Zhitong Financial News, GenScript Biotech (01548) announced that Legend Biotech, a non-wholly-owned subsidiary of the company, has issued a press release on December 11, 2023 (New York time), announcing the patient-reported outcome data of the Phase 3 Cartitude4 study announced by Legend Biotech through oral presentations at the 2023 American Society of Hematology Annual Meeting (ASH Annual Meeting) and the data published through two other reports.
Patient-reported outcomes from the Cartitude-4 study showed a clinically meaningful improvement in health-related quality of life and a reduction in multiple myeloma symptoms with Carvykti**
Patient-reported outcomes from the Phase 3 Cartitude-4 study, presented in oral presentations at the 2023 ASH Annual Meeting (Abstract 1063), showed that patients with multiple myeloma who had previously received one to third line** and lenalidomide-resistant patients were treated with carvykti (ciltacabtagene) in a single infusion, compared with the standard** who received pomalidomide, bortezomib, and dexamethasone (PVD) or daratumumab, pomalidomide, and dexamethasone (DPD). autoleucel, cilta-cel, cilta-cel) and health-related quality of life were significantly improved. Patient-reported outcome data also showed that patients in the Carvykti** group experienced a significant reduction in disease-specific symptoms after a single infusion, while patients in the standard** group showed a trend toward worsening or less improvement in symptoms in most domains and symptoms compared to baseline.
Analysis data of Cartitude-4** showed a good progression-free survival (PFS) rate
Complementary analysis of the Cartitude-4 research data was presented as a poster (Abstract 4866) at the ASH Annual Meeting. At data cut-off, 176 of the 208 patients were randomized to the carvykti** group. The median age of patients was 61 years, 34% of patients had received a prior first-line *** At a median follow-up of 16 months after randomization, 22% of patients received one cycle of bridging**, 59% received two cycles**, and 18% received three cycles**, during which the disease burden of all patients who received ** was effectively controlled.
After 12 months of infusion, the PFS rate was 85%, the overall survival (OS) rate was 92%, the median PFS had not been reached, the overall response rate (ORR) was 99%, and 86% of patients achieved a complete response or better (>CR). Of the patients (n=144) with evaluable minimal residual disease (MRD), 77% achieved MRD-negative with complete remission or better (> CR).
The most common CAR-T cell-related toxicities include cytokine release syndrome (CRS), which occurs in 76% of patients (grade 3 in 1%), neurotoxicity in 21% (grade 3 and 4 in 3%), and immune effector cell-associated neurotoxicity syndrome (ICANS) in 5% of patients (no grade 3 to 4). Other neurotoxicity occurred in 17% of patients (grade 3 and 4 in 2%). By the time of data cut-off, all patients had remission with CRS and ICANNS.
Data from Cohorts A and B of the Cartitude-2 study show a deep durable response
The second oral presentation of the ASH Annual Meeting presents long-term efficacy and safety data for Cohorts A and B of the Cartitude-2 study (Abstract 1021). At a median follow-up of 29 months, patients with multiple myeloma who had received a first to third line** and lenalidomide-tolerant (Cohort A) and patients with an early recurrence (Cohort B) experienced a deep durable response after receiving carvykti in the first line**.
In Cohort A (n=20) and Cohort B (n=19), the ORR of receiving Carvykti ** was 95% (CR, 90%) and 100% (CR, 90%), respectively. In Cohort A, the PFS rate at 24 months was 75% and the OS rate at 24 months was 75%. In Cohort B, the 24-month PFS rate and OS rate were 73% and 84%, respectively. There were no new CAR-T-related safety signals in either cohort, but a new case of CAR-T-associated cellular neurotoxicity (Grade 2) was added to Cohort B.