgvs-relapsed-or-refractory-multiple-myeloma

3. Dose escalation study of talquetamab in participants with relapsed or refractory multiple myeloma (MonumenTAL-1). Clinicaltrials.gov. Updated November 10, 2025. Accessed November 11, 2025. https://clinicaltrials.gov/study/NCT03399799

4. A study of talquetamab in participants with relapsed or refractory multiple myeloma (MonumenTAL-1). Clinicaltrials.gov. Updated November 10, 2025. Accessed November 11, 2025. https://clinicaltrials.gov/study/NCT4634552