Single-Arm Study of Toripalimab in Combination With Cisplatin and Gemcitabine in Recurrent Metastatic Nasopharyngeal Carcinoma Systemic Treatment Naïve Participants

This study aims to investigate toripalimab with chemotherapy in participants with nasopharyngeal cancer.

开始日期2024-10-01

申办/合作机构

Coherus BioSciences, Inc.

NCT06611826 / Not yet recruiting临床2期IIT

A Prospective, Single-arm Phase II Clinical Study of GEP (Gemcitabine, Recombinant Human Endostatin, and Carrellizumab) Combined With High-low-dose Radiotherapy in Non-locally Treatable Recurrent Nasopharyngeal Carcinoma

This research aims to assess both effectiveness and safety of combining R-GEP regimen comprising gemcitabine, recombinant human endostatin, and cerexinib with low- and high-dose radiotherapy in managing unresectable recurrent nasopharyngeal carcinoma.

开始日期2024-09-30

申办/合作机构

浙江省肿瘤医院

NCT06029270 / Recruiting临床2期IIT

A Randomized Phase II Study of Nivolumab Versus Nivolumab and BMS-986016 (Relatlimab) as Maintenance Treatment After First-Line Treatment With Platinum-Gemcitabine-Nivolumab for Patients With Epstein-Barr Virus-Associated Recurrent/Metastatic Nasopharyngeal Carcinoma (REMAIN)

This phase II trial tests the addition of BMS-986016 (relatlimab) to the usual immunotherapy after initial treatment for nasopharyngeal cancer that has come back after a period of improvement (recurrent) or that has spread from where it first started (primary site) to other places in the body (metastatic). Relatlimab is a monoclonal antibody that may interfere with the ability of tumor cells to grow and spread. The usual approach of treatment is initial treatment with chemotherapy such as the combination of cisplatin (or carboplatin) and gemcitabine, along with immunotherapy such as nivolumab. After the initial treatment is finished, patients may continue to receive additional immunotherapy. Carboplatin is in a class of medications known as platinum-containing compounds. It works in a way similar to the anticancer drug cisplatin, but may be better tolerated than cisplatin. Carboplatin works by killing, stopping or slowing the growth of tumor cells. Immunotherapy with monoclonal antibodies, such as nivolumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Gemcitabine is a chemotherapy drug that blocks the cells from making deoxyribonucleic acid (DNA) and may kill cancer cells. Giving BMS-986016 in addition to the usual immunotherapy after initial treatment may extend the time without the tumor cells growing or spreading longer than the usual approach in patients with recurrent or metastatic nasopharyngeal cancer.

开始日期2024-07-15

申办/合作机构

National Cancer Institute

100 项与复发性鼻咽癌相关的临床结果

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0 项与复发性鼻咽癌相关的专利（医药）

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项与复发性鼻咽癌相关的文献（医药）

2024-11-01·Oral Oncology

Gemcitabine, capecitabine, and tislelizumab in recurrent/metastatic nasopharyngeal carcinoma following prior anti-PD-1 therapy failure: A retrospective study

Article

作者: Zhao, Yang ; Li, Ruichen ; Yan, Li ; Tian, Shu ; Zhu, Yi ; Qiu, JianJian ; Wang, Xiaoshen ; Niu, Xiaoshuang ; Yang, Rui

PURPOSETo evaluate the effectiveness and safety of low-dose gemcitabine and metronomic capecitabine in combination with tislelizumab for patients with recurrent or metastatic nasopharyngeal carcinoma (RM-NPC) who have previously received other anti-PD-1 therapies.METHODSThis retrospective, observational study included patients with RM-NPC who had prior treatment with anti-PD-1 therapy and subsequently received tislelizumab along with low-dose gemcitabine and metronomic capecitabine between March 2019 and August 2023. Progression-free survival (PFS) was estimated using the Kaplan-Meier method.RESULTSAmong 25 eligible patients, 8 (20%) achieved a complete response (CR). The objective response rate (ORR) was 68%, and the disease control rate (DCR) was 80%. The 1-year PFS rate was 78%. All patients experienced treatment-related adverse events, which were all grade 1 or 2.CONCLUSIONThe combination of tislelizumab with low-dose gemcitabine and metronomic capecitabine demonstrated promising antitumor effectiveness in RM-NPC patients who had failed previous anti-PD-1 therapy, with a manageable safety profile.

