A Phase II Open Label, Randomized Study Testing the Efficacy of Retifanlimab in Combination with Bevacizumab and Hypofractionated Radiotherapy in Patients with Recurrent GBM

This phase II trial tests how well retifanlimab with bevacizumab and hypofractionated radiotherapy, compared to bevacizumab and hypofractionated radiotherapy alone, works in treating patients with glioblastoma that has come back after a period of improvement (recurrent). A monoclonal antibody is a type of protein that can bind to certain targets in the body, such as molecules that cause the body to make an immune response (antigens). Immunotherapy with monoclonal antibodies, such as retifanlimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Bevacizumab is in a class of medications called antiangiogenic agents. It works by stopping the formation of blood vessels that bring oxygen and nutrients to tumor. This may slow the growth and spread of tumor. Hypofractionated radiation therapy delivers higher doses of radiation therapy over a shorter period of time and may kill more tumor cells and have fewer side effects. Giving retifanlimab with bevacizumab and hypofractionated radiotherapy may work better in treating patients with recurrent glioblastoma than bevacizumab and hypofractionated radiotherapy alone.

开始日期2024-09-30

申办/合作机构

National Cancer Institute

NCT06290622 / Withdrawn临床1期IIT

PD-1, LAG-3 and TIM-3 Checkpoint Blockade in DLBCL Post Chimeric Antigen Receptor T-cEll Therapy fAilUre (PLATEAU Study)

This study is investigating the optimal dose and the advantage in combining investigational immunotherapy drugs known as Retifanlimab, INCAGN02385 and INCAGN02390 to improve the responses to CAR T-cell therapy. Additionally, the study will investigate that triple checkpoint blockade of PD-1, TIM-3 and LAG-3 molecules will overcome CAR T-cell therapy resistance in patients with suboptimal responses.

开始日期2024-08-30

申办/合作机构

The University of Alabama at Birmingham

NCT06389799 / Recruiting临床2期IIT

A Phase 2, Open Label Study of PEmigatinib and REtifanlimab in Advanced Dedifferentiated LIposarcoma

Dedifferentiated liposarcomas (DDLPS) are aggressive soft tissue sarcomas with no effective medical treatment options.
Immunotherapy with checkpoint inhibitors, so-called PD-1 inhibitors, have shown some effect in DDLPS in previous studies. Effect of immunotherapy can be improved by combining it with other types of tumor drugs. Medicines that inhibit signaling via the FGF receptor, so-called FGFR inhibitors, have shown a tumor-slowing effect in DDLPS in early studies. FGFR inhibitors can also induce changes that make the tumor more available to treatment with immunotherapy.
The study aims to investigate whether the combination of an FGFR inhibitor, pemigatinib, with a PD-1 inhibitor, retifanlimab can provide a tumor-slowing effect in patients with advanced DDLPS who have progressed on first-line treatment.

开始日期2024-06-20

申办/合作机构

Lund University Hospital

100 项与瑞弗利单抗相关的临床结果

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100 项与瑞弗利单抗相关的转化医学

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100 项与瑞弗利单抗相关的专利（医药）

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项与瑞弗利单抗相关的文献（医药）

2024-12-31·mAbs

Antibodies to watch in 2024

Article

作者: Crescioli, Silvia ; Kaplon, Hélène ; Wang, Lin ; Reichert, Janice M. ; Visweswaraiah, Jyothsna ; Chenoweth, Alicia

