A Single Center, Single Dose, Open-label Study in Healthy Japanese Participants to Evaluate the Safety, Tolerability, and Pharmacokinetics of Otilimab

This study will assess the safety, tolerability and pharmacokinetics (PK) profiles of otilimab in healthy Japanese participants.

开始日期2023-02-08

申办/合作机构

GSK Plc

JPRN-jRCT2071210132

/ Completed临床1期IIT

A single center, single dose, open-label study in healthy Japanese participants to evaluate the safety, tolerability, and pharmacokinetics of otilimab.

开始日期2022-03-23

申办/合作机构-

CTRI/2020/12/029972

/ Not yet recruiting临床3期

A multi-centre long-term extension study to assess the safety and efficacy of GSK3196165 in the treatment of rheumatoid arthritis. - contRAst-X

开始日期2021-02-01

申办/合作机构-

100 项与奥替利单抗相关的临床结果

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100 项与奥替利单抗相关的转化医学

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100 项与奥替利单抗相关的专利（医药）

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项与奥替利单抗相关的文献（医药）

2025-03-01·BMJ Open

Long-term safety and efficacy of anti-GM-CSF otilimab in patients with rheumatoid arthritis: long-term extension of three phase 3 randomised trials (contRAst X)

Article

作者: Gupta, Anubha ; Nijhawan, Rina ; Bracher, Marguerite ; Curtis, Paula ; Shelton, Celia ; Strand, Vibeke ; Brooks, David ; Saurigny, Didier ; Fleischmann, Roy M ; Taylor, Peter C ; Wang, Millie ; Wang, Reena ; Takeuchi, Tsutomu ; Rayner, Kirsty ; O'Shea, Ciara ; Atsumi, Tatsuya ; McInnes, Iain B ; Weinblatt, Michael E

Objectives:

To investigate the long-term safety and efficacy of otilimab, an antigranulocyte-macrophage colony-stimulating factor monoclonal antibody, for patients with rheumatoid arthritis (RA).

Methods:

ContRAst X ( NCT04333147 ) was a phase 3, multicentre, long-term extension trial. Patients with RA aged ≥18 years who completed a qualifying contRAst trial (contRAst 1–3) and who the investigator thought might benefit from long-term otilimab treatment were eligible to enter contRAst X. Patients who received otilimab (90 mg/150 mg) in their qualifying trial maintained the same dose; patients who received tofacitinib or sarilumab were rerandomised 1:1 to either otilimab dose. Patients could continue background conventional synthetic disease-modifying antirheumatic drugs. The primary objective was long-term safety (up to 4 years).

Results:

Of the 2916 patients who entered contRAst X, 2915 received otilimab (exposure range: 7–896 days); the majority were withdrawn due to early trial termination. For otilimab 90 mg and 150 mg, the incidence of adverse events (AEs) was 62% (n=902/1456) and 64% (n=931/1459), the incidence of AEs of special interest was 8% (n=120/1456) and 7% (n=95/1459) and the incidence of serious AEs was 8% (n=123/1456) and 8% (n=114/1459), respectively. There were no instances of pulmonary alveolar proteinosis (PAP), active tuberculosis (TB), TB reactivation or serious hypersensitivity reactions. The proportions of clinical disease activity index low disease activity responders remained relatively stable throughout, with no apparent reduction following the switch from tofacitinib/sarilumab to otilimab.

Conclusion:

No new safety signals or instances of PAP were associated with long-term (≤2.5 years) treatment with otilimab.

Trial registration number:

ClinicalTrials.gov: NCT04333147 .

2023-12-01·Annals of the rheumatic diseases

Anti-GM-CSF otilimab versus tofacitinib or placebo in patients with active rheumatoid arthritis and an inadequate response to conventional or biologic DMARDs: two phase 3 randomised trials (contRAst 1 and contRAst 2)

Article

作者: Wang, Reena ; Gupta, Anubha ; McInnes, Iain B ; O'Shea, Ciara ; Watts, Sarah ; Strand, Vibeke ; Brooks, David ; Shelton, Celia ; Saurigny, Didier ; van der Heijde, Désirée ; Taylor, Peter C ; Goode, Christopher ; Weinblatt, Michael E ; Mukherjee, Sumanta ; Smith, Julia E ; Wang, Millie ; Fleischmann, Roy M ; Davies, John ; Takeuchi, Tsutomu ; Bracher, Marguerite ; Atsumi, Tatsuya ; Schifano, Lorrie A

Objectives:

To investigate the efficacy and safety of otilimab, an antigranulocyte-macrophage colony-stimulating factor antibody, in patients with active rheumatoid arthritis.

