A Randomized Phase 2 Study Assessing the Efficacy and Safety of Olvimulogene Nanivacirepvec Followed by Platinum-doublet Chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor Compared With Docetaxel in Patients With NSCL Cancer After First Progression While on Front-line Immune Checkpoint Inhibitor-based Maintenance

This Phase 2, open-label, randomized study in non-small-cell lung cancer (NSCLC) is designed to evaluate the efficacy and safety of an intravenously delivered oncolytic vaccinia virus, Olvi-Vec, followed by platinum-doublet chemotherapy + Physician's Choice of Immune Checkpoint Inhibitor (ICI) vs. docetaxel for patients with advanced or metastatic NSCLC who have shown first disease progression (i.e., progressive disease not yet confirmed by further scan after initial scan showing progression) while on front-line treatment or maintenance ICI therapy after front-line treatment with platinum-doublet chemotherapy + ICI as standard of care.

开始日期2024-09-26

申办/合作机构

Genelux Corp.

[+1]

NCT07136285

/ Recruiting临床1/2期

PIb/II, Open-label, Multicenter Study to Evaluate the Safety, Tolerability and Efficacy of I.V. Olvi-Vec Combined With Platinum Plus Etoposide in Patients With Advanced SCLC Who Are Platinum-recurrent or Platinum-refractory

Oncolytic virus product named Olvi-Vec combined with Platinum plus Etoposide in patients with late phase SCLC

开始日期2023-07-24

申办/合作机构

恒翼生物医药（上海）股份有限公司

[+1]

NCT05281471

/ Recruiting临床3期

A Randomized Phase 3 Study Assessing the Efficacy and Safety of Olvi-Vec Followed by Platinum-doublet Chemotherapy and Bevacizumab Compared With Physician's Choice of Chemotherapy and Bevacizumab in Women With Platinum-Resistant/Refractory Ovarian Cancer (PRROC) (OnPrime, GOG-3076)

The OnPrime study is a multi-center, randomized open-label phase 3 study evaluating the safety and efficacy of Olvi-Vec followed by platinum-doublet chemotherapy and bevacizumab compared to the Active Comparator Arm with Physician's Choice of chemotherapy and bevacizumab in women diagnosed with platinum-resistant/refractory ovarian cancer (includes fallopian tube cancer and primary peritoneal cancer). This Phase III trial builds on the efficacy and safety data reported in the previous Phase II VIRO-15 trial with promising objective response rate and progression-free survival observed in heavily pre-treated patients with platinum-resistant/refractory ovarian cancer. The phase II results also showed that the intra-peritoneal route of delivery was efficient in generating tumor cell killing and immune activation, and led to clinical reversal of platinum-resistance or refractoriness in this difficult-to-treat patient population.

开始日期2022-08-31

申办/合作机构

Genelux Corp.

[+1]

100 项与纳欧莫洛基相关的临床结果

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100 项与纳欧莫洛基相关的转化医学

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100 项与纳欧莫洛基相关的专利（医药）

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项与纳欧莫洛基相关的文献（医药）

2023-10-01·International journal of gynecological cancer : official journal of the International Gynecological Cancer Society

Correction: A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinum-doublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab in women with platinum-resistant/refractory ovarian cancer

Article

Correction: A phase III, multicenter, randomized study of olvimulogene nanivacirepvec followed by platinumdoublet chemotherapy and bevacizumab compared with platinum-doublet chemotherapy and bevacizumab

2023-07-01·JAMA oncology

Clinical Activity of Olvimulogene Nanivacirepvec-Primed Immunochemotherapy in Heavily Pretreated Patients With Platinum-Resistant or Platinum-Refractory Ovarian Cancer: The Nonrandomized Phase 2 VIRO-15 Clinical Trial.

Article

作者: Mori, Kristina M ; Holloway, Robert W ; Ahmad, Sarfraz ; Kendrick, James E ; Abaid, Lisa N ; Mendivil, Alberto A ; Brown, John V ; McKenzie, Nathalie D ; LeBlanc, Jane

Importance:

Patients with platinum-resistant or platinum-refractory ovarian cancer (PRROC) have limited therapeutic options, representing a considerable unmet medical need.

Objective:

To assess antitumor activity and safety of intraperitoneal (IP) olvimulogene nanivacirepvec (Olvi-Vec) virotherapy and platinum-based chemotherapy with or without bevacizumab in patients with PRROC.

