Johnson & Johnson’s GPRC5D-targeting T-cell engager Talvey has played second fiddle to its BCMA-targeting multiple myeloma drugs Tecvayli and Carvykti, but it could be heading for an earlier-line approval. J&J sneaked into its first-quarter presentation that it filed Talvey with US and EU regulators based on results from the Monumental-3 trial, in second-line-plus patients. However, the company hasn’t toplined that study as positive, leaving questions about how successful it might have been. When asked for clarification by ApexOnco a spokesperson replied: “J&J will be sharing Monumental-3 data that informed the filings at a future medical congress.” The trial tests Talvey plus Darzalex, with or without Pomalyst, versus Darzalex/Pomalyst in patients with at least one prior therapy, including Revlimid and a proteasome inhibitor (but not an anti-CD38 antibody). Talvey currently has FDA accelerated approval for fifth-line multiple myeloma. Another big readout could come this year, from the Monumental-6 trial testing Talvey plus either Tecvayli or Pomalyst in second-line-plus disease, but after anti-CD38 therapy. Tecvayli recently got the US nod, alongside Darzalex, in the second line. Talvey sales are lagging, totalling $152m in the first quarter, versus $202m for Tecvayli and $597m for Carvykti. Phase 3 trials of Talvey in multiple myelomaTrialSettingRegimenPrimary endpointNoteMonumental-3≥2nd-line (incl prior proteasome & Revlimid)+ DPd, or Dd, vs DPdPFSJ&J disclosed US + EU filings Apr 2026; data to be presented at future medical meetingMonumental-61-4 prior lines (incl prior Revlimid & CD38)+ Tecvayli + d, or Pd, vs EPd or PVdPFSCompletes Apr 2026Monumental-5≥5th-line (incl prior proteasome, imid & CD38)MonoRx, vs BlenrepORR, PFSWithdrawn (“business decision”)Notes: D=Darzalex; d=dexamethasone; E=Empliciti; P=Pomalyst; R=Revlimid; V=Velcade. Source: OncologyPipeline & clinicaltrials.gov.
Johnson & Johnson’s GPRC5D-targeting T-cell engager Talvey has played second fiddle to its BCMA-targeting multiple myeloma drugs Tecvayli and Carvykti, but it could be heading for an earlier-line approval. J&J sneaked into its first-quarter presentation that it filed Talvey with US and EU regulators based on results from the Monumental-3 trial, in second-line-plus patients. However, the company hasn’t toplined that study as positive, leaving questions about how successful it might have been. When asked for clarification by ApexOnco a spokesperson replied: “J&J will be sharing Monumental-3 data that informed the filings at a future medical congress.” The trial tests Talvey plus Darzalex, with or without Pomalyst, versus Darzalex/Pomalyst in patients with at least one prior therapy, including Revlimid and a proteasome inhibitor (but not an anti-CD38 antibody). Talvey currently has FDA accelerated approval for fifth-line multiple myeloma. Another big readout could come this year, from the Monumental-6 trial testing Talvey plus either Tecvayli or Pomalyst in second-line-plus disease, but after anti-CD38 therapy. Tecvayli recently got the US nod, alongside Darzalex, in the second line. Talvey sales are lagging, totalling $152m in the first quarter, versus $202m for Tecvayli and $597m for Carvykti.
Phase 3 trials of Talvey in multiple myeloma
| Trial | Setting | Regimen | Primary endpoint | Note |
|---|
| Monumental-3 | ≥2nd-line (incl prior proteasome & Revlimid) | + DPd, or Dd, vs DPd | PFS | J&J disclosed US + EU filings Apr 2026; data to be presented at future medical meeting |
| Monumental-6 | 1-4 prior lines (incl prior Revlimid & CD38) | + Tecvayli + d, or Pd, vs EPd or PVd | PFS | Completes Apr 2026 |
| Monumental-5 | ≥5th-line (incl prior proteasome, imid & CD38) | MonoRx, vs Blenrep | ORR, PFS | Withdrawn (“business decision”) |
