Legend Biotech Corporation (LEGN) and Johnson & Johnson (JNJ) have announced encouraging long-term data from the Phase 3 CARTITUDE-4 study, showcasing the potential of Carvykti (ciltacabtagene autoleucel) in treating relapsed or lenalidomide-refractory multiple myeloma. This groundbreaking cell therapy demonstrated a significant extension in overall survival (OS) for patients who have received at least one prior line of therapy, making Carvykti the first and only cell therapy to outperform standard treatments in this patient group as early as the second-line setting.
The CARTITUDE-4 study compared Carvykti to conventional treatments like pomalidomide, bortezomib, and dexamethasone (PVd), or daratumumab, pomalidomide, and dexamethasone (DPd) for relapsed or lenalidomide-refractory multiple myeloma after a single prior line of therapy. After a median follow-up of nearly three years (34 months), the median OS was not reached for patients receiving Carvykti. At the 30-month mark, the OS rates were an impressive 76% for the Carvykti arm compared to 64% for those treated with standard therapies. This translates to a 45% reduction in the risk of death for patients receiving Carvykti, underscoring the therapy’s clinically meaningful benefits, even after the first relapse.
The study also unveiled remarkable results in progression-free survival (PFS). The median PFS was not reached in the Carvykti arm, while it was 11.79 months in the standard therapy group, indicating sustained, deep, and durable responses with Carvykti. Notably, patients receiving Carvykti achieved a 77% complete response or better and an 85% overall response rate. These results are further supported by the high rates of minimal residual disease (MRD) negativity in the Carvykti arm (62% at 10-5 and 57% at 10-6) compared to standard therapies (18.5% and 9%, respectively).
The median duration of response was not reached in the Carvykti arm, while it was 18.69 months for patients on standard therapies. Similarly, the median time to symptom worsening remained elusive in the Carvykti arm but was 34.33 months for patients treated with conventional therapies. This demonstrates the sustained benefits of Carvykti in managing symptoms and delaying disease progression.
William Blair, a renowned investment firm, views these data as a significant step forward for Legend Biotech, solidifying the rationale for using Carvykti as a second-line treatment option. While they acknowledge that near-term revenue and stock performance will depend on the availability of commercial manufacturing slots, they remain confident that Legend’s valuation accurately reflects the approval of Carvykti in second-line-plus treatment, its projected peak revenue, and the progress of its other pipeline programs.