2024-10-02·Expert Opinion on Investigational Drugs

Progress in the clinical development of investigational systemic agents for recurrent and metastatic nasopharyngeal carcinoma

Review

作者: Lim, Darren Wt ; Yan, Kelvin ; Ma, Brigette B.B.Y.

INTRODUCTIONNasopharyngeal carcinoma (NPC) remains an endemic disease in certain parts of the world, with many patients presenting with advanced disease on diagnosis. Chemotherapy had remained the standard of care with minimal progress made until recent years. This review aims to provide an overview of recent significant breakthroughs and up-and-coming novel strategies in treating this deadly disease.AREAS COVEREDThis review focuses on the latest clinical development of promising investigational agents in the treatment of advanced NPC. These include anti-vascular agents, signaling pathways inhibitors and immunotherapy.EXPERT OPINIONThe addition of immune-checkpoint inhibitors (CPI) to platinum-based chemotherapy has undoubtedly changed the therapeutic landscape of R/M NPC in the first-line setting. This leaves much room for further research on the optimal treatment strategy in subsequent-line settings, likely including the addition of CPI to anti-vascular agents or novel CPI combinations, with or without chemotherapy as a backbone. Other potential approaches include optimal CPI maintenance therapy after first-line CPI-chemotherapy combination. Potential novel agents on the horizons are antibody-drug conjugates, bi-specific antibodies and signaling inhibitors, with several phase II/III studies currently underway.

2024-10-01·International Journal of Radiation Oncology*Biology*Physics

A Randomised, Multicentre, Phase II Trial of Camrelizumab with or without Metastasis-directed Stereotactic Body Radiotherapy in Recurrent or Metastatic Nasopharyngeal Carcinoma

Article

作者: Wang, Feng ; Chua, Melvin L.K. ; Zhang, Jianwen ; Zhang, Lu ; Tu, Honglei ; Lei, Qianqian ; Chua, Melvin L K ; Zhang, Xin ; Xie, Yue ; Lim, Darren W.T. ; Lim, Darren W T ; Sui, Jiang Dong ; Shu, Xiaolei ; Wang, Chengchen ; Liu, Huawen ; Huang, Luo ; Long, Bin ; Wang, Yuwei ; Wang, Ying ; Neo, Jialing ; Tan, Sze Huey ; Yang, Jieying ; Yan, Jin

PURPOSETo investigate the efficacy of metastasis-directed therapy (MDT) when added to camrelizumab (Cam) in patients with recurrent or metastatic nasopharyngeal carcinoma (R/M-NPC).METHODSWe conducted a randomised, controlled, multicentre, phase II trial in 3 centres from China (NCT04830267). Patients with R/M-NPC, without prior exposure to immunotherapy, who presented with ≥2 lesions, and at least 1 measurable lesion were randomised 1:1 to either Cam alone or Cam plus MDT (Cam+MDT). Patients randomised to the MDT group must have 1 lesion that is amendable to stereotactic body radiotherapy (SBRT) prescribed to 27Gy in 3 fractions every other day. Primary endpoint was objective response rate (ORR) of unirradiated lesions by RECIST v1.1.RESULTSBetween April 2021 and August 2023, 39 patients were randomly assigned to receive either Cam (n=20) or Cam+MDT (n=19). 17/39 (43.6%) patients had oligometastatic disease (≤3 lesions); 18/39 (46.2%) had liver involvement; 3/39 (7.7%) had locoregional recurrent disease. ORR of unirradiated lesions did not differ between the treatment groups (26.3% [Cam+MDT] vs 30.0% [Cam], P=1.0). DCR of unirradiated lesions was 73.7% in the Cam+MDT group compared with 60.0% in the Cam group (P=0.571). After a median follow-up of 25.8 months, median progression-free survival was 9.3 (95% CI: 6.2-NR) months in the Cam+MDT group and 8.8 (95% CI: 3.3-NR) months in the Cam group (P=0.750). Exploratory analyses suggested a longer overall survival (OS) with Cam+MDT for patients with >3 lesions (HR 0.23 [95% CI: 0.07-0.77], P=0.009). G3 and above adverse events were comparable between the treatment groups (15.8% [Cam+MDT] vs 20.0% [Cam]). Overall rate of capillary proliferation was 17.9% (7/39) on the trial.CONCLUSIONSOur study did not meet its primary endpoint of superior ORR of unirradiated lesions with the addition of MDT to Cam in patients with R/M-NPC.