Methods:

Two phase 3, double-blind randomised controlled trials including patients with inadequate responses to methotrexate (contRAst 1) or conventional synthetic/biologic disease-modifying antirheumatic drugs (cs/bDMARDs; contRAst 2). Patients received background csDMARDs. Through a testing hierarchy, subcutaneous otilimab (90/150 mg once weekly) was compared with placebo for week 12 endpoints (after which, patients receiving placebo switched to active interventions) or oral tofacitinib (5 mg two times per day) for week 24 endpoints. Primary endpoint: proportion of patients achieving an American College of Rheumatology response ≥20% (ACR20) at week 12.

Results:

The intention-to-treat populations comprised 1537 (contRAst 1) and 1625 (contRAst 2) patients. Primary endpoint: proportions of ACR20 responders were statistically significantly greater with otilimab 90 mg and 150 mg vs placebo in contRAst 1 (54.7% (p=0.0023) and 50.9% (p=0.0362) vs 41.7%) and contRAst 2 (54.9% (p<0.0001) and 54.5% (p<0.0001) vs 32.5%). Secondary endpoints: in both trials, compared with placebo, otilimab increased the proportion of Clinical Disease Activity Index (CDAI) low disease activity (LDA) responders (not significant for otilimab 150 mg in contRAst 1), and reduced Health Assessment Questionnaire-Disability Index (HAQ-DI) scores. Benefits with tofacitinib were consistently greater than with otilimab across multiple endpoints. Safety outcomes were similar across treatment groups.

Conclusions:

Although otilimab demonstrated superiority to placebo in ACR20, CDAI LDA and HAQ-DI, improved symptoms, and had an acceptable safety profile, it was inferior to tofacitinib.

Trial registration numbers:

NCT03980483,NCT03970837.

2023-12-01·Annals of the rheumatic diseases

Anti-GM-CSF otilimab versus sarilumab or placebo in patients with rheumatoid arthritis and inadequate response to targeted therapies: a phase III randomised trial (contRAst 3)

Article

作者: Gupta, Anubha ; Bracher, Marguerite ; Watts, Sarah ; Strand, Vibeke ; Brooks, David ; Shelton, Celia ; Saurigny, Didier ; Goode, Christopher ; Mukherjee, Sumanta ; Wang, Millie ; Taylor, Peter C ; Smith, Julia E ; O'Shea, Ciara ; Takeuchi, Tsutomu ; Wang, Reena ; Atsumi, Tatsuya ; Fleischmann, Roy M ; Weinblatt, Michael E ; McInnes, Iain B ; Davies, John ; Schifano, Lorrie A

Objectives:

To investigate the efficacy and safety of otilimab, an anti-granulocyte-macrophage colony-stimulating factor antibody, in patients with active rheumatoid arthritis and an inadequate response to conventional synthetic (cs) and biologic disease-modifying antirheumatic drugs (DMARDs) and/or Janus kinase inhibitors.

Methods:

ContRAst 3 was a 24-week, phase III, multicentre, randomised controlled trial. Patients received subcutaneous otilimab (90/150 mg once weekly), subcutaneous sarilumab (200 mg every 2 weeks) or placebo for 12 weeks, in addition to csDMARDs. Patients receiving placebo were switched to active interventions at week 12 and treatment continued to week 24. The primary end point was the proportion of patients achieving an American College of Rheumatology ≥20% response (ACR20) at week 12.

Results:

Overall, 549 patients received treatment. At week 12, there was no significant difference in the proportion of ACR20 responders with otilimab 90 mg and 150 mg versus placebo (45% (p=0.2868) and 51% (p=0.0596) vs 38%, respectively). There were no significant differences in Clinical Disease Activity Index, Health Assessment Questionnaire-Disability Index, pain Visual Analogue Scale or Functional Assessment of Chronic Illness Therapy-Fatigue scores with otilimab versus placebo at week 12. Sarilumab demonstrated superiority to otilimab in ACR20 response and secondary end points. The incidence of adverse or serious adverse events was similar across treatment groups.

Conclusions:

Otilimab demonstrated an acceptable safety profile but failed to achieve the primary end point of ACR20 and improve secondary end points versus placebo or demonstrate non-inferiority to sarilumab in this patient population.

Trial registration number:

NCT04134728.