Design, Setting, and Participants:

This open-label, nonrandomized multisite phase 2 VIRO-15 clinical trial enrolled patients with PRROC with disease progression following their last prior line of therapy from September 2016 to September 2019. Data cutoff was on March 31, 2022, and data were analyzed between April 2022 and September 2022.

Interventions:

Olvi-Vec was administered via a temporary IP dialysis catheter as 2 consecutive daily doses (3 × 109 pfu/d) followed by platinum-doublet chemotherapy with or without bevacizumab.

Main Outcomes and Measures:

Primary outcomes were objective response rate (ORR) via Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST 1.1) and cancer antigen 125 (CA-125) assay, and progression-free survival (PFS). Secondary outcomes included duration of response (DOR), disease control rate (DCR), safety, and overall survival (OS).

Results:

Twenty-seven heavily pretreated patients with platinum-resistant (n = 14) or platinum-refractory (n = 13) ovarian cancer were enrolled. The median (range) age was 62 (35-78) years. The median (range) prior lines of therapy were 4 (2-9). All patients completed both Olvi-Vec infusions and chemotherapy. Median follow-up duration was 47.0 months (95% CI, 35.9 months to NA). Overall, ORR by RECIST 1.1 was 54% (95% CI, 33%-74%), with a DOR of 7.6 months (95% CI, 3.7-9.6 months). The DCR was 88% (21/24). The ORR by CA-125 was 85% (95% CI, 65%-96%). Median PFS by RECIST 1.1 was 11.0 months (95% CI, 6.7-13.0 months), and the PFS 6-month rate was 77%. Median PFS was 10.0 months (95% CI, 6.4-NA months) in the platinum-resistant group and 11.4 months (95% CI, 4.3-13.2 months) in the platinum-refractory group. The median OS was 15.7 months (95% CI, 12.3-23.8 months) in all patients, with a median OS of 18.5 months (95% CI, 11.3-23.8 months) in the platinum-resistant group and 14.7 months (95% CI, 10.8-33.6 months) in the platinum-refractory group. Most frequent treatment-related adverse events (TRAEs) (any grade, grade 3) were pyrexia (63.0%, 3.7%, respectively) and abdominal pain (51.9%, 7.4%, respectively). There were no grade 4 TRAEs, and no treatment-related discontinuations or deaths.

Conclusions and Relevance:

In this phase 2 nonrandomized clinical trial, Olvi-Vec followed by platinum-based chemotherapy with or without bevacizumab as immunochemotherapy demonstrated promising ORR and PFS with a manageable safety profile in patients with PRROC. These hypothesis-generating results warrant further evaluation in a confirmatory phase 3 trial.

Trial Registration:

ClinicalTrials.gov Identifier: NCT02759588.

2021-12-01·Gynecologic oncology2区 · 医学

A phase 1b study of intraperitoneal oncolytic viral immunotherapy in platinum-resistant or refractory ovarian cancer

2区 · 医学

Article

作者: LeBlanc, Jane ; Kennard, Jessica A ; Kendrick, James E ; Stephens, Amanda J ; Holloway, Robert W ; Manyam, Madhavi ; Ahmad, Sarfraz

OBJECTIVE:

Our objective was to assess safety and adverse events associated with intraperitoneal Olvi-Vec virotherapy in patients with platinum-resistant or refractory ovarian cancer (PRROC). Secondary objectives included objective response rate (ORR) per RECIST 1.1 and progression-free survival (PFS).

METHODS:

Olvi-Vec is a modified vaccinia virus that causes oncolysis and immune activation. An open-label phase 1b trial using a 3 + 3 dose escalation was conducted. Intraperitoneal Olvi-Vec was given as monotherapy in two consecutive daily doses. Translational analyses included anti-virus antibody levels, viral shedding, circulating tumor cells (CTCs) and T cells.

RESULTS:

Twelve patients (median age: 69 years, range: 45-77) with median 5 prior therapies (range: 2-10) and 2 prior platinum lines (range: 1-5) were enrolled. There were three dose level cohorts: 3 × 10⁹ (n = 6), 1 × 10¹⁰ (n = 5), and 2.5 × 10¹⁰ (n = 1) plaque forming units (PFU)/day on two consecutive days. Treatment-related adverse events (TRAEs) included G1/G2 nausea (n = 6), fever (n = 6), abdominal distention (n = 5), and abdominal pain (n = 4). There were no Grade 4 TRAEs, no dose relationship to TRAEs, and no deaths attributed to Olvi-Vec. The ORR was 9% (1/11). Stable disease (SD) was 64% (7/11), and SD ≥15 weeks was 46% (5/11). Median PFS was 15.7 weeks (95%CI: 5.7-34.5), including extended PFS in four patients (23.2, 34.5, 59.4+ and 70.8 weeks). Three patients had extended overall survival (deceased 33.6 months, and alive with disease at 54 and 59 months). CTCs diminished in 6/8 (75%) baseline-positive patients. Immune activation was demonstrated from virus-enhanced tumor infiltration of CD8+ T-cells and activation of tumor-specific T-cells in peripheral blood.

