This is a single-arm pilot feasibility study evaluating the combination of Botensilimab and Balstilimab with Radiation Therapy (RT) in Non-Microsatellite Instability High (MSI-H) or Proficient Mismatch Repair (pMMR) chemorefractory colorectal cancer (CRC) with liver metastasis.

开始日期2026-01-01

申办/合作机构

The Massachusetts General Hospital

[+1]

NCT07152821

/ Not yet recruiting临床3期IIT

Botensilimab + Balstilimab vs Best Supportive Care as Therapy in Chemo-refractory, Unresectable, Colorectal Adenocarcinoma: The BATTMAN Trial

This study is being done to answer the main question of: Do patients with colorectal cancer that cannot be removed by surgery, that is treated with two new immunotherapy drugs, botensilimab and balstilimab, live longer? Other important questions include: Is their quality of life better? Do their tumours slow in growth or possibly shrink in size? Are there markers in their tumour or blood that can predict whether they achieve any of these benefits? In addition, the study is done to confirm the safety of these immunotherapy drugs and to determine how long it takes for the body to metabolize them.

开始日期2025-11-30

申办/合作机构

Canadian Cancer Trials Group

[+2]

NCT06843551

/ Recruiting临床2期IIT

A Phase 2 Single Arm Trial of Stereotactic Body Radiation Therapy Followed by Dual Immune Checkpoint Inhibition for Patients With Metastatic Pancreatic Ductal Adenocarcinoma - The Miami "EMPIRE" Trial - Eradication of Metastatic Pancreatic Cancer With Immuno-Radiation

The purpose of this study is to assess if radiation therapy (which uses high-energy radiation to damage or destroy cancer cells) combined with immune checkpoint inhibitors (medications that helps the body recognize and attack cancer cells) will be beneficial for patients with metastatic pancreatic ductal adenocarcinoma.

开始日期2025-06-18

申办/合作机构

University of Miami

[+1]

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165

项与巴替利单抗相关的文献（医药）

2025-04-10·JOURNAL OF CLINICAL ONCOLOGY

Botensilimab (Fc-enhanced anti–cytotoxic lymphocyte-association protein-4 antibody) Plus Balstilimab (anti–PD-1 antibody) in Patients With Relapsed/Refractory Metastatic Sarcomas

Article

作者: Bullock, Andrea J. ; Schwartz, Gary K. ; Jones, Robin L. ; Grossman, Joseph E. ; Trent, Jonathan C. ; Johnson, Benny ; Avagyan, Manushak ; O'Day, Steven ; Agulnik, Mark ; Chand, Dhan ; Henick, Brian ; Delepine, Chloe ; Singh, Arun ; Gordon, Michael S. ; El-Khoueiry, Anthony B. ; Wu, Wei ; Mahadevan, Daruka ; Stebbing, Justin ; Wilky, Breelyn A. ; Tsimberidou, Apostolia M.

PURPOSE:

Outcomes for patients with advanced sarcomas are poor and there is a high unmet need to develop novel therapies. The purpose of this phase I study was to define the safety and efficacy of botensilimab (BOT), an Fc-enhanced anti–cytotoxic lymphocyte-association protein-4 antibody, plus balstilimab (BAL), an anti–PD-1 antibody, in advanced sarcomas.

METHODS:

BOT was administered intravenously (IV) at 1 mg/kg or 2 mg/kg once every 6 weeks in combination with BAL IV at 3 mg/kg once every 2 weeks for up to 2 years. The primary end point was to determine dose-limiting toxicities during the dose-escalation period. Secondary end points include objective response rate (ORR), duration of response (DOR), disease control rate, and progression-free survival (PFS) by RECIST 1.1. Exploratory end points include assessing patient biomarkers including tumor mutational burden, cytokines, and PD-L1 expression.

RESULTS:

Overall, 64 patients with sarcoma were treated; all were evaluable for safety and 52 for efficacy. The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. No grade 4 or 5 TRAEs were reported. For all evaluable patients, ORR was 19.2% (95% CI, 9.6 to 32.5), and 27.8% (95% CI, 9.7 to 53.5) for evaluable patients with angiosarcoma (n = 18); 33.3% in visceral and 22.2% in cutaneous subtypes. Median PFS for evaluable patients was 4.4 months (95% CI, 2.8 to 6.1), with a 6-month PFS rate of 36% (95% CI, 22 to 50) and a median DOR of 21.7 months (95% CI, 1.9 to not reached).

CONCLUSION:

The combination of BOT/BAL demonstrated promising efficacy and safety in a large cohort of heavily pretreated sarcoma patients. This encouraging activity warrants further investigation (ClinicalTrials.gov identifier: NCT03860272 ).

2025-02-17·CLINICAL CANCER RESEARCH

The Prostaglandin EP4 Antagonist Vorbipiprant Combined with PD-1 Blockade for Refractory Microsatellite-Stable Metastatic Colorectal Cancer: A Phase Ib/IIa Trial

Article

作者: Niger, Monica ; Cristarella, Eleonora ; Vitalini, Cristina ; Rovati, Lucio C. ; Chiodoni, Claudia ; Morano, Federica ; Brambilla, Nadia ; Zaffaroni, Nadia ; Doldi, Valentina ; Girolami, Federica ; Ghelardi, Filippo ; Giacovelli, Giampaolo ; Pietrantonio, Filippo ; Benincasa, Elena ; Palazzo, Michele ; Nichetti, Federico ; Sabella, Giovanna ; Manca, Paolo

Abstract:

Purpose::

Novel combinations are required to overcome resistance to immune checkpoint inhibitors in proficient mismatch repair (pMMR) or microsatellite-stable (MSS) metastatic colorectal cancer (mCRC). We aimed to determine whether vorbipiprant, a prostaglandin E2 receptor EP4 subtype antagonist, can convert immune-resistant mCRC into a tumor responsive to anti–PD-1 inhibition.

