Pivotal phase III SUNMO study demonstrated an 11.5 month median progression-free survival - three times longer than R-GemOx1This well-tolerated investigational combination therapy avoids traditional chemotherapy and may be suitable for outpatient community careThese data demonstrate Roche's commitment to providing options for diverse patient and healthcare system needs in this difficult-to-treat lymphoma Basel, 20 June 2025 - Roche (SIX: RO, ROG; OTCQX: RHHBY) presented today results from the phase III SUNM ...

Core Insights - Roche's phase III SUNMO study results indicate that the combination of Lunsumio® (mosunetuzumab) and Polivy® (polatuzumab vedotin) significantly improves progression-free survival (PFS) and objective response rate (ORR) in patients with relapsed or refractory large B-cell lymphoma (LBCL) compared to the standard treatment R-GemOx [1][2][5] Study Results - The combination therapy showed a 59% reduction in the risk of disease progression or death (hazard ratio [HR] 0.41, p<0.0001) with a median PFS of 11.5 months, which is three times longer than the 3.8 months observed with R-GemOx [2][4] - The 12-month PFS rate was 48.5% for the combination therapy compared to 17.8% for R-GemOx [2][3] - Objective response rates were 70.3% for the combination versus 40.0% for R-GemOx, with complete response rates of 51.4% compared to 24.3% [3][4] Safety Profile - The safety profile of the Lunsumio and Polivy combination was consistent with known profiles of the individual drugs, with low incidence of cytokine release syndrome (CRS) and similar rates of grade 3-4 adverse events compared to R-GemOx [4][5] - Fewer patients in the combination group discontinued treatment due to adverse events (2.2% vs. 4.7%) [4] Clinical Implications - The combination therapy may provide a well-tolerated alternative to traditional chemotherapy, suitable for outpatient settings, addressing the urgent need for effective treatments in difficult-to-treat LBCL [3][6] - The National Comprehensive Cancer Network (NCCN) has included Lunsumio and Polivy in its guidelines as a category 2A recommendation for second-line treatment of diffuse large B-cell lymphoma [2][3] Roche's Commitment - Roche aims to enhance treatment options for patients with lymphomas through its extensive portfolio and ongoing clinical trials, including the STARGLO study evaluating Columvi® (glofitamab) [7][8] - The company has a strong focus on developing innovative therapies for hematologic diseases, with a robust pipeline that includes various bispecific antibodies and antibody-drug conjugates [13][14]

Key Takeaways INCY's Monjuvi gets FDA approval for use in relapsed or refractory follicular lymphoma. The approval was backed by phase III inMIND data showing improved progression-free survival. This marks the second U.S. approval for Monjuvi in a blood cancer indication.Incyte (INCY) announced that the FDA has approved its humanized Fc-modified cytolytic CD19-targeting monoclonal antibody, Monjuvi (tafasitamab-cxix), for a new cancer indication.The U.S. regulatory body approved Monjuvi in combination wit ...

Core Insights - Genmab A/S announced promising results from the Phase 1b/2 EPCORE NHL-2 trial, demonstrating the efficacy of epcoritamab in combination with R-ICE for patients with relapsed/refractory diffuse large B-cell lymphoma (R/R DLBCL) [2][4][5] Trial Results - The overall response rate (ORR) was reported at 87 percent, with a complete response (CR) rate of 65 percent and a partial response (PR) rate of 23 percent [2][6] - At six months, 81 percent of responses were ongoing, 74 percent of patients were progression-free, and 100 percent of patients were alive [2][6] - Among patients who progressed within 12 months after first-line treatment, the ORR was 85 percent and the CR rate was 55 percent [4] - For patients who progressed after 12 months from first-line therapy, the ORR was 91 percent and the CR rate was 82 percent [4] Safety Profile - The safety profile indicated low-grade cytokine release syndrome (CRS) with no treatment discontinuations due to treatment-emergent adverse events (TEAEs) [3][5] - The most common TEAEs included neutropenia (74 percent), anemia (68 percent), and thrombocytopenia (68 percent) [3] - Serious infections were reported in 16 percent of patients, with no Grade 5 TEAEs observed [3] Industry Context - DLBCL accounts for approximately 25-30 percent of all non-Hodgkin's lymphoma cases globally, with around 25,000 new cases diagnosed annually in the U.S. [6][7] - The investigational treatment with epcoritamab aims to address significant unmet needs in the management of R/R DLBCL and other hematologic malignancies [5][12] Future Development - Genmab is collaborating with AbbVie to further develop epcoritamab as a core therapy for B-cell lymphomas, with ongoing trials evaluating its use in various treatment lines [5][12] - The EPCORE NHL-2 trial is part of a broader clinical program aimed at advancing epcoritamab both as monotherapy and in combination therapies [8][12]