项与奥替利单抗相关的新闻（医药）

2025-12-25

·百度百家

RA治疗新纪元：CSFs靶点药物的崛起与研发进展

在自身免疫性疾病领域，类风湿性关节炎（Rheumatoid arthritis，RA）一直备受关注，成为生物制品企业竞相角逐的焦点。RA市场受TNFα抑制剂推动，规模巨大且持续增长。 RA与TNFα抑制剂的相互推动，共同缔造了一个全球范围内的数百亿美元的RA市场，同时也孕育出了5款备受瞩目的TNFα抑制剂。以美国为例，其RA市场在2014年已达到197亿美元的庞大规模，并且呈现出持续的高速增长态势，预计到2019年将激增至305亿美元。在此背景下，CSFs靶点药物正在成为新宠，具有潜力。随着RA市场的持续扩容，患者的用药选择也呈现出多元化的趋势。TNFα抑制剂曾经独步天下的地位已受到挑战，IL-6代表的白介类抗体产品以及小分子口服JAK抑制剂凭借各自的优势逐渐获得市场的认可。未来，这类产品有望持续侵蚀TNFα抑制剂的市场份额。同时，CTLA4与CD20靶点的产品阿巴西普和利妥昔单抗在RA领域也占据了一席之地。集落刺激因子抑制剂，包括G-CSF、M-CSF和GM-CSF等，正逐渐成为RA治疗的新选择。集落刺激因子，如我们熟悉的粒细胞刺激因子G-CSF，曾作为肿瘤辅助用药在化疗后发挥“升白”作用。如今，随着更多靶点进入临床试验阶段，集落刺激因子抑制剂有望成为RA治疗的新选择。值得注意的是，集落细胞刺激因子并不仅限于G-CSF。CSF1类（M-CSF）、CSF2类（GM-CSF）、CSF3类（G-CSF）以及多重CSF（IL-3）等均属于集落细胞刺激因子的范畴。这些因子在髓系细胞的发育、增殖、激活和分化过程中发挥着重要作用。虽然最初它们被用作肿瘤、抗病毒感染等的辅助治疗药物，但如今在RA领域的应用也正逐渐受到关注。 ❒ M-CSF相关药物 JNJ-40346527、PLX5622等是当前开发的M-CSF受体激酶抑制剂药物，呈现出很好的研发前景。针对M-CSF靶点的临床在研项目颇为丰富，其中强生的JNJ-40346527与第一三共制药的PLX5622作为口服M-CSF受体激酶抑制剂备受瞩目。PLX5622源自创新公司Plexxikon，后者拥有多条CSFs受体酪氨酸激酶小分子抑制剂的研发管线。此外，还有两款抗体药物——Five Prime与施贵宝联合开发的M-CSF受体拮抗剂FPA008，以及辉瑞的M-CSF抗体PD-0360324，同样值得期待。 ❒ GM-CSF相关药物 Mavrilimumab等GM-CSF药物显示出良好的研发进程，为RA治疗增添新选择。 GM-CSF及其受体的药物研发同样热络，且多以抗体类药物为主。阿斯利康旗下Medlmmune的GM-CSF受体抑制剂Mavrilimumab已率先完成临床2期实验，展现出良好的研发进度。其他几款针对GM-CSF的抗体，包括MorphoSysAG与葛兰素史克合作的GSK3196165、KaloBios公司的KB003、武田的Namilumab以及Morphotek公司的MORAb-022，也都在积极推进中。 ❒ G-CSF相关药物 CSL公司的CSL324是目前针对G-CSF靶点的重要在研药物，期望能带来治疗突破。 G-CSF通过与同源二聚体GSF受体结合，激活Jak1和Jak2酪氨酸激酶，进而触发下游Stat-3通路。该通路在G-CSF诱导中性粒细胞表达趋化因子受体CXCR2的过程中扮演关键角色。在RA、脉管炎、囊肿性纤维化、IBD等炎症反应疾病中，G-CSF血清水平往往升高，促进活化中心粒细胞浸润组织，加剧病变。因此，阻断G-CSF活性或封闭其受体，以降低招募和活化能力，成为治疗炎症疾病的重要策略。目前，针对G-CSF靶点的临床在研药物仅有澳大利亚CSL公司的G-CSF受体单抗CSL324，期待其能为炎症疾病治疗带来新突破。