CONCLUSIONS:

Oncolytic viral therapy with intraperitoneal Olvi-Vec showed promising safety, clinical activities, and immune activation in patients with PRROC, warranting further clinical investigation.

项与纳欧莫洛基相关的新闻（医药）

2026-03-24

·allsci.com

Calidi to advance IL-15-armed onco virus into first-in-human in Australia

Calidi Biotherapeutics, based in San Diego, has engaged Avance Clinical, a full-service contract research organization (CRO), to facilitate Australian regulatory approval and initiate a first-in-human trial for CLD-401, the company’s lead oncolytic virotherapy candidate. CLD-401 is a genetically modified vaccinia virus designed for intravenous delivery to patients with advanced solid tumors. Calidi (NYSE American: CLDI) stated it will also pursue an IND filing with the US FDA in 2026. CLD-401 is the first candidate derived from Calidi’s RedTail platform, which the company also refers to as featuring engineered enveloped oncolytic virus technology. The platform uses an envelope designed to shield the virus from immune clearance in the bloodstream, enabling systemic intravenous delivery rather than direct intratumoral injection. CLD-401 is a vaccinia virus engineered to replicate selectively in tumor cells and express an IL-15 superagonist, an activator of innate and adaptive immune responses, within the tumor microenvironment. The planned Phase I trial will evaluate safety, pharmacodynamics, and efficacy of CLD-401 as monotherapy in patients with solid tumors who have exhausted other therapeutic options. Preclinical data on CLD-401 have been published evaluating tumor targeting, efficacy, and safety in animal models. Calidi has indicated that initial target indications for CLD-401 include non-small cell lung cancer, head and neck cancer, and other advanced solid tumors. The company is also expanding the RedTail platform to incorporate T-cell engager approaches for solid tumors, although no additional candidates have been publicly disclosed. The oncolytic virus field includes several companies pursuing systemic intravenous delivery, an approach for which no products are currently approved. Programs exploring this strategy include: • Olvi-Vec (GL-ONC1) — Genelux — Phase II — intravenously delivered engineered vaccinia virus • Pelareorep — Oncolytics Biotech — late-stage/registration-directed development — intravenously delivered reovirus • CF33/VAXINIA — Imugene — Phase I — intravenously delivered chimeric poxvirus • TG6002 — Transgene — early-stage clinical development — vaccinia virus evaluated with intravenous administration Approved oncolytic virus therapies, such as Talimogene laherparepvec for melanoma, rely on local administration rather than systemic delivery. Other advanced candidates, including Cretostimogene grenadenorepvec, remain investigational and are also delivered locally. Calidi’s approach — using an engineered viral construct designed to enhance systemic circulation and reduce immune clearance — aims to address a longstanding limitation in the field, although these features are supported by preclinical data and have not yet been validated in human studies. The decision to initiate clinical work in Australia rather than the United States reflects a regulatory pathway that can offer faster trial activation timelines. Calidi stated it will pursue the Australian regulatory process in parallel with its US FDA IND submission. Your email address will not be published. Required fields are marked * Comment * Name * Email * Website

