CARVYKTI, a BCMA-directed CAR-T cell therapy developed by Legend Biotech, has demonstrated a significant improvement in overall survival for patients with relapsed or refractory multiple myeloma (r/rMM). The Phase III CARTITUDE-4 trial results, presented at the International Myeloma Society meeting, indicate a 45% reduction in the risk of death compared to treatment with PVd/DPd regimens.
The study reported a hazard ratio of 0.55 (p=0.0009), highlighting a statistically significant survival benefit. At 30 months, 76% of patients treated with CARVYKTI were alive, versus 64% in the PVd/DPd arm. This data positions CARVYKTI as a leading autologous BCMA CAR-T therapy in the treatment landscape for r/rMM.
Market Impact and Future Projections
Piper Sandler maintains an Overweight rating on Legend Biotech shares with a price target of $90.00, citing CARVYKTI's strong market performance. Current demand for CARVYKTI exceeds supply, and analysts predict revenues will reach $918 million in the current year, potentially doubling to $1.75 billion by 2025 as supply increases to 10,000 autologous doses by the end of 2025.
Pipeline Expansion
Legend Biotech is actively expanding the clinical development of CARVYKTI. The CARTITUDE-5 trial is now fully enrolled, and the CARTITUDE-6 trial is enrolling rapidly. These trials could potentially establish CARVYKTI as a first-line therapy for multiple myeloma, further solidifying its market position.
Financial Stability
As of the second quarter of 2024, Legend Biotech reported approximately $1.3 billion in cash reserves, which is expected to fund operations through to operating profit in 2026. The company has an outstanding obligation to Janssen of $292 million.
Analyst Confidence
Several analyst firms, including BMO Capital, Scotiabank, and H.C. Wainwright, have reiterated their Outperform and Buy ratings for Legend Biotech, reflecting confidence in the company's continued success and the promising future of CARVYKTI. Scotiabank has revised its price target to $70.00, TD Cowen to $67.00, and BTIG holds a Buy rating with a $91.00 price target, all maintaining a positive outlook.
