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A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer.

Publication ,  Journal Article
Nguyen, VP; Campbell, KM; Nowicki, TS; Elumalai, N; Medina, E; Baselga-Carretero, I; DiNome, ML; Chang, HR; Oseguera, DK; Ribas, A; Glaspy, JA
Published in: Cancer Res Commun
August 2023

PURPOSE: Neoadjuvant combination immune checkpoint blockade and intralesional oncolytic virotherapy have the potential to activate antitumor responses in patients with breast cancer. EXPERIMENTAL DESIGN: Eligibility for this pilot phase I trial included patients with localized HER2-negative breast cancer who received systemic nivolumab and ipilimumab and intratumor talimogene laherparepvec (T-VEC; NCT04185311). The primary objective was to evaluate the safety and adverse event profile of immunotherapy combined with T-VEC in patients with localized, HER2-negative breast cancer. RESULTS: Six patients were enrolled, 4 having relapses after prior neoadjuvant chemotherapy and 2 who were previously untreated. Toxicities included 1 patient having grade 3 hypotension and type 1 diabetes mellitus, 3 patients with hypothyroidism, and all patients having constitutional symptoms known to be associated with the administration of T-VEC. One patient had a pathologic complete response, 3 patients had pathologic partial responses, 1 showed no significant response, and 1 had disease progression. Biopsies demonstrated increased immune cell infiltration in samples from patients who responded to therapy. CONCLUSIONS: This triple immunotherapy regimen provided responses in patients with advanced or relapsed HER2-negative breast cancer, at the expense of long-term toxicities. SIGNIFICANCE: Systemic immune checkpoint blockade with a programmed death receptor 1 and a CTL antigen-4 blocking antibody, combined with intralesional oncolytic virotherapy, is a chemotherapy-free combination aimed at inducing an antitumor immune response locally and systemic immunity.

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Published In

Cancer Res Commun

DOI

EISSN

2767-9764

Publication Date

August 2023

Volume

3

Issue

8

Start / End Page

1628 / 1637

Location

United States

Related Subject Headings

  • Pilot Projects
  • Oncolytic Virotherapy
  • Nivolumab
  • Neoplasm Recurrence, Local
  • Neoadjuvant Therapy
  • Melanoma
  • Ipilimumab
  • Immune Checkpoint Inhibitors
  • Humans
  • Female
 

Citation

APA
Chicago
ICMJE
MLA
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Nguyen, V. P., Campbell, K. M., Nowicki, T. S., Elumalai, N., Medina, E., Baselga-Carretero, I., … Glaspy, J. A. (2023). A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer. Cancer Res Commun, 3(8), 1628–1637. https://doi.org/10.1158/2767-9764.CRC-23-0145
Nguyen, Vina P., Katie M. Campbell, Theodore S. Nowicki, Nila Elumalai, Egmidio Medina, Ignacio Baselga-Carretero, Maggie L. DiNome, et al. “A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer.Cancer Res Commun 3, no. 8 (August 2023): 1628–37. https://doi.org/10.1158/2767-9764.CRC-23-0145.
Nguyen VP, Campbell KM, Nowicki TS, Elumalai N, Medina E, Baselga-Carretero I, et al. A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer. Cancer Res Commun. 2023 Aug;3(8):1628–37.
Nguyen, Vina P., et al. “A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer.Cancer Res Commun, vol. 3, no. 8, Aug. 2023, pp. 1628–37. Pubmed, doi:10.1158/2767-9764.CRC-23-0145.
Nguyen VP, Campbell KM, Nowicki TS, Elumalai N, Medina E, Baselga-Carretero I, DiNome ML, Chang HR, Oseguera DK, Ribas A, Glaspy JA. A Pilot Study of Neoadjuvant Nivolumab, Ipilimumab, and Intralesional Oncolytic Virotherapy for HER2-negative Breast Cancer. Cancer Res Commun. 2023 Aug;3(8):1628–1637.

Published In

Cancer Res Commun

DOI

EISSN

2767-9764

Publication Date

August 2023

Volume

3

Issue

8

Start / End Page

1628 / 1637

Location

United States

Related Subject Headings

  • Pilot Projects
  • Oncolytic Virotherapy
  • Nivolumab
  • Neoplasm Recurrence, Local
  • Neoadjuvant Therapy
  • Melanoma
  • Ipilimumab
  • Immune Checkpoint Inhibitors
  • Humans
  • Female