Evidence map›Paper›PMID 39915002›Full record

Trial reportJournal for immunotherapy of cancer2025

Oncolytic virus OH2 extends survival in patients with PD-1 pretreated melanoma: phase Ia/Ib trial results and biomarker insights.

Xuan Wang, Hui Tian, Zhihong Chi, Lu Si, Xinan Sheng, Han Hu, Xiangyong Gu, Siming Li, Caili Li, Bin Lian and 10 more

2 registry-linked trialsAbstract readClinical Trial, Phase IClinical Trial, Phase II
In one paragraph

Trial report in Journal for immunotherapy of cancer, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 1 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04386967 phase1 / phase2completednot on this map

Open and Incremental Phase I Clinical Trial of Recombinant Human GM-CSF Type II Herpes Simplex Virus (OH2) Injection (Vero Cells) in the Treatment of Advanced Solid Tumors

TypeinterventionalSponsorBinhui Biopharmaceutical Co., Ltd.Ran2018 to 2026Enrolled44ConditionsSolid Tumor, MelanomaArmsOH2 injection, Keytruda
NCT05868707 phase3recruitingnot on this map

To Evaluate a Phase III Study of OH2 Versus Investigator-selected Salvage Chemotherapy or Best Supportive Care in Melanoma Patients Who Had Failed Standard Therapy

TypeinterventionalSponsorBinhui Biopharmaceutical Co., Ltd.Ran2023 to 2027Enrolled340ConditionsMelanomaArmsOH2, Salvage chemotherapy or best supportive care
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 1 synthesis or guideline pooled it.

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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

20 authors.

Xuan Wang *Department of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.ORCID http://orcid.org/0000-0002-4160-0761
Hui Tian *Department of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.
Zhihong ChiDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.
Lu SiDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.ORCID http://orcid.org/0000-0002-2123-9761
Xinan ShengDepartment of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Peking University CancerHospital, Beijing, China.ORCID http://orcid.org/0000-0001-9359-0975
Han HuNational "111" Center for Cellular Regulation and Molecular Pharmaceutics, Hubei University of Technology, Wuhan, Hubei, China.ORCID http://orcid.org/0000-0002-8188-6143
Xiangyong GuWuhan Binhui Biopharmaceutical Co., Ltd, Wuhan, Hubei, China.
Siming LiDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.
Caili LiDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.
Bin LianDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.ORCID http://orcid.org/0000-0003-0090-1290
Li ZhouDepartment of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Peking University CancerHospital, Beijing, China.ORCID http://orcid.org/0000-0002-9331-0600
Lili MaoDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.
Bixia TangDepartment of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Peking University CancerHospital, Beijing, China.ORCID http://orcid.org/0000-0002-3458-461X
Xieqiao YanDepartment of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Peking University CancerHospital, Beijing, China.
Xiaoting WeiDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China.
Juan LiDepartment of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Peking University CancerHospital, Beijing, China.
Binlei LiuWuhan Binhui Biopharmaceutical Co., Ltd, Wuhan, Hubei, China.
Jun GuoDepartment of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Peking University CancerHospital, Beijing, China.
Yan KongDepartment of Melanoma and Sarcoma, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing),Peking University Cancer Hospital, Beijing, China 1008ccl@163.com k-yan08@163.com.
Chuanliang CuiDepartment of Genitourinary Oncology, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education, Beijing), Peking University CancerHospital, Beijing, China 1008ccl@163.com k-yan08@163.com.ORCID http://orcid.org/0000-0001-6455-0843

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundOH2 is an oncolytic virus derived from herpes simplex virus type 2. A phase Ia/Ib clinical trial in China was conducted in patients with unresected stage III-IV melanoma, the majority of whom had the acral type, to assess the safety and preliminary efficacy of OH2.

methodsThe trial enrolled patients with histologically confirmed unresectable stage III or advanced stage IV melanoma. In phase Ia, nine patients received OH2 single-dose treatment across three dose levels (10

resultsAll 44 patients were enrolled. OH2 was well tolerated without serious adverse events (AEs) or deaths reported. No Grade 3 or higher treatment-related AEs occurred. In phase Ia, the 1-year survival rate was 92.9% (95% CI, 59.1% to 99.0%), with a median overall survival of 28.9 months (95% CI, 12.7 to not reached). In phase Ib, 10 patients achieved immune-partial response (iPR)/partial response (PR), yielding an objective response rate (ORR) of 37.0% (95% CI, 19.4% to 57.6%), with 6 patients still responding. The rate of the durable response (PR or complete response lasting at least 6 months) was at least 29.6% (8/27). Notably, 7 of 12 III-IVM1a patients who previously received programmed cell death protein-1 (PD-1) therapy achieved iPR/PR, with an ORR of 58.3% (95% CI, 27.7% to 84.8%) and a disease control rate of 75.0% (95% CI, 42.8% to 94.5%). Biomarker analysis indicated that elevated baseline neutrophil activation state correlated with poorer clinical outcomes. A phase III clinical trial is ongoing in China (NCT05868707).

conclusionsOH2 oncolytic virotherapy exhibited a favorable safety profile without dose-limiting toxicities (DLTs) and demonstrated durable antitumor efficacy in patients with melanoma, especially in those who had progressed on anti-PD-1 treatment. TRIAL REGISTRATION NUMBER: ClinicalTrials.gov identifier NCT04386967.

Indexed as

Biomarkers, TumorMelanomaOncolytic VirotherapyOncolytic VirusesProgrammed Cell Death 1 ReceptorAdultAgedFemaleHumansMaleMiddle AgedBiomarkers, TumorPDCD1 protein, humanProgrammed Cell Death 1 ReceptorImmunotherapyNeutrophilOncolytic virusSkin Cancer

Identifiers

PMID39915002
PMCPMC11804204

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.