The 'Antibodies to Watch' article series provides an annual summary of commercially sponsored monoclonal antibody therapeutics currently in late-stage clinical development, regulatory review, and those recently granted a first approval in any country. In this installment, we discuss key details for 16 antibody therapeutics granted a first approval in 2023, as of November 17 (lecanemab (Leqembi), rozanolixizumab (RYSTIGGO), pozelimab (VEOPOZ), mirikizumab (Omvoh), talquetamab (Talvey), elranatamab (Elrexfio), epcoritamab (EPKINLY), glofitamab (COLUMVI), retifanlimab (Zynyz), concizumab (Alhemo), lebrikizumab (EBGLYSS), tafolecimab (SINTBILO), narlumosbart (Jinlitai), zuberitamab (Enrexib), adebrelimab (Arelili), and divozilimab (Ivlizi)). We briefly review 26 product candidates for which marketing applications are under consideration in at least one country or region, and 23 investigational antibody therapeutics that are forecast to enter regulatory review by the end of 2024 based on company disclosures. These nearly 50 product candidates include numerous innovative bispecific antibodies, such as odronextamab, ivonescimab, linvoseltamab, zenocutuzumab, and erfonrilimab, and antibody-drug conjugates, such as trastuzumab botidotin, patritumab deruxtecan, datopotamab deruxtecan, and MRG002, as well as a mixture of two immunocytokines (bifikafusp alfa and onfekafusp alfa). We also discuss clinical phase transition and overall approval success rates for antibody therapeutics, which are crucial to the biopharmaceutical industry because these rates inform decisions about resource allocation. Our analyses indicate that these molecules have approval success rates in the range of 14-32%, with higher rates associated with antibodies developed for non-cancer indications. Overall, our data suggest that antibody therapeutic development efforts by the biopharmaceutical industry are robust and increasingly successful.

2024-10-01·Surgical Oncology Clinics of North America

Updates in the Management of Advanced Nonmelanoma Skin Cancer

Review

作者: Yan, Flora ; Schmalbach, Cecelia E ; Schmalbach, Cecelia E.

Basal cell carcinoma (BCC), cutaneous squamous cell carcinoma (cSCC), and Merkel cell carcinoma (MCC) comprise the majority of nonmelanoma skin cancers. Advances have been made in treatment. Sentinel node biopsy should be considered for locally advanced, clinically node-negative cSCCs and MCCs. BCC patients failing traditional surgery and/or radiation are candidates for systemic hedgehog inhibitor therapy. Immune checkpoint inhibitor treatment is available for patients who failed traditional treatment with surgery and/or radiation or who are not candidates for these modalities. Specifically, cemiplimab is approved for advanced BCC; cemiplimab and pembrolizumab for advanced cSCC; and avelumab, pembrolizumab, and retifanlimab-dlwr for recurrent/metastatic MCC.

2024-07-01·GYNECOLOGIC ONCOLOGY

Antitumor activity and safety of the PD-1 inhibitor retifanlimab in patients with recurrent microsatellite instability-high or deficient mismatch repair endometrial cancer: Final safety and efficacy results from cohort H of the POD1UM-101 phase I study

Article

作者: Tian, Chuan ; Cornfeld, Mark ; Gladieff, Laurence ; Pautier, Patricia ; Bowman, Jill ; Van Gorp, Toon ; Lorusso, Domenica ; Gennigens, Christine ; Berton, Dominique ; Kryzhanivska, Anna

OBJECTIVE:

Retifanlimab is a humanized immunoglobulin G4 monoclonal antibody against programmed death 1 being investigated in several solid tumor types. We report final results from patients with recurrent microsatellite instability-high (MSI-H)/mismatch repair deficient (dMMR) endometrial cancer treated with retifanlimab in a POD1UM-101 expansion cohort.

METHODS:

Eligible patients (≥18 years; histologically proven/unresectable/recurrent, MSI-H/dMMR endometrial cancer; checkpoint inhibitor naive) received retifanlimab 500 mg intravenously every 4 weeks for ≤2 years. Primary endpoint was safety/tolerability.

RESULTS:

At data cutoff (May 17, 2023), 76 patients had received at least one retifanlimab dose. Median (range) age was 67 (49-88) years; 88.2% of patients had recurrent metastatic disease and 80.3% had visceral metastases. Seventy-five patients (98.7%) had received at least one prior systemic therapy. Median retifanlimab exposure was 10.0 (0.03-25.9) months; 23 patients completed treatment. 38 patients (50.0%) had grade ≥3 treatment-emergent adverse events (TEAEs), most commonly anemia (n = 10 [13.2%]). 63 patients (82.9%) had treatment-related AEs (TRAEs; grade ≥3, n = 14 [18.4%]); most common was fatigue (n = 14 [18.4%]). Two patients had TEAEs that led to death; no TRAEs were fatal. 39 patients had objective responses (51.3%; 95% CI, 39.6-63.0%); 19 patients (25.0%) had complete response and 20 (26.3%) had partial response. Median progression-free survival was 12.2 months; 30 patients (76.9%) had duration of response (DOR) ≥12 months. Median DOR was not reached after median follow-up time of 26.0 months.

