Trial reportJournal for immunotherapy of cancer2019
Final analyses of OPTiM: a randomized phase III trial of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in unresectable stage III-IV melanoma.
Trial report in Journal for immunotherapy of cancer, 2019. 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 269 papers, 5 of them syntheses that pooled it.
What it found
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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
269 citing papers in PubMed, 5 syntheses or guidelines pooled it, 415 citations in OpenAlex.
- Efficacy of oncolytic virus in the treatment of intermediate-to-advanced solid tumors: a systematic review and meta-analysis.Journal of virology · 2025Pooled it
- SEOM-GEM clinical guidelines for cutaneous melanoma (2023).Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2024Guideline
- The efficacy and safety assessment of oncolytic virotherapies in the treatment of advanced melanoma: a systematic review and meta-analysis.Virology journal · 2023Pooled it
- Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immunotherapy for the treatment of melanoma, version 3.0.Journal for immunotherapy of cancer · 2023Guideline
- Electrochemotherapy of skin metastases from malignant melanoma: a PRISMA-compliant systematic review.Clinical & experimental metastasis · 2022Pooled it
- A phase 1b/2 study of cabozantinib in combination with pembrolizumab in advanced cutaneous melanoma.Cancer · 2026Trial
- Clinical Pharmacology Characterization of the First-In-Class Oncolytic Viral Therapy T-VEC in Adults and Pediatric Subjects.Journal of clinical pharmacology · 2026Trial
- RP1 Combined With Nivolumab in Advanced Anti-PD-1-Failed Melanoma (IGNYTE).Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2025Trial
- 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
- Talimogene laherparepvec in combination with ipilimumab versus ipilimumab alone for advanced melanoma: 5-year final analysis of a multicenter, randomized, open-label, phase II trial.Journal for immunotherapy of cancer · 2023Trial
- Intratumoral oncolytic herpes virus G47∆ for residual or recurrent glioblastoma: a phase 2 trial.Nature medicine · 2022Trial
- A phase I dose-escalation, safety/tolerability, and preliminary efficacy study of the intratumoral administration of GEN0101 in patients with advanced melanoma.Cancer immunology, immunotherapy : CII · 2022Trial
- Clinical activity of single-dose systemic oncolytic VSV virotherapy in patients with relapsed refractory T-cell lymphoma.Blood advances · 2022Trial
- Preclinical evaluation of triple-mutated oncolytic herpes virus expressing fusion-type interleukin 12 for malignant melanoma.Molecular therapy. Oncology · 2026Article
- The promise of immunotherapy in the treatment of sarcoma: A state-of-the-art review of practice changing research and future directions.Human vaccines & immunotherapeutics · 2026Review
- Dissecting residual disease in spheroids reveals pan-cancer persistence signatures and a therapeutic window for oncolytic viruses.Molecular therapy. Oncology · 2026Article
- Reversal of repeated red cards reprieves RP-1.Molecular therapy. Oncology · 2026Article
- Comprehensive preclinical evaluation of second-generation miRNA-regulated Coxsackievirus B3-BHP: Potent antitumor efficacy and safety.Molecular therapy. Oncology · 2026Article
- Beyond cold to hot: oncolytic virotherapy as the next cornerstone of immuno-oncology.Nature reviews. Clinical oncology · 2026Review
- Microwave therapy for the treatment of cutaneous melanoma metastases - A pilot study.Journal of the European Academy of Dermatology and Venereology : JEADV · 2026Article
209 more citing papers are in PubMed but not listed here.
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
7 authors at 7 institutions in 4 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundTalimogene laherparepvec is an oncolytic immunotherapy approved in the US, Europe, Australia and Switzerland. We report the final planned analysis of OPTiM, a randomized open-label phase III trial in patients with unresectable stage IIIB-IVM1c melanoma.
methodsPatients were randomized 2:1 to receive intratumoral talimogene laherparepvec or subcutaneous recombinant GM-CSF. In addition to overall survival (OS), durable response rate (DRR), objective response rate (ORR), complete responses (CR), and safety are also reported. All final analyses are considered to be descriptive and treatment responses were assessed by the investigators.
resultsOf 436 patients in the intent-to-treat population, 295 were allocated to talimogene laherparepvec and 141 to GM-CSF. Median follow-up in the final OS analysis was 49 months. Median OS was 23.3 months (95% confidence interval [CI], 19.5-29.6) and 18.9 months (95% CI, 16.0-23.7) in the talimogene laherparepvec and GM-CSF arms, respectively (unstratified hazard ratio, 0.79; 95% CI, 0.62-1.00; p = 0.0494 [descriptive]). DRR was 19.0 and 1.4% (unadjusted odds ratio, 16.6; 95% CI, 4.0-69.2; p < 0.0001); ORR was 31.5 and 6.4%. Fifty (16.9%) and 1 (0.7%) patient in the talimogene laherparepvec and GM-CSF arms, respectively, achieved CR. In talimogene laherparepvec-treated patients, median time to CR was 8.6 months; median CR duration was not reached. Among patients with a CR, 88.5% were estimated to survive at a 5-year landmark analysis. Talimogene laherparepvec efficacy was more pronounced in stage IIIB-IVM1a melanoma as already described in the primary analysis. The safety reporting was consistent with the primary OPTiM analysis.
conclusionsIn this final planned OPTiM analysis, talimogene laherparepvec continued to result in improved longer-term efficacy versus GM-CSF and remained well tolerated. The final analysis also confirms that talimogene laherparepvec was associated with durable CRs that were associated with prolonged survival.
trial registrationClinicalTrials.gov identifier: NCT00769704 .
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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.