免疫性血小板减少症 （ Immune thrombocytopenia， ITP） 是一种自身免疫疾病，其特征为自身抗体介导的血小板破坏。使用 抗 CD38 单克隆抗体 ，有望通 过 对 CD38 阳性细胞 （包括浆细胞） 的靶向清除来治疗该疾病。 撰文丨王聪 编辑丨王多鱼 排版丨水成文 2024 年 6 月 20 日， 中国医学科学院血液病医院 张磊 教授团队在国际顶尖医学期刊《 新英格兰医学杂志 》 （NEJM） 发表临床研究论文 【1】 ，这项 1/2 期临床研究显示，国产新药—— 抗 CD38 单克隆抗体 （CM313，由 康诺亚 开发） 治疗免疫性血小板减少症的安全性良好，显示出持久的疗效反应。在 研究纳 入的 22 例患者中，21 例 （95%） 在治疗期间连续两次血小板计数至少达到50× 10 9 /L，出血患者比例从基线的 68% 分别下降到第 8 周的 5% 和第 24 周 的 10%，而且长期缓解率高达 60% 以上。 值得一提的是，这是《 新英格兰医学杂志 》 （NEJM） 首次发表 中国原创新药 的 1/2 期临床试验结果。 2025 年 5 月 29 日， 张磊 教授团队 （ 孙婷 ...

Core Insights - Roche announced two-year follow-up data from the phase III STARGLO study, showing a 40% improvement in overall survival for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) compared to MabThera®/Rituxan® (rituximab) plus GemOx [1][5] Group 1: Study Results - The median follow-up was 24.7 months, with overall survival not reached for the Columvi combination, while it was 13.5 months for the R-GemOx group [1] - The Columvi combination demonstrated a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% CI: 0.29–0.58) [2] - Among patients achieving complete remission (CR), 89% were alive and 82% maintained remission one year post-treatment [2][5] Group 2: Treatment Implications - Columvi is approved in over 30 countries for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant [4] - The combination therapy has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment [4] - There is an urgent need for rapidly available treatments for DLBCL, as many patients do not have access to the latest therapies [3] Group 3: Safety and Efficacy - The safety profile of the Columvi combination remained consistent with previous analyses, with a higher median number of treatment cycles (11 vs. 4) due to disease progression in the R-GemOx arm [2] - Common adverse events included cytokine release syndrome, generally of low grade [2] Group 4: Company Strategy - Roche aims to provide tailored treatment options through its CD20xCD3 bispecific antibody program, which includes Columvi and other therapies [6][8] - The company is also investigating Columvi in combination with other treatments for previously untreated DLBCL in ongoing studies [9]

Core Insights - Roche announced two-year follow-up data from the phase III STARGLO study, showing a 40% improvement in overall survival for patients treated with Columvi® (glofitamab) in combination with gemcitabine and oxaliplatin (GemOx) compared to MabThera®/Rituxan® (rituximab) plus GemOx [1][4] Group 1: Study Results - The median follow-up was 24.7 months, with overall survival not reached for the Columvi combination, while it was 13.5 months for the R-GemOx group [1] - The Columvi combination demonstrated a 59% reduction in the risk of disease progression or death (hazard ratio = 0.41, 95% confidence interval: 0.29–0.58) [2] - Among patients achieving complete remission (CR) at the end of treatment, 89% were alive and 82% maintained remission one year post-treatment [2][4] Group 2: Treatment Implications - Columvi is approved in over 30 countries for patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not candidates for autologous stem cell transplant [3] - The combination of Columvi and GemOx has been added to the National Comprehensive Cancer Network Clinical Practice Guidelines as a category 1 preferred recommendation for second-line DLBCL treatment [3] - There is an urgent need for rapidly available treatments for DLBCL, as many patients do not have access to the latest therapies [2][9] Group 3: Safety and Efficacy - The safety profile of the Columvi combination remained consistent with previous analyses, with a higher rate of adverse events observed, including cytokine release syndrome, which was generally low grade [2][4] - Patients receiving the Columvi combination had a higher median number of treatment cycles (11 versus 4) due to disease progression in the R-GemOx arm [2] Group 4: Company Strategy - Roche is focused on developing tailored treatment options for blood cancers, including the CD20xCD3 bispecific antibody program, which includes Columvi and Lunsumio® [5][7] - The company is also investigating Columvi in combination with other therapies for previously untreated DLBCL in ongoing studies [8]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, which is consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][16] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, primarily due to higher license revenues and lower expenses [17] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, mainly due to net loss from operations and timing of cash receipts [17] Business Line Data and Key Metrics Changes - Milestone and royalty payments contributed an additional $5.6 million to total revenue for the quarter [6] - The LOTUS-seven study showed a 95.5% overall response rate and a 90.9% complete response rate in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with ongoing trials showing promising data [5][9] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][10] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant patient reach and commercial opportunity [9][10] - Regulatory discussions are planned based on data from 100 patients, aligning with recent examples of bispecific combination therapies [10][29] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the cash runway extending into the second half of 2026, positioning the company to deliver on upcoming catalysts [20] - The management is encouraged by the promising data from ongoing trials and believes in multiple pathways to achieve peak revenue goals [22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [7][19] - The company is engaged in discussions for potential research collaborations to advance its preclinical assets [8][19] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with encouraging complete response rates serving as strong biomarkers for durability [24][27] Question: Competitive strategy and regulatory engagement - Management plans to engage with regulatory authorities after gathering data from approximately 100 patients, assessing the best path forward [29][47] Question: Expected patient numbers at upcoming conferences - Management confirmed that 40 patients have been enrolled, with additional patients expected to be presented at the EHA conference [33][34] Question: LOTUS-five trial data expectations - Management reiterated that the timing for top-line data from the LOTUS-five trial could be late 2025 or early 2026, depending on the number of PFS events [42][43] Question: Discontinuation of the ADCT-602 program - Management clarified that the discontinuation of the ADCT-602 program has minimal financial impact, allowing focus on other research programs [49][50]

