Johnson & Johnson Reports Positive Results For Talvey With Darzalex Faspro In Treating R/R MM
Johnson & Johnson said Phase 3 MonumenTAL-3 results showed Talvey plus Darzalex Faspro, with or without pomalidomide, reduced risk of progression or death by up to 72% and risk of death by up to 53% versus DPd, according to the company. At 24 months, PFS was 81.3% vs 51.2% and OS 89.2% vs 79.1%. J&J filed an sBLA with the FDA and a Type II variation with the EMA.
Positive Phase 3 efficacy and new regulatory filings for Talvey combinations increase probability of label expansion in R/R multiple myeloma.
Johnson & Johnson reported Phase 3 MonumenTAL-3 results showing Talvey + Darzalex Faspro reduced progression/death risk vs DPd regimen and filed sBLA/Type II variation.
Near-term: sentiment tailwind for JNJ oncology pipeline; magnitude likely moderate until FDA/EMA decisions or additional safety/endpoint details emerge.
Background
Talvey received FDA accelerated approval in 2023 for R/R multiple myeloma after at least four prior lines; MonumenTAL-3 tests Talvey with Darzalex Faspro ± pomalidomide.
Why it matters
The disclosed Phase 3 results (up to 72% reduced progression/death risk; up to 53% reduced death risk; higher 24-month PFS and OS) support a supplemental label expansion request for combination use after at least one prior line.
Market relevance
Late-stage clinical efficacy plus new regulatory filings is a direct catalyst for JNJ’s hematology pipeline expectations.
Market effects
Reinforces competitive momentum in multiple myeloma combination regimens and may lift sentiment for CD38-targeting and next-line therapy strategies.
Potential incremental positive read-through for US and Europe biotech/pharma sentiment tied to FDA/EMA review cycles.
Could modestly affect global multiple-myeloma treatment expectations and investor positioning around late-stage hematology pipelines.
Alternative perspectives
Efficacy headlines may not translate into durable commercial impact if safety/tolerability, subgroup consistency, or confirmatory endpoint requirements disappoint later.
The article omits safety/treatment-emergent adverse events and does not specify FDA/EMA review timelines; those can dominate post-submission price action.
Key entities
- companyJohnson & Johnson
Sponsor of the MonumenTAL-3 Phase 3 trial and submitter of sBLA to FDA and Type II variation to EMA for Talvey combinations.
- drugTalvey
J&J therapy evaluated in combination with Darzalex Faspro in MonumenTAL-3.
- drugDarzalex Faspro
CD38-targeting therapy used as the backbone regimen in the trial comparisons.
- regulatorFDA
Received a supplemental Biologics License Application for the Talvey + Darzalex Faspro combination.
- regulatorEMA
Received a Type II variation application for the combination regimen.