项与复发性鼻咽癌相关的新闻（医药）

2024-10-08

·医药笔记

宜联生物：B7H3 ADC启动鼻咽癌三期临床

▎Armstrong 2024年10月7日，宜联生物在Clinicaltrials.gov网站上注册了B7H3 ADC新药YL201治疗鼻咽癌的三期临床试验。该三期临床计划入组400例复发性鼻咽癌患者，对比化疗，预计2027年底初步完成，主要终点为ORR和OS。今年ESMO会议上，宜联生物披露了YL201最新临床数据。截至2024年8月9日，在276例存在至少一次基线后肿瘤评估的患者中，总体客观缓解率(ORR)为44.6%，疾病控制率(DCR)为83.7%。ES-SCLC队列共计72例可评估疗效的患者，既往全部接受过含铂化疗，95%接受过anti-PD-(L)1治疗。NPC队列共计70例可评估疗效的患者，既往全部接受过含铂化疗和anti-PD-(L)1治疗，75%接受过2线及以上标准治疗。YL201在NPC患者中的ORR为48.6%（≥2.0 mg/kg ORR为48.6%），mPFS为7.2个月（≥2.0 mg/kg mPFS为7.2个月）。在接受过2线及以上标准治疗的患者中，ORR为51.0%，mPFS为7.0个月，与NPC总体人群相当。安全性方面，312例总体人群中≥G3 TRAE发生率为51%，SAE发生率为28%。最常见的TRAE为血液学毒性，包括白细胞减少症（≥G3 29%）、贫血（≥G3 22%）、中性粒细胞减少症（≥G3 30%）等；非血液学TRAE包括食欲减少（≥G3 1%）、恶心（≥G3 1%）等，间质性肺炎（ILD）仅有3例报道（1.0%）。总结上个月，宜联生物已经注册了YL201治疗小细胞肺癌的三期临床。此次则意味着YL201成为首个进入鼻咽癌三期临床的B7H3 ADC。昨日，宜联生物还宣布与安进达成合作，开展B7H3 ADC+DLL3/CD3双抗联合治疗小细胞肺癌的临床试验。 Armstrong技术全梳理系列 GPRC5D靶点全梳理； CD40靶点全梳理； CD47靶点全梳理；补体靶向药物技术全梳理；补体药物：眼科治疗的重要方向； Claudin 6靶点全梳理； Claudin 18.2靶点全梳理；靶点冷暖，行业自知；中国大分子新药研发格局；被炮轰的“me too”；佐剂百年史；胰岛素百年传奇； CUSBEA：风雨四十载；中国新药研发的焦虑；中国生物医药企业的研发竞争；中国双抗竞争格局；中国ADC竞争格局；中国双抗技术全梳理；中国ADC技术全梳理； Ambrx技术全梳理； Vir Biotech技术全梳理； Immune-Onc技术全梳理；亘喜生物技术全梳理；康哲药业技术全梳理；科济药业技术全梳理；恺佧生物技术全梳理；同宜医药技术全梳理；百奥赛图技术全梳理；腾盛博药技术全梳理；创胜集团技术全梳理；永泰生物技术全梳理；中国抗体技术全梳理；德琪医药技术全梳理；德琪医药技术全梳理2.0；和铂医药技术全梳理；荣昌生物技术全梳理；再鼎医药技术全梳理；药明生物技术全梳理；恒瑞医药技术全梳理；豪森药业技术全梳理；正大天晴技术全梳理；吉凯基因技术全梳理；基石药业技术全梳理；百济神州技术全梳理；百济神州技术全梳理第2版；信达生物技术全梳理；信达生物技术全梳理第2版；中山康方技术全梳理；复宏汉霖技术全梳理；先声药业技术全梳理；君实生物技术全梳理；嘉和生物技术全梳理；志道生物技术全梳理；道尔生物技术全梳理；尚健生物技术全梳理；康宁杰瑞技术全梳理；科望医药技术全梳理；科望医药技术全梳理2.0；岸迈生物技术全梳理；礼进生物技术全梳理；康桥资本技术全梳理；余国良的抗体药布局；荃信生物技术全梳理；安源医药技术全梳理；三生国健技术全梳理；仁会生物技术全梳理；乐普生物技术全梳理；同润生物技术全梳理；宜明昂科技术全梳理；派格生物技术全梳理；迈威生物技术全梳理； Momenta技术全梳理； NGM技术全梳理；普米斯生物技术全梳理；普米斯生物技术全梳理2.0；三叶草生物技术全梳理；贝达药业抗体药全梳理；泽璟制药抗体药全梳理；恒瑞医药抗体药全梳理；齐鲁制药抗体药全梳理；石药集团抗体药全梳理；豪森药业抗体药全梳理；华海药业抗体药全梳理；科伦药业抗体药全梳理；百奥泰技术全梳理；凡恩世技术全梳理。

