A Study to Evaluate the Efficacy and Safety of Genotype-guided Targeted Agents in Combination With POLA-RCHP VERSUS POLA-RCHP in Patients With Previously Untreated Diffuse Large B-cell Lymphoma

The purpose of this study is to compare the efficacy and safety of genotype-guided targeted agents in combination with polatuzumab vedotin plus rituximab, cyclophosphamide, doxorubicin, and prednisone (Pola RCHP-X) versus Pola RCHP in Chinese patients with previously untreated diffuse large B-cell lymphoma (DLBCL).

开始日期2024-12-31

申办/合作机构-

NCT06453044 / Not yet recruiting临床2期IIT

A Phase 2 Study of Mosunetuzumab With Polatuzumab Vedotin in Patients With Relapsed/Refractory Follicular Lymphoma

This phase II trial tests how well mosunetuzumab and polatuzumab vedotin works in treating patients with grade 1-3a follicular lymphoma that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab is a monoclonal antibody that may interfere with the ability of cancer cells to grow and spread. Polatuzumab vedotin is a monoclonal antibody, polatuzumab, linked to a toxic agent called vedotin. Polatuzumab attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Giving mosunetuzumab and polatuzumab vedotin may kill more cancer cells in patients with relapsed or refractory grade 1-3a follicular lymphoma.

开始日期2024-08-24

申办/合作机构

City of Hope National Medical Center

[+1]

NCT06015880 / Recruiting临床1期IIT

A Phase 1 Study of Mosunetuzumab With Polatuzumab Vedotin and Lenalidomide (M+Pola+Len) in Relapsed/Refractory (R/R) Diffuse Large B-Cell Lymphoma (DLBCL)

This phase I trial studies the side effects and best dose of mosunetuzumab when given together with polatuzumab vedotin and lenalidomide in treating patients with diffuse large B-cell lymphoma (DLBCL) that has come back after a period of improvement (relapsed) or that has not responded to previous treatment (refractory). Mosunetuzumab and polatuzumab vedotin are monoclonal antibodies that may interfere with the ability of cancer cells to grow and spread. Polatuzumab, linked to a toxic agent called vedotin, attaches to CD79B positive cancer cells in a targeted way and delivers vedotin to kill them. Lenalidomide may stimulate or suppress the immune system in different ways and stop cancer cells from growing and by preventing the growth of new blood vessels that cancer cells need to grow. Giving mosunetuzumab with polatuzumab vedotin and lenalidomide may work better in treating patients with relapsed/refractory DLBCL.

开始日期2024-05-20

申办/合作机构

National Cancer Institute

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153

项与维泊妥珠单抗相关的文献（医药）

2024-03-01·Annals of hematology

Refractory hemophagocytic lymphohistiocytosis secondary to polatuzumab vedotin plus rituximab and bendamustine

Letter

作者: Kong, Fancong ; Lv, Kebing ; Zhou, Yulan ; Li, Fei ; Yu, Min

A 66-yr-old woman was diagnosed with stage IVB diffuse large B-cell lymphoma (DLBCL), accompanied by multiple lymphadenopathy and no bone marrow infiltration.The lymphoma remained uncontrolled after the first-line treatment with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisolone (R-CHOP); then rituximab plus gemcitabine, cisplatin, and dexamethasone (R-GDP), PD-1/Bcl-2/Btk inhibitor; and other multi-line treatments.Clin. and laboratory parameters relative to timing of Pola+ BR and tocilizumab. On the 7th day of the Pola+ BR treatment, the patient caught fever and CRS, with hyperferritinemia, increased sIL-2R, cytopenias, hypertriglyceridemia, and splenomegaly.On the 38th day of Pola + BR treatment, various examination indicators continued to deteriorate, and the patient was diagnosed with HLH and refractory to glucocorticoids and ruxolitinib.These improved significantly after continuous infusion of tocilizumab combined with gradual reduction, and HLH was assessed as PR after 4 wk.

2024-02-01·The Lancet. Haematology

Polatuzumab vedotin plus rituximab and lenalidomide in patients with relapsed or refractory diffuse large B-cell lymphoma: a cohort of a multicentre, single-arm, phase 1b/2 study

Article

作者: Panizo, Carlos ; Triguero, Ana ; Sharma, Sunil ; Abrisqueta, Pau ; Banerjee, Lalita ; Bastos-Oreiro, Mariana ; González-Barca, Eva ; Pérez, José María Arguiñano ; Jin, Hyun Yong ; Musick, Lisa ; McMillan, Andrew ; Seymour, Erlene ; Hirata, Jamie ; de Guzman, Jayson ; Miall, Fiona ; Diefenbach, Catherine

BACKGROUND:

Diffuse large B-cell lymphoma comprises nearly 30% of non-Hodgkin lymphoma cases and patients with relapsed or refractory diffuse large B-cell lymphoma who are ineligible for stem-cell transplantation have few treatment options and poor prognoses. We aimed to determine whether the novel combination of polatuzumab vedotin in combination with rituximab and lenalidomide (Pola+R+Len) would provide a tolerable treatment option with enhanced antitumour response in patients with relapsed or refractory diffuse large B-cell lymphoma.