临床2期临床1期

2026-03-23

·医麦客

首个溶瘤联合疗法上市在即，多家企业加速冲刺

免费早鸟票，200 张限量领取 2026 年 3 月 24 日医麦客新闻 eMedClub News 2026 年，溶瘤病毒疗法或迎来关键转折。监管上，Replimune 的 RP1 将于 4 月 10 日迎来 PDUFA 审决，若获批将成为治疗抗 PD-1 疗法失败的黑色素瘤的首个溶瘤病毒联合疗法。CG Oncology 与 Candel 亦计划年内递交 BLA 申请，至少两款管线有望步入冲刺阶段。技术路径上，HSV-1、腺病毒、痘苗病毒及 RNA 免疫调节剂各显其能，在载体设计、克服免疫抑制、联合用药及给药方式上持续创新。适应症从黑色素瘤、膀胱癌向胰腺癌、卵巢癌、肺癌等「硬骨头」纵深拓展，静脉给药的成功探索更让溶瘤疗法具备了治疗转移性肿瘤的潜力。随着多款候选药物在难治性实体瘤中验证潜力，溶瘤免疫疗法正加速从概念走向临床，成为肿瘤免疫治疗的重要新力量。本文聚焦国外代表性企业的核心管线进展。 Replimune Replimune 专注于开发基于 HSV-1 骨架的溶瘤免疫疗法，核心管线 RP1（vusolimogene oderparepvec）联合纳武利尤单抗针对抗 PD-1 疗法失败的黑色素瘤患者的 BLA 申请已获 FDA 受理，PDUFA 日期定为 2026 年 4 月 10 日。若顺利获批，RP1 将成为该适应症的首个溶瘤病毒联合疗法。 RP1 是一款经基因工程改造的单纯疱疹病毒（HSV）溶瘤免疫疗法，通过搭载融合蛋白（GALV-GP R-）和 GM-CSF，旨在最大化肿瘤杀伤效力、增强肿瘤细胞死亡的免疫原性，并激活全身性抗肿瘤免疫反应。 2025 年 ESMO 大会公布数据显示，在抗 PD-1 治疗失败的肢端黑色素瘤患者中，RP1 联合纳武利尤单抗治疗的总缓解率（ORR）达 44%（18 例中 8 例缓解），中位缓解持续时间为 11.9 个月，安全性以 1-2 级暂时性不良事件为主。此外，正在进行的 Ⅱ 期临床试验 ARTACUS 显示，RP1 单药疗法在局部晚期器官移植后皮肤鳞状细胞癌（CSCC）中 ORR 为 34.6%，完全缓解率（CR）为 23.1%，2 年缓解持续率达 61.0%。另一核心管线 RP2 同样基于 HSV 改造，除携带 GALV-GP R-和 GM-CSF 外，还表达抗 CTLA-4 抗体样分子，旨在将免疫疗效聚焦于肿瘤并限制脱靶毒性。其针对转移性葡萄膜黑色素瘤的 Ⅱ/Ⅲ 期研究 REVEAL 正在推进，预计 2027 年 Q1 完成阶段过渡，无进展生存期（PFS）分析有望支持加速批准。 CG Oncology CG Oncology 核心管线 Cretostimogene（CG0070）是一种在研的、经膀胱内给药的溶瘤免疫疗法，乐普生物拥有该管线在大中华区权益。在中危非肌层浸润性膀胱癌（NMIBC）领域，全球首个 Ⅲ 期 PIVOT-006 试验的顶线数据预计 2026 年上半年公布，涵盖 AUA/SUO 指南定义的最广泛患者类型。在高危领域，据第 26 届 SUO 年会公布数据显示，其针对高风险、卡介苗（BCG）无反应、伴有 Ta/T1 期疾病患者的试验 BOND-003 队列 P 中，3 个月、6 个月和 9 个月时的高级别无复发生存率（HG-EFS）分别达到 95.7%、84.6% 和 80.4%。根据后续数据，首个适应症（高危 BCG 无反应 NMIBC）的 BLA 提交计划在 2026 年完成。联合疗法上，cretostimogene 联合吉西他滨的 Ⅱ 期临床试验 CORE-008 队列 CX（高风险、曾接受 BCG 治疗及 BCG 无反应的 NMIBC）首次结果预计在 2026 年上半年公布。 