CONCLUSIONS:

Retifanlimab was generally well tolerated and demonstrated encouraging anti-tumor activity in patients with pre-treated recurrent MSI-H/dMMR endometrial cancer.

112

项与瑞弗利单抗相关的新闻（医药）

2024-11-04

·佰傲谷BioValley

一路崩坏的MacroGenics，CEO也要辞职了

MacroGenics局势崩坏至此？该公司联合创始人、总裁兼首席执行官Scott Koenig正在计划离职。日前，MacroGenics宣布了领导层交接，Scott Koenig计划在明年初辞去总裁兼首席执行官的职位。不过Scott Koenig将继续作为MacroGenics的顾问和股东。受到该消息的影响，MacroGenics的股价反而出现小幅度上涨。管线一款接一款失败 MacroGenics成立于2000年，是老牌抗体公司。基于其DART 、TRIDENT等技术平台，公司与赛诺菲、吉利德、Incyte、再鼎医药、天境生物等公司建立了重要的合作关系，单抗和双抗管线大多进行了授权转让。不过平台技术的安全性验证遭遇不小挑战。特别是公司重点押注的B7H3靶点，单抗，双抗产品皆这折戟于不良事件。 2019年1月，FDA叫停了CD3/B7H3双抗MGD009针对B7H3阳性实体瘤的临床I期试验，因为该临床出现了肝脏不良事件。目前公司官网已无该管线信息。 2022年7月，B7H3单抗MGA271一项治疗复发难治性头颈鳞癌的II期临床试验被MacroGenic宣布停止，原因是该临床出现了11.3%的死亡事件（62名患者中7人死亡），可能与出血事件有关。 2024年8月，B7H3 ADC药物Vobramitamab Duocarmazine（MGC-018）的II期临床TAMARACK被MacroGenic宣布停止，原因是TAMARACK试验中发生了5例患者死亡事件。不过该B7H3 ADC联合lorigerlimab（PD-1×CTLA-4 DART分子）的1/2期剂量递增研究继续患者招募，并计划于今年晚些时候进行剂量扩展研究。延伸阅读：B7H3 ADC毒性累积此外，2024年3月，艾伯维终止了与MacroGenics在ADAM9 ADC上的合作，因为临床I期数据未达预期。目前，MacroGenics重点管线有三款，分别是处于早期临床的B7H3 ADC MGC026和PD-1×CTLA-4 DART分子lorigerlimab，以及临床前的ADAM9 ADC MGC028。管线一款接着一款的失败，也就算了，毕竟管线开发失败乃是兵家常事。可难受的，还有缺钱的窘境，以及管线持续烧钱的现况。缺钱的窘境 MacroGenics共开发了三款商业化产品，分别是MARGENZA、ZYNYZ、TZIELD。 ZYNYZ和TZIELD早早的被授权出去，并为MacroGenics带来了不菲的收入，但是架不住MacroGenics花钱快啊。根据MacroGenics发布的2024年第二季度财报，公司季度净亏损5570万美元。截止第二季度，现金流只剩下1.4亿美元的MacroGenics，也有些着急了。打包出售MARGENZA MARGENZA（Margetuximab）是一款HER2单抗，于2020年获FDA批准，用于治疗转移性HER2+乳腺癌患者。