Patients and Methods::

This phase Ib/IIa prospective, open-label, single-arm trial followed a 3 + 3 dose-escalation and dose-optimization design. A total of 28 patients with chemorefractory pMMR/MSS mCRC were given dose-escalated oral vorbipiprant (30, 90, or 180 mg twice daily), along with biweekly intravenous balstilimab (3 mg/kg), an anti–PD-1 antibody. The primary endpoints included safety and the disease control rate (DCR). Secondary endpoints were the overall response rate, duration of response, progression-free survival, and overall survival.

Results::

No dose-limiting toxicities were observed. Of the 28 patients, seven (25%) experienced serious adverse events, but only one was attributed to vorbipiprant and one to balstilimab. The trial achieved a DCR of 50% observed across the entire cohort. In the subgroup of patients with liver metastases (n = 12), the DCR was 25%. The overall response rate was 11%, with three patients showing a partial response (median duration of response, 7.4 months). The median progression-free survival was 2.6 months, and the median overall survival was 14.2 months. Translational exploratory analyses suggested that vorbipiprant may boost response to anti–PD-1 in patients with immunogenic tumors.

Conclusions::

The combination of vorbipiprant and a PD-1 inhibitor (balstilimab) yielded sufficient activity in refractory pMMR/MSS mCRC, which is worthy of confirmation in future clinical trials in biomarker-enriched populations.

2025-02-01·JOURNAL OF ETHNOPHARMACOLOGY

Synergistic effects of Lianhuaqingwen in combination with Oseltamivir and Baloxavir against seasonal influenza virus: In vitro and in vivo assessment

Article

作者: Duan, Xuefeng ; Li, Xuanxuan ; Du, Han ; Bi, Yuhai ; Zhang, Cheng ; Yang, Jing ; Qi, Hui ; Rong, Wenwan ; Ma, Zhenghai ; Yuan, Manhua ; Li, Jianxiong ; Ji, Tiannan ; Zhang, Ning ; Dai, Bo

ETHNOPHARMACOLOGICAL RELEVANCE:

Lianhuaqingwen (LH), a traditional Chinese medicine, presents a broad-spectrum antiviral effect and has been widely used to treat influenza. Given the potential rise of drug-resistant influenza viruses, it is necessary to develop new antiviral drugs and explore combination therapies involving LH in tandem with existing antivirals such as Oseltamivir acid (Osel) or Baloxavir (Bal). These multidrug combinations could help effectively control the seasonal influenza epidemics and reduce the disease burden.

AIM OF THE STUDY:

This study aimed to evaluate the antiviral effects of LH, alone and in combination with Osel or Bal, against human seasonal influenza viruses in vitro and in vivo models.

MATERIALS AND METHODS:

The antiviral efficacy of LH alone and LH in combination with Osel/Bal against seasonal influenza A viruses (IAVs) (H1N1 and H3N2 subtypes) and influenza B viruses (IBVs) (BV- and BY-lineages) was assessed in vitro using MDCK cells. The median effective concentration (EC₅₀) was determined, and the drug synergies were analyzed. Additionally, the antiviral activity of LH monotherapy and LH + Osel/Bal combination therapy were evaluated in vivo using an H1N1-infected BABL/c mouse model by monitoring changes in body weight, survival rate, lung viral titer, pathological damage, and inflammatory reaction.

RESULTS:

In vitro, LH alone and in combination with Osel/Bal exhibited antiviral activity against both IAVs and IBVs. The addition of LH to Osel/Bal improved the therapeutic efficacy compared to Osel/Bal alone. In vivo, LH monotherapy reduced body weight loss and increased the survival rates of H1N1-infected mice. LH in combination with Osel/Bal resulted in lower virus titers, more effective relief of pathological damage, and comparable low expression of inflammatory factors in the lungs of H1N1-infected mice compared to the use of Osel/Bal alone. Transcriptomic analysis of the lungs revealed that LH + Osel/Bal significantly increased the expression of genes associated with antiviral and anti-inflammatory effects.

CONCLUSIONS:

This study evaluated the antiviral effects of LH monotherapy and combination therapy with Osel/Bal against human seasonal influenza viruses in vitro and in vivo models. The results suggest that combining LH with Osel or Bal could enhance the antiviral efficiency for influenza viruses compared to the monotherapy using any of these three drugs.

189

项与巴替利单抗相关的新闻（医药）

2025-09-09

·investor.agenusbio.com

France Grants Reimbursed Compassionate Access (AAC) for Agenus’ BOT/BAL in Refractory MSS Metastatic Colorectal Cancer