临床3期抗体药物偶联物临床结果临床失败

2024-09-06

·PRNewswire

Akeso to Present Data from 13 Clinical Studies at ESMO 2024, Featuring its Internally Developed Cadonilimab, Ivonescimab, Ligufalimab, and other I/O Antibodies

HONG KONG, Sept. 5, 2024 /PRNewswire/ -- Akeso, Inc. (9926.HK) will showcase promising results from 13 clinical studies on its internally developed PD-1/CTLA-4 bispecific antibody cadonilimab, PD-1/VEGF bispecific antibody ivonescimab, next-generation CD47 monoclonal antibody ligufalimab, and commercially available PD-1 monoclonal antibody penpulimab at the ESMO Congress 2024 from September 13th to 17th (CEST). These studies span advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies. Notably, ivonescimab's clinical results in combination with ligufalimab will be presented for the first time. Data on ivonescimab ± ligufalimab plus chemotherapy for mCRC and ivonescimab combined with chemotherapy for TNBC will be featured in the Mini Oral Session. Additionally, the Phase III study of anlotinib combined with penpulimab versus sorafenib for HCC will be presented as a late-breaking abstract in the Proffered Paper Session. Stay tuned for additional updates! Details of the Presentations: Colorectal Cancer Abstract Title: The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC) Key Study Findings: For first-line treatment of MSS-type mCRC, previous immunotherapies have shown limited benefits. Ivonescimab has achieved meaningfully significant ORR, DCR, and PFS (although data is immature) in these mCRC patients. When combined with ligufalimab (CD47), the clinical outcome improved further, surpassing current standard treatments. These findings highlight the promising potential of ivonescimab, both alone and in combination with ligufalimab, for treating MSS-type mCRC. Session Type: Mini Oral Session Number: 514MO Presentation Presentation Time: Saturday, 14 September 15:50-15:55 (CEST) Speaker: Yanhong Deng, Sun Yat-sen University Sixth Affiliated Hospital Triple-Negative Breast Cancer Abstract Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC) Key Study Findings : Most patients were PD-L1 negative (53.3%). The proportion of patients who had previously received taxane-based neoadjuvant therapy (60%) was higher than in similar targeted drug studies. Ivonescimab demonstrated robust ORR and DCR. PFS results were meaningfully significant, even in patients with limited follow-up time and immature data. The safety profile of ivonescimab aligns with results from prior studies. Session Type: Mini Oral Session Number: 347MO Presentation Time: Monday, 16 September 08:30-08:35 (CEST) Speaker: Xiaojia Wang, Zhejiang Provincial Cancer Hospital Head And Neck Squamous Cell Carcinoma Abstract Title: Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC) Key Study Findings: PD-1 is the standard first-line treatment for CPS≥1 R/M HNSCC but has limited efficacy. Preliminary data from this study suggest that ivonescimab improves ORR and PFS for patients needing rapid tumor shrinkage. Ivonescimab combined with ligufalimab (CD47) further extends both ORR and PFS. Ivonescimab, both as monotherapy and in combination with ligufalimab, has yielded preliminary results that significantly outperform currently approved PD-1 treatments. A Phase III head-to-head trial against Keytruda is scheduled to initiate patient enrollment in the fourth quarter of 2024. Session Type: Poster Session Number: 876P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Neoadjuvant and Adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study Session Type: Poster Session Number: 866P Presentation Time: Saturday, 14 September 2024 (CEST) Hepatocellular Carcinoma Abstract Title: Primary results from the phase III ALTN-AK105-III-02 study: Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC) Session Type: Proffered Paper Session Number: LBA40 Presentation Time: Friday,13 September 16:55-17:05 (CEST) Gynecological Oncology Abstract Title: A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy Session Type: Poster Session Number: 732P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: a multicenter retrospective analysis in China Session Type: Poster Session Number: 727P Presentation Time: Saturday, 14 September 2024 (CEST) Abstract Title: Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients : an open, prospective, single arm, phase II trial Session Type: Poster Session Number: 760P Presentation Time: Saturday, 14 September 2024(CEST) Nasopharyngeal Carcinoma Abstract Title: Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1 resistant recurrent or metastatic nasopharyngeal carcinoma: an open-label, single-arm, phase II clinical trial Session Type: Poster Session Number: 893P Presentation Time: Saturday, 14 September 2024(CEST) Biliary Tract Cancer Abstract Title: Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, single-arm clinical trial Session Type: Poster Session Number: 52P Presentation Time: Monday, 16 September 2024 (CEST) Gastric Cancer Abstract Title: Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial Session Type: Poster Session Number: 1455P Presentation Time: Monday, 16 September 2024(CEST) Abstract Title: Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients Session Type: Poster Session Number: 1473TiP Presentation Time: Monday, 16 September 2024 (CEST) Esophageal Squamous Cell Carcinoma Abstract Title: Efficacy and safety of cadonilimab combined albumin-paclitaxel, cisplatin and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LAESCC): results from the CAPITAL trial Session Type: Poster Session Number: 1446P Presentation Time: Monday, 16 September 2024 (CEST) SOURCE Akeso, Inc.