值得注意的是，再鼎曾在2018年引进了Margetuximab，Margetuximab于2023年9月获得中国药监局批准，不过由于再鼎并未启动商业化运营，MacroGenics无法拿到其里程碑款项。今年早些时候，再鼎终止了与MacroGenics关于Margetuximab合作，协议已于2024年5月14日生效。 MARGENZA在MacroGenics自己商业化运营下，销售情况惨淡。根据MacroGenics发布的2024年第二季度财报，产品季度净销售额约为525万美元。如果产品不赚钱，就及时卖掉回血。 2024年10月，MacroGenics将MARGENZA打包出售给TerSera Therapeutics LLC。根据协议条款，TerSera将以4000万美元的前期付款+3500万美元的里程碑付款获得MARGENZA的全球权利。相较于MARGENZA的营收，说不上是卖了一个好价钱，但起码让MacroGenics回笼了一笔资金。指望Incyte的里程碑打款 ZYNYZ（retifanlimab）是一款PD-1单抗，于2017年授权给Incyte。ZYNYZ于2023年3月23日首次获得FDA批准，用于治疗转移性或复发局部晚期默克尔细胞癌（MCC）成人患者。根据Incyte公司财报，ZYNYZ在今年前六个月的销售额仅为100万美元。延伸阅读：FDA加速批准PD-1单抗一线治疗默克尔细胞癌 MacroGenics与Incyte于2024年7月达成协议，宣布已经实现与retifanlimab开发进度相关的1亿美元里程碑。此外，MacroGenics还有资格从Incyte获得高达 2.1亿美元的剩余开发和监管里程碑，以及高达3.3亿美元的潜在商业里程碑。以及，MacroGenics从Incyte获得该产品全球净销售额的15%至24%的分层特许权使用费。 TZIELD早就被卖了 TZIELD（teplizumab）是一款CD3单抗，于2018年授权给了Provention Bio。TZIELD于2022年11月获得FDA批准，用于预防/延缓1型糖尿病。 2023年3月，赛诺菲以约29亿美元收购了Provention Bio，获得了TZIELD。延伸阅读：1型糖尿病百年首个革命性疗法，CD3单抗终获批 MacroGenics原本还拥有TZIELD的专利权，能够获得TZIELD全球净销售额的个位数专利使用费。但是由于MacroGenics等不及这笔权益慢慢变现，直接就在2024年3月将Tzield的专利权以1亿美元的预付款出售给了药物专利权收购公司DRI Healthcare Trust。小结 MacroGenics共开发了三款商业化产品，但三款产品现在都不属于MacroGenics了。作为技术公司，不善商业操作，将管线授权出去也是一种优选择。但是MacroGenics孵化了三款商业化产品，手握专利权，按理来说，应该是躺下收钱了。参考资料： 1.https://ir.macrogenics.com/news-releases/news-release-details/macrogenics-announces-leadership-transition 2.https://ir.macrogenics.com/news-releases/news-release-details/macrogenics-provides-update-corporate-progress-second-quarter 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 · · · · · · · ·