LEXINGTON, Mass.--(BUSINESS WIRE)-- Agenus Inc. (Nasdaq: AGEN), a leader in immuno‑oncology, today announced its investigational combination botensilimab plus balstilimab (BOT/BAL) is now available to eligible patients with refractory microsatellite‑stable (MSS) metastatic colorectal cancer (mCRC) under France’s compassionate access (Accès compassionnel, or AAC) framework. The French National Agency of Medicines and Health Products Safety’s (ANSM) listings for botensilimab and balstilimab are live and detail eligibility (including MSS and no active liver metastases) and dosing. BOT/BAL remains investigational and is not approved for commercial marketing in France or elsewhere. How AAC reimbursement works Once the ANSM authorizes AAC, hospital use is covered 100% by Assurance Maladie. Hospitals are reimbursed at the invoiced purchase price (TTC), outside the Diagnosis-related Group (DRG), referred to in France as “en sus du GHS”. During AAC the manufacturer either provides the medicine free of charge or invoices an “indemnity”—a temporary, company‑set price for the product. For AAC, the maximum indemnity must be declared to the French Ministers after the first authorization. Agenus has declared a maximum indemnity for BOT/BAL in line with these rules. Ex‑post rebate mechanisms apply where relevant. “This is a breakthrough for patients and their physicians. MSS colorectal cancer resists currently approved immunotherapies, and available options to patients after standard regimens are scarce. On behalf of patients, families, and the clinical community, we thank ANSM, Assurance Maladie, and the Ministry for their leadership. We will support French centers without delay to ensure reliable supply of BOT/BAL and high quality real world evidence,” commented Garo Armen, PhD, Chairman & CEO of Agenus. Why it matters Peer‑reviewed and congress data show durable activity of BOT/BAL in refractory MSS mCRC, particularly in patients without active liver metastases—a population with limited options. Recent updates describe ~21‑month median OS, ~42% 2‑year survival, and ~20% ORR in expanded cohorts. International patient access European Union (EU) and the European Economic Area (EEA) patients may obtain planned care in France under Directive 2011/24/EU, usually with prior authorization for hospital or specialist care and reimbursement is provided by the patient’s home system based on its national tariffs. Outside the EU, countries such as Turkey operate treatment‑abroad programs on a case‑by‑case basis. Patients should consult their National Contact Point or insurer as France’s reimbursement for French residents does not automatically extend to non-residents. About France’s Compassionate Access (AAC) AAC is a pre‑authorization access route managed by ANSM for patients with serious or rare conditions without adequate alternatives. It is distinct from marketing authorization and from commercial pricing; coverage activates automatically at 100% for hospital use once authorized, with financing en sus du GHS and reimbursement at TTC purchase price. About the BOT/BAL Phase 3 Program Agenus will initiate the global Phase 3 BATTMAN trial (NCT07152821) in Q4 2025 to confirm efficacy in refractory MSS mCRC and support broader availability. About Agenus Agenus is a leading immuno-oncology company targeting cancer with a comprehensive pipeline of immunological agents. The company was founded in 1994 with a mission to expand patient populations benefiting from cancer immunotherapy through combination approaches, using a broad repertoire of antibody therapeutics, adoptive cell therapies (through MiNK Therapeutics) and adjuvants (through SaponiQx). Agenus has robust end-to-end development capabilities, across commercial and clinical cGMP manufacturing facilities, research and discovery, and a global clinical operations footprint. Agenus is headquartered in Lexington, MA. For more information, visit www.agenusbio.com or @agenus_bio. Information that may be important to investors will be routinely posted on our website and social media channels. About Botensilimab (BOT) Botensilimab (BOT) is a human Fc enhanced multifunctional anti-CTLA-4 antibody designed to boost both innate and adaptive anti-tumor immune responses. Its novel design leverages mechanisms of action to extend immunotherapy benefits to “cold” tumors which generally respond poorly to standard of care or are refractory to conventional PD-1/CTLA-4 therapies and investigational therapies. Botensilimab augments immune responses across a wide range of tumor types by priming and activating T cells, downregulating intratumoral regulatory T cells, activating myeloid cells and inducing long-term memory responses. Approximately 1,200 patients have been treated with botensilimab and/or balstilimab in phase 1 and phase 2 clinical trials. Botensilimab alone, or in combination with Agenus’ investigational PD-1 antibody, balstilimab, has shown clinical responses across nine metastatic, late-line cancers. For more information about botensilimab trials, visit www.clinicaltrials.gov. About Balstilimab (BAL) Balstilimab is a novel, fully human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1 (programmed cell death protein 1) from interacting with its ligands PD-L1 and PD-L2. It has been evaluated in more than 900 patients to date and has demonstrated clinical activity and a favorable tolerability profile in several tumor types. Forward-Looking Statements This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding its botensilimab and balstilimab programs, expected regulatory timelines and filings, and any other statements containing the words "may," "believes," "expects," "anticipates," "hopes," "intends," "plans," "forecasts," "estimates," "will," “establish,” “potential,” “superiority,” “best in class,” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recent Annual Report on Form 10-K for 2024, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this press release, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Investors 917-362-1370 investor@agenusbio.com Media 781-674-4422 communications@agenusbio.com