申请上市临床2期临床1期临床申请

2024-12-24

·佰傲谷BioValley

被收购不到一年，关掉两家工厂，裁员330人

2024年2月，诺华以每股68欧元（总价27亿欧元）现金成功收购 MorphoSys。诺华的出手也是成功救MorphoSys于水火，在此之前，MorphoSys为节约成本已经裁员了17%，并且砍掉所有临床前管线。然而这还没到一年时间，诺华不仅为这笔交易计提了8亿美元的减值损失，最近还关闭MorphySys两家位于德国和美国的工厂，并伴随着330人被裁。卖权益卖对了 MorphoSys是一家德国生物技术公司，成立于1992年。 MorphoSys的主要收入主要来源于Monjuvi，一款CD19单抗，最初由Xencor公司开发，2010年，MorphoSys从该公司获得了开发和商业化Monjuvi的全球独家授权。 2020年8月1日，Monjuvi获FDA加速批准上市，联合来那度胺用以复发/难治性弥漫性大B细胞淋巴瘤（DLBCL）患者治疗。作为一款CD19靶向药，Monjuvi一上市就已经面临三款CD19 CAR-T的竞争，彼时诺华的Kymriah、吉利德的Yescarta和Tecartus都已经相继获批，虽然相比CAR-T，Monjuvi具备生产上的优势和给药便利性，但是并没有让其具备更亮眼的市场表现，至今年销售额没能突破一亿美元大关。虽然不指望获得多少销售收入，但是MorphoSys通过出售Monjuvi的相关权益已获得了不菲收入。 2020年1月，MorphoSys以7.5亿美元预付款+1.5亿美元股权投资+11亿美元里程碑付款把Monjuvi美国之外市场的独家的商业化权益以及美国共同商业化权益卖给了Incyte，并且双方还是分摊在美国商业化收益和成本。 2021年8月，MorphoSys把大中华区权益以3500万美元预付款+8250万美元里程碑以及销售分成卖给了诺诚健华。在被诺华收购的同一天，把Monjuvi的全球权益以2500万美元卖给了Incyte公司。如果单单算首付款，MorphoSys已经赚到了9.6亿美元，这是自己通过销售远远达不到的。这些通过出售Monjuvi权益获得的收入，支撑了MorphoSys多年的研发工作，不过钱总有花完的时候，加上两个合作管线失败（otilimab、gantenerumab）的打击，MorphoSys为了维持现金流采取了重组措施（2023年2月），放弃所有临床前管线，并裁员17%。 8亿美元的减值 MorphoSys被收购时，公司的管线真正意义上只剩下两条在研管线了，分别是pelabresib和tulmimetostat（一款口服EZH2/EZH1小分子抑制剂，处于临床II期阶段，用于治疗原发性血小板增多症 (ET) 。把Monjuvi的权益彻底卖给了Incyte之后，MorphoSys将不再享有Monjuvi的里程碑付款与销售分成。 Pelabresib正是诺华青睐MorphoSys的最重要原因，一种口服小分子BET抑制剂，旨在抑制MF相关基因的表达。Pelabresib目前处于III期临床阶段，与Incyte的Jakafi联用于之前没有接受过JAK抑制剂治疗的骨髓纤维化患者。诺华也有一款JAK1/2抑制剂Ruxolitinib（已上市），收购Pelabresib可以强化Ruxolitinib的组合。能让诺华下定决心收购MorphoSys，主要得益于Pelabresib的Ⅲ期临床MANIFEST-2的大获成功。 2023年11月，该项临床达到了主要终点目标，即第24周时，66%的pelabresib+Ruxolitinib组MF患者达到SVR35（脾脏体积减少35%以上），约为Ruxolitinib单药组的（35%）近一倍。安全性与既往观察到的安全性一致；没有观察到新的安全性信号，另外，与Ruxolitinib相比，Pelabresib+Ruxolitinib报告的贫血不良事件更少。基于该临床结果，MorphoSys计划在2024年下半年年提交Pelabresib+Ruxolitinib作为MF患者一线治疗的上市申请。然而，pelabresib自从到了诺华手里之后，上市计划一再被推迟，并且还报告了令人不安的安全信号。今年4月，MANIFEST-2的Pelabresib+ruxolitinib组报告了6例发展为更具侵袭性的急性髓性白血病（AML），而对照组只有2例，随后，MorphoSys便向FDA通报了这些安全信号。并且诺华对Pelabresib的进一步的随访数据也不是很满意。据诺华二季度财报，公司认为需要获得48周的随访数据来确定pelabresib的最终上市计划，然而在获得48周的数据后，诺华又表示，需要更长的随访时间来确定pelabresib获批的监管路径，此外，公司还会根据随访情况，评估是否需要额外的临床试验以支持上市批准，这最终可能会pelabresib的整个上市申请计划推迟数年。这笔交易看起来已经是一笔不划算的买卖，在诺华公布2024Q3财报中，诺华为笔交易已经计提了8亿美元的减值损失。随着pelabresib上市申请计划的一再推迟，这笔交易的减值仍将持续。参考出处 https://www.biospace.com/business/novartis-cuts-morphosys-sites-in-boston-munich-affecting-330-jobs 本周好文推荐如需转载请联系佰傲谷并在醒目位置注明出处 · · · · · · · ·

并购细胞疗法免疫疗法临床2期上市批准

2024-01-10

·FiercePharma

JPM24, Day 2: Lilly CEO says competition benefits obesity field; Novavax readies phase 3 combo trial