财报抗体药物偶联物临床2期临床1期引进/卖出

2024-10-30

·GlobeNewswire-Health Care

MacroGenics Announces Leadership Transition

Scott Koenig, M.D., Ph.D., to step down as President and CEOBoard to initiate search process to identify new CEO ROCKVILLE, MD, Oct. 30, 2024 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ: MGNX), a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that Scott Koenig, M.D., Ph.D., intends to step down as President and Chief Executive Officer early next year. The Company’s Board of Directors has retained Heidrick & Struggles to lead a search process to identify its next Chief Executive Officer and has established a special committee of the Board to oversee the transition process. William Heiden, Chairman of the Board of Directors said, “Scott was a co-founder of MacroGenics twenty-four years ago and the Company has achieved many milestones under his leadership – including several partnered or company-owned FDA approved monoclonal antibody therapeutics developed by the company. On behalf of the Board, I want to thank Scott for his incredible dedication to the Company’s mission of discovering and developing novel therapeutics to improve patient care.” Mr. Heiden continued, “Today, MacroGenics has several innovative antibody-based therapeutics in development for the treatment of cancer, as well as significant alliances with leading pharmaceutical and biotechnology companies to develop and commercialize novel therapeutics. The Company today has a broad portfolio of promising assets and a strong balance sheet, and the Board and Scott agreed that this is the right time to transition to our next phase of leadership. We look forward to continuing to benefit from his perspectives as an advisor and shareholder.” “I am proud of our many achievements since our founding in 2000, in which we built a fully integrated, science-focused biotechnology company and have been successful in discovering, developing, manufacturing, and commercializing novel immunotherapeutics derived from our proprietary Fc-engineered antibody, bi-specific DART molecule, and antibody drug conjugate (ADC) technologies,” said Dr. Koenig. “Since the company’s IPO in 2013, we were able to fund a significant part of the development portfolio through the achievement of over $1 billion of non-dilutive capital via partnerships. Thanks to the incredible passion and dedication of the people at MacroGenics, three novel therapeutics from our pipeline advanced to approval, including MARGENZA® and ZYNYZ® to treat patients with cancer, and TZIELD® for individuals with early-stage Type 1 diabetes, and we have advanced a rich portfolio of clinical and preclinical molecules in development. I am confident that MacroGenics is well positioned in its current mission to address the significant unmet medical needs of patients with cancer. I look forward to continuing to support the Company in its work to achieve its key strategic objectives and create value for all our stakeholders.” About MacroGenics, Inc. MacroGenics is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and MARGENZA are trademarks or registered trademarks of MacroGenics, Inc. Cautionary Note on Forward-Looking Statements Any statements in this press release about future expectations, plans and prospects for MacroGenics (“Company”), including statements about the Company’s strategy, future operations, clinical development of and regulatory plans for the Company’s therapeutic candidates, expected timing of the release of final safety and efficacy data, including mature median rPFS and other statements containing the words “subject to”, "believe", “anticipate”, “plan”, “expect”, “intend”, “estimate”, “potential,” “project”, “may”, “will”, “should”, “would”, “could”, “can”, the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: risks that TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s revenue, expenses and costs may not be as expected, risks relating to TZIELD, vobramitamab duocarmazine, lorigerlimab, ZYNYZ, MARGENZA or any other product candidate’s market acceptance, competition, reimbursement and regulatory actions; future data updates, especially timing and results of mature median radiographic progression-free survival, other efficacy and safety data with respect to vobramitamab duocarmazine; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; availability and timing of data from ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof. ###

