Johnson & Johnson (J&J, NYSE: JNJ) announced positive topline results from the Phase 3 MajesTEC‑9 study of TECVAYLI (teclistamab‑cqyv), demonstrating superior progression‑free survival (PFS) and overall survival (OS) compared to standard of care in patients with relapsed/refractory multiple myeloma (RRMM) who are predominantly refractory to anti‑CD38 and lenalidomide therapies.
Regulatory Milestone
Item
Detail
Company
Johnson & Johnson (NYSE: JNJ)
Drug
TECVAYLI (teclistamab‑cqyv)
Study
Phase 3 MajesTEC‑9
Population
RRMM patients refractory to anti‑CD38 and lenalidomide
Comparator
Pomalidomide/bortezomib/dexamethasone (PVd) or carfilzomib/dexamethasone (Kd)
Primary Endpoint
Progression‑free survival (PFS)
Key Secondary
Overall survival (OS)
Results
71% reduction in PFS risk, 40% reduction in OS risk
Safety Profile
Clinically manageable, consistent with known profile
Drug Profile & Mechanism of Action
Mechanism: First‑in‑class bispecific T‑cell engager (TCE) antibody binding to CD3 on T‑cells and BCMA on B‑cells
Administration:Subcutaneous injection, offering convenience vs. IV‑infused CAR‑T therapies
Currently Approved: 4L+ RRMM in US (2022), EU (2023), and China (2024); this data supports 2L+ expansion
Innovation: Only off‑the‑shelf BCMA‑targeted therapy demonstrating survival benefit in heavily pretreated population
Clinical Evidence – Phase 3 MajesTEC‑9
Endpoint
TECVAYLI
PVd/Kd
Hazard Ratio
p‑Value
PFS (median)
Not reached
9.5 months
0.29
< 0.0001
OS (median)
Not reached
21.2 months
0.60
0.003
ORR
78.4 %
54.2 %
–
< 0.0001
≥CR Rate
45.2 %
22.1 %
–
< 0.0001
Grade ≥ 3 CRS
2.1 %
–
–
–
Grade ≥ 3 Neurotoxicity
1.8 %
–
–
–
Market Impact & Competitive Landscape
Parameter
2026E
2027E
2028E
US RRMM 2L+ Patients
18,000
19,000
20,000
TECVAYLI Market Share
0 %
22 %
35 %
Annual Cost (USD)
–
$325,000
$310,000
J&J Revenue (US)
–
$1.29 billion
$2.17 billion
Global Revenue
–
$2.8 billion
$4.5 billion
Competitors:
CAR‑T therapies: Abecma (BMS/2seventy) and Carvykti (J&J/Legend) – require leukapheresis and manufacturing delay
Antibody‑drug conjugates: Blenrep (GSK) – returned to GSK after failure
Other bispecifics: Elranatamab (Pfizer) – pending approval
Differentiation: TECVAYLI’s subcutaneous administration and immediate availability provide competitive edge over CAR‑T logistics
Strategic Positioning & Next Steps
Regulatory Filing: J&J plans sNDA submission to FDA in Q2 2026 for 2L+ indication; PDUFA targetQ1 2027
Manufacturing: Established global supply chain with three production sites (US, EU, China) capable of supporting 50,000+ patients annually
Commercial Readiness: 250‑person US oncology sales force already detailing TECVAYLI for 4L+; seamless expansion to 2L+ upon approval
Pipeline Synergy: Data supports potential expansion to 1L transplant‑ineligible patients and combination with Darzalex in earlier lines
Forward‑Looking Statements This brief contains forward‑looking statements regarding regulatory submissions, commercial forecasts, and market penetration for TECVAYLI. Actual results may differ due to FDA review outcomes, competitive dynamics, and market access challenges.-Fineline Info & Tech
By Fineline Cube