CARVYKTI® Performance and Market Position - CARVYKTI® demonstrates superior Overall Survival (OS) compared to Standard of Care (SoC) in Multiple Myeloma[15, 25] - CARVYKTI® has a strong launch with a 79% Net Trade Sales Compound Annual Growth Rate (CAGR) since launch, leading the industry[15] - CARVYKTI® Net Trade Sales grew by 135% in Q1 2025 compared to Q1 2024[34] - Outpatient treatment represents up to approximately 48% of CARVYKTI® volume in the U S [44] Manufacturing and Supply - The company aims to achieve 10,000 annualized doses of CARVYKTI® exiting 2025 and 20,000 annualized doses exiting 2027[58] - Commercial production at the Tech Lane facility in Belgium is targeted to initiate in the second half of 2025[58] Pipeline and R&D - The company has 11 pipeline programs in Hematologic Malignancies, Solid Tumors, and Autoimmune Diseases[11] - Legend Biotech and Novartis have an exclusive agreement to advance DLL3-targeted CAR-T therapies, including LB2102 for small cell lung cancer[74] - LB2102 targets DLL-3, which is approximately 80% positive in Small Cell Lung Cancer (SCLC)[80] Multiple Myeloma Market - Multiple Myeloma accounts for 10% of all hematologic cancers[17] - There were 187,952 new cases of Multiple Myeloma worldwide in 2022[18]

Core Insights - Johnson & Johnson announced long-term follow-up data from the CARTITUDE-1 study, showing that 33% of patients with relapsed or refractory multiple myeloma treated with CARVYKTI® achieved progression-free survival of five years or more with a single infusion [1][3][4] - The CARTITUDE-4 analysis demonstrated significant overall survival and progression-free survival benefits across various patient subgroups, including those with standard and high-risk cytogenetics [1][5] Group 1: CARTITUDE-1 Study Findings - In the CARTITUDE-1 study, 32 out of 97 patients (33%) achieved progression-free survival for at least five years after receiving CARVYKTI® [1][3] - The median overall survival for patients in the study was reported at 60.7 months, indicating a durable response to the treatment [3] - Among the patients who remained progression-free, the majority had undergone a median of six prior lines of therapy, with 90.6% being triple-class refractory [3][7] Group 2: Safety Profile - The safety profile of CARVYKTI® in the CARTITUDE-1 study remained consistent with previous findings, with no new safety signals identified [4] - Two new cases of second primary malignancies were reported, but no new cases of Parkinsonism or cranial nerve palsies were observed [4] - The incidence of cytokine release syndrome (CRS) was noted in 84% of patients, with 4% experiencing Grade 3 or higher CRS [21] Group 3: CARTITUDE-4 Study Insights - The CARTITUDE-4 study, presented at the ASCO Annual Meeting, showed that CARVYKTI® improved progression-free survival and overall survival compared to standard care in various patient subgroups [5][9] - The study included patients with relapsed and lenalidomide-refractory multiple myeloma who had received one to three prior lines of therapy [9] Group 4: Future Directions - Johnson & Johnson is focusing on shifting treatment strategies from managing progression to aiming for a cure in multiple myeloma [6] - Upcoming presentations at the European Hematology Association (EHA) 2025 Congress will further discuss the findings from the CARTITUDE studies [6]