A phase II study of talimogene laherparepvec for patients with inoperable locoregional recurrence of breast cancer

• Published in: Scientific reports Vol. 11; no. 1; pp. 22242 - 8
• Main Authors: Kai, Megumi, Marx, Angela N., Liu, Diane D., Shen, Yu, Gao, Hui, Reuben, James M., Whitman, Gary, Krishnamurthy, Savitri, Ross, Merrick I., Litton, Jennifer K., Lim, Bora, Ibrahim, Nuhad, Kogawa, Takahiro, Ueno, Naoto T.
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 15.11.2021; Nature Publishing Group; Nature Portfolio
• Subjects: 631/67; 631/67/1059; 631/67/1347; 692/308; 692/4028; 692/699/67; Adult; Adverse events; Aged; Antitumor activity; Biological Products - administration & dosage; Biological Products - adverse effects; Biological Products - therapeutic use; Biomarkers; Breast cancer; Breast Neoplasms - diagnosis; Breast Neoplasms - etiology; Breast Neoplasms - mortality; Breast Neoplasms - therapy; Combined Modality Therapy; Female; Genetic Therapy - methods; Herpesvirus 1, Human; Humanities and Social Sciences; Humans; Immune response; Immunophenotyping; Immunotherapy; Lymphocyte Count; Lysis; Middle Aged; multidisciplinary; Oncolytic Virotherapy - adverse effects; Oncolytic Virotherapy - methods; Patients; Prognosis; Science; Science (multidisciplinary); Survival; T-Lymphocyte Subsets - immunology; T-Lymphocyte Subsets - metabolism; T-Lymphocyte Subsets - pathology; Treatment Outcome; Tumors
• ISSN: 2045-2322; 2045-2322
• DOI: 10.1038/s41598-021-01473-2

Talimogene laherparepvec (T-VEC) is an immunotherapy that generates local tumor lysis and systemic antitumor immune response. We studied the efficacy of intratumoral administration of T-VEC as monotherapy for inoperable locoregional recurrence of breast cancer. T-VEC was injected intratumorally at 10 6 PFU/mL on day 1 (cycle 1), 10 8 PFU/mL on day 22 (cycle 2), and 10 8 PFU/mL every 2 weeks thereafter (cycles ≥ 3). Nine patients were enrolled, 6 with only locoregional disease and 3 with both locoregional and distant disease. No patient completed the planned 10 cycles or achieved complete or partial response. The median number of cycles administered was 4 (range, 3–8). Seven patients withdrew prematurely because of uncontrolled disease progression, 1 withdrew after cycle 3 because of fatigue, and 1 withdrew after cycle 4 for reasons unrelated to study treatment. Median progression-free survival and overall survival were 77 days (95% CI, 63–NA) and 361 days (95% CI, 240–NA). Two patients received 8 cycles with clinically stable disease as the best response. The most common grade 2 or higher adverse event was injection site reaction (n = 7, 78%). Future studies could examine whether combining intratumoral T-VEC with concurrent systemic therapy produces better outcomes.