Candel therapeutics Candel Therapeutics 核心管线 aglatimagene besadenovec（CAN-2409）是一种即用型、复制缺陷型腺病毒候选药物，通过将单纯疱疹病毒胸苷激酶基因递送至肿瘤，诱导免疫原性细胞死亡，并在肿瘤微环境中释放多种肿瘤抗原，从而激发个体化抗肿瘤免疫反应。其针对中高风险局限性前列腺癌，计划于 2026 年第四季度提交 BLA，Ⅲ 期试验的后续随访正在进行。早在 2024 年，CAN-2409 联合伐昔洛韦与标准治疗——外照射放疗（SoC）联合用于新诊断的局部中高危前列腺癌的 Ⅲ 期临床试验已成功达到主要终点。与接受安慰剂加标准治疗放疗的患者（n=249）相比，接受 CAN-2409 联合前体药物及标准治疗放疗的患者（n=496），前列腺癌复发或因任何原因死亡的风险降低了 30%。同时，其针对 ICI 难治性转移性非鳞状 NSCLC 的关键 Ⅲ 期试验将于 2026 年 Q2 启动。 Oncolytic Pelareorep 是一款静脉注射的双链 RNA 免疫治疗剂，通过激活先天性和适应性免疫反应，将免疫「冷」肿瘤转化为「热」肿瘤，从而诱导抗肿瘤免疫。该药已在胰腺癌、转移性乳腺癌、肛门癌及结直肠癌的多项研究中验证其潜力，并获 FDA 授予结直肠癌和胰腺癌快速通道认定。在二线 KRAS 突变型 MSS 转移性结直肠癌（mCRC）中，临床研究 REO022 数据显示：pelareorep 联合贝伐珠单抗及 FOLFIRI 方案治疗，中位总生存期（mOS）达 27 个月，中位无进展生存期（mPFS）为 16.6 个月，ORR 为 33%，三项核心指标均显著优于标准疗法（11.2 个月、5.7 个月、10%）。 Genelux Genelux 核心在研产品 Olvi-Vec 是一种经改良的非致病性溶瘤痘苗病毒，恒翼生物拥有该管线在大中华区独家权益。目前，Olvi-Vec 在三大适应症领域同步推进：在卵巢癌领域，Ⅲ 期研究 OnPrime/GOG-3076 旨在评估 Olvi-Vec 联合铂类双药及贝伐珠单抗对比医生选择化疗联合贝伐珠单抗在铂耐药/难治性患者中的疗效与安全性；在非小细胞肺癌领域，Ⅱ 期试验 VIRO-25 旨在评估 Olvi-Vec 联合铂类双药及免疫检查点抑制剂对比多西他赛的疗效与安全性；此外，在中国开展的 Ib/II 期试验 Olvi-Vec-SCLC-202 则针对复发性小细胞肺癌评估 Olvi-Vec 联合铂类双药的疗效与安全性，目前正在进行剂量选择。 Theriva Theriva 领先管线 VCN-01 是一种系统性给药的溶瘤腺病毒，旨在选择性地、强效地在肿瘤细胞内复制，并降解构成癌症治疗重要物理和免疫抑制屏障的肿瘤基质。这种独特的作用机制使 VCN-01 能够发挥多种抗肿瘤效应：1. 选择性感染和裂解肿瘤细胞；2. 增强联合给药的化疗药物的进入和灌注；3. 增加肿瘤免疫原性，使肿瘤暴露于患者的免疫系统和联合给药的免疫疗法。此外，全身给药使 VCN-01 能够对原发肿瘤和转移灶都发挥作用。针对转移性胰腺导管腺癌（PDAC），VCN-01 已获得 EMA 关于 Ⅲ 期试验设计的积极科学建议，同意其联合吉西他滨/白蛋白结合型紫杉醇用于一线治疗的方案，包括样本量、重复给药及适应性设计。公司计划在 2026 年上半年与 FDA 举行 Ⅱ 期结束会议，以最终确定跨国关键 Ⅲ 期试验的设计。此前公布的随机对照 2b 期试验 VIRAGE 数据显示，接受 VCN-01 联合标准治疗的 PDAC 患者，其 OS、PFS 和缓解持续时间（DoR）均较对照组有所延长。