免疫疗法临床1期临床3期临床2期

2025-09-06

·Biotech前瞻

全球即将迎来第三款CTLA-4抑制剂上市，来自信达生物

2025 【信达生物丨信迪利单抗】 2025年2月5日，CDE官网最新公示，信达生物申报的伊匹木单抗注射液和信迪利单抗注射液拟纳入优先审评，适应症为伊匹木单抗注射液联合信迪利单抗用于可切除的微卫星高度不稳定型（MSI-H）或错配修复缺陷型（dMMR）结肠癌患者的新辅助治疗。早在2024年10月14日，施贵宝宣布其“双免疫联合疗法”纳武利尤单抗联合伊匹木单抗的上市申请已获得中国国家药监局（NMPA）批准，用于一线治疗不可切除或转移性微卫星高度不稳定性（MSI-H）或错配修复缺陷型（dMMR）结直肠癌患者。由此可见，dMMR/MSI-H型结直肠癌患者，对ICIs治疗高度敏感。该部分人群，新辅助治疗阶段，也迎来突破！ 2025 阅读指南 1、MSI-H/dMMR mCRC 新辅助 2、MSS/pMMR mCRC 新辅助 3、PD-1/CTLA-4双抗丨AK104-IIT-013 ✦ • ✦ MSI-H/dMMR mCRC 新辅助 2024年6月，信达生物在ASCO年会上报告了IBI310（重组全人源抗CTLA-4单抗）联合信迪利单抗新辅助治疗结肠癌的1b期研究数据，该研究摘要还登上了ASCO Daily News封面。基于这些数据，IBI310联合信迪利单抗的新辅助治疗已进入3期临床研究（Neoshot）。研究结果显示，截至2024年2月4日，101名患者随机分组，其中IBI310联合信迪利单抗组的病理完全缓解（pCR）率显著高于单药组（80.0% vs 47.7%）。在安全性方面，两组均未出现额外风险，且对后续手术无影响。信达生物表示，目前部分IIB-III期结肠癌患者手术难度大、预后差，且MSI-H/dMMR结肠癌的新辅助化疗pCR率较低（约5%）。IBI310联合信迪利单抗有望改变这一现状，降低术前分期，缩小手术范围，提高完全切除率，减少术后化疗需求，降低复发率，从而改善患者的长期预后。 MSS/pMMR mCRC 新辅助 2024年ESMO GI大会上，Mehraneh D Jafari团队汇报了一项BOTENSILIMAB (BOT)加BALSTILIMAB (BAL)新辅助治疗可切除的错配修复正常和缺陷型结直肠癌——NEST-1研究。 NEST研究：PD1+CTLA4 双免新辅助治疗结直肠癌，MSS/MSI 均获益背景目前错配修复正常/微卫星稳定型(pMMR/MSS)结直肠癌(CRC)缺乏有效的治疗方法1 联合治疗转移性MSS CRC2的有效率> 20% Botensilimab (BOT):下一代多功能抗CTLA-4抗体 Balstilimab (BAL):一种抗PD-1抗体 NEST-1 (NCT05571293)4是首个BOT/BAL新辅助可切除结肠癌的研究研究设计和入组标准可切除的非转移性结肠癌无静脉注射禁忌症治疗结束后1-6周内进行手术切除目前入组患者结果 NEST 1和NEST 2分别入组了10名患者，其中NEST 1中70%的患者接受了辅助化疗治疗。BOT/BAL新辅助是安全的，未延迟计划手术。 71%的MSS结肠癌有病理反应(≥50%) 100% MSI-H结肠癌有主要病理反应（MPR）结论在pMMR/MSS和dMMR/MSI-H结肠癌中，新辅助BOT/BAL是一种安全有效的方案。在pMMR结肠癌中，反应率随着BAL剂量的增加以及手术间隔的增加而增加，完全反应率高达50%。在未来的研究中，降低分期和病理反应可能会减少对手术和/或辅助化疗的依赖。 EA2201 研究：O+Y 双免新辅助治疗 dMMR/MSI-H 直肠腺癌，pCR+cCR率 57% ECOG-ACRIN EA2201是一项两阶段，单臂，II期多中心研究，旨在探讨纳武利尤单抗联合伊匹木单抗新辅助治疗微卫星不稳定性高/错配修复缺陷直肠肿瘤的安全性和有效性。背景单中心研究表明，抗程序性细胞死亡蛋白-1 (anti-PD-1)单药治疗MSI-H/dMMR局限性直肠癌的临床完全缓解(cCR)和/或病理完全缓解(pCR)率为38-100%。（Ludford, JCO 2023; Chen, Lancet Gastroenterol Hepatol 2023; Hu, Lancet Gastroenterol Hepatol 2022;Cercek, NEJM 2022; Cercek, ASCO 2024）在局部MSI-H/dMMR结肠癌中，抗PD-1联合抗CTLA-4新辅助治疗pCR率为68% (NICHE-1, NICHE-2)。（Chalabi, Nature Med 2020;Chalabi, NEJM 2024） MSIH/dMMR局部晚期直肠腺癌(LARC)的最佳免疫治疗时间和双重治疗的作用尚不明确。假设:对于MSI-H/dMMR LARC患者，nivolumab和ipilimumab以及短期放射治疗(SCRT)新辅助将增加TME的pCR率。