METHODS:

This completed phase 1b/2, open-label, multicentre, single-arm study (GO29834) evaluated the safety and efficacy of Pola+R+Len in patients with relapsed or refractory diffuse large B-cell lymphoma at 19 sites in three countries (USA, Spain, and UK). Patients (≥18 years old) were eligible for inclusion if they had histologically documented CD20-positive relapsed or refractory diffuse large B-cell lymphoma and Eastern Cooperative Oncology Group performance status of 2 or lower, had received at least one previous line of chemoimmunotherapy, including an anti-CD20 agent, and were ineligible for stem-cell transplantation. The dose-escalation phase (1b) used escalating doses of lenalidomide to find the recommended phase 2 dose. Patients received six 28-day cycles of induction treatment with intravenous rituximab 375 mg/m² and intravenous polatuzumab vedotin 1·8 mg/kg (all cohorts) plus oral lenalidomide at the following doses: 10 mg (cohort A); 15 mg (cohort B); and 20 mg (cohort C). Rituximab and polatuzumab vedotin were administered on day 1 and lenalidomide on days 1-21 of each 28-day cycle. During the dose-expansion phase (2), patients received six 28-day cycles of Pola+R+Len at the recommended phase 2 dose established during dose escalation. In both phases, patients with a complete response or partial response at the end of induction were eligible for post-induction therapy with rituximab 375 mg/m² on day 1 and lenalidomide 10 mg/day on days 1-21 of each 28-day cycle for a maximum of 6 cycles. The primary safety objective of the dose-escalation phase was identification of the maximum tolerated dose through incidence of dose-limiting toxic effects. The primary efficacy outcome of the dose-expansion phase was Independent Review Committee-assessed complete response rate at end of induction, based on PET-CT. Analyses were conducted in the safety population, which included all patients who received at least one dose of any study drug, and the efficacy population, which included all patients who received at least one dose of any study drug at the recommended phase 2 dose. This study is registered with ClinicalTrials.gov, number NCT02600897.

FINDINGS:

Between July 11, 2017 and Feb 3, 2020, 57 patients were enrolled (median age 71 years [IQR 60-75]; 38 [67%] were male and 19 (33%) were female; 47 [82%] were not Hispanic or Latino; and the median previous lines of therapy was 2 [IQR 1-3]). 18 participants were included in phase 1b and 39 were included in phase 2. Phase 1b confirmed a 20 mg recommended phase 2 dose for lenalidomide. After a median follow-up of 11·8 months (IQR 4·7-25·8), the complete response rate, as assessed by the Independent Review Committee, was 31% (90% CI 20-43). The most common grade 3-4 adverse events were neutropenia (35 [61%] of 57) and thrombocytopenia (eight [14%] of 57). Serious adverse events were reported in 23 (40%) of 57 patients and one patient died due to a treatment-related adverse event (neutropenic sepsis).

INTERPRETATION:

Although the combination of Pola+R+Len did not meet the prespecified activity threshold, some patients derived clinical benefit and the regimen had a tolerable safety profile in patients with relapsed or refractory diffuse large B-cell lymphoma.

FUNDING:

Genentech/F Hoffmann-La Roche.

2024-01-01·Nature medicine1区 · 医学

Mosunetuzumab with polatuzumab vedotin in relapsed or refractory aggressive large B cell lymphoma: a phase 1b/2 trial

1区 · 医学

Article

作者: Batlevi, Connie Lee ; Pham, Song ; Sabry, Waleed ; Ghosh, Nilanjan ; Kamdar, Manali ; Ead, Wahib S ; To, Iris ; Lossos, Izidore S ; Assouline, Sarit ; Diefenbach, Catherine ; Jing, Jing ; Wu, Hao ; Nakhoda, Shazia K ; Modi, Dipenkumar ; Olszewski, Adam J ; Smith, Stephen D ; Dorritie, Kathleen ; Naik, Seema ; Wei, Michael C ; Huw, Ling-Yuh ; Mehta, Amitkumar ; Budde, Lihua E ; Chavez, Julio C ; Jia, Ting

Abstract:

Relapsed/refractory aggressive large B cell lymphoma (LBCL) remains an area of unmet need. Here we report the primary analysis of a phase 1b/2 trial of outpatient mosunetuzumab (a CD20xCD3 T-cell-engaging bispecific antibody) plus polatuzumab vedotin (an anti-CD79B antibody–drug conjugate) in relapsed/refractory LBCL. The phase 2 component is a single arm of an ongoing multi-arm trial. The primary endpoint during dose expansion was independent review committee (IRC)-assessed best overall response rate. Secondary endpoints included investigator-assessed overall response rate, complete response, duration of response, progression-free survival and overall survival. At data cutoff, 120 patients were enrolled (22 dose escalation, 98 dose expansion). The primary endpoint was met during dose expansion, with IRC-assessed best overall response rate and complete response rates of 59.2% (58/98; 95% confidence interval (CI): 48.8–69.0) and 45.9% (45/98; 95% CI: 35.8–56.3), respectively (median follow-up, 23.9 months). Median duration of complete was not reached (95% CI: 20.5–not estimable (NE)). Median progression-free survival was 11.4 months (95% CI: 6.2–18.7). Median overall survival was 23.3 months (95% CI: 14.8–NE). Across dose escalation and expansion, the most common grade 3 or higher adverse events were neutropenia (25.0%, 30/120) and fatigue (6.7%, 8/120). Any-grade cytokine release syndrome occurred in 16.7% of patients. These data demonstrate that mosunetuzumab plus polatuzumab vedotin has a favorable safety profile with highly durable responses suitable as second-line therapy in transplant-ineligible relapsed/refractory LBCL. ClinicalTrials.gov identifier: NCT03671018.