此外，VCN-01 在视网膜母细胞瘤领域也已获得孤儿药和罕见儿科疾病认定。公司计划在 2026 年与 FDA 和 EMA 进一步讨论，以确定针对该适应症的 Ⅱ/Ⅲ 期试验方案，包括目标人群和终点设计。 Theolytics Theolytics 首发管线 THEO-260 是一款基于腺病毒改造的溶瘤免疫疗法，其核心差异化在于同时靶向肿瘤细胞与肿瘤微环境，尤其是通过裂解癌症相关成纤维细胞（CAFs）来解除肿瘤的物理和免疫抑制屏障。目前，THEO-260 正在铂类耐药卵巢癌患者中探索两种给药路径的潜力。首个临床试验 OCTOPOD-IV 已进入 Ⅱa 期阶段，采用静脉输注给药方式。第二项在美国进行的临床试验 OCTOPOD-IP 也已启动，该试验将与德克萨斯大学 MD 安德森癌症中心合作，研究针对晚期卵巢癌患者的腹腔内给药疗效。责任编辑丨菊校对丨菊参考资料： 1.https://ir.replimune.com/news-releases/news-release-details/replimune-reports-fiscal-third-quarter-2026-financial-results 2.https://ir.cgoncology.com/news-releases/news-release-details/cg-oncology-reports-2025-year-end-financial-results-and-provides 3.https://ir.candeltx.com/news-releases/news-release-details/candel-therapeutics-reports-fourth-quarter-and-full-year-2025 4.https://oncolyticsbiotech.com/press_releases/oncolytics-biotech-launches-randomized-colorectal-cancer-study/ 5.https://investors.genelux.com/news-releases/news-release-details/genelux-corporation-participate-upcoming-conferences 6.https://therivabio.com/press_releases/theriva-biologics-reports-full-year-2025-operational-highlights-and-financial-results/ 7.https://www.theolytics.com/news. 精彩活动长按识别二维码立即参与↓ 3 月 24 日 19:00-20:00 破解困局——流式在创新药药效与安全性协同优化中的应用推荐 2 3 月 26 日 19:00-20:30 从工艺到设备：生物药提质增效、合规可控实战分享推荐 3 3 月 31 日 19:00-20:30 从 iPSC 心脏细胞表征到药物心脏安全：技术体系与实践应用声明：本文旨在于传递行业发展信息、探究生物医药前沿进展。文章内容仅代表作者观点，并不代表医麦客立场，亦不构成任何价值判断、投资建议或医疗指导，如有需求请咨询专业人士投资或前往正规医院就诊。版权说明：欢迎个人转发文章至朋友圈，谢绝媒体或机构未经授权以任何形式转载至其他平台。如需转载请在文章下方留言获取授权。封面来源网络，如有侵犯版权，请联系删除点点“分享”、“点赞”和“在看” 给我充点儿电吧~