研究设计统计学主要终点: 病理完全缓解(pCR) 如果TME率低于预期(<85%)，则允许采用pCR +临床完全缓解(cCR)的联合终点次要终点: 低位肿瘤的括约肌保留率，5年DFS, OS，安全性/毒性样本量计算: 两阶段，计划入组31例患者无效假设:反应率(pCR) 25%;备选假设:pCR 50% 90% 把握度，I类错误0.09 如果在第一阶段观察到3个或更多pCR，则研究将继续进行第二阶段预先规定的中期分析是在第一阶段入组完成后进行(n=14)。结果基线特征：入组了14名患者，其中T4分期4例（28.6%），N2，5例（35.7%）。主要终点：pCR +cCR率 57.1%（8/14）；接受TME的pCR率100%（3/3）。接受方案治疗(n=14): Nivo/ipi: 14/14者(范围，1-4周期;中位 4;平均3.29) SCRT: 12/14例患者 TME: 3/14 未完成所有方案规定治疗的原因(n=11): 由于实现cCR而推迟TME (n=5) 受试者撤回知情同意(n=2) 不良事件(n=4) 安全性:最常见的1/2级TRAEs (n):疲劳(9)，腹泻(8)，甲状腺功能减退(6)，贫血(5)，恶心/呕吐(4)，AST/ALT升高(4)，瘙痒(4)，斑丘疹(4)。 5/14(35.7%)患者出现3级或4级TRAE；未发现5级事件；“治疗相关”=至少可能与医生的治疗有关。 EA2201 下一步研究计划 EA2201正在重新设计，SCRT和TME之前给予4个周期的纳武单抗/伊匹单抗治疗，如果有必要，在SCRT和TME之前给予额外的2个周期的纳武单抗单药治疗结论这些非常有希望的数据与免疫治疗的疗效是一致的，有望避免对MSI-H/dMMR LARC进行更激进的三联干预 MSI-H/dMMR LARC的最佳免疫治疗时间和双重免疫治疗的作用有待进一步探讨 MSI-H/dMMR LARC的进一步个性化治疗具有潜在作用克服潜在的抗PD-1耐药性，最佳治疗方式，治疗持续时间，毒性最小化。 PD-1/CTLA-4双抗丨AK104-IIT-013 除了上述提到的两项PD-1单抗联合CTLA-4单抗研究外，也追踪到本次大会上，卡度尼利单抗（PD-1/CTLA-4双抗）也有探索，分别为：局部晚期直肠癌患者接受短程放疗后序贯化疗和卡度尼利单抗的疗效与安全性：前瞻性、多中心II期试验(AK104-IIT-013)的初步发现。疗效数据截至截止日期，已有9名患者在接受新辅助治疗后完成了影像学评估。这9名患者中有3名达到了临床完全缓解（cCR）并采取了观察等待（W&W）策略，6名患者接受了全直肠系膜切除术（TME），R0切除率达到100%，pCR（病理完全缓解）率为33.3%（2/6）。CR（完全缓解）率为55.6%（5/9）。安全性数据所有入组的患者均包括在安全性分析中。 5名（22.7%）患者经历了3-4级治疗相关不良事件（TRAEs），包括血小板减少症、皮疹、白细胞减少症。在2名患者（9.1%）中观察到免疫相关不良事件（irAEs），只有1名患者经历了3级免疫相关不良事件，即免疫相关性皮炎。没有记录到严重的不良事件或5级不良事件。新辅助XELOX化疗联合或不联合卡度尼利单抗在局部晚期pMMR直肠癌中的初步结果：一项随机、开放标签的II期试验的初步结果疗效数据截至2024年4月6日，没有患者出现疾病进展。 25名患者（A组13名，B组12名）接受了手术，R0切除率达到100%。 A组的pCR（病理完全缓解）率为15.4%（2/13），B组为0%。 A组的MPR（主要病理缓解）率为46.2%（6/13），B组为8.3%（1/12）。安全性数据卡度尼利单抗组最常见的治疗相关不良事件（TRAEs，任何级别）是转氨酶升高（50.0%）、发热（31.3%）以及甲状腺功能亢进/减退（18.8%）。未观察到5级不良事件。随着免疫治疗在临床上的不断推广和应用，免疫逐步前移，联合放疗和化疗，在多个瘤种中进行转化、新辅助研究探索。在结直肠癌领域，期望MSS型患者，通过小样本探索性研究，给予更多积极的抗肿瘤信号，并具有安全可控的安全性，继而改变临床治疗格局，惠及更广泛的肿瘤患者。参考文献1. Kasi PM et al. Oncogene. 2023 Oct; 42 (44): 3252-3259. 2. El-Khoueiry AB. Journal of Clinical Oncology 2023 41:4_suppl, LBA8 3. Wilky B, et al. Oral Presentation at CTOS 2023. Dublin, Ireland. Paper 31 4. Kasi PM et al. NEST-1 clinical trial.. JCO 42, 117-117(2024). 5. 2024 ESMO GI # 249P 6. 2024 ESMO GI # 243P ✦ • ✦ 【会员福利】随着运营内容的日渐丰富，Biotech前瞻公众号将为会员提供疾病基础知识幻灯的同时，ASCO和ESMO为代表的国际大会会后简版幻灯材料也会在会后一周左右时间发给会员。另外，上述所展示的幻灯，会员有专属价格获得可编辑无水印资料。研究设计小课堂和其他系列图表资料，不定期还有会员福利惊喜赠送或享限时优惠价格哦！早购买，早获益，意愿者请联系如下。【会员专属】探索医药奥秘，Biotech前瞻与您同行！