393

项与维泊妥珠单抗相关的新闻（医药）

2024-07-01

·E药经理人

辉瑞“挖”诺华战将掌舵肿瘤商业化，决战肿瘤“五霸”，还差点啥？

销售额占比接近1/2的产品专利将到期、增速已疲软，430亿美元世纪并购后核心产品陷增长困境，三天前官宣的辉瑞肿瘤商业化新负责人如何收拾这笔“烂摊子”？撰文| 润屿 Erin 编辑| 顿河润屿 2023年，116亿美元抗肿瘤业务收入，一款专利将到期、增速已疲软的产品就占到一半。增长压力下，辉瑞豪掷430亿美元将ADC先驱Seagen收入麾下，力图换来多款重磅炸弹“希望之星”。这笔收购的完成在2023年短暂拯救了辉瑞持续下滑的股价。然而此后，辉瑞的股价至今仍在27～29美元之间徘徊，Seagen带来的市值高点似乎也在1700亿美元止步不前。于是，辉瑞在2024年重振旗鼓，成立肿瘤事业部，提出2030年拥有至少8种重磅抗肿瘤药物，新产品占肿瘤业务总收2/3的目标。有Seagen的加持，数量不在话下。但在质量上，前有罗氏、BMS、默沙东等公认的肿瘤“五霸”封路，后有诺华、第一三共等源源不断的新品上市，狼环伺虎下，辉瑞又将如何突出重围？这或许也是三天前辉瑞从诺华挖来商业化负责人Tina Deignan的原因，这位曾经的“O”药灵魂人物，率领诺华两大核药在美商业化的“老将”，如何重领辉瑞“硬刚”肿瘤五霸，直面新品冲击？ O药战将如何“盘活”辉瑞肿瘤销售？ 2023年12月，伴随Seagen的加入，辉瑞进行了一次组织架构调整，成立“the Pfizer Oncology Division”（辉瑞肿瘤事业部），并任命辉瑞肿瘤业务研发主管Chris Boshoff担任该事业部的负责人、执行副总裁。同时，辉瑞肿瘤事业部的调整还“以人才为中心”进行了相应的调整，根据肿瘤药物的早期研发、临床开发、商业化等环节分别任命了相应的主管。本次Tina Deignan的加入就是接替原来商业化负责人Suneet Varma的职位。Suneet Varma即将在2025年初从该职位退休。值得一提的是，辉瑞肿瘤事业部于今年1月1日启用后，Chris Boshoff还在今年2月的投资者活动上宣布了辉瑞的野心，“公司的目标是到2030年拥有至少八种重磅抗肿瘤药物，重点发力乳腺癌、泌尿生殖系统肿瘤、血液肿瘤和胸腔癌症，并且来自新产品/新适应证的收入将占到肿瘤药物总收入的三分之二。” 其实从产品数量上来看，在提出这一目标时，辉瑞已经手握Ibrance（哌柏西利），Inlyta（阿昔替尼）和Xtandi（恩扎卢胺）三款重磅药物，再加上Seagen的ADC产品Padcev、Adcetris、Tivdak，以及目前辉瑞/Seagen正在高速增长的诸多抗肿瘤药物，2030年8款重磅药物的目标对于辉瑞来说简直轻而易举。不过，尽管对于数量目标十拿九稳，辉瑞最大的挑战其实是新产品/新适应证占据抗肿瘤总收入的三分之二——这是一个质量上的目标。要知道，如今在哌柏西利之后，辉瑞的重磅炸弹产品其实已经出现了断层。2023年抗肿瘤业务总收入才116亿美元，哌柏西利收入就几乎占据了一半。如何在六年时间内使创新产品销售快速放量，并成为业绩发展的新动能，辉瑞缺的不仅是爆款产品，更是为实现产品商业价值更精密的布局。其中，人才无疑是关键要素之一。从Tina Deignan的履历上来看，其实是业内少有曾经兼具肿瘤免疫疗法、放射疗法商业化经验的商业化负责人。 Tina Deignan拥有柏林圣三一学院免疫学博士学位和柏林商学院商业研究硕士学位。 2007年，Tina Deignan加入BMS，在此后的15年间，一路从产品经理做到美国免疫学负责人。自2014年O药首次在FDA获批后，Tina Deignan也是O药美国商业化团队的主要负责人之一，几乎伴随O药最重要的市场准入阶段。而在2022年，Tina Deignan加入诺华后，也是诺华核药疗法的美国商业化团队的“灵魂人物”之一，两大核心重磅产品Lutathera和Pluvicto在美国的商业化都少不了Tina Deignan的身影。据悉，Pluvicto已经是全球销售额最高的核药产品，在2023年已经实现了9.8亿美元销售额，增速高达260%，美国市场贡献了主要收入。而辉瑞与安斯泰来合作的产品雄激素受体信号转导抑制剂恩扎卢胺（Xtandi），已经于2023年11月获批新适应证早期前列腺癌，是诺华Pluvicto的直接竞争对手。此外，辉瑞在2023年10月推出的Braftovi-Mektovi组合疗法，用于治疗携带BRAF V600E突变的转移性非小细胞肺癌（NSCLC）患者，也直击阻击诺华Tafinlar-Mekinist组合疗法的市场。 “新东家”和“老东家”的“正面刚”是一方面，对于Tina Deignan的挑战还有如何盘活辉瑞的成熟产品。另一个棘手的问题是，辉瑞CEO曾将公司在抗肿瘤业务的发展定为公司的头等大事，接下来，在这位抗肿瘤药物商业化拥有20年丰富经验的“老将”的加盟下后，辉瑞又将如何与BMS、罗氏等老牌选手“硬刚”？推荐阅读 * 辉瑞困于辉瑞 * 辉瑞“硬刚”肿瘤五霸，BMS大裁员，罗氏再砍管线，Q1营收TOP10药企仍在阵痛中… 对战肿瘤“五霸”，辉瑞到底差什么？很明显，无论是制定花钱花在刀刃上的调整计划，还是肿瘤业务的组织架构迅速配合到位，辉瑞明显已经正式出击了。但是，他能在2030年实现8款重磅级肿瘤药的目标吗？