The J.P. Morgan Healthcare Conference rolled on Tuesday with corporate updates from Eli Lilly and other companies. As the J.P. Morgan Healthcare Conference rolls on in San Francisco, BioNTech, Alnylam, and many other companies updated investors on their businesses heading into 2024. We'll update this page throughout the day; be sure to check back regularly. Tuesday, Jan. 9 at 8:30 p.m. ET AstraZeneca laid out its lofty goals for the end of the decade, which include not only delivering “industry-leading growth” by 2030, but placing in at least “the top-three position” in its five focus areas, chief financial officer Aradhana Sarin said during the company’s presentation. That means AZ is looking to be a top player in oncology, rare diseases, vaccines/immunotherapies, respiratory diseases/immunology plus the field of cardiovascular, renal and metabolism. With a wide geographic footprint and a vast pipeline contributing to “strong growth potential,” the company calls its growth profile “relatively de-risked” compared to peers. As for a more short-term goal, the drugmaker is targeting double-digit growth from 2021 to 2025, a rate that it is “very much on track” to achieve, Sarin said. Even more important than the numbers is the “confidence we have in delivering that growth ambition,” the CFO said. That confidence is backed by the company’s existing products and new indications, plus the previously divulged plan of launching 15 meds by 2030. Release Tuesday, Jan. 9 at 8:09 p.m. ET Novavax is in discussions with Walgreens to add the company's COVID-19 vaccine to the pharmacy's stores for the 2024-25 season, company executives told Fierce Pharma on the sidelines of this year's J.P. Morgan Healthcare Conference. The chain pharmacy elected not to carry the vaccine this season, sticking only with the mRNA options. Meanwhile, Novavax is in the latter half of its first full COVID vaccination season in the U.S., joining Moderna and Pfizer, though its shot remains under emergency use authorization. The Maryland vaccine maker expects that to change, however, with FDA approval tentatively planned for the end of August or early September, according to Chief Operating Officer John Trizzino New CEO John Jacobs is finally coming up for air after a year marked by significant cuts to administrative, manufacturing and R&D costs. The company disclosed that a second round of "focused headcount reductions" would be included in the most recent $300 million cost-cutting plan, announced in November. But he's bullish now, saying the company has $2 billion in cash that's "virtually guaranteed" when considering cash on hand, government contracts and existing receivables. Novavax reported having $666 million in cash as of the end of September 2023. Jacobs says that's enough for the company to solo develop its COVID-flu combination vaccine, slated for a phase 3 trial in humans this year. UPDATED: Tuesday, Jan. 9 at 6:19 p.m. ET Eli Lilly CEO David Ricks threw credit to Novo Nordisk for pursuing GLP-1s for obesity during his Tuesday presentation: “We have tremendous respect for Novo Nordisk and have competed with them for like 100 years and know each other pretty well. “I think here's a case where probably competition spurs us both on to go faster and build out more indications and really take the insight—which, credit to Novo, was to exploit high dose GLPs to pursue weight loss, noticing the separation between A1C and weight loss at the higher doses and we're following them and driving that and I think the world would benefit from that.” The obesity market lends itself to more involvement given the massive demand. Ricks said the two companies are not fighting over a “fixed pie,” but instead using their combined powers to advance the GLP-1 field into addressing other health challenges such as cardiovascular risks, sleep apnea and so on. Ricks said that Novo is the first competitor Lilly thinks about, but another potential threat is the number of larger companies buying into obesity using M&A. “If you're sitting in a boardroom of a large drug company, you're probably asking the CEO, like where's our obesity program? So they're getting one,” Ricks said with a laugh. “Some of them will succeed. Some won't.” First-mover advantage is often crucial in the pharma industry and obesity is no different, especially given the manufacturing scale needed to make a difference in the space, according to Ricks. New entrants will need to push hard on the additional health benefits of their medicines beyond obesity, he added. “We should take them all seriously, and I think sometimes competition discovers new things that we didn't think of, and that's good,” Ricks said. “There is a huge addressable market here. So I'm not saying it'll be two companies that find it all. But probably the benefit of time and experience with this platform really lends to us and a Danish company.” UPDATED: Tuesday, Jan. 9 at 5:40 p.m. ET After more than 25 years in the field, Novo Nordisk has largely proved its obesity thesis, CEO Lars Fruergaard Jørgensen said Tuesday at the J.P. Morgan Healthcare Conference. But even as the potentially multi-billion-dollar market opens up, “we are just getting going,” the CEO said. Not long after Wegovy’s obesity launch, demand outstripped supply, with that inventory uncertainty persisting through 2023. As for the coming year, “I’m very comfortable looking into 2024—and specifically for Wegovy in the U.S.—that we can add significant additional volumes,” Jørgensen explained. That additional capacity for 2024 didn’t come all at once, either, the CEO pointed out. “This is a continued journey of building capacity for the years to come,” Jørgensen said. UPDATED: Tuesday, Jan. 9 at 5:30 p.m. ET GSK expects that Nucala could see around £500 million to £1 billion in additional peak sales in chronic obstructive pulmonary disease (COPD) if a phase 3 readout expected in the second half of 2024 turns out positive, CEO Emma Walmsley said Tuesday. Previously, Nucala’s direct rival, AstraZeneca’s Fasenra, failed two COPD trials. Meanwhile, GSK’s Nucala follow-on candidate, the long-acting IL-5 antibody depemokimab, should deliver phase 3 data in the first half of this year. Walmsley put that drug’s peak sales potential at more than £3 billion. That’s much more than the £1 billion to £2 billion range that the company put out during an investor update in mid-2021. Compared with the 2021 update, the anti-GM-CSF antibody otilimab has lost its place in GSK’s immunology portfolio after disappointing phase 3 results led to its