Ovarian cancer: polyvalent vaccine+immunoadjuvant OPT-821 fails phase 2

  • O’Cearbhaill RE & et al.
  • Gynecol Oncol
  • 22 Oct 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Polyvalent vaccine (Globo-H, GM2, Tn-MUC1-32mer, TF)-keyhole limpet hemocyanin conjugate with immunological adjuvant OPT-821 was modestly immunogenic but fails to prolong survival vs OPT-821 alone in relapsed patients with ovarian cancer.

Why this matters

  • Effective maintenance strategies are needed to prevent relapse or prolong remission.

Study design

  • Phase 2, double-blind Gynecologic Oncology Group (GOG) 255 study of 170 patients with epithelial carcinoma of the ovary, fallopian tube, or peritoneum, recurred after primary treatment.
  • Patients were randomly assigned 1:1 to receive OPT-821±vaccine-KLH conjugate subcutaneously at weeks 1, 2, 3, 7, and 11, and then every 12 weeks.
  • Funding: National Cancer Institute.

Key results

  • 77.2% of patients had stage III disease at diagnosis.
  • 7%-45% of patients showed positive IgG responses and 21%-49% showed positive IgM responses with different antigens.
  • MUC1 was the most immunogenic antigen.
  • 77% of patients discontinued because of progression.
  • Maximum toxicities were:
    • grade 4 myeloid dysplastic syndrome and depression/personality change (1 each, unlikely related);
    • grade 3 gastrointestinal disorders and others (n=21, 4 related).
  • Grade 2 injection site reactions were more common in the combination group (35% vs 13%).
  • No difference was observed in PFS between groups (HR, 0.98; 95% CI, 0.71-1.43) or OS (HR, 0.83; 95% CI, 0.55-1.24).

Limitations

  • Baseline immunocompetence was not evaluated.