他能单挑肿瘤五大“霸主”——默沙东、BMS、罗氏、强生和阿斯利康吗？悬念非常大。肿瘤“五霸”内部混战本身就很激烈：争百亿元级重磅畅销药排位，比拼肿瘤业务总收入，争肿瘤领域新型技术产品布局，最关键的，是在争夺下一个大药大爆的机会。但从新冠一梦中苏醒过来的辉瑞，既缺早期研发能力，又缺成熟或潜在的重磅炸弹产品。过去很长一段时间，辉瑞肿瘤管线十分丰富，已获批抗肿瘤药不低于20款，但最大的问题是，始终缺乏爆款。收购Seagen之前，辉瑞抗肿瘤药主要是上述三款小分子药——哌柏西利，阿昔替尼和恩扎卢胺。成为肿瘤业务支柱的，只有哌柏西利。但可惜的是，这款产品的“花期”太短，由于后继竞争者强势进攻，以及临床试验数次失利，辉瑞没能坚守哌柏西利50亿美元重磅药物的地位。作为内分泌治疗进入靶向时代后全球首款上市的CDK4/6抑制剂，哌柏西利的出现，具有划时代意义。2020年，哌柏西利突破50亿美元大关。2019至2021年，哌柏西利均在辉瑞销售额TOP3产品之列。但自竞品礼来阿贝西利上市后，由于阿贝西利打入各市场的策略和节奏把控得较好，很快就造成了较强劲的威胁。近几年，哌柏西利销售额在全球市场增速放缓，2022年同比下降6%，2023年，延续下降趋势，降幅同样为6%。2023年，该产品营收额已跌出50亿美元开外。2027年，哌柏西利专利届满，留给辉瑞的时间，其实不多了。在失守50亿美元大药的同时，辉瑞肿瘤业务存在一个最大的问题是，目前没有一个产品立马接续。 2023年，辉瑞的肿瘤业务部门表现不佳。在初级保健、专业护理和肿瘤三大业务板块中，肿瘤业务营收占比最低，为116.27亿美元，较上一年下滑了4%，比起其余两大业务表现相对较为弱势。同时，这一收入情况，与肿瘤“五霸”比起来，还存在较大的差距。如果仅按照主要产品收入来看，2023年，拥有K药、O药的默沙东与BMS肿瘤业务收入均在260亿美元以上水平，罗氏逾200亿美元，强生、AZ也在170亿美元之上。关键是，尽管都遇到了专利悬崖等危机，但“五霸”中多数企业能够再坚守几年市场地位，抑或是产品销售额已无限趋近百亿美元水平，又或是已经找到了潜在重磅炸弹。但于辉瑞而言，除了哌柏西利，目前能够支撑肿瘤业务收入的产品，似乎力量是受限的。 2023年，辉瑞销售额排名前20的产品中，肿瘤药仅贡献了3款，除了哌柏西利，剩下两款小分子药，销售额均限于10亿美元上下水平。其中，恩扎卢胺（Xtandi，前列腺癌领域）销售额在2023年出现小幅下降，至11.91亿元，该药同样也将在2027年失去专利保护。辉瑞有意识地将肿瘤业务KPI，放在了发展大分子药物上，他将Seagen的几款产品，视作扭转肿瘤业务的拐点。不能忽略的是，今年Q1，辉瑞抗肿瘤领域的收入同比增长了19%，表现算很亮眼，辉瑞强调由收购Seagen而获得的4种产品，带来了重磅增长潜力。但从长期来看，Seagen这几款产品竞争力如何？ Seagen四款产品分别是Adcetris、Padcev、Tivdak、Polivy，其中三款为“first-in-class”的ADC药物，一款为合作ADC药物。在2023年被辉瑞收购之前，四款药物能为Seagen带来了17亿美元的收入。不过，Evaluate Pharma数据显示，2023年，辉瑞/Seagen的ADC销售额为19.52亿美元。这样来看，Seagen的ADC收入增速并不快。值得注意的是，Evaluate Pharma预测，2028年，第一三共的ADC收入将由2023年的24.59亿美元增长至99.98亿美元，说明有DS-8201等明星产品加持，市场给到的预期非常高。但与此同时，Evaluate Pharma预计2028年辉瑞/Seagen的ADC收入达52.77亿美元，据此推算，按现有辉瑞的商业化产品实力，实现2030年的销售既定目标，是有一些难度的。那么如何实现预期，一边要看焕新的肿瘤业务团队能不能打赢这场仗，另一边要看辉瑞能不能不能在剩下的6年时间里，诞生一款增速相当快的肿瘤产品。今年Q1，辉瑞启动了三项关键的III期研究，包括选择性CDK4抑制剂atirmociclib的首次III期试验，以及Elrexfio用于治疗多发性骨髓瘤的第四次III期临床试验。但系列后期产品何时上市，潜力如何，能否抵御同疾病领域市场竞争？这仍是悬在辉瑞头上的一个大问题。回复“逆商”，了解电子期刊详情精彩推荐 CM10 | 集采 | 国谈 | 医保动态 | 药审 | 人才 | 薪资 | 榜单 | CAR-T | PD-1 | mRNA | 单抗 | 商业化 | 国际化｜猎药人系列专题 | 出海启思会 | 声音·责任 | 创百汇 | E药经理人理事会 | 微解药直播 | 大国新药 | 营销硬观点 | 投资人去哪儿 | 分析师看赛道 | 药事每周谈 | 医药界·E药经理人 | 中国医药手册创新100强榜单 | 恒瑞 | 中国生物制药 | 百济 | 石药 | 信达 | 君实 | 复宏汉霖｜翰森 | 康方生物 | 上海医药 | 和黄医药 | 东阳光药 | 荣昌 | 亚盛医药 | 齐鲁制药 | 康宁杰瑞 | 贝达药业 | 微芯生物 | 复星医药｜再鼎医药｜亚虹医药跨国药企50强榜单 | 辉瑞 | 艾伯维 | 诺华 | 强生 | 罗氏 | BMS | 默克 | 赛诺菲 | AZ | GSK | 武田 | 吉利德科学 | 礼来 | 安进 | 诺和诺德 | 拜耳 | 莫德纳 | BI | 晖致 | 再生元