discontinuation in 2022. Taking its place is camlipixant, a chonic cough program that GSK got last year from its $2 billion acquisition of Bellus Health. After the FDA's recent complete response letter for Merck’s rival med gefapixant, GSK believes camlipixant could generate more than £2.5 billion in peak sales. The drug’s phase 3 program is on track to report results in the second half of 2025. UPDATED: Tuesday, Jan. 9 at 4:55 p.m. ET Four years after the arrival of the company’s CEO Paul Hudson, the “new” Sanofi has finally started to take shape. With the goal to become a tech-powered, immunology powerhouse, Sanofi is now in the midst of a “real moment,” Hudson said Tuesday at the J.P. Morgan Healthcare Conference in San Francisco. “It’s been a long time in the making, and we really feel like we’re demonstrating that we’re the new Sanofi,” he said. Much of the company’s momentum will continue to hinge on its Regeneron-partnered megablockbuster Dupixent, which Hudson expects to reel in roughly 13 billion euros in sales in 2024. But while Dupixent will continue to grow “until its end,” Hudson knows the medicine’s patent cliff is looming sometime during the next decade. In turn, Sanofi is going all-in on R&D, with the goal to generate more than 10 billion euros in sales from new medicines by 2030. “This is a very important moment for the company to have multiple shots on goal in massive diseases,” Hudson said. “This is a deck stacked for success.” After declines for its hematology franchise earlier in the decade, Roche is riding the rebound. The company's hemophilia A blockbuster Hemlibra is providing much of the sales firepower, but newer T-cell engagers Lunsumio and Columvi are giving Roche more reasons for optimism. Those two meds are off to strong starts, and Roche is running studies to potentially move them into earlier treatment lines. Also in Roche's hematology portfolio is the lucrative antibody-drug conjugate Polivy. In all, Roche sees its blood-cancer franchise delivering 14% average annual growth through 2026, following sizable sales declines in 2020 and 2021. Story UPDATED: Tuesday, Jan. 9 at 3:37 p.m. ET While 2024 will be “monumental” for Sarepta Therapeutics, the company’s ambitions extend to 2030, when it’s poised to “become a big biotech,” CEO Doug Ingram said at the conference. Last year, the biotech scored an accelerated approval for its Duchenne muscular dystrophy (DMD) gene therapy Elevidys under a restricted label. Now, Sarepta hopes to expand the approved usage to cover all DMD patients. Despite missing the primary endpoint in a key trial, the company maintains its belief that the data “exceeded the threshold for substantial evidence of effectiveness,” Ingram said. Meanwhile, the FDA is “committed to evaluating a labeling expansion to the fullest extent possible,” according to the CEO’s presentation. The treatment brought in an estimated $200 million in 2023 after its June approval. Mizuho analysts called the sales estimate “better than expected” and believe the “odds are high” for the potential label expansion. Sarepta projected its total 2023 revenue to come in at $945 million, exceeding its previous guidance. Release UPDATED: Tuesday, Jan. 9 at 10:45 a.m. ET After its overwhelming success during the pandemic, Pfizer was knocked down a peg in 2023. Its launches came up short and the company was blindsided by a sudden drop in demand for its pandemic products. After some retooling, the company is set for a “year of execution,” Pfizer CEO Albert Bourla said. “We used to be the stars of the industry for a few years, so the drop really hurts.” The silver lining for the company in 2023 was a record nine FDA approvals for novel products, including two for Abrysvo, though the company has some regrets about the early performance of its RSV vaccine launch. Story The new year brings Merck closer to 2028 when the company will lose patent protection for mega-blockbuster Keytruda. At the J.P. Morgan Healthcare Conference, CEO Rob Davis tried to de-emphasize the impact of the Keytruda cliff by focusing on the company’s pipeline assets, including three antibody-drug conjugates that Merck has in-licensed from Daiichi Sankyo and a Moderna-partnered cancer vaccine. Last January, Merck said its pipeline of oncology prospects could eventually produce $10 billion annually. A year later, Merck has jacked up its oncology portfolio estimate to $20 billion-plus by the middle of the next decade. “I know that the conversation continues to be about Keytruda and 2028,” Davis said. “But increasingly, we’re not focused on 2028. It’s just another year.” Story UPDATED: Tuesday, Jan. 9 at 10:36 a.m. ET As COVID vaccine revenues sink across the board, mRNA specialist BioNTech is turning its attention to its oncology pipeline. This year pledges to be one of “significant execution,” CEO and co-founder Ugur Sahin, M.D., said in a strategic update. The company projects revenues of approximately €3 billion ($3.28 billion) for 2024, mainly driven by its Pfizer-partnered COVID vaccine Comirnaty, which is expected to “remain profitable.” That would be a drop from last year, given that BioNTech has guided for 2023 COVID-19 vaccine sales of €4 billion. Also last year, BioNTech added six new prospects to its oncology pipeline, which now includes a mix of phase 2 and phase 3 assets. Outside of cancer therapies, the company is working on an mRNA-based combination COVID and influenza vaccine alongside Pfizer. BioNTech’s full corporate update will take place later today at 12 p.m. ET. Release Alnylam collected revenues of $1.24 billion in 2023 thanks to its polyneuropathy of hATTR amyloidosis meds Onpattro and Amvuttra, plus its hepatic porphyria therapy Givlaari and primary hyperoxaluria type 1 treatment Oxlumo. The company’s ATTR franchise garnered $913 million, while the two ultra-rare drugs pulled a total of $329 million. Total revenues from Alnylam’s portfolio were up 39% from 2022. The company believes it is on the way toward positioning itself as a “top-tier, global, multi-product commercial company with a broad pipeline and organic platform poised to deliver sustainable innovation well into the future, a profile rarely seen in our industry,” CEO Yvonne Greenstreet said in a statement. The RNAi drugmaker will report results from its phase 3 study of its vutrisiran in cardiomyopathy of ATTR amyloidosis early this year. Alnylam will further discuss its financial results and commercial updates at the J.P. Morgan Healthcare Conference today during its presentation at 12:45 p.m. ET. Release

