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Clinical Trial
. 2023 Feb;29(2):450-457.
doi: 10.1038/s41591-023-02210-0. Epub 2023 Feb 9.

Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial

Hatem Soliman  1 , Deanna Hogue  2 , Hyo Han  3 , Blaise Mooney  4 , Ricardo Costa  3 , Marie C Lee  3 , Bethany Niell  4 , Angela Williams  4 , Alec Chau  4 , Shannon Falcon  4 , Aixa Soyano  3 , Avan Armaghani  3 , Nazanin Khakpour  3 , Robert J Weinfurtner  4 , Susan Hoover  3 , John Kiluk  3 , Christine Laronga  3 , Marilin Rosa  5 , Hung Khong  3 , Brian Czerniecki  3
Affiliations
Clinical Trial

Oncolytic T-VEC virotherapy plus neoadjuvant chemotherapy in nonmetastatic triple-negative breast cancer: a phase 2 trial

Hatem Soliman et al. Nat Med. 2023 Feb.

Erratum in

Abstract

Talimogene laherparepvec (T-VEC) is an oncolytic virus hypothesized to enhance triple-negative breast cancer (TNBC) responses to neoadjuvant chemotherapy (NAC). This article describes the phase 2 trial of T-VEC plus NAC (ClinicalTrials.gov ID: NCT02779855 ). Patients with stage 2-3 TNBC received five intratumoral T-VEC injections with paclitaxel followed by doxorubicin and cyclophosphamide and surgery to assess residual cancer burden index (RCB). The primary end point was RCB0 rate. Secondary end points were RCB0-1 rate, recurrence rate, toxicity and immune correlates. Thirty-seven patients were evaluated. Common T-VEC toxicities were fevers, chills, headache, fatigue and injection site pain. NAC toxicities were as expected. Four thromboembolic events occurred. The primary end point was met with an estimated RCB0 rate = 45.9% and RCB0-1 descriptive rate = 65%. The 2-year disease-free rate is equal to 89% with no recurrences in RCB0-1 patients. Immune activation during treatment correlated with response. T-VEC plus NAC in TNBC may increase RCB0-1 rates. These results support continued investigation of T-VEC plus NAC for TNBC.

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