Unknown MAH — Talvey EMA EPAR public assessment report (EMEA/H/C/005864, 2023)
Johnson & Johnson · 2023 · EMA EPAR public assessment report · company profile →
Report summary
Talvey (talquetamab) received accelerated assessment for relapsed/refractory multiple myeloma, addressing a significant unmet medical need. This novel bispecific antibody targets GPRC5D and CD3, demonstrating T-cell mediated cytotoxicity in non-clinical studies. Clinical trials (MonumenTAL-1) showed high objective response rates and durable responses in heavily pre-treated patients. Key safety concerns include high incidences of cytokine release syndrome (77%), neurotoxicity (28.9%), and serious infections (19% Grade 3/4). While discontinuations due to adverse events were low, treatment modifications were frequent. Long-term safety data and a confirmatory Phase 3 study are ongoing. The report also details manufacturing, quality control, and pharmacokinetic/pharmacodynamic profiles.
Key findings — cited to the page
| maximum severity of infections Grade 3 or 4 | 19.6 % | · p.121 |
| participants with at least 1 TEAE of infection (any grade) | 96 participants | · p.121 |
| participants with at least 1 TEAE of infection (any grade) | 84 participants | · p.121 |
| percentage of participants with at least 1 TEAE of infection (any grade) | 58.7 % | · p.121 |
| participants with Grade 5 infection | 3 participants | · p.121 |
| percentage of participants with Grade 5 infection | 2.1 % | · p.121 |
| Neurotoxicity Grade 3+ incidence | 2.6 % | MonumenTAL-1 · p.149 |
| Grade 3 CRS (prior bispecific therapy) | 0 % | MonumenTAL-1 · p.140 |
| Infections Grade 3+ incidence | 20 % | MonumenTAL-1 · p.149 |
| ICANS Grade 3+ incidence | 2.3 % | MonumenTAL-1 · p.149 |
| Grade 3 CRS (prior CAR-T therapy) | 2.7 % | MonumenTAL-1 · p.140 |
| percentage of participants with at least 1 TEAE of infection (any grade) | 66.2 % | · p.121 |
Source: Johnson & Johnson ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Oncology library →