免疫疗法临床3期临床2期

2026-03-21

·OC学习笔记

领跑卵巢癌溶瘤病毒赛道，Olvi-Vec三期顶线数据预计下半年发布

▲公司临床招募信息一、资讯速览美国Genelux公司3月19日发布2025全年财报宣布，其溶瘤病毒候选药物Olvi-Vec（olvimulogene nanivacirepvec，GL-ONC1）用于铂耐药/难治性卵巢癌的III期注册性试验（OnPrime/GOG-3076，NCT05281471）进展顺利。独立数据监测委员会审查后建议试验继续进行，无需任何方案修改。该试验主要终点（无进展生存期）的顶线数据预计于2026年下半年公布。 Olvi-Vec是目前全球唯一进入III期临床的以卵巢癌为核心适应症的溶瘤病毒疗法，此前II期VIRO-15试验已显示客观缓解率54%、中位无进展生存期11.0个月。本次III期结果备受业内关注，或将为这一高未满足需求的患者群体提供新的治疗选择。国际顶级肿瘤学期刊《JAMA Oncology》2023年发表Olvi-Vec II期临床结果的同时，明确指出：这款药物在解决“铂耐药/难治性卵巢癌这一关键未满足医疗需求”上展现出显著潜力。 AdventHealth癌症研究所妇科肿瘤主任Robert W. Holloway博士表示：“Olvi-Vec可能为这些患者带来改变生命的治疗方案。它显著修饰肿瘤免疫微环境，逆转铂耐药，并诱导肿瘤特异性T细胞应答。” GlobalData肿瘤分析师Jasminemay Barcelon指出：“若Olvi-Vec在本适应症中证实疗效，将为卵巢癌提供一种新型个性化治疗选择，并有望成为商业成功产品。” 二、Olvi-Vec：领跑卵巢癌溶瘤病毒赛道 Olvi-Vec是一种基因改造的痘苗病毒，OnPrime/GOG-3076 III期注册性试验（NCT05281471）正在美国31个中心持续招募中。在III期之前，Olvi-Vec已完成II期VIRO-15试验（NCT02759588，27例重度预处理铂耐药/难治性卵巢癌患者）。根据JAMA Oncology 2023年发表的结果： RECIST 1.1客观缓解率（ORR）为54%（24例可评估患者中2例完全缓解、11例部分缓解，95% CI：33%–74%）；疾病控制率（DCR）为88%（21/24例）；中位无进展生存期（PFS）为11.0个月（95% CI：6.7–13.0个月）； CA-125生物标志物缓解率为85%（26例可评估患者中，95% CI：65%–96%）。治疗相关不良事件主要为可控的发热和腹痛，无治疗相关死亡事件。 Olvi-Vec采用腹腔注射序贯方案，先通过病毒选择性裂解肿瘤细胞并重塑肿瘤微环境，随后衔接铂类双药化疗+贝伐珠单抗。该设计旨在实现铂耐药逆转。 ▲公司管线推进一览三、溶瘤病毒赛道全景一览以下表格汇总卵巢癌溶瘤病毒主要在研项目（数据截至2026年3月）：国内亮点：广西医科大学赵永祥团队开发的NDV-GT（基因改造新城疫病毒，插入猪源α1,3GT基因）采用静脉注射路线，通过触发人体超急性排斥反应实现溶瘤与免疫激活。 2025年发表于《Cell》杂志的I期篮式试验显示，23例晚期难治性癌症患者疾病控制率为90%，其中卵巢癌亚组有患者获得部分缓解并维持12个月。目前已规划后续II/III期研究。刷屏网络的“把癌细胞变成猪肉”的新型溶瘤病毒抗癌疗法进展到哪儿了？从上表不难看出Olvi-Vec的领跑优势；而国内自主创新NDV-GT疗法提升了给药便利性，增强了中国患者的可及性。四、国内用药路径及展望 Olvi-Vec已将大中华区独家开发和商业化权益授权给新索拉（Newsoara）生物制药。目前国内卵巢癌适应症尚无临床试验站点（仅小细胞肺癌Ib/2期在上海胸科医院、浙江人民医院等中心开展）。若2026下半年III期顶线数据达到主要终点，预计将启动中国桥接研究或上市申请。 VIRO-15试验首次证实腹腔递送Olvi-Vec联合免疫化疗在重度预处理铂耐药/难治性卵巢癌患者中具有令人鼓舞的抗肿瘤活性与可接受安全性，为溶瘤病毒疗法在实体瘤领域的应用提供了重要证据。该结果直接支持了Genelux当前III期OnPrime/GOG-3076试验的设计。让我们共同期待下半年的数据发布，如果数据积极，国内站点也希望早日跟上。声明：本文数据来源于ClinicalTrials.gov、Genelux公司2026年3月财报、JAMA Oncology 2023、Cell 2025及相关同行评议文献。如有错讹还请联系修订，感谢大家的关注！最后和大家说下，这两天家人生病住院，未来一周可能会暂停公众号更新，多多理解。