临床3期优先审批ASCO会议临床结果临床2期

2025-08-28

·PRNewswire

FDA Tightens Survival Standards as Cancer Drug Pipeline Hits $866B Market Milestone

USA News Group News Commentary Issued on behalf of Oncolytics Biotech Inc. VANCOUVER, BC, Aug. 28, 2025 /PRNewswire/ -- Federal budget cuts have put pressure on cancer research efforts in the United States, but private investment is helping to fill the gap, with oncology ventures securing hundreds of millions in funding so far in 2025. The Senate's recent restoration of $15 million for the Pancreatic Cancer Research Program (PCARP) was a win, yet its earlier elimination underscored the fragility of public support. Against this backdrop, investors are zeroing in on companies with standout science, solid pipelines, and clear regulatory strategies, including Oncolytics Biotech Inc. (NASDAQ: ONCY), ImmunityBio, Inc. (NASDAQ: IBRX), Agenus Inc. (NASDAQ: AGEN), Sutro Biopharma, Inc. (NASDAQ: STRO), and Castle Biosciences, Inc. (NASDAQ: CSTL). Major pharmaceutical companies have committed in the range of $20 billion in recent partnerships to advance next-generation immunotherapies, while venture capital investors continue backing innovative oncology startups despite economic headwinds. The timing couldn't be more strategic, as there are several companies demonstrating robust survival data and regulatory alignment now commanding premium valuations as big pharma races to replace expiring patents with breakthrough platforms. Oncolytics Biotech Inc. (NASDAQ: ONCY) has reached a pivotal inflection point, advancing toward what could become a registration-enabling trial for its breakthrough immunotherapy, pelareorep, in first-line metastatic pancreatic ductal adenocarcinoma (mPDAC). Recently, the company confirmed active discussions with the U.S. Food and Drug Administration (FDA) to finalize pivotal study parameters, positioning Oncolytics for potential initiation of trial activities by Q4 2025. This regulatory engagement represents a critical milestone, transitioning from proof-of-concept research to regulatory-stage development in one of oncology's most challenging therapeutic areas. The strategic emphasis on mPDAC builds on compelling survival data and addresses a massive unmet medical need. Pelareorep functions as a systemically delivered oncolytic virus that transforms immunologically "cold" tumors into "hot" targets responsive to immune-based treatments. Clinical data reveals pelareorep combinations achieved a remarkable 21.9% two-year overall survival rate in first-line pancreatic cancer patients, substantially outperforming the 9.2% historical benchmark established by standard chemotherapy protocols. Importantly, pelareorep demonstrated a 62% objective response rate when combined with chemotherapy and checkpoint inhibitors. This outcome carries particular weight given checkpoint inhibitors currently lack approval for pancreatic cancer treatment, suggesting pelareorep may unlock immunotherapy effectiveness in historically resistant tumor types. "We have turned the corner from proof-of-concept studies and will be sprinting toward regulatory clarity for the remainder of the year," said Jared Kelly, CEO of Oncolytics. "As we shore up our intellectual property, get a clear registration path for pelareorep, and allow our GOBLET data to mature, we will establish our position as the only platform immunotherapy in gastrointestinal tumors." The mechanism behind these outcomes involves pelareorep's dual action profile. The virus selectively replicates within cancer cells and activates broad immune responses against tumor tissue. Translational studies from GOBLET and AWARE-1 trials demonstrate how treatment elevates PD-L1 expression, amplifies interferon signaling, and mobilizes tumor-infiltrating lymphocytes throughout the bloodstream. "This robust data set, amassed from several studies in cancers that have historically resisted immunotherapeutic approaches, provides definitive validation of pelareorep's immune-mediated mechanism of action," said Dr. Thomas Heineman, Chief Medical Officer of Oncolytics. "We observed tumor biopsy-confirmed virus replication, immune cell activation, and the recruitment of cytotoxic T cells into the TME - all consistent with the durable responses observed in patients with metastatic PDAC and HR+/HER2- breast cancer who were treated with pelareorep." These mechanistic insights, combined with survival data from over 1,100 patients across multiple clinical programs, have shaped management's focus on pancreatic cancer as the lead indication for regulatory advancement. Leadership changes reflect Oncolytics' execution-oriented approach. CEO Jared Kelly and Chief Business Officer Andrew Aromando both contributed to Ambrx Biopharma's US$2 billion acquisition by Johnson & Johnson. Kelly assumed the CEO role in June 2025, while Aromando joined a few weeks later to oversee business development initiatives. The company has also eliminated its At-the-Market and Equity Line facilities, signaling confidence in current cash resources to reach key development milestones. Regulatory momentum supports accelerated development timelines. Pelareorep maintains both Fast Track and Orphan Drug designations from the FDA specifically for pancreatic cancer, acknowledging both therapeutic promise and critical patient need. These designations facilitate expedited review processes and can enhance partnership attractiveness with major pharmaceutical companies. The broader market context highlights the commercial opportunity. Pancreatic cancer maintains among the lowest survival rates of common malignancies, with five-year survival below 14%. While immunotherapies have revolutionized treatment across multiple cancer types, mPDAC has remained largely resistant to immune-based approaches, creating substantial unmet need for effective therapeutic combinations. During July, Oncolytics conducted a key opinion leader event featuring gastrointestinal oncology specialists who analyzed patient survival outcomes and biomarker validation studies. Expert feedback reinforced that pelareorep's immune activation mechanism addresses fundamental treatment gaps in first-line mPDAC therapy. Current FDA discussions center on study design parameters that could support regulatory submission for commercial approval. Should the agency accept Oncolytics' proposed framework emphasizing overall survival endpoints, the resulting trial would provide definitive evidence of pelareorep's clinical and commercial viability in pancreatic cancer treatment. Oncolytics anticipates sharing updated clinical development timelines during Q3 2025, with trial initiation activities potentially commencing by Q4 2025. With robust survival data, established regulatory plans, and experienced leadership driving strategic execution, the company appears well-positioned to advance pelareorep through its most critical development phase. CONTINUED… Read this and more news for Oncolytics Biotech at: In other recent industry developments and happenings in the market include: ImmunityBio, Inc. (NASDAQ: IBRX) achieved groundbreaking results in its pilot study for recurrent glioblastoma, reporting 100% disease control in all five patients treated with its investigational immune-boosting regimen combining ANKTIVA, NK cell therapy, and Optune Gio Tumor Treating Fields. Three of the five patients responded to treatment, with two achieving near complete responses while the remaining two maintained stable disease in this chemotherapy-free approach. ANKTIVA treatment increased absolute lymphocyte count in all five patients who had experienced lymphopenia after standard radiation and chemotherapy. "Although