Johnson & Johnson: TECVAYLI improves PFS and OS in second-line multiple myeloma
- MajesTEC‑9 compared teclistamab monotherapy (TECVAYLI) versus PVd or Kd in RRMM patients with 1–3 prior lines, including lenalidomide and anti‑CD38 exposure.
- TECVAYLI cut risk of progression/death by 71% (HR 0.29) and risk of death by 40% (HR 0.60); ≥CR was 65.9% vs 16.8%.
- Safety: CRS occurred in 66% (mostly Grade 1), Grade 3/4 infections 41.6% vs 29.0%, Grade 5 TEAEs 6.5% vs 3.5%; median treatment duration 13.1 vs 7.0 months.
- Regulatory: Johnson & Johnson has submitted applications to FDA and EMA to expand TECVAYLI into second‑line use and TECVAYLI is approved in combination with daratumumab for patients with ≥1 prior line.
Study design
MajesTEC‑9 randomized teclistamab (TECVAYLI) monotherapy versus investigator‑choice PVd (pomalidomide+bortezomib+dexamethasone) or Kd (carfilzomib+dexamethasone) in relapsed/refractory multiple myeloma patients with 1–3 prior lines who had received lenalidomide and an anti‑CD38 antibody; the population was predominantly refractory to anti‑CD38 (85%) and lenalidomide (79%).
Key efficacy results
TECVAYLI reduced risk of progression or death by 71% (HR 0.29) and risk of death by 40% (HR 0.60) versus PVd/Kd; complete response or better (≥CR) was 65.9% vs 16.8%; median treatment duration was 13.1 vs 7.0 months.
Safety
Overall TEAE rates were similar (99.7% vs 97.9%); Grade 3/4 TEAEs occurred in 84.9% vs 76.3%; Grade 5 TEAEs were 6.5% vs 3.5%, mostly infections within the first six months; Grade 3/4 infections were 41.6% vs 29.0%; cytokine release syndrome occurred in 66% (mostly Grade 1) and resolved in all cases; ICANS was infrequent (4.1%, mainly Grade 1/2).
Regulatory status
Applications to expand TECVAYLI into second‑line use have been submitted to FDA and EMA, and in March 2026 FDA approved TECVAYLI in combination with daratumumab and hyaluronidase (DARZALEX FASPRO) for patients with at least one prior line of therapy.
Source: J&J