抗体药物偶联物并购专利到期高管变更

2024-07-01

·PMLiVE

AbbVie announces CHMP recommendation for Tepkinly in follicular lymphoma

AbbVie has announced that its IgG1-bispecific antibody Tepkinly (epcoritamab) has been recommended by the European Medicines Agency’s human medicines committee to treat specific cases of follicular lymphoma (FL). The Committee for Medicinal Products for Human Use (CHMP) has recommended that the drug, which is being co-developed by AbbVie and Genmab as part of the companies’ oncology collaboration, be granted conditional marketing authorisation as a monotherapy for adults with relapsed or refractory (R/R) FL who have received at least two prior therapies. The CHMP’s recommendation of the therapy was supported by positive results from the phase 1/2 EPCORE NHL-1 clinical trial, which evaluated the safety and efficacy of Tepkinly in more than 120 adults with R/R FL. FL is the second-most common form of non-Hodgkin lymphoma, accounting for up to 30% of all cases. The disease is considered incurable, with patients frequently relapsing and the prognosis worsening after each subsequent relapse. Administered subcutaneously, Tepkinly is designed to simultaneously bind to CD3 on T cells and CD20 on B cells and induce T-cell-mediated killing of CD20-positive cells. Mariana Cota Stirner, vice president, therapeutic area head for haematology at AbbVie, said: “Patients with FL are likely to face disease recurrence and shorter durability of response with each subsequent line of treatment. “This positive opinion recognises the unmet need in the EU for individuals with R/R FL, following failure of other therapies.” AbbVie announced earlier this year that Tepkinly had been recommended by the National Institute for Health and Care Excellence to treat certain adults with diffuse large B-cell lymphoma (DLBCL). The agency’s decision specifically applies to patients who have DLBCL that has returned or not responded to at least two previous treatments, including Roche’s CD79b-directed antibody-drug conjugate Polivy (polatuzumab vedotin), unless this is contraindicated or not tolerated. AbbVie and Genmab also received accelerated approval by the US Food and Drug Administration (FDA) last month for epcoritamab, under the brand name Epkinly, to treat adults with R/R FL. Both companies share commercial responsibilities for epcoritamab in the US and Japan, while AbbVie is responsible for further global commercialisation.