they are early, these results are very encouraging, given the high risk and low survival rates associated with GBM," said Dr. Patrick Soon-Shiong, Founder, Executive Chairman and Global Chief Scientific and Medical Officer at ImmunityBio. "There is compelling evidence that ANKTIVA's mechanism of proliferating NK and T cells plays an important role in treating patients with cancer Independent of tumor type. By activating the immune system the goal of providing durable responses is at hand." Based on these preliminary findings, ImmunityBio is initiating a randomized Phase 2 trial targeting second-line glioblastoma patients with recurring disease following standard care. The company also announced a new Phase 2 study to assess ANKTIVA in patients with long COVID, expanding its clinical research beyond cancer applications. Agenus Inc. (NASDAQ: AGEN) reported significant progress in the second quarter of 2025 as it is advancing its botensilimab (BOT) and balstilimab (BAL) immunotherapy combination, which delivered 42% two-year survival in refractory MSS colorectal cancer. "Our team is committed to advancing BOT/BAL to deliver meaningful benefits to patients with treatment-resistant cancers, and we are working with regulatory agencies to expedite access through a streamlined Phase 3 trial," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "With significant clinical progress, strategic partnerships, and prudent financial management, we are well-positioned to execute our vision of transforming cancer care." Agenus secured regulatory alignment for its Phase 3 BATTMAN trial initiation in Q4 2025 and expects a $91 million capital infusion from Zydus Lifesciences collaboration upon closing, and anticipates several significant milestones in the second half of 2025, including the global BATTMAN Phase 3 trial launch and new BOT/BAL clinical data presentations at major oncology congresses. Sutro Biopharma, Inc. (NASDAQ: STRO) delivered exceptional revenue growth in the second quarter of 2025, reporting $63.7 million compared to $25.7 million in Q2 2024, driven primarily by the Astellas collaboration and recognition of previously deferred revenue from Ipsen's decision not to advance the STRO-003 program. "Over the past several months, we've generated compelling preclinical data across our entire pipeline, further supporting our candidates' best-in-class potential as well as highlighting the unique capabilities of our platform technology," said Jane Chung, CEO of Sutro. "As we look to the second half of the year, we are well capitalized to meet our top priority of pipeline execution which we believe is critical to increasing shareholder value and we continue to look for ways to implement operating efficiencies and further extend our cash runway." Sutro's pipeline includes STRO-006, an integrin beta-6 ADC expected to enter clinical development in 2026, and a dual-payload ADC platform with an IND filing anticipated in 2027. The oncology company pioneering site-specific antibody drug conjugates maintained a strong cash position of $205.1 million and reduced operating expenses while preparing to initiate clinical trials for STRO-004, its next-generation Tissue Factor-targeting exatecan ADC, in the second half of 2025. Castle Biosciences, Inc. (NASDAQ: CSTL) announced the publication of new evidence supporting the use of its DecisionDx-SCC test in guiding treatment pathway decisions for NCCN high-risk cutaneous squamous cell carcinoma patients. A new validation study demonstrates that DecisionDx-SCC significantly outperforms current staging systems in predicting risk of local recurrence and metastasis, while a clinician survey confirms test results align with treatment decision-making thresholds for adjuvant radiation therapy and surveillance imaging. "These new data indicate that DecisionDx-SCC test results provide individualized risk predictions that doctors can use to guide risk-aligned escalation or de-escalation of care in their NCCN high-risk SCC patients," said Dr. Désirée Ratner, Mohs micrographic surgeon and clinical professor of dermatology at the NYU Grossman School of Medicine. "The ability of the test to reliably identify those patients with NCCN high-risk SCC at risk of developing local recurrence or metastasis is not only practice-changing for physicians who treat SCC, but also life-changing for their patients." The 40-gene expression profile test uses a patient's tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis and stratify patients into Class 1 (low), Class 2A (higher), or Class 2B (highest) risk categories. Castle Biosciences continues expanding clinical evidence for its genomic tests, with DecisionDx-SCC now validated for predicting local recurrence in addition to metastatic risk and likelihood of benefit from adjuvant radiation therapy. Source: CONTACT: USA NEWS GROUP [email protected] (604) 265-2873 DISCLAIMER: Nothing in this publication should be considered as personalized financial advice. We are not licensed under securities laws to address your particular financial situation. No communication by our employees to you should be deemed as personalized financial advice. Please consult a licensed financial advisor before making any investment decision. This is a paid advertisement and is neither an offer nor recommendation to buy or sell any security. We hold no investment licenses and are thus neither licensed nor qualified to provide investment advice. The content in this report or email is not provided to any individual with a view toward their individual circumstances. USA News Group is a wholly-owned subsidiary of Market IQ Media Group, Inc. ("MIQ"). MIQ has been paid a fee for Oncolytics Biotech Inc. advertising and digital media from the company directly. There may be 3rd parties who may have shares of Oncolytics Biotech Inc., and may liquidate their shares which could have a negative effect on the price of the stock. This compensation constitutes a conflict of interest as to our ability to remain objective in our communication regarding the profiled company. Because of this conflict, individuals are strongly encouraged to not use this publication as the basis for any investment decision. The owner/operator of MIQ own shares of Oncolytics Biotech Inc. which were purchased in the open market, and reserve the right to buy and sell, and will buy and sell shares of Oncolytics Biotech Inc. at any time without any further notice commencing immediately and ongoing. We also expect further compensation as an ongoing digital media effort to increase visibility for the company, no further notice will be given, but let this disclaimer serve as notice that all material, including this article, which is disseminated by MIQ has been approved by Oncolytics Biotech Inc.; this is a paid advertisement, we currently own shares of Oncolytics Biotech Inc. and will buy and sell shares of the company in the open market, or through private placements, and/or other investment vehicles. While all information is believed to be reliable, it is not guaranteed by us to be accurate. Individuals should assume that all information contained in our newsletter is not trustworthy unless verified by their own independent research. Also, because events and circumstances frequently do not occur as expected, there will likely be differences between the any predictions and actual results. Always consult a licensed investment professional before making any investment decision. Be extremely careful, investing in securities carries a high degree of risk; you may likely lose some or all of the investment. Logo: SOURCE USA News Group WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