临床结果临床3期临床2期免疫疗法

2024-09-03

·GlobeNewswire-Health Care

Viracta Therapeutics to Present at the H.C. Wainwright 26th Annual Global Investment Conference

SAN DIEGO, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Viracta Therapeutics, Inc. (Nasdaq: VIRX), a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide, today announced that Mark Rothera, President and Chief Executive Officer, will present at the H.C. Wainwright 26th Annual Global Investment Conference taking place in New York City on Wednesday, September 11, 2024, at 8:30 a.m. EDT. A live webcast of the presentation will be available on the Investors section of the Viracta website under "Events and Presentations" and archived for 90 days. About Viracta Therapeutics, Inc.Viracta is a clinical-stage precision oncology company focused on the treatment and prevention of virus-associated cancers that impact patients worldwide. Viracta’s lead product candidate is an all-oral combination therapy of its proprietary investigational drug, nanatinostat, and the antiviral agent valganciclovir (collectively referred to as Nana-val). Nana-val is currently being evaluated in multiple ongoing clinical trials, including a potentially registrational, global, multicenter, open-label Phase 2 basket trial for the treatment of multiple subtypes of relapsed or refractory (R/R) Epstein-Barr virus-positive (EBV+) lymphoma (NAVAL-1), as well as a multinational, open-label Phase 1b/2 clinical trial for the treatment of patients with recurrent or metastatic (R/M) EBV+ nasopharyngeal carcinoma (NPC) and other advanced EBV+ solid tumors. Viracta is also pursuing the application of its “Kick and Kill” approach in other virus-related cancers. For additional information, please visit www.viracta.com. Investor Relations Contact:Michael FaermChief Financial OfficerViracta Therapeutics, Inc.ir@viracta.com SOURCE Viracta Therapeutics, Inc.

临床2期