上市批准加速审批临床结果

2024-06-30

·赛柏蓝

2024年医保目录调整启动｜这些药品大降价

编者按：本文来自新康界，作者慧玲；赛柏蓝授权转载，编辑yuki 7月1日起，2024年医保药品目录调整正式开启申报工作。这是从2018年国家医保局成立以来，连续第七年的调整。实际上，每年医保目录调整前，药品降价已成为部分药企的常规操作。主动降价，也被视作相关药企积极参与医保谈判的诚意之举。据新康界统计，6月以来已有不少未进医保的药品主动申请降价，包括卡度尼利单抗、德曲妥珠单抗、维泊妥珠单抗、抗骨增生片等品种，降幅分别达到53.4%、22%、7%、6%。 6月部分主动下调价格的药品情况 01 未进医保，去年大卖近14亿在国家医保局发布目录调整信息后不久，有消息称，康方生物下调了其双抗新药卡度尼利单抗（开坦尼）的价格，单支价格从原先的13220元/125mg/瓶降至6166元/125mg/瓶，降幅53.4%。同日，康方生物确认了这一价格且取消赠药，称这一价格将给予患者购药更大灵活性，并表示将积极参加今年医保谈判。据悉，卡度尼利单抗上市后一直靠自费市场，此次降价后年治疗费用约为44万元，正好能挤入今年医保谈判的门槛。但康方生物表示，降价是为参加医保做出的调整。卡度尼利的年费用只是回到了没有赠药方案的水平，并不存在所谓大幅降价。目前康方正在积极筹备卡度尼利进医保的相关材料。抗癌药卡度尼利单抗是国内首个双特异性抗体，2022年6月，卡度尼利单抗踩线获批上市，但没有在当年进入医保目录，反而在自费市场表现十分亮眼。刚上市半年，卡度尼利单抗大卖5亿元，2023全年销售额达到13.58亿元，同比增长149%。仅从等级医院市场销售情况来看，卡度尼利单抗在2023年销售额同比上涨928.9%，达1.71亿元；2024年一季度销售4.7千万元。面对今年医保目录的调整，卡度尼利单抗似乎已做好准备。卡度尼利单抗全国等级医院销售情况截至2023年底，继国内第六个获批上市的PD-L1，同时也是第四个国产PD-L1——索卡佐利单抗年底获批上市后，目前国内共有17个获批上市的PD-(L)1产品，其中有11款PD-1、6款PD-L1，涉及超过10个瘤种和相关的泛瘤种。 17个产品中，有9个产品共22项申请正处于扩展新适应症的上市申请中，另外还有7个产品共计9项申请正在NDA新药首次上市申请中。然而2023年版（2024年1月开始执行）的医保目录中，只有4个国产品牌继续续约，未新增进口品牌或其他国产品牌进入目录。迫于PD-1竞争的愈演愈烈，康方生物或试图通过将卡度尼利单抗降价的方式，以减轻医保基金的压力，从而提高进医保概率。 02 多款重磅药物主动降价 2024年医保目录调整已然成为影响未来发展的风向标，包括PD-1、罕见病药物、慢病药物、抗病毒药物和新兴治疗领域等。 6月14日，据辽宁省药品和医用耗材集中采购网发布的《关于执行淡竹叶配方颗粒等175个药品主动降价结果的通知》，注射用维泊妥珠单抗药品价格从10400元/30mg/瓶主动降价至9580元/30mg/瓶，价格下降7%，虽调价幅度不大，但依据市场规则价格也有所松动。 6月19日，湖北省医疗保障局对近期主动申请下调挂网价的部分挂网药品进行了审核及公示。共包括98个主动下调价格的药品，如吉林一正药业的抗骨增生片，价格从403.2元/瓶下调至377.66/瓶，降幅达6%。值得一提的是，湖南科伦制药是此次降幅最为明显的企业。其上榜的注射用头孢曲松钠本身已是医保产品，价格从464元/2g下调至44.88元/2g、214.5元/1g下调至26.4元/1g，分别降幅达90%、88%。据悉，阿斯利康的德曲妥珠单抗也于近日主动申报药品降价，由原先的8860元/支降为6912元/支，降幅达22%，并同步取消慈善赠药，也展现出了参与新一轮医保谈判的决心。随着医保目录工作调整的开启，多个药品赶在6月30日之前压线获批，为国谈而努力。6月25日，国家药监局官网发布130个产品受理号获批，其中有26款新药、4个过评、超100个报产申请。其中几款产品都卡在了新国谈到来之际。如海思科的1类新药考格列汀片，用于2型糖尿病，是全球首个超长效DPP-4抑制剂且双周口服降糖药。此前已有恒瑞的瑞格列汀、科伦的曲格列汀，如今考格列汀片也加入了国内DDP4药物竞争。同样卡点新国谈资质的，还有绿叶制药的注射用罗替高汀微球、南京优科的氯维地平乳状注射液等。注射用罗替高汀微球每周给药一次，是全球首个治疗帕金森病的长效缓释微球制剂；南京优科的氯维地平乳状注射液是国内首家，用于高血压治疗。 03 18款罕见病药物有望纳入医保目录自诺西那生钠注射液国谈成功后，越来越多高值罕见病药被纳入国家医保目录，如2023年被纳入目录的艾加莫德α注射液(20ml:0.4g/瓶）、依库珠单抗注射液（30ml:300mg/瓶）。在纳入医保前，两款药物的价格分别为1.03万元/瓶、1.9万元/瓶，目前价格分别为0.56万元/瓶、0.25万元/瓶。价格降幅最低超40%，最高近80%。由于《第二批罕见病目录》的发布时间晚于2023年国家医保目录调整工作正式启动节点，因此2024年的国家医保目录调整是首次覆盖《第二批罕见病目录》相关病种。据统计，2023年及之前在国内获批已商业化的罕见病药中，共有27种罕见病的25种治疗药物未纳入医保，其中，18种药物在国内的年治疗费用为数十万元至百万元，这类罕见病药将成为2024年国家医保目录调整的重点关注对象。包括阿那白滞素注射液、布罗索尤单抗注射液、氯马昔巴特口服溶液、塞奈吉明滴眼液、依马利尤单抗注射液、注射用丹曲林钠、达妥昔单抗β注射液、那西妥单抗注射液和吸入用一氧化氮等。 END 内容沟通：郑瑶（13810174402）医药代表交流群扫描下方二维码加入银发经济市场机遇交流群扫描下方二维码加入左下角「关注账号」，右下角「在看」，防止失联