高管变更IPO抗体药物偶联物

2024-10-25

·ioncology

ESMO ASIA 2024丨一文了解胸部肿瘤口头报告

点击蓝字关注我们 2024年欧洲肿瘤内科学会亚洲年会（ESMO Asia Congress 2024）将于当地时间12月6日~8日在新加坡召开。ESMO ASIA是亚太地区讨论肿瘤学领域重磅突破的领先平台，近日在官方网站正式公布本次大会的摘要题目及作者信息。肿瘤瞭望小编带您先睹为快，一览胸部肿瘤领域入选优选口头报告（Proffered Paper）和微型口头报告（Mini Oral）的临床研究。 1 优选口头报告（Proffered Paper）摘要号：LBA8 英文标题：Phase II trial of atezolizumab plus carboplatin and paclitaxel in patients with metastatic or recurrent thymic carcinoma: Marble study 中文标题：阿替利珠单抗+卡铂/紫杉醇治疗转移性或复发性胸腺癌的II期临床试验：Marble研究讲者：Tomoyasu Mimori (日本) 摘要号：625O 英文标题：Efficacy and safety of Lucitanib (AL3810) in second or subsequent-line treatment of advanced recurrent or metastatic thymic carcinoma: a randomized, double-blind, placebo-controlled multicenter phase II trial 中文标题：Lucitanib在晚期复发或转移性胸腺癌二线或后续治疗中的疗效和安全性：一项随机、双盲、安慰剂对照的多中心II期试验讲者：方文涛（上海交通大学医学院附属胸科医院）摘要号：LBA5 英文标题：Zongertinib in patients with HER2-mutant NSCLC: Updated analysis of Beamion LUNG-1 中文标题：Zongertinib治疗HER2突变型NSCLC患者：Beamion LUNG-1的最新分析讲者：Noboru Yamamoto (日本) 摘要号：LBA6 英文标题：PACIFIC-5: A phase 3 study of consolidation durvalumab (D) in patients (pts) with unresectable stage III NSCLC and no progression after concurrent or sequential chemoradiotherapy (cCRT or sCRT) 中文标题：PACIFIC-5：针对同步或序贯放化疗（cCRT或sCRT）后未出现进展不可切除III期NSCLC患者进行巩固性度伐利尤单抗治疗的III期研究讲者：吴一龙（广东省人民医院）摘要号：LBA7 英文标题：Efficacy and safety of datopotamab deruxtecan (Dato-DXd) in patients (pts) with previously-treated EGFR-mutated advanced non-small cell lung cancer (NSCLC): a pooled analysis of TROPION-Lung01 and TROPION-Lung05 中文标题：Dato-DXd对既往接受过治疗的EGFR突变晚期非小细胞肺癌患者的疗效和安全性：TROPION-Lung01和TROPION-Lung05的汇总分析讲者：Myung-Ju Ahn (韩国) 2 微型口头报告（Mini Oral）摘要号：626MO 英文标题：Tarlatamab in previously treated small cell lung cancer (SCLC): Subgroup analysis of patients from the Asia region in the phase 2 DeLLphi-301 study 中文标题：Tarlatamab治疗既往接受过治疗的小细胞肺癌：II期DeLLphi-301研究中亚洲地区患者的亚组分析讲者：Hiroaki Akamatsu (日本) 摘要号：627MO 英文标题：POD1UM-304: Phase 3 Study of Retifanlimab Plus Platinum-Based Chemotherapy (Chemo) as First-Line (1L) Therapy For Nonsquamous or Squamous Metastatic Non–Small Cell Lung Cancer (mNSCLC) 中文标题：POD1UM-304：Retifanlimab+铂类化疗作为非鳞或鳞状转移性非小细胞肺癌一线疗法的III期研究讲者：陆舜(上海交通大学医学院附属胸科医院) 摘要号：614MO 英文标题：A Phase Ⅱ Study of Becotatug (JMT101) in Combination with Osimertinib (Osi) in Patients (pts) with classical EGFR-mutated Non-small Cell Lung Cancer (NSCLC) (BOOSTER Study) 中文标题：Becotatug联合奥希替尼治疗经典型EGFR突变非小细胞肺癌患者的Ⅱ期BOOSTER临床研究讲者：张力(中山大学肿瘤防治中心) 摘要号：630MO 英文标题：First-line (1L) osimertinib (osi) ± platinum-pemetrexed chemotherapy (CTx) for EGFR-mutated (EGFRm) advanced non-small cell lung cancer (NSCLC): FLAURA2 Asian cohort 中文标题：一线奥希替尼±铂类-培美曲塞化疗治疗EGFR突变晚期非小细胞肺癌：FLAURA2亚洲队列讲者：James Chih-Hsin Yang (中国台湾) 摘要号：628MO 英文标题：Comparing Subcutaneous vs Intravenous Amivantamab with Lazertinib in EGFR-Mutated Advanced NSCLC: Analysis of Asian Patients From PALOMA-3 中文标题：比较皮下注射vs静脉注射Amivantamab联合Lazertinib治疗EGFR突变晚期NSCLC：对PALOMA-3亚洲患者的分析讲者：Se-Hoon Lee (韩国) 摘要号：629MO 英文标题：ALESIA 7-year update: alectinib vs crizotinib in Asian patients (pts) with treatment-naïve advanced ALK+ non-small cell lung cancer (NSCLC) 中文标题：ALESIA研究7年随访更新：阿来替尼vs克唑替尼在未经治疗的晚期ALK+非小细胞肺癌亚洲患者中的疗效对比讲者：周彩存(上海市东方医院) （来源：《肿瘤瞭望》编辑部）声明凡署名原创的文章版权属《肿瘤瞭望》所有，欢迎分享、转载。本文仅供医疗卫生专业人士了解最新医药资讯参考使用，不代表本平台观点。该等信息不能以任何方式取代专业的医疗指导，也不应被视为诊疗建议，如果该信息被用于资讯以外的目的，本站及作者不承担相关责任。

