J&J and Legend’s Carvykti Demonstrates Significant Survival Benefit in Earlier-Line Multiple Myeloma Treatment

Significant Survival Improvement:
Johnson & Johnson and Legend Biotech's Carvykti, a CAR-T therapy, has shown a statistically significant and clinically meaningful improvement in overall survival for patients with multiple myeloma in the second-line setting.

CARTITUDE-4 Study:
The Phase III CARTITUDE-4 study compared Carvykti with standard combination therapies in patients who had tried one to three prior lines of therapy, demonstrating Carvykti's efficacy in extending patient lives.

Second-Line Approval:
Carvykti received FDA approval as a second-line therapy for multiple myeloma based on CARTITUDE-4 data, which showed a 59% reduction in the risk of disease progression or death versus standard therapies.

Safety Profile:
Despite its benefits, Carvykti carries risks of cytokine release syndrome and neurological toxicities, necessitating close monitoring of patients for high fever and altered mental status.

Regulatory Milestones:
The European Commission granted conditional approval for Carvykti in earlier lines of relapsed and refractory multiple myeloma, recognizing its potential to significantly improve outcomes for eligible patients.

Manufacturing Expansion:
J&J and Legend are working to strengthen their supply of Carvykti, aiming to double capacity by the end of 2024 compared to 2023, and have partnered with Novartis for additional manufacturing support.