Financial Data and Key Metrics Changes - Total revenues for Q1 2025 were $23 million, including net product revenues of $17.4 million, consistent with Q1 2024 and an increase from $16.4 million in Q4 2024 [5][17] - Net loss for Q1 2025 was $38.6 million, an improvement from a net loss of $46.6 million in Q1 2024, attributed to higher license revenues and lower expenses [18] - Cash and cash equivalents as of March 31, 2025, were $194.7 million, down from $250.9 million at December 31, 2024, primarily due to net loss from operations [18] Business Line Data and Key Metrics Changes - The company reported $5.6 million in milestone and royalty payments included in total revenue for the quarter [6] - The LOTUS-seven study showed an overall response rate of 95.5% and a complete response rate of 90.9% in 22 efficacy evaluable patients [14] Market Data and Key Metrics Changes - The company is focusing on maintaining its position as a treatment option for third-line plus DLBCL patients, with promising data from the LOTUS-seven study [5][10] - The competitive landscape is highlighted by the potential of ZYNLATA plus glufitamab to be a best-in-class combination in a highly competitive market [6][11] Company Strategy and Development Direction - The company aims to expand the use of ZYNLATA into earlier lines of therapy in DLBCL and indolent lymphomas, believing in the potential for significant revenue growth [10][22] - The strategy includes pursuing regulatory discussions and compendia strategies based on the data from ongoing trials [8][11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the upcoming catalysts and the company's cash runway expected to fund operations into the second half of 2026 [10][21] - The management is optimistic about the promising data from ongoing trials and the potential to change treatment paradigms for patients with aggressive lymphoma [15][22] Other Important Information - The LOTUS-five trial is on track to reach the pre-specified number of progression-free survival events by the end of 2025, with top-line data expected thereafter [8][20] - The company is engaged in discussions for potential research collaborations to advance its programs [9][20] Q&A Session Summary Question: Follow-up time for patients and CR conversion times - Management indicated that follow-up assessments are ongoing, with high complete response rates being a strong biomarker for durability [27][28] Question: Competitive strategy and regulatory engagement - The company plans to engage with regulatory authorities once sufficient data from approximately 100 patients is available [30] Question: Expected patient numbers at upcoming conferences - Management confirmed that more patients than the 22 already discussed will be presented at the EHA and ICML conferences, but exact numbers cannot be disclosed [34] Question: Timing for LOTUS-five data readout - The company expects to reach the pre-specified number of PFS events this year, with data readout potentially at the end of this year or early next year [42] Question: Discontinuation of the ADCT-602 program - The discontinuation of the ADCT-602 program has minimal capital implications, allowing focus on advancing other research programs [50][51]

Core Insights - Artiva Biotherapeutics announced promising long-term Phase 1/2 data for AlloNK® in combination with rituximab for patients with relapsed/refractory B-cell non-Hodgkin lymphoma, showing a 64% complete response rate and a median duration of response of at least 19.4 months [1][2][3] Group 1: Clinical Data - AlloNK + rituximab demonstrated a 64% complete response rate (9 out of 14 patients) in heavily pretreated patients who were naïve to prior CAR-T cell therapy [1][3] - The median duration of response is at least 19.4 months, indicating durability comparable to approved auto-CAR-T therapies [1][3] - The safety profile of AlloNK + rituximab was well-tolerated among 45 patients, with no reports of immune effector cell associated neurotoxicity syndrome (ICANS) or graft-versus-host disease [7] Group 2: Comparison with CAR-T Therapies - The complete response rate of AlloNK + rituximab is comparable to outcomes from approved auto-CAR-T therapies, which reported 58% for Yescarta, 53% for Breyanzi, and 40% for Kymriah [3] - The median duration of response for AlloNK + rituximab is competitive with auto-CAR-T therapies, which showed 11.1 months for Yescarta, 23.1 months for Breyanzi, and not reached for Kymriah at 40.3 months follow-up [3] Group 3: Mechanism and Future Implications - AlloNK has shown the potential to enhance the activity of monoclonal antibodies, driving deep and durable responses in both aggressive B-NHL and potentially in autoimmune diseases [2][7] - The tolerability profile of AlloNK supports its use in outpatient community settings, making it a viable option for patients with refractory autoimmune diseases [7]