Core Insights - Johnson & Johnson announced updated results from the Phase 3 CARTITUDE-4 study, indicating that at least 80% of standard-risk patients with relapsed or refractory multiple myeloma remained progression and treatment-free after a single infusion of CARVYKTI as early as second-line treatment [1][2][3] - The study suggests that stronger immune fitness in patients treated earlier may correlate with longer progression-free survival [1][3] Group 1: Study Results - In the CARTITUDE-4 study, 80% of as-treated patients with standard-risk cytogenetics did not experience disease progression at 30 months following CARVYKTI infusion [1][2] - Among 176 patients treated with CARVYKTI as early as second line, the 30-month progression-free survival (PFS) rate for standard-risk patients was 80.5% [2] - All patients (100%) who achieved minimal residual disease-negative complete response at 12 months remained progression-free at 30 months [2] Group 2: Immune Fitness and Treatment Paradigm - Translational analyses indicated that patients receiving CARVYKTI after one or two prior lines of therapy exhibited stronger immune fitness compared to those with three or more prior lines [3] - The findings support a shift in treatment paradigm, emphasizing the importance of early intervention for achieving deeper and more durable responses in multiple myeloma [2][3] Group 3: Broader Implications - Johnson & Johnson is collecting and analyzing clinical and real-world data to further understand long-term remission outcomes and safety trends associated with CARVYKTI [4] - The comprehensive experience from over 9,000 patients treated globally provides a foundation for expanding CARVYKTI's use into earlier treatment settings [4]

CARVYKTI® Performance and Market Position - CARVYKTI® achieved net trade sales of $524 million in Q3 2025, representing an 84% year-over-year (YoY) growth[23] - Over 9,000 clinical and commercial patients have been treated with CARVYKTI® to date[23] - CARVYKTI® label was updated by the FDA to include Overall Survival (OS) analysis from the Phase 3 CARTITUDE-4 study[23] - U S QoQ growth of 11% primarily driven by continued strong demand with 60% utilization in earlier line settings[51] - OUS QoQ growth of 58% primarily driven by launch uptake in 14 markets worldwide[51] Clinical Advancements and Pipeline - CARTITUDE-4 study showed approximately a 70% reduction in the risk of progression or death in patients who received cilta-cel[27] - The CARTITUDE-4 study also demonstrated a 45% reduction in the risk of death in patients receiving cilta-cel versus standard of care (SOC)[27] - The company has 10 pipeline programs, including hematologic malignancies, solid tumors, and autoimmune diseases[43] - Greatest benefit in 1 prior line of therapy, reducing the risk of progression or death versus SOC with a hazard ratio (HR) of 0 35[36] Financial Performance and Outlook - The company has a cash position of approximately $1 billion as of September 30, 2025[43, 75] - Operating margin improved from -142% in Q2 2023 to -16% in Q3 2025[66] - Adjusted net loss improved from $42 million in Q3 2024 to $19 million in Q3 2025[68]

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]