Trial reportJournal for immunotherapy of cancer2017
Durable response rate as an endpoint in cancer immunotherapy: insights from oncolytic virus clinical trials.
Trial report in Journal for immunotherapy of cancer, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00769704 (A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease), which is not on this map. Cited by 32 papers, 1 of them a synthesis that pooled 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.
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.
A Randomized Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of Treatment With OncoVEX^GM-CSF Compared to Subcutaneously Administered GM-CSF in Melanoma Patients With Unresectable Stage IIIb, IIIc and IV Disease
Who cites it
32 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Evaluation of classical clinical endpoints as surrogates for overall survival in patients treated with immune checkpoint blockers: a systematic review and meta-analysis.Journal of cancer research and clinical oncology · 2018Pooled it
- A phase II randomized trial of talimogene laherparepvec oncolytic immunotherapy with or without radiotherapy for patients with cutaneous metastases from solid tumors.Radiotherapy and oncology : journal of the European Society for Therapeutic Radiology and Oncology · 2024Trial
- Trial
- Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma.Journal for immunotherapy of cancer · 2019Trial
- Beyond cold to hot: oncolytic virotherapy as the next cornerstone of immuno-oncology.Nature reviews. Clinical oncology · 2026Review
- Review
- Long-Term Outcomes and Toxicities in Patients With Metastatic Non-Small Cell Lung Cancer Treated With Immunotherapy Containing Regimens.Cancer reports (Hoboken, N.J.) · 2025Article
- Association of heightened host and tumor immunity with prolonged duration of response to checkpoint inhibition across solid tumors.Scientific reports · 2025Article
- A comprehensive insights of cancer immunotherapy resistance.Medical oncology (Northwood, London, England) · 2025Review
- OV Modulators of the Paediatric Brain TIME: Current Status, Combination Strategies, Limitations and Future Directions.International journal of molecular sciences · 2024Review
- Article
- Clinical applications of gene therapy for rare diseases: A review.International journal of experimental pathology · 2023Review
- Bayesian network enables interpretable and state-of-the-art prediction of immunotherapy responses in cancer patients.PNAS nexus · 2023Article
- In silico cancer immunotherapy trials uncover the consequences of therapy-specific response patterns for clinical trial design and outcome.Nature communications · 2023Article
- Therapy with oncolytic viruses: progress and challenges.Nature reviews. Clinical oncology · 2023Review
- CF33-hNIS-anti-PD-L1 oncolytic virus followed by trastuzumab-deruxtecan in a patient with metastatic triple negative breast cancer: a case study.Therapeutic advances in medical oncology · 2023Article
- Review
- The Evolution and Future of Targeted Cancer Therapy: From Nanoparticles, Oncolytic Viruses, and Oncolytic Bacteria to the Treatment of Solid Tumors.Nanomaterials (Basel, Switzerland) · 2021Review
- Lights and Shadows in Immuno-Oncology Drug Development.Cancers · 2021Article
- Real-life use of talimogene laherparepvec (T-VEC) in melanoma patients in centers in Austria, Switzerland and Germany.Journal for immunotherapy of cancer · 2021Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTraditional response criteria may be insufficient to characterize full clinical benefits of anticancer immunotherapies. Consequently, endpoints such as durable response rate (DRR; a continuous response [complete or partial objective response] beginning within 12 months of treatment and lasting ≥6 months) have been employed. There has not, however, been validation that DRR correlates with other more traditional endpoints of clinical benefit such as overall survival.
methodsWe evaluated whether DRR was associated with clinically meaningful measures of benefit (eg, overall survival [OS], quality of life [QoL], or treatment-free interval [TFI]) in a phase 3 clinical trial of an oncolytic virus for melanoma treatment. To evaluate the association between DRR and OS and to mitigate lead time bias, landmark analyses were used. QoL was evaluated using the FACT-BRM questionnaire (comprising the FACT-BRM Physical, Social/Family, Emotional, and Functional well-being domains, the Additional Concerns, Physical and Mental treatment-specific subscales, and the Trial Outcome Index [TOI]). TFI was defined as time from the last study therapy dose to first subsequent therapy dose (including any systemic anticancer therapy for melanoma after study therapy discontinuation).
resultsFour hundred thirty-six patients were included in the intent-to-treat population. Achieving DR was associated with a statistically significant improvement in OS in a landmark analysis at 9 months (HR = 0.07; P = 0.0003), 12 months (HR = 0.05, P < 0.0001), and 18 months (HR = 0.11; P = 0.0002) that persisted after adjusting for disease stage and line of therapy. Achieving a DR was associated with a longer median TFI (HR = 0.33; P = 0.0007) and a higher TOI improvement rate (58.1% versus 30.0%; P = 0.025).
conclusionsAchieving a DR was associated with clinical benefits such as improved OS and QoL and prolonged TFI, thus supporting the usefulness of DR as a meaningful immunotherapy clinical trial endpoint.
trial registrationClinicalTrials.gov identifier, NCT00769704 ( https://clinicaltrials.gov/ct2/show/NCT00769704 ) October 7, 2008.
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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.