100 项与纳欧莫洛基相关的药物交易

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KEGG	Wiki	ATC	Drug Bank
-	纳欧莫洛基	-	DB16268

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
卵巢子宫内膜样癌	临床3期	美国	Genelux Corp.	2022-08-31
输卵管癌	临床3期	美国	Genelux Corp.	2022-08-31
卵巢透明细胞癌	临床3期	美国	Genelux Corp.	2022-08-31
卵巢浆液性肿瘤	临床3期	美国	Genelux Corp.	2022-08-31
铂耐药性卵巢癌	临床3期	美国	Genelux Corp.	2022-08-31
原发性腹膜癌	临床3期	美国	Genelux Corp.	2022-08-31
晚期肺非鳞状非小细胞癌	临床2期	美国	Genelux Corp.	2024-09-26
转移性非小细胞肺癌	临床2期	美国	Genelux Corp.	2024-09-26
非小细胞肺癌 III期	临床2期	美国	Genelux Corp.	2024-09-26
复发性非小细胞肺癌	临床2期	美国	Genelux Corp.	2024-09-26

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临床结果

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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


NCT07136285 (OLVI-VEC-SCLC-202, Company_Website) 人工标引	临床1/2期	小细胞肺癌	9	Olvi-Vec +platinum +etoposide	鏇襯鬱遞窪蓋範鹽襯築(遞鹹窪衊簾築窪鬱鹹構) = 醖廠鹽窪網憲鹹窪觸簾積鏇鑰觸鹹窪廠鏇壓範 (鹹淵蓋鏇築窪夢醖選築 ) 更多	积极	2026-01-05
NCT07136285 (OLVI-VEC-SCLC-202, Company_Website) 人工标引	临床1/2期	小细胞肺癌	9	Olvi-Vec +platinum +etoposide (Cohort 4)	鏇襯鬱遞窪蓋範鹽襯築(遞鹹窪衊簾築窪鬱鹹構) = 築齋艱醖壓鹹遞顧憲窪積鏇鑰觸鹹窪廠鏇壓範 (鹹淵蓋鏇築窪夢醖選築 ) 更多	积极	2026-01-05
NCT06463665 (VIRO-25, Company_Website) 人工标引	临床2期	非小细胞肺癌	5	Olvi-Vec +platinum+ICI	糧鏇網窪範築鹽憲醖構(選糧網餘糧衊鏇餘鬱蓋) = 選觸齋餘壓構顧醖獵艱齋選遞製繭網簾鹽選糧 (製淵繭窪襯餘選衊壓簾 )	积极	2026-01-05
CTR20223399 (OLVI-VEC-SCLC-202, Company_Website) 人工标引	临床1/2期	晚期小细胞肺癌	7	Olvi-Vec + platinum + etoposide	蓋壓簾艱構艱糧構範餘(窪網繭積鹽網選顧選願) = mostly mild to moderate, including fever, anemia, reduced lymphocyte counts, and nausea. 夢顧鑰醖繭積糧顧醖鹹 (窪壓壓糧醖積淵願淵淵 ) 更多	积极	2025-03-25
NCT02759588 (VIRO-15, Pubmed \| JAMA Oncol)	临床2期	铂耐药性卵巢癌	27	Olvimulogene nanivacirepvec	鏇憲遞鑰窪壓糧鏇願壓(鹹構醖鏇壓憲網淵願醖) = 繭襯醖蓋蓋繭遞餘製製齋膚築遞願壓鏇鑰觸壓 (築窪糧窪構齋製鬱繭築, 33 ~ 74) 更多	积极	2023-07-01
NCT02759588 (ESMO2020) 人工标引	临床2期	铂耐药性卵巢癌	27	carboplatin+bevacizumab+Olvi-Vec	膚構觸膚鑰齋淵遞網淵(淵鑰遞觸顧遞窪壓積齋) = 憲餘淵構鬱鹽憲蓋憲構壓憲糧糧窪顧構繭窪選 (鑰鬱艱鑰壓艱鏇鑰簾獵, 6.7 ~ 13.0) 更多	积极	2020-09-17
NCT02759588 (VIRO-15, IGCS2019)	临床1期	铂耐药性卵巢癌 neutralizing antibody (NA) titers \| virus-encoded glucuronidase activity (GA) \| Prognostic Nutritional Index (PNI)	11	GL-ONC1	壓廠鹽憲範網醖鑰壓遞(積築糧簾範憲憲製鏇願) = 夢獵餘觸積窪願夢遞鑰夢窪醖構構構襯製願夢 (窪醖鹹鹹繭艱選齋衊糧 ) 更多	积极	2019-09-18
NCT02759588 (VIRO-15, IGCS2019)	临床1期		11	Cytotoxic therapy	壓廠鹽憲範網醖鑰壓遞(積築糧簾範憲憲製鏇願) = 齋糧壓遞繭顧淵繭艱鹽夢窪醖構構構襯製願夢 (窪醖鹹鹹繭艱選齋衊糧 ) 更多	积极	2019-09-18
NCT01443260 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	腹膜癌	9	GL-ONC1	膚襯糧構餘膚壓構淵襯(繭衊艱網夢廠鹽範鏇憲) = transient flu-like symptoms and increased abdominal pain, resulting from treatment-induced peritonitis. 簾鑰齋築繭鏇鹹醖衊艱 (膚鬱醖網蓋壓獵糧膚糧 ) 更多	积极	2018-09-15
NCT02759588 (ASCO 12018 \| ASCO 22018) 人工标引	临床1期	复发性卵巢癌	11	GL-ONC1	膚憲艱淵顧選簾憲廠積(艱醖築醖顧醖憲衊顧夢) = grade 1-2 chills (n = 7), nausea (7), fever (6), abdominal pain/distention (4), & vomiting (3)，no differences in toxicity for the two dose levels 夢觸醖製艱鏇繭製鬱範 (鬱繭餘淵糧鑰淵顧網築 ) 更多	积极	2018-06-04
NCT01584284 (Pubmed \| Clin Cancer Res) 人工标引	临床1期	晚期头颈癌	19	GL-ONC1+radiotherapy+chemotherapy	遞網範醖膚蓋選鬱鹹獵(選繭鹽憲廠製醖網網艱) = Not reached 構鹹鹽觸膚膚願製製鹹 (廠醖淵鹽遞簾齋鏇廠觸 ) 更多	积极	2017-10-01
NCT01584284 (ASCO2015)	临床1期	局部晚期头颈部鳞状细胞癌	24	GL-ONC1	淵窪選選鏇製獵壓顧範(製顧餘蓋鑰壓壓積壓夢) = 範淵壓鑰襯壓繭網範糧淵顧鏇膚鹽簾範餘壓觸 (顧齋遞襯齋願簾鹹糧願 ) 更多	-	2015-05-20