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外链

KEGG	Wiki	ATC	Drug Bank
D11827	-	-	DB15766

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
转移性Merkel细胞癌	美国	Incyte Corp.	2023-03-22

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
子宫内膜癌	临床3期	中国	再鼎医药（上海）有限公司	2021-09-20
肛管鳞状细胞癌	临床3期	美国	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	日本	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	澳大利亚	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	比利时	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	丹麦	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	法国	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	德国	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	意大利	Incyte Corp.	2021-01-12
肛管鳞状细胞癌	临床3期	挪威	Incyte Corp.	2021-01-12

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临床结果

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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


NCT04438824 (ESMO2024) 人工标引	临床2期	去分化脂肪肉瘤	28	Palbociclib+retifanlimab	襯鬱鑰鹹願製鹹積獵鹹(壓網壓憲衊夢製鬱醖簾) = 簾衊遞齋廠築構鹽鬱糧壓觸遞鹹顧積憲築膚鹹 (齋醖蓋構齋鏇壓積廠觸, 4.7 ~ 33.6) 更多	积极	2024-09-13
NCT03328026 (ASCO2024) 人工标引	临床1/2期	转移性乳腺癌 \| 晚期乳腺癌 CAMLs \| CTCs	54	SV-BR-1-GM±pembrolizumab±retifanlimab	憲蓋顧範醖鏇鬱鹹築艱(獵鹹繭鑰築衊鬱獵簾夢) = 積廠網積膚醖製醖淵艱繭齋齋糧鹹繭遞範顧構 (鏇築鏇鬱範簾積窪鑰鹽 ) 更多	积极	2024-05-24
NCT04634825 (CTgov)	临床2期	转移性头颈部鳞状细胞癌	62	Enoblituzumab+Retifanlimab (Retifanlimab Cohort)	餘範艱鑰選築鬱網簾壓(構觸廠遞膚齋範繭襯蓋) = 選鹹膚淵糧壓範鑰顧選製廠鏇鏇淵構蓋構願築 (衊齋鏇積鹽膚顧範鹽窪, 蓋醖鏇餘構遞構憲願壓 ~ 顧憲憲鬱膚製膚艱醖觸) 更多	-	2023-12-20
NCT04634825 (CTgov)	临床2期	转移性头颈部鳞状细胞癌	62	Enoblituzumab+Tebotelimab (Tebotelimab Cohort)	遞醖憲願網積鏇範構觸(淵製襯鬱衊範壓積淵繭) = 壓鏇餘衊艱餘廠鹹壓構鹽廠衊積製願構鬱膚觸 (選膚獵艱鏇範積糧淵憲, 艱艱餘淵築憲餘鹽壓憲 ~ 蓋憲觸糧鏇製衊衊築鬱) 更多	-	2023-12-20
NCT03059823 (POD1UM-101, ESMO2023) 人工标引	临床1期	错配修复缺陷子宫内膜癌 \| MSI-H 子宫内膜癌 MSI-High \| Deficient DNA Mismatch Repair (dMMR)	76	Retifanlimab 500 mg	衊顧壓鑰積憲鹽膚鬱憲(餘製觸繭鏇選膚願膚蓋) = 淵願襯蓋餘齋餘獵鹹鹽製憲願鹹願衊齋窪鬱鬱 (製衊憲憲蓋鹽鑰鏇齋窪, 32 ~ 55)	积极	2023-10-22