疫苗临床3期

100 项与奥替利单抗相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
D11343	奥替利单抗	-	DB06303

研发状态

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
类风湿关节炎	临床3期	中国	GSK Plc	2019-05-16
类风湿关节炎	临床3期	巴西	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	匈牙利	GSK Plc	2019-05-16
类风湿关节炎	临床3期	印度	GSK Plc	2019-05-16
类风湿关节炎	临床3期	意大利	GSK Plc	2019-05-16
类风湿关节炎	临床3期	马来西亚	GSK Plc	2019-05-16
类风湿关节炎	临床3期	菲律宾	GlaxoSmithKline Trading Services Ltd.	2019-05-16
类风湿关节炎	临床3期	菲律宾	葛兰素史克（中国）投资有限公司	2019-05-16
类风湿关节炎	临床3期	波兰	GSK Plc	2019-05-16
类风湿关节炎	临床3期	俄罗斯	GSK Plc	2019-05-16

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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


NCT04333147 (contRAst X, Pubmed \| BMJ Open)	临床3期	类风湿关节炎	2,916	Otilimab 90 mg	糧願膚獵繭壓製鹽選範(鹹願獵築壓膚觸積餘鹹) = 遞廠壓齋顧鬱觸襯齋艱鹽積膚簾齋鏇構鬱鬱壓 (網簾構廠壓簾範淵廠顧 ) 更多	积极	2025-03-01
				Otilimab 150 mg	糧願膚獵繭壓製鹽選範(鹹願獵築壓膚觸積餘鹹) = 獵壓鬱憲鏇鏇鏇餘製願鹽積膚簾齋鏇構鬱鬱壓 (網簾構廠壓簾範淵廠顧 ) 更多
NCT04333147 (contRAst X, CTgov)	临床3期	类风湿关节炎	2,916	csDMARD(s)+Otilimab (GSK3196165) (Otilimab 90 mg)	鹽廠鬱鹹襯鬱遞餘襯醖 = 糧窪夢餘鑰膚獵簾願選齋鏇獵膚觸繭顧糧窪繭 (範鬱衊廠製鏇繭壓構願, 選鏇衊觸廠範網膚製簾 ~ 願築餘憲艱範遞壓簾膚) 更多	-	2024-02-07
				csDMARD(s)+Otilimab (GSK3196165) (Otilimab 150 mg)	鹽廠鬱鹹襯鬱遞餘襯醖 = 簾簾願構壓膚簾齋齋衊齋鏇獵膚觸繭顧糧窪繭 (範鬱衊廠製鏇繭壓構願, 顧鏇艱顧餘鏇壓遞築窪 ~ 窪繭窪顧簾夢糧鏇醖繭) 更多
NCT04134728 (contRAst 3, Pubmed \| Ann Rheum Dis)	临床3期	类风湿关节炎	549	Otilimab 90 mg	獵夢選鬱窪簾餘襯築糧(願鏇廠淵糧齋壓憲醖壓) = 積膚願遞窪鏇膚網構鹹醖衊製壓選蓋遞夢醖願 (壓艱顧鏇遞觸積夢積鬱 )	不佳	2023-12-01
				Otilimab 150 mg	獵夢選鬱窪簾餘襯築糧(願鏇廠淵糧齋壓憲醖壓) = 衊鬱醖構獵夢艱製襯餘醖衊製壓選蓋遞夢醖願 (壓艱顧鏇遞觸積夢積鬱 )
NCT03980483 \| NCT03970837 (contRAst 1 and contRAst 2, Pubmed)	临床3期	类风湿关节炎	-	Otilimab 90 mg	觸構鏇範遞淵衊壓蓋憲(觸願鑰糧鏇醖憲築網築) = 窪繭襯積簾製願遞選構選願餘淵醖廠淵遞遞繭 (齋鬱鹽繭壓構窪顧蓋衊 )	不佳	2023-12-01
				Otilimab 150 mg	觸構鏇範遞淵衊壓蓋憲(觸願鑰糧鏇醖憲築網築) = 壓壓鹽艱蓋鹹鏇築觸網選願餘淵醖廠淵遞遞繭 (齋鬱鹽繭壓構窪顧蓋衊 )