临床结果免疫疗法临床3期孤儿药

100 项与巴替利单抗相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
D11820	-	-	DB15676

研发状态

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适应症	最高研发状态	国家/地区	公司	日期
宫颈癌	申请上市	美国	Recepta Biopharma SA	2022-01-30
不能切除的大肠癌	临床3期	-	Agenus, Inc.	2025-11-30
肝转移	临床3期	法国	Agenus, Inc.	2024-10-15
转移性胃腺癌	临床3期	法国	Agenus, Inc.	2024-10-15
肛门肿瘤	临床3期	荷兰	Agenus, Inc.	2024-01-29
食管鳞状细胞癌	临床3期	荷兰	Agenus, Inc.	2024-01-29
MMRD实体瘤	临床3期	荷兰	Agenus, Inc.	2024-01-29
晚期癌症	临床3期	美国	Agenus, Inc.	2021-08-02
晚期癌症	临床3期	亚美尼亚	Agenus, Inc.	2021-08-02
子宫颈转移癌	临床3期	美国	Agenus, Inc.	2021-08-02

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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


NCT03104699 (Phase 2 study \| Phase I dose escalation, CTgov)	临床1/2期	局部晚期恶性实体瘤 \| 复发性宫颈癌 \| 子宫颈转移癌 ... 更多	211	Balstilimab (Phase 1: Balstilimab Dose 1)	範繭襯鏇廠鏇鑰遞鹹窪 = 築網壓築膚構醖衊窪夢憲製簾蓋艱選壓艱廠艱 (壓願夢淵鏇鏇蓋鑰糧鹹, 範鏇構鹹襯願窪鑰製廠 ~ 艱網鑰憲觸獵襯鹹窪鬱) 更多	-	2025-07-30
				Balstilimab (Phase 1: Balstilimab Dose 2)	範繭襯鏇廠鏇鑰遞鹹窪 = 願獵築構夢醖鏇餘淵艱憲製簾蓋艱選壓艱廠艱 (壓願夢淵鏇鏇蓋鑰糧鹹, 艱蓋餘蓋簾衊繭獵積襯 ~ 窪顧製遞鹽網窪顧網衊) 更多
NCT03860272 (Pubmed \| J Clin Oncol) 人工标引	临床1期	肉瘤	64	Botensilimab + Balstilimab	鏇齋齋網鏇遞憲膚觸醖(鏇糧鏇遞壓獵積淵鬱淵) = The most common treatment-related adverse event (TRAE) was diarrhea/colitis occurring in 35.9% of patients, with grade 3 in 6.3% of patients. 網觸獵獵衊範淵鹹繭齋 (範築艱鬱衊夢範鬱製願 )	积极	2025-01-27
				Botensilimab + Balstilimab (angiosarcoma)
UNICORN (ASCO_GI2025)	临床2期	错配修复缺陷或微高卫星不稳定性结肠癌新辅助 pMMR \| dMMR	56	Botensilimab 1 mg/kg	廠鬱憲製鑰獵鏇蓋衊窪(壓繭糧夢廠憲夢觸艱觸) = 繭夢餘積獵夢鬱衊窪觸衊獵範網選窪簾膚夢壓 (顧淵顧衊築鬱窪艱構積 ) 更多	积极	2025-01-23
				Botensilimab 1 mg/kg + Balstilimab 3 mg/kg	夢選顧網餘簾餘遞襯範(簾淵構製醖蓋衊積艱願) = 襯窪齋壓衊選齋觸願積鏇壓糧簾簾遞憲鑰網鏇 (網艱夢衊憲窪壓齋廠構 ) 更多
NCT05627635 (ASCO_GI2025)	临床1期	微卫星稳定型结直肠癌 MSS	14	Folinic acid, fluorouracil, oxaliplatin, bevacizumab, botensilimab, balstilimab (FOLFOX-3B)	繭淵窪壓廠齋觸鹽艱艱(齋醖鹽衊獵衊衊廠構簾) = one pt at DL1 with transient G3 AST/ALT elevation and transient G2 colitis (resolved with steroids and infliximab), one pt at DL1 with G2 hypothyroidism and one patient at DL2 with G2 hyperthyroidism 齋遞構蓋餘廠觸憲築蓋 (製膚簾網築選範蓋網積 ) 更多	积极	2025-01-23
NCT05608044 (ASCO_GI2025)	临床2期	转移性微卫星稳定结直肠癌 MSS \| pMMR \| KRAS mutant ... 更多	234	Botensilimab 75 mg Q6W	夢觸窪鹽繭齋襯築鏇襯(鏇顧鏇簾憲糧鏇範繭築) = 鬱遞鏇廠鬱願艱蓋齋製廠網膚鏇衊積範窪艱糧 (觸鏇鏇積餘艱廠襯繭繭 ) 更多	积极	2025-01-23
				Botensilimab 150 mg Q6W	夢觸窪鹽繭齋襯築鏇襯(鏇顧鏇簾憲糧鏇範繭築) = 獵衊壓獵範製範衊遞窪廠網膚鏇衊積範窪艱糧 (觸鏇鏇積餘艱廠襯繭繭 ) 更多
NCT05033132 (ESMO_Asia)	临床2期	宫颈癌二线 PD-L1阳性	115	巴替利单抗	構憲鏇顧積壓遞窪膚網(鹹築構觸夢襯夢築淵憲) = 夢壓積範廠壓醖衊艱壓獵淵廠齋簾醖廠鹹製醖 (選齋構鹽壓艱夢齋廠衊 ) 更多	积极	2024-12-06
				巴替利单抗+泽弗利单抗	構憲鏇顧積壓遞窪膚網(鹹築構觸夢襯夢築淵憲) = 選醖積壓鑰廠膚觸醖艱獵淵廠齋簾醖廠鹹製醖 (選齋構鹽壓艱夢齋廠衊 ) 更多
NCT05864534 (Pubmed \| Neuro Oncol)	临床2期	胶质瘤	-	FcE-aCTLA-4	範襯夢壓顧選醖鹽顧築(鏇衊選壓獵壓鹽鹽餘製) = 範遞繭壓淵積獵鏇觸艱鏇鏇網膚鏇醖鹽繭網簾 (憲夢遞選選鏇鬱齋簾鹹 )	-	2024-11-04
NCT03860272 (ESMO2024) 人工标引	临床1期	肉瘤	63	Botensilimab balstilimab	糧範製蓋夢築鑰鬱廠鑰(簾壓積鹽獵膚鬱構範築) = Any grade immune-mediated adverse events (AEs) occurred in 52% of pts, most commonly, diarrhea/colitis (38%; 11% Gr3). No Gr4 or 5 treatment-related AEs occurred. 醖遞衊夢網簾築鬱顧製 (築壓積夢艱獵窪簾糧襯 ) 更多	积极	2024-09-13
NCT03860272 (NEST-1, Biospace) 人工标引	临床1/2期	结肠癌新辅助 Microsatellite Stable (MSS) \| MSI-High	20	botensilimab with balstilimab + botensilimabal dosbalstilimablimab (MSS + NEST-1 cohort)	衊壓鏇襯鹹醖鏇願築鑰(壓遞壓艱淵蓋鬱廠憲蓋) = 顧艱製襯顧願鹽願衊積艱衊窪選醖遞鹹窪齋壓 (窪襯顧選衊窪簾艱壓鹹 ) 更多	积极	2024-07-28
				botensilimab with balstbalstilimab + botensilimabal dose of balstilimab (MSI-H + NEST-1 cohort)	衊壓鏇襯鹹醖鏇願築鑰(壓遞壓艱淵蓋鬱廠憲蓋) = 鬱願鏇衊積鹹齋構網鏇艱衊窪選醖遞鹹窪齋壓 (窪襯顧選衊窪簾艱壓鹹 ) 更多
NCT05608044 (BusinessWire) 人工标引	临床2期	转移性微卫星稳定结直肠癌	-	Botensilimab 75mg + Balstilimab 240mg	鬱鏇襯製艱襯壓獵鏇鏇(襯遞鬱糧廠餘製觸艱憲) = 顧蓋艱積蓋壓衊網壓夢築鹽積衊襯鏇膚膚製憲 (糧願製構鹹鹽網廠鑰餘, 10.4 ~ 31.4) 更多	积极	2024-07-18
				Botensilimab 150mg + Balstilimab 240mg	鬱鏇襯製艱襯壓獵鏇鏇(襯遞鬱糧廠餘製觸艱憲) = 築網網鹹廠襯鏇衊選鹽築鹽積衊襯鏇膚膚製憲 (糧願製構鹹鹽網廠鑰餘, 2.7 ~ 18.1)