NCT04370704 (ASCO2023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	21	INCAGN02385 350 mg+INCAGN02390 400 mg	餘淵襯淵壓壓製夢製鬱(膚鏇糧糧構窪積繭襯憲) = occurred in 1 pt in part 1 (grade [G] 3 vasculitis) and 1 pt in part 2 (G3 myocarditis and pericardial effusion) 鹽簾觸壓築製齋醖網選 (淵鑰構積願鹹繭鹹夢顧 ) 更多	积极	2023-05-26
NCT04370704 (ASCO2023) 人工标引	临床1/2期	HR阳性/HER2低表达实体瘤	21	retifanlimab 500 mg+INCAGN02385 350 mg+INCAGN02390 400 mg		积极	2023-05-26
NCT04225039 (ASCO2023) 人工标引	临床2期	复发性胶质母细胞瘤	32	INCAGN01876+Retifanlimab+FSRT (single-arm, primary efficacy cohort)	襯壓積糧獵糧構繭艱遞(齋構廠製網鏇構選製顧) = 築構餘觸壓觸鹹醖選廠顧網積鏇壓夢壓窪簾膚 (製窪簾餘遞襯襯夢衊獵, 2.1 ~ 6.2) 更多	不佳	2023-05-26
NCT04225039 (ASCO2023) 人工标引	临床2期	复发性胶质母细胞瘤	32	INCAGN01876+Retifanlimab+FSRT (two-arm neoadjuvant window-of-opportunity cohort)	襯壓積糧獵糧構繭艱遞(齋構廠製網鏇構選製顧) = 構構網憲鏇艱餘顧繭網顧網積鏇壓夢壓窪簾膚 (製窪簾餘遞襯襯夢衊獵 ) 更多	不佳	2023-05-26
NCT04577014 (ASCO2023) 人工标引	临床2期	局部晚期软组织肉瘤一线	43	Retifanlimab+gemcitabine+docetaxel	積齋淵鹹積鹽顧衊鹹選(鏇壓鹹鹹窪鏇膚鬱衊築) = 蓋憲鑰簾壓窪獵衊選襯積觸選襯衊觸鹽鏇壓繭 (鹹襯廠獵簾鬱鏇醖鏇鹽 ) 更多	积极	2023-05-26
NCT04231981 (ORPHEUS, ASCO2023) 人工标引	临床2期	阴茎鳞状细胞癌	18	Retifanlimab	鹹繭餘憲製觸鹽願糧築(窪糧選憲衊鬱襯築製窪) = 襯淵積衊窪艱鑰糧構製構鬱憲鬱糧鏇鏇齋餘顧 (糧構繭構夢醖糧鹹簾窪, 5.8 ~ 39.2) 更多	积极	2023-05-26
NCT03599713 (POD1UM-201, CTgov)	临床2期	转移性Merkel细胞癌	107	retifanlimab (Chemotherapy: Naïve)	獵繭廠餘蓋糧範鹹鑰醖(艱鏇觸憲繭願夢襯網遞) = 衊鏇憲膚衊憲憲簾襯鏇齋願衊鏇餘夢鏇餘醖構 (衊衊簾襯窪製簾繭齋範, 廠夢範願夢壓簾簾鹽餘 ~ 鬱餘襯醖餘壓觸網網簾) 更多	-	2023-05-03
NCT03599713 (POD1UM-201, CTgov)	临床2期	转移性Merkel细胞癌	107	retifanlimab (Chemotherapy: Refractory)	齋鏇獵選繭鏇蓋艱壓鏇(觸襯觸範鏇網夢願簾鹽) = 願壓鏇醖鹹製艱範鏇衊範襯構鑰鑰觸積衊鏇淵 (糧鏇鬱憲鏇築衊網網遞, 築壓蓋壓製醖襯築鏇壓 ~ 鹹艱餘觸製襯餘醖淵顧) 更多	-	2023-05-03
NCT03599713 (POD1UM-201, FDA) 人工标引	临床2期	转移性Merkel细胞癌	65	RETIFANLIMAB	鹽衊醖鬱襯窪網襯網齋(餘鑰夢壓窪蓋鹹膚夢築) = 醖廠鑰醖憲鏇簾淵鹹襯鏇願網鏇鹽鏇築積鹽構 (壓顧窪餘鏇鏇選築積蓋, 40 ~ 65) 更多	积极	2023-03-22