Johnson & Johnson: TECVAYLI + TALVEY reduce progression risk 89% and death risk 62% in earlier-line RRMM
- TECVAYLI + TALVEY reduced risk of progression or death by 89% (HR 0.11) and risk of death by 62% (HR 0.38) versus investigator’s choice standard of care.
- TALVEY + pomalidomide reduced risk of progression or death by 73% (HR 0.27) versus standard of care.
- MonumenTAL-6 randomized patients with relapsed/refractory multiple myeloma who received 1–4 prior lines, including an anti‑CD38 antibody and lenalidomide, across three arms (Tec‑Tal, Tal‑P, investigator’s choice EPd or PVd).
- The Independent Data Monitoring Committee recommended unblinding at the first interim analysis; full data will be presented at a future major medical meeting and shared with global regulators.
Topline efficacy
The Phase 3 MonumenTAL-6 study reported that both investigational arms met the primary endpoint of progression‑free survival assessed by independent review. The TECVAYLI (teclistamab) plus TALVEY (talquetamab) combination (Tec‑Tal) reduced risk of progression or death by 89% (HR 0.11; 95% CI 0.08–0.16; p<0.0001) and reduced the risk of death by 62% (HR 0.38). The TALVEY plus pomalidomide (Tal‑P) arm reduced risk of progression or death by 73% (HR 0.27; 95% CI 0.20–0.35) versus investigator’s choice.
Study design and population
MonumenTAL-6 (NCT06208150) is a global, randomized Phase 3 trial comparing Tec‑Tal and Tal‑P to investigator’s choice of elotuzumab+pomalidomide+dexamethasone (EPd) or pomalidomide+bortezomib+dexamethasone (PVd) in patients with relapsed/refractory multiple myeloma who had received one to four prior lines of therapy, including an anti‑CD38 monoclonal antibody and lenalidomide. The primary endpoint is PFS by independent review; key secondary endpoints include ORR, ≥CR, MRD‑negative CR and overall survival.
Safety and next steps
Investigators reported overall safety profiles for Tec‑Tal and Tal‑P consistent with the known safety profiles of each monotherapy. Based on the strength of the data, the Independent Data Monitoring Committee recommended unblinding at the first interim analysis. Johnson & Johnson said full results will be presented at a forthcoming major medical meeting and submitted to global health authorities.
Source: J&J