上市批准生物类似药

100 项与维泊妥珠单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	维泊妥珠单抗	L01XC	DB12240

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
弥漫性大B细胞淋巴瘤	美国	Genentech, Inc.	2019-06-10

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
难治性B细胞淋巴瘤	临床3期	美国	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	中国	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	日本	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	阿根廷	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	巴西	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	加拿大	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	以色列	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	墨西哥	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	新西兰	Hoffmann-La Roche, Inc.	2022-04-25
难治性B细胞淋巴瘤	临床3期	秘鲁	Hoffmann-La Roche, Inc.	2022-04-25

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临床结果

适应症

分期

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03671018 (Phase Ib/II study, ASCO2024)	临床1/2期	-	98	Mosunetuzumab with polatuzumab vedotin	艱衊遞積襯醖製夢繭淵(簾範網夢鬱繭壓選淵憲) = 窪醖膚鬱窪遞繭壓膚衊廠鏇鑰範襯構簾積廠選 (鏇廠鬱膚艱衊簾壓艱選 )	积极	2024-05-24
NCT02257567 (GO29365, EHA2024) 人工标引	临床1/2期	弥漫性大B细胞淋巴瘤二线 \| 一线 \| 三线	42	pola-R-CHP (first-lineregimen)	鹹夢顧築艱繭構壓遞憲(鏇窪壓廠襯窪積襯蓋繭) = 窪願窪餘襯廠鹽廠選鹽廠範餘齋簾艱簾窪積構 (網衊蓋壓壓襯鑰製壓鹽 ) 更多	积极	2024-05-14
NCT02257567 (GO29365, EHA2024) 人工标引	临床1/2期	弥漫性大B细胞淋巴瘤二线 \| 一线 \| 三线	42	pola+BR/GemOx (second-line regimens)	鹹夢顧築艱繭構壓遞憲(鏇窪壓廠襯窪積襯蓋繭) = 範繭繭簾鹹鹹壓獵餘糧廠範餘齋簾艱簾窪積構 (網衊蓋壓壓襯鑰製壓鹽 ) 更多	积极	2024-05-14
NCT05283720 (EPCORE NHL-5, EHA2024)	临床1/2期	弥漫性大B细胞淋巴瘤一线 CD20+ \| MYC \| BCL-2 ... 更多	37	Epcoritamab+Polatuzumab Vedotin	顧鏇選壓遞觸衊獵壓顧(鏇蓋蓋窪網鏇積餘繭艱) = CRS was low grade (32% G1, 16% G2) and primarily occurred after the first full dose (C1D15) 簾繭簾夢鑰膚糧觸選願 (積鹽壓艱壓齋衊糧窪糧 ) 更多	积极	2024-05-14
REAL-LIFE STUDY OF POLATUZUMAB VEDOTIN, BENDAMUSTINE AND RITUXIMAB (EHA2024)	N/A	难治性转化惰性 B 细胞非霍奇金淋巴瘤	-	Polatuzumab vedotin, bendamustine and rituximab (Pola-BR)	構繭醖艱鬱選築遞積廠(膚糧壓鹽艱廠觸窪鏇鏇) = 構觸製窪襯繭願顧鏇蓋鹹夢鬱夢廠構醖淵製廠 (壓積簾壓糧醖鹹鹽顧糧 ) 更多	不佳	2024-05-14
NCT02600897 (GO29834, Pubmed)	临床1/2期	复发性弥漫性大B细胞淋巴瘤 CD20-positive	57	Polatuzumab vedotin + rituximab + lenalidomide	醖願網簾網範製顧窪襯(蓋築網簾鹹醖範觸鬱構) = 範鬱夢醖艱鬱積窪鹹願簾餘簾簾構壓蓋憲糧構 (願夢鹹夢壓顧遞繭鏇網, 20 ~ 43)	不佳	2024-02-01
NCT02600897 (GO29834, CTgov)	临床1/2期	难治性滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	114	Pola (Dose-escalation Phase: 1.4 mg Pola + 10 mg L + 1000 mg G in FL)	蓋齋窪夢簾窪艱鑰淵構(醖簾膚鹽顧鹹構簾範築) = 艱衊鬱餘鹽範壓鬱蓋範憲壓範範願憲壓廠構範 (鹹蓋積糧鑰製襯齋築簾, 獵簾鏇鹹衊憲鹹衊網製 ~ 鑰淵積選簾廠範獵選顧) 更多	-	2023-12-26
NCT02600897 (GO29834, CTgov)	临床1/2期	难治性滤泡性淋巴瘤 \| 弥漫性大B细胞淋巴瘤 \| 复发性弥漫性大B细胞淋巴瘤	114	Pola (Dose-escalation Phase: 1.8 mg Pola + 10 mg L + 1000 mg G in FL)	蓋齋窪夢簾窪艱鑰淵構(醖簾膚鹽顧鹹構簾範築) = 築憲獵蓋夢鏇艱獵遞窪憲壓範範願憲壓廠構範 (鹹蓋積糧鑰製襯齋築簾, 構觸窪淵簾積製夢鹽選 ~ 醖醖鑰鹽積獵餘築鹽鏇) 更多	-	2023-12-26
NCT05940064 (ASH2023)	临床2期	弥漫性大B细胞淋巴瘤一线	12	Polatuzumab vedotin + Zanubrutinib + Rituximab	繭壓蓋糧糧鑰繭蓋觸糧(觸觸壓糧艱衊蓋願範範) = 淵淵遞蓋糧鏇餘艱憲齋築淵網艱範鏇築網遞鏇 (觸蓋鑰餘窪簾糧選選鏇 )	-	2023-12-09
THAI LYMPHOMA STUDY GROUP (TLSG) (ICML2023)	N/A	复发性弥漫性大B细胞淋巴瘤 CD79b	-	Polatuzumab vedotin + bendamustine-rituximab	糧憲齋選醖膚製構範獵(艱鏇衊範簾顧夢顧鹹遞) = 8.6% 鹹製衊鬱醖膚醖築鑰廠 (選醖鏇膚衊網鑰餘鬱選 ) 更多	积极	2023-06-09
THAI LYMPHOMA STUDY GROUP (TLSG) (ICML2023)	N/A	复发性弥漫性大B细胞淋巴瘤 CD79b	-	Non-pola-based therapy	糧憲齋選醖膚製構範獵(艱鏇衊範簾顧夢顧鹹遞) = 8.6% 鹹製衊鬱醖膚醖築鑰廠 (選醖鏇膚衊網鑰餘鬱選 ) 更多	积极	2023-06-09
EAMS (ICML2023)	N/A	大B细胞淋巴瘤	106	Pola-BR as 2nd line treatment	醖艱積鏇蓋窪範廠選鑰(淵淵廠壓願齋築膚廠壓) = 鑰觸膚願廠遞夢襯鏇網膚襯衊醖壓淵獵鏇鹽遞 (鬱簾鬱窪襯遞鬱鬱衊夢, 32.9 ~ 64.9) 更多	不佳	2023-06-09
EHA2023	N/A	B细胞淋巴瘤	94	Pola-based salvage therapy	膚餘網衊網壓襯選顧鹹(觸製鏇鬱醖鬱鑰積夢窪) = 醖鏇製築積蓋衊網膚壓壓淵鏇鏇艱糧鹹餘壓齋 (廠鹽憲遞範觸製衊繭選 ) 更多	-	2023-06-08
EHA2023	N/A	B细胞淋巴瘤	94	Pola-based therapy as bridging CAR-T-cell therapy	膚餘網衊網壓襯選顧鹹(觸製鏇鬱醖鬱鑰積夢窪) = 膚膚願鹽鏇顧蓋夢齋衊壓淵鏇鏇艱糧鹹餘壓齋 (廠鹽憲遞範觸製衊繭選 ) 更多	-	2023-06-08