NCT03980483 (contRAst 1, CTgov)	临床3期	类风湿关节炎	1,537	GSK3196165 (Otilimab) (GSK3196165 90mg + MTX)	膚淵積願鏇齋夢鏇遞製 = 獵遞齋網醖範憲網淵廠淵範廠艱鬱衊遞糧膚糧 (網鬱構蓋夢網鏇窪鏇鹽, 淵糧醖艱獵鹹廠廠夢願 ~ 衊積膚獵獵簾願膚廠窪) 更多	-	2023-10-25
				GSK3196165 (Otilimab) (GSK3196165 150mg + MTX)	膚淵積願鏇齋夢鏇遞製 = 醖構選壓繭鬱窪製繭遞淵範廠艱鬱衊遞糧膚糧 (網鬱構蓋夢網鏇窪鏇鹽, 夢醖構鹹糧願餘蓋顧膚 ~ 築遞衊廠獵衊構積願憲) 更多
NCT04134728 (contRAst 3 \| ContRAst-3, CTgov)	临床3期	类风湿关节炎	550	csDMARD+GSK3196165 (GSK3196165 90mg + csDMARD)	範醖鑰蓋襯糧窪遞構鹽 = 艱齋膚壓鏇選淵憲獵廠廠蓋齋觸製獵衊鹽壓鑰 (遞鏇廠選鑰繭蓋願構築, 選鹹選繭網鏇繭淵醖齋 ~ 夢顧構淵夢積艱獵衊艱) 更多	-	2023-07-17
				csDMARD+GSK3196165 (GSK3196165 150mg + csDMARD)	範醖鑰蓋襯糧窪遞構鹽 = 選醖艱餘鹽鹽壓顧鹹積廠蓋齋觸製獵衊鹽壓鑰 (遞鏇廠選鑰繭蓋願構築, 選壓願壓糧鬱鬱顧範築 ~ 範網構簾餘淵簾選觸選) 更多
NCT03970837 (contRAst 2, Corporate Publications) 人工标引	临床3期	类风湿关节炎	-	Otilimab	鹽膚獵糧膚膚膚簾壓齋(襯壓網襯鬱顧構鹹製鏇) = the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 糧鹽糧醖醖廠蓋遞築簾 (鬱齋壓網淵餘蓋獵築壓 )	积极	2022-10-27
NCT04134728 (ContRAst-3, Corporate Publications) 人工标引	临床3期	类风湿关节炎	-	otilimab	廠艱獵蓋衊網網餘網鏇(繭鹹夢餘範鹹廠簾鏇鑰) = the third trial in the programme, did not demonstrate statistical significance on the primary endpoint of ACR20[1] response versus placebo at week 12 in patients with inadequate response to biologic DMARDs and/or Janus Kinase inhibitors. 獵糧壓積鹹蓋鏇壓鏇簾 (遞衊醖窪築範廠觸鹽鹽 )	不佳	2022-10-27
				Placebo
NCT04376684 (OSCAR, CTgov)	临床2期	新型冠状病毒感染	1,156	placebo (Part 1: Placebo 1)	齋襯範選範膚衊選鹹鬱 = 餘糧顧繭獵蓋鬱鑰夢獵積衊鏇顧窪壓糧鏇蓋壓 (鏇夢簾獵鏇範觸觸齋繭, 糧遞簾襯鬱艱鬱衊鬱膚 ~ 鹽製淵夢鬱齋鹽繭構顧) 更多	-	2022-03-09
				Otilimab (Part 1: Otilimab 90 mg)	齋襯範選範膚衊選鹹鬱 = 鑰鬱鹽鏇願鏇壓製艱衊積衊鏇顧窪壓糧鏇蓋壓 (鏇夢簾獵鏇範觸觸齋繭, 鑰鹽淵夢鏇蓋夢夢鏇積 ~ 遞鹽膚夢範範顧壓顧簾) 更多
NCT02504671 (BAROQUE, ACR2019)	临床2期	类风湿关节炎	222	Otilimab 90 mg	網選簾憲醖憲糧糧願網(壓醖糧簾網淵窪壓齋膚) = 鏇糧壓獵淵壓膚鑰鹽鏇網襯構鏇糧衊鬱糧顧淵 (築廠壓膚憲艱繭製餘簾 ) 更多	积极	2019-11-10
				Otilimab 180 mg	簾鏇積遞鏇鹹築觸鏇獵(艱觸鑰觸積網憲鏇艱窪) = 繭製積觸艱觸鏇遞積範鬱蓋遞積齋餘網築艱鹽 (窪築廠繭築壓積觸製網, 22% ~ 69%) 更多