High response rates for T‐VEC in early metastatic melanoma (stage IIIB/C‐IVM1a)

  title={High response rates for T‐VEC in early metastatic melanoma (stage IIIB/C‐IVM1a)},
  author={Viola Franke and Danique M S Berger and Willem M. C. Klop and Bernies van der Hiel and Bart A. Van de Wiel and Sylvia ter Meulen and Michel W.J.M Wouters and Winan J. van Houdt and Alexander C. J. van Akkooi},
  journal={International Journal of Cancer},
Talimogene laherparepvec (T‐VEC) is a modified herpes simplex virus, type 1 (HSV‐1), which can be administered intralesionally in patients with stage IIIB/C‐IVM1a unresectable melanoma (EMA label). The phase 3 OPTiM registration study showed an overall response rate (ORR) of 26%. Since December 2016, 48 eligible patients started treatment at the Netherlands Cancer Institute. We included 26 patients in this study with a follow up time ≥6 months, reporting Overall Response Rate (ORR), Disease… 

T-VEC for stage IIIB-IVM1a melanoma achieves high rates of complete and durable responses and is associated with tumor load: a clinical prediction model

The prediction model shows that use of T-VEC in patients with less tumor burden is associated with better outcomes, suggesting use earlier in the course of the disease.

Re-introduction of T-VEC Monotherapy in Recurrent Melanoma is Effective

Real world data on re-introduction of T-VEC monotherapy in stage IIIB/C-IVM1a melanoma suggests T- VEC could be a treatment option for chronic disease control.

Neoadjuvant nivolumab + T-VEC combination therapy for resectable early stage or metastatic (IIIB-IVM1a) melanoma with injectable disease: study protocol of the NIVEC trial

This is the first trial investigating the efficacy and safety of neoadjuvant treatment of T-VEC and nivolumab followed by surgical resection in patients with stage IIIB-IVM1a melanoma, with the potential of high pathologic response rates and acceptable toxicity.

External Validation of a Dutch Predictive Nomogram for Complete Response to T-VEC in an Independent American Patient Cohort

The validation model reinforces the conclusion that for the best response to T-VEC, it should be used early on in the course of the disease, when the tumor burden is cutaneous with smaller diameter and fewer of metastases.

A Retrospective Chart Review Study of Real-World Use of Talimogene Laherparepvec in Unresectable Stage IIIB–IVM1a Melanoma in Four European Countries

The differences between European countries were apparent, with physicians in the Netherlands using T-VEC in patients with earlier advanced disease stage and in the first-line setting compared with other countries.

Efficacy of Talimogene Laherparepvec (T-VEC) Therapy in Patients with In-Transit Melanoma Metastasis Decreases with Increasing Lesion Size

T-V EC lesion diameter was persistently associated with clinical response and is a readily assessed predictor of successful T-VEC therapy, corroborates recent data suggesting response rates to T- VEC may be higher than reported in clinical trials.

False positive FDG uptake in melanoma patients treated with talimogene laherparepvec (T‐VEC)

False positive results indicate that new‐onset FDG uptake in locoregional lymph nodes during T‐VEC treatment does not necessarily reflect progressive disease, but may be associated with immune infiltration.

Talimogene Laherparepvec (T-VEC) for the Treatment of Advanced Locoregional Melanoma After Failure of Immunotherapy: An International Multi-Institutional Experience

T-VEC after failure of IO is effective in unresectable, metastatic stage IIIB-IV melanoma and initiation sequentially or concurrently did not significantly affect in-field response.

Real-life use of talimogene laherparepvec (T-VEC) in melanoma patients in centers in Austria, Switzerland and Germany

This real-life cohort treatment with T-VEC showed a high ORR and a large number of durable CRs, similar to previous studies of the therapy in patients with distant metastases.

Talimogene laherparepvec treatment to overcome loco-regional acquired resistance to immune checkpoint blockade in tumor stage IIIB–IV M1c melanoma patients

The usage of T-VEC is described in stage IVM1b-M1c melanoma patients, who achieved complete remission or stable disease upon systemic treatment but suffered from a loco-regional recurrence, and represents an effective and tolerable treatment option.



Talimogene Laherparepvec Improves Durable Response Rate in Patients With Advanced Melanoma.

  • R. AndtbackaH. Kaufman R. Coffin
  • Medicine, Biology
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2015
T-VEC is the first oncolytic immunotherapy to demonstrate therapeutic benefit against melanoma in a phase III clinical trial and represents a novel potential therapy for patients with metastatic melanoma.

Systemic versus local responses in melanoma patients treated with talimogene laherparepvec from a multi-institutional phase II study

A post hoc analysis of the systemic effects of talimogene laherparepvec in injected lesions and two types of uninjected lesions—non-visceral lesions and visceral lesions shows support of a delayed regional and systemic anti-tumor immune response to talimogen lahersparePvec.

Improved survival with vemurafenib in melanoma with BRAF V600E mutation.

Vemurafenib produced improved rates of overall and progression-free survival in patients with previously untreated melanoma with the BRAF V600E mutation in a phase 3 randomized clinical trial.

Efficacy and safety of talimogene laherparepvec versus granulocyte-macrophage colony-stimulating factor in patients with stage IIIB/C and IVM1a melanoma: subanalysis of the Phase III OPTiM trial

The subgroup of patients with stage IIIB, IIIC and IVM1a melanoma derived greater benefit in DRR and ORR from talimogene laherparepvec compared with GM-CSF, and the overall response rate (ORR) was well tolerated.

Improved survival with ipilimumab in patients with metastatic melanoma.

Ipilimumab, with or without a gp100 peptide vaccine, as compared with gp100 alone, improved overall survival in patients with previously treated metastatic melanoma.

OPTIM trial: a Phase III trial of an oncolytic herpes virus encoding GM-CSF for unresectable stage III or IV melanoma.

A prospective, randomized Phase III clinical trial in patients with unresectable Stage IIIb or c and Stage IV melanoma has been initiated and the rationale, study design, end points and future development of the Oncovex(GM-CSF) Pivotal Trial in Melanoma (OPTIM) trial are discussed in this article.

Potential clinical and immunotherapeutic utility of talimogene laherparepvec for patients with melanoma after disease progression on immune checkpoint inhibitors and BRAF inhibitors

Talimogene laherparepvec was active in patients with advanced melanoma with disease progression following multiple previous systemic therapies; no new safety signals were identified.

Phase II clinical trial of a granulocyte-macrophage colony-stimulating factor-encoding, second-generation oncolytic herpesvirus in patients with unresectable metastatic melanoma.

The 26% response rate, with durability in both injected and uninjected lesions including visceral sites, together with the survival rates, are evidence of systemic effectiveness, combined with a limited toxicity profile, warrants additional evaluation of JS1/34.5-/47-/GM-CSF in metastatic melanoma.

Randomized, Open-Label Phase II Study Evaluating the Efficacy and Safety of Talimogene Laherparepvec in Combination With Ipilimumab Versus Ipilimumab Alone in Patients With Advanced, Unresectable Melanoma.

  • J. ChesneyI. Puzanov H. Kaufman
  • Medicine, Biology
    Journal of clinical oncology : official journal of the American Society of Clinical Oncology
  • 2018
The study met its primary end point; the objective response rate was significantly higher with talimogene laherparepvec plus ipilimumab versus ipilitationab alone, indicating that the combination has greater antitumor activity without additional safety concerns versus ipILimumab.