Survival-benefit of neoadjuvant T-VEC maintained over 5 years of follow-up

Neoadjuvant talimogene laherparepvec (T-VEC) treatment in patients with resectable, stage IIIB–IVM1 melanoma resulted in a durable survival-benefit compared with surgery alone, as shown by the 5-year follow-up data of the largest randomised T-VEC trial.

T-VEC is a genetically modified herpes simplex 1 virus that, when injected into a cancer lesion, results in the lyses and release of tumour-antigens and subsequent stimulation of local and systemic immune responses [1]. The initial analysis of the large (n=150) phase 2, multicentre, randomised trial (NCT02211131) reported a significant survival benefit of neoadjuvant T-VEC compared with surgery alone after 2 years [2]. Prof. Reinhard Dummer (University of Zürich, Switzerland) presented the actual results of the final read-out after 5 years of follow-up [3].

The 5-year event-free survival in participants treated with neoadjuvant T-VEC was 43.7% versus 27.4% in participants with surgery alone (HR 0.57). The 5-year overall survival was 77.3% versus 62.7% (neoadjuvant T-VEC vs surgery; HR 0.54). Of note, more participants in the surgery-only arm received systemic anti-cancer treatment compared with the T-VEC arm: 78.3% vs 54.8% (for adjuvant therapy this was 31.9% vs 13.7%). Hazard ratios for both event-free and overall survival did not change compared with the 3-year survival data.

“The results from this final analysis suggest that intratumorally administered oncolytic agents like T-VEC can elicit a meaningful long-term systemic effect. This supports neoadjuvant T-VEC followed by surgery in advanced resectable melanoma,” concluded Prof. Dummer.

1. Ramelyte E, et al. Cancer Cell. 2021;39(3):394–406.
2. Dummer R, et al. Nat Med. 2021;27(10):1789–1796.
3. Dummer R, et al. Final 5-year results of the phase II, multicenter, randomized, open-label trial of talimogene laherparepvec (T-VEC) neoadjuvant treatment (Tx) plus surgery vs immediate surgery in patients (pts) with resectable stage IIIB-IVM1a melanoma. Abstract LBA39, ESMO Congress 2022, 09–13 September, Paris, France.

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Posted on 16 November 202223 April 2024