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Patient-Reported Outcomes from the CARTITUDE-4 Study Showed Clinically Meaningful Improvements in Health-Related Quality of Life and Reductions in Multiple Myeloma Symptoms Following Treatment with CARVYKTI (ciltacabtagene autoleucel) In CARTITUDE-4, CARVYKTI demonstrated clinically meaningful improvements in patient-reported outcomes when compared to standard of care The as-treated population in CARTITUDE-4 demonstrated strong rates of progression-free survival and overall response Longer-term data from CARTITUDE-2 showed deep and durable responses in earlier lines of treatment among patients in Cohort A and Cohort B SOMERSET, N.J.--(BUSINESS WIRE)--December 11, 2023--Legend Biotech Corporation (NASDAQ: LEGN) (Legend Biotech), a global biotechnology company developing, manufacturing, and commercializing novel therapies to treat life-threatening diseases, announced today patient-reported outcome (PRO) data from the Phase 3 CARTITUDE-4 study from an oral presentation at the 2023 American Society of Hematology (ASH) Annual Meeting (Abstract #1063). These data showed clinically meaningful improvement in health-related quality of life following a single CARVYKTI (ciltacabtagene autoleucel; cilta-cel) infusion in adults lenalidomide-refractory multiple myeloma (MM) who received one to three prior lines of therapy (LOT), compared to patients treated with the standard of care (SOC) treatment regimens of either pomalidomide, bortezomib and dexamethasone (PVd) or daratumumab, pomalidomide and dexamethasone (DPd). 1 The PRO data also demonstrated meaningful reductions in disease-specific symptoms after a single infusion for patients in the CARVYKTI arm, while patients in the SOC treatment arm trended toward worsening or lower degrees of improvement from baseline for most domains and symptoms. Eligible patients in the CARTITUDE-4 study had lenalidomide-refractory MM, and had one to three prior LOT, including a proteasome inhibitor (PI) and an immunomodulatory drug. Four hundred nineteen patients were randomized, with 208 patients in the CARVYKTI arm and 211 patients in the SOC arm. At the clinical cut-off on November 1, 2022, 99 patients in the CARVYKTI arm and 66 patients in the SOC arm had baseline and 12-month PRO assessments, representing data prior to disease progression. When compared to SOC, patients who received the CARVYKTI infusion exceeded clinically meaningful thresholds for average improvement from baseline to 12 months in global health status (10.1 points vs. -1.5 points), pain (-10.2 points vs. -3.9 points), and the visual analogue scale (8.0 points vs. 1.4 points). 1 "The CARTITUDE-4 data presented today reinforce the impact that a single infusion of CARVYKTI may provide to patients," said Roberto Mina, Assistant Professor, Division of Hematology, Department of Molecular Biotechnology and Health Sciences, University of Torino, Turin, Italy. When compared to SOC, the PRO data for CARVYKTI neared clinically meaningful thresholds when evaluating improvements in fatigue (-9.1 points vs. 2.8 points) and emotional functioning (9.5 points vs. 2.2 points), and numerically favored CARVYKTI for all other domains established by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30; 100-point scale). The median time until MM symptom worsening in the CARVYKTI arm was 23.7 months compared to 18.9 months in the SOC arm (hazard ratio [HR], 0.42), as measured with the Multiple Myeloma Symptom and Impact Questionnaire (MySIm-Q; 5-point scale). 1 CARTITUDE-4 As-Treated Analysis Illustrated Favorable Progression-Free Survival (PFS) Rate An additional analysis of the CARTITUDE-4 study data was presented as a poster (Abstract #4866) at the ASH Annual Meeting. At the clinical cut-off, 176 of the 208 patients were randomized to the CARVYKTI treatment arm. The median age of this patient population was 61 years and 34 percent had received 1 prior LOT. At a median follow-up of 16 months