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A Phase Ib Trial of Personalized Neoantigen Therapy Plus Anti-PD-1 in Patients with Advanced Melanoma, Non-small Cell Lung Cancer, or Bladder Cancer
Patrick A. Ott ,
Siwen Hu-Lieskovan ,
Bartosz Chmielowski ,
Ramaswamy Govindan ,
Aung Naing ,
Nina Bhardwaj ,
Kim Margolin ,
Mark M. Awad ,
Matthew D. Hellmann ,
Jessica J. Lin ,
Terence Friedlander ,
Meghan E. Bushway ,
Kristen N. Balogh ,
Tracey E. Sciuto ,
Victoria Kohler ,
Samantha J. Turnbull ,
Rana Besada ,
Riley R. Curran ,
Benjamin Trapp ,
Julian Scherer ,
Asaf Poran ,
Dewi Harjanto ,
Dominik Barthelme ,
Ying Sonia Ting ,
Jesse Z. Dong ,
Yvonne Ware ,
Yuting Huang ,
Zhengping Huang ,
Amy Wanamaker ,
Lisa D. Cleary ,
Melissa A. Moles ,
Kelledy Manson ,
Joel Greshock ,
Zakaria S. Khondker ,
Ed Fritsch ,
Michael S. Rooney ,
Mark DeMario ,
Richard B. Gaynor ,
Lakshmi Srinivasan
October 2020
October 2020
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Abstract
<p class="first" id="d728605e451">Neoantigens arise from mutations in cancer cells
and are important targets of T cell-mediated
anti-tumor immunity. Here, we report the first open-label, phase Ib clinical trial
of a personalized neoantigen-based vaccine, NEO-PV-01, in combination with PD-1 blockade
in patients with advanced melanoma, non-small cell lung cancer, or bladder cancer.
This analysis of 82 patients demonstrated that the regimen was safe, with no treatment-related
serious adverse events observed. De novo neoantigen-specific CD4+ and CD8+ T cell
responses were observed post-vaccination in all of the patients. The vaccine-induced
T cells had a cytotoxic phenotype and were capable of trafficking to the tumor and
mediating cell killing. In addition, epitope spread to neoantigens not included in
the vaccine was detected post-vaccination. These data support the safety and immunogenicity
of this regimen in patients with advanced solid tumors (Clinicaltrials.gov: NCT02897765).
</p>