Ressler et al. reported the safety and efficacy of a single-arm, phase II, neoadjuvant, two-stage clinical trial of T-VEC in cutaneous BCC, which was preliminarily stopped for early success after the first stage. Neoadjuvant T-VEC treatment was effective and well tolerated, with an objective response rate of 55.6% and a complete pathological response rate of 33.3%. The 6-month relapse-free survival and overall survival rates were 100%. T-VEC altered the intratumoral immune cell composition, including the appearance of hyper-expanded cytotoxic T cell clones and IGHG1 plasma cells, decreased Tregs, and alterations in the TAM populations.
Contributed by Shishir Pant
ABSTRACT: We present a single-arm, phase II, neoadjuvant trial with the oncolytic virus talimogene laherparepvec (T-VEC) in 18 patients with difficult-to-resect cutaneous basal cell carcinomas. The primary end point, defined as the proportion of patients, who after six cycles of T-VEC (13 weeks), become resectable without the need for plastic reconstructive surgery, was already achieved after stage I (9 of 18 patients; 50.0%); thus the study was discontinued for early success. The objective response rate was 55.6% and the complete pathological response rate was 33.3%. Secondary end points included safety, relapse-free survival and overall survival, time to occurrence of new basal cell carcinomas and biological read outs. Only mild adverse events occurred. The 6-month relapse-free survival and overall survival rates were 100%. In two patients a new basal cell carcinoma was diagnosed. T-VEC led to a significant increase in cytotoxic T cells (P_=_0.0092), B cells (P_=_0.0004) and myeloid cells (P_=_0.0042) and a decrease in regulatory T cells (P_=_0.0290) within the tumor microenvironment. Together, neoadjuvant T-VEC represents a viable treatment option for patients with difficult-to-resect basal cell carcinomas (EudraCT no. 2018-002165-19).
Author Info: (1) Medical University of Vienna, Department of Dermatology, Vienna, Austria. julia.ressler@meduniwien.ac.at. (2) Medical University of Vienna, Department of Dermatology, Vienna, A
Author Info: (1) Medical University of Vienna, Department of Dermatology, Vienna, Austria. julia.ressler@meduniwien.ac.at. (2) Medical University of Vienna, Department of Dermatology, Vienna, Austria. St. Anna Children's Cancer Research Institute (CCRI), Vienna, Austria. (3) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (4) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (5) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (6) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (7) Medical University of Vienna, Department of Dermatology, Vienna, Austria. University of Applied Sciences FH Campus Wien, Division of Biomedical Science, Vienna, Austria. (8) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (9) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (10) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (11) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (12) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (13) Medical University of Vienna, Department of Obstetrics and Gynecology, Vienna, Austria. (14) Medical University of Vienna, Department of Dermatology, Vienna, Austria. Medical University of Vienna, SERD Skin and Endothelium Research Division, Vienna, Austria. (15) Medical University of Vienna, Center of Medical Statistics, Informatics and Intelligent Systems, Vienna, Austria. (16) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (17) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (18) St. Anna Children's Cancer Research Institute (CCRI), Vienna, Austria. (19) Medical University of Vienna, Department of Dermatology, Vienna, Austria. (20) Medical University of Vienna, Department of Dermatology, Vienna, Austria.
