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Roche's Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma
GlobeNewswire News Room· 2025-06-20 15:45
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 ...
Roche’s Lunsumio and Polivy combination significantly prolongs remission for people with relapsed or refractory large B-cell lymphoma
Globenewswire· 2025-06-20 15:45
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]
三生制药(1530.HK):BD出海金额创纪录 ASCO数据表现亮眼
Ge Long Hui· 2025-06-07 18:08
三生PD-1/VEGF 双抗(707) 12.5 亿美金首付款授权辉瑞,创新能力得到验证 三生双抗成功授权辉瑞,首付款创新高。5 月20 日,三生制药宣布将PD-1/VEGF 双抗SSGJ-707 的全球 (不包含中国内地)开发、生产、商业化权利授予辉瑞,总交易金额最高可达60.5 亿美元(含12.5 亿首 付款,总额最多为48 亿美元的潜在付款,创国产创新药出海首付纪录),以及根据授权地区产品销售 额计算得到的两位数百分比的梯度销售分成,辉瑞同时1 亿美元战略入股。未来辉瑞可能重点扩展非小 细胞肺癌及结直肠癌领域。 机构:中信建投证券 研究员:贺菊颖/袁清慧/魏佳奥 核心观点 三生制药在创新药国际化合作与临床进展上双获突破:5 月20 日与辉瑞达成 PD-1/VEGF 双抗 SSGJ-707 海外权益授权,总金额最高达 61.5 亿美元(含 1 亿美元战略入股),创本土双抗出海重磅纪录;6 月1 日 ASCO 公布该药单药治疗晚期 NSCLC 的 II期数据,鳞癌/非鳞癌客观缓解率分别达75%/64 %,疾病 控制率97%,且 3 级以上治疗相关不良反应仅24.1%。此次合作充分体现公司双抗平台的临床价值, ...
New two-year follow-up of Roche’s Columvi extends overall survival in relapsed or refractory diffuse large B-cell lymphoma patients
Globenewswire· 2025-05-23 05:00
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]
Seagen(SGEN) - 2020 Q3 - Earnings Call Transcript
2025-04-29 20:13
Seagen (SGEN) Q3 2020 Earnings Call April 29, 2025 04:13 PM ET Speaker0 Good day, and welcome to the C Gen Third Quarter twenty twenty Financial Results Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Ms. Peggy Pinkston, Vice President of Investor Relations. Please go ahead. Speaker1 Thank you, operator, and good afternoon, everyone. I'd like to welcome all of you to C Gen's third quarter twenty twenty f ...