Talimogene Laherparepvec (T-VEC)


ASCO 2020: Early phase 1 safety data of T-VEC injected into liver tumors in combination with pembrolizumab at standard doses showed that this is feasible and tolerable.

Poster discussion #3015, Hecht R, Pless M, Cubillo A, et al.
Details about this recruiting trial in Switzerland are here.

ASCO 2020: Further analysis of the T-VEC plus ipilimumab trial versus ipilimumab alone in advanced melanoma showed that Complete Response was higher in the T-VEC plus ipi than in the ipi alone arm and that CR was associated with prolonged OS.

ESMO 2019: Primary 2-year results of a phase 2 trial for T-VEC neoadjuvant treatment plus surgery vs surgery in patients with resectable stage IIIB-IVM1a melanoma

In the largest randomized, open-label trial of neoadjuvant therapy in resectable stage IIIB-IVM1a melanoma, T-VEC improved 2-year relapse-free-survival and overall survival.
Oral presentation (LBA66) by R. Dummer et al.

ESMO 2019: T-VEC in combination with ipilimumab (ipi) versus ipi alone for advanced melanoma: 3-year landmark analysis

At the 3-year landmark follow-up of a randomized, open-label, phase 2 trial, the T-VEC + Ipi combination continued to provide durable and statistically superior ORR compared with Ipi alone in metastatic melanoma.
Oral presentation (LBA70) by J. A. Chesney et al.

ESMO 2019: Efficacy of T-VEC in melanoma patients with locoregional (LR) recurrence, including in-transit metastases (ITM)

this subgroup analysis of the phase 3 OPTiM study showed that in T-VEC-treated patients with ITM (without lymph node metastases) as site of first recurrence, an ORR of 81% and complete response rate of 36% were observed. In comparison in the overall OPTiM population (stage IIIB-IV melanoma), the ORR was 26% and CR rate was 11%.
Poster 1342P, by M. Middleton et al.

ESMO 2019: Real Life Use of Talimogene laherparepvec in melanoma in centers in Austria and Switzerland

In this real life cohort, treatment with TVEC shows a high overall and complete remission rate with the majority of complete responses being durable.
Poster 343P by C. Hoeller et al.

New ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up of cutaneous melanoma by O. Michielin et al. https://www.esmo.org/Guidelines/Melanoma

ASCO 2019: In study 266 (Dummer, et al.), neoadjuvant T-VEC led to a significant improvement in the 1-year RFS rate in patients with resectable advanced melanoma compared with surgery alone (HR, 0.73; 80% CI, 0.56-0.93; P = .048).

Prof. Dummer commented that neoadjuvant T-VEC resulted in a higher pCR rate in resectable melanoma than that observed by the overall clinical response rate and may account for the higher R0 resection rate in the T-VEC arm than the surgery-alone arm.

ASCO 2019: In the OPTIM trial in patients with unresected stage IIIB–IVM1c melanoma, T-VEC improved significantly PFS compared to GM-CSF (Milhelm et al.)

driven primarily by patients with stage IIIB-IVM1a melanoma. This is consistent with previous data showing more pronounced overall survival benefit with T-VEC for local regional disease.

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