- 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.
- 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.
- 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).
- Baseline immunocompetence was not evaluated.