Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia Journal Article

Authors: Maslak, P. G.; Dao, T.; Bernal, Y.; Chanel, S. M.; Zhang, R.; Frattini, M.; Rosenblat, T.; Jurcic, J. G.; Brentjens, R. J.; Arcila, M. E.; Rampal, R.; Park, J. H.; Douer, D.; Katz, L.; Sarlis, N.; Tallman, M. S.; Scheinberg, D. A.
Article Title: Phase 2 trial of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia
Abstract: A National Cancer Institute consensus study on prioritization of cancer antigens ranked the Wilms tumor 1 (WT1) protein as the top immunotherapy target in cancer. We previously reported a pilot study of a multivalent WT1 peptide vaccine (galinpepimut-S) in acute myeloid leukemia (AML) patients. We have now conducted a phase 2 study investigating this vaccine in adults with AML in first complete remission (CR1). Patients received 6 vaccinations administered over 10 weeks with the potential to receive 6 additional monthly doses if they remained in CR1. Immune responses (IRs) were evaluated after the 6th and 12th vaccinations by CD4(+) T-cell proliferation, CD8(+) T-cell interferon-g secretion (enzyme-linked immunospot), or the CD8-relevant WT1 peptide major histocompatibility complex tetramer assay (HLA-A*02 patients only). Twenty-two patients (7 males; median age, 64 years) were treated. Fourteen patients (64%) completed >= 6 vaccinations, and 9 (41%) received all 12 vaccine doses. Fifteen patients (68%) relapsed, and 10 (46%) died. The vaccine was well tolerated, with the most common toxicities being grade 1/2 injection site reactions (46%), fatigue (32%), and skin induration (32%). Median disease-free survival from CR1 was 16.9 months, whereas the overall survival from diagnosis has not yet been reached but is estimated to be >= 67.6 months. Nine of 14 tested patients (64%) had an IR in >= 1 assay (CD4 or CD8). These results indicated that the WT1 vaccine was well tolerated, stimulated a specific IR, and was associated with survival in excess of 5 years in this cohort of patients.
Keywords: transplantation; age; outcomes; t-cell responses; cancer-immunotherapy; immune-responses; aml; older patients; 1st complete remission; synthetic analog peptides
Journal Title: Blood Advances
Volume: 2
Issue: 3
ISSN: 2473-9529
Publisher: American Society of Hematology  
Date Published: 2018-02-13
Start Page: 224
End Page: 234
Language: English
ACCESSION: WOS:000424874400006
DOI: 10.1182/bloodadvances.2017014175
PMCID: PMC5812332
PUBMED: 29386195
Notes: Article -- Source: Wos
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MSK Authors
  1. Renier J Brentjens
    189 Brentjens
  2. Martin Stuart Tallman
    408 Tallman
  3. Joseph G Jurcic
    127 Jurcic
  4. Jae Hong Park
    132 Park
  5. Raajit Kumar Rampal
    128 Rampal
  6. Suzanne M Chanel
    29 Chanel
  7. Tao Dao
    57 Dao
  8. Peter Maslak
    166 Maslak
  9. Maria Eugenia Arcila
    336 Arcila
  10. Dan Douer
    80 Douer
  11. Rong Hua Zhang
    17 Zhang
  12. Yvette J Bernal
    20 Bernal