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

Megumi Kai, Angela N. Marx, Diane D. Liu, Yu Shen, Hui Gao, James M Reuben, Gary Whitman, Savitri Krishnamurthy, Merrick I. Ross, Jennifer K. Litton, Bora Lim, Nuhad Ibrahim, Takahiro Kogawa, Naoto T. Ueno

Research output: Contribution to journalArticlepeer-review

14 Scopus citations

Abstract

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 106 PFU/mL on day 1 (cycle 1), 108 PFU/mL on day 22 (cycle 2), and 108 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.

Original languageEnglish (US)
Article number22242
JournalScientific reports
Volume11
Issue number1
DOIs
StatePublished - Dec 2021

ASJC Scopus subject areas

  • General

MD Anderson CCSG core facilities

  • Biostatistics Resource Group

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