Core Insights - Johnson & Johnson has submitted a Type II variation application to the European Medicines Agency (EMA) for an indication extension of TECVAYLI® (teclistamab) in combination with DARZALEX® (daratumumab SC) for treating adult patients with relapsed/refractory multiple myeloma (RRMM) who have received at least one prior therapy [1][2] Group 1: Clinical Study and Results - The application is supported by data from the Phase 3 MajesTEC-3 study, which showed a statistically significant improvement in progression-free survival (PFS) and overall survival (OS) compared to standard treatment [1][2] - The MajesTEC-3 study enrolled 587 patients and demonstrated an 83.4% reduction in the risk of disease progression or death compared to standard regimens at nearly three years follow-up (hazard ratio [HR], 0.17; 95% confidence interval [CI], 0.12-0.23; P<0.0001) [2][4] - More than 90% of patients who remained progression-free at six months continued to be progression-free at three years [2] Group 2: Treatment Efficacy and Safety - Teclistamab and daratumumab SC work in a complementary manner by targeting both BCMA and CD38, enhancing immune-mediated responses earlier in treatment [2] - The combination regimen showed similar rates of Grade 3/4 treatment-emergent adverse events (TEAE) compared to standard care (95.1% vs. 96.6%) [2] - The most common Grade 3/4 events were cytopenia and infection, with infections observed in 96.5% of patients receiving teclistamab and daratumumab SC [2] Group 3: Regulatory and Market Position - The FDA has granted Breakthrough Therapy Designation for the teclistamab and daratumumab SC combination, expediting its development and regulatory review [2] - Johnson & Johnson aims to redefine treatment possibilities in multiple myeloma by using the right medicines early and combining them for optimal outcomes [3] Group 4: Background on Multiple Myeloma - Multiple myeloma is an incurable blood cancer affecting plasma cells, with over 35,000 new diagnoses in the EU in 2022 [8] - Patients experience frequent relapses, and remissions become progressively shorter with each line of therapy [8]

Company Overview - Arcellx is actively engaging with investors at the 67th Annual ASH Meeting in Orlando, Florida, highlighting its leadership under Rami Elghandour as Chairman and CEO [1] - The company is focusing on the evolving landscape of multiple myeloma, which is a significant area of interest for stakeholders [2] Clinical Development - Dr. Krina Patel presented the latest results from the iMMagine-1 Registrational Phase II study at the ASH Medical Congress, indicating ongoing advancements in clinical trials [3] - Following Dr. Patel's presentation, Dr. Chris Heery, the Chief Medical Officer, will moderate a physician panel to discuss further insights [3]

Clinical Trial Updates - Phase 3 SENTRY试验的顶线数据预计在2026年3月公布[8, 25] - Phase 3 XPORT-EC-042子宫内膜癌试验的顶线数据预计在2026年中期公布[8, 67] - 评估SPd治疗复发性多发性骨髓瘤患者的3期全球研究(XPORT-MM-031/EMN29)的顶线数据预计在2026年上半年公布[70, 73] - SENTRY (XPORT-MF-034) 是一项针对JAKi初治骨髓纤维化患者，Selinexor联合Ruxolitinib的3期试验，已于2025年9月完成患者招募，共353名患者[23, 24] Commercial Performance - 2025年第三季度，美国XPOVIO净产品收入为3200万美元，比2024年第三季度的2950万美元增长8.5%[37] - 公司重申2025年全年净产品收入指导范围为1.1亿美元至1.2亿美元[37, 54] - 社区环境持续驱动约60%的美国整体净产品收入[37] Financial Highlights - 2025年第三季度总收入为4400万美元，高于2024年第三季度的3880万美元[51] - 预计现有流动资金，在计入2025年10月8日宣布的融资交易的影响后，足以支持公司计划运营至2026年第二季度[53] - 研发和SG&A费用预计为2.35亿美元至2.45亿美元[54] Myelofibrosis Market Opportunity - Selinexor联合Ruxolitinib疗法在美国市场可能达到每年约10亿美元的净销售额峰值[41, 43] - 约75%的患者有意愿接受联合治疗[42]

Financial Performance & Guidance - Karyopharm's Q2 2025 U S net product revenue was $29 7 million, a 6% increase from $28 0 million in Q2 2024[69] - The company anticipates full year 2025 U S XPOVIO net product revenue to be between $110 million and $120 million[69] - Karyopharm projects total revenue between $140 million and $155 million for 2025, with R&D and SG&A expenses ranging from $240 million to $250 million[88] Myelofibrosis (MF) Program - Selinexor has a peak U S revenue opportunity of up to ~$1 billion in myelofibrosis, pending positive data and regulatory approval[9, 19, 70] - In a Phase 1 trial, 79% of patients achieved SVR35 (spleen volume reduction of 35% or more) at week 24 with selinexor plus ruxolitinib[28] - Preliminary extrapolated data from the Phase 3 SENTRY trial suggests a potentially more favorable safety profile for selinexor plus ruxolitinib compared to ruxolitinib alone, with Grade 3+ anemia rates potentially lower at ~26% compared to 37%[35, 37] - Top-line data from the Phase 3 SENTRY trial of selinexor in myelofibrosis is expected in March 2026[9, 33] Endometrial Cancer (EC) Program - The company is focusing the Phase 3 XPORT-EC-042 trial on patients with TP53wt EC who are pMMR or dMMR and medically ineligible for checkpoint inhibitors[46] - Top-line data from the Phase 3 XPORT-EC-042 trial in endometrial cancer is anticipated in mid-2026[91] Multiple Myeloma (MM) Program - Enrollment is complete in the Phase 3 XPORT-MM-031 trial evaluating SPd in patients with previously treated multiple myeloma (n~120)[60] - Top-line data from the Phase 3 XPORT-MM-031 trial in multiple myeloma is expected in the first half of 2026[93]

Core Insights - The European Commission has approved an indication extension for DARZALEX® (daratumumab) subcutaneous formulation in combination with bortezomib, lenalidomide, and dexamethasone for newly diagnosed multiple myeloma patients [1][3] - The Phase 3 CEPHEUS study demonstrated significant improvements in minimal residual disease (MRD)-negativity rate, progression-free survival, and complete response rates compared to standard care [1][4] Company Overview - Janssen-Cilag International NV, a subsidiary of Johnson & Johnson, has been a leader in multiple myeloma treatment for over 20 years, with daratumumab becoming a foundational therapy used in over 618,000 patients globally [6][7] - The company aims to provide access to daratumumab-based regimens for all patient populations, regardless of age or fitness, marking a critical step towards achieving a functional cure for multiple myeloma [3][6] Clinical Study Findings - The CEPHEUS study involved 395 patients with newly diagnosed multiple myeloma who were ineligible for stem cell transplantation, comparing daratumumab-VRd to standard VRd [4][5] - At a median follow-up of 59 months, the MRD-negativity rate was 60.9% for daratumumab-VRd versus 39.4% for VRd, with a significant odds ratio of 2.37 [1][4] - The study also reported a 43% reduction in the risk of progression or death with daratumumab-VRd compared to VRd, with median progression-free survival not reached for daratumumab-VRd [1][4] Safety Profile - The safety profile of daratumumab-VRd aligns with known safety profiles for daratumumab SC and VRd, with common Grade 3/4 adverse events including neutropenia (44.2% vs 29.7% for VRd) and thrombocytopenia (28.4% vs 20.0% for VRd) [2][4]