Nivolumab shows benefit in recurrent/metastatic gynecologic cancers

  • Naumann RW & et al.
  • J Clin Oncol
  • 5 Sep 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
Access to the full content of this site is available only to registered healthcare professionals. Access to the full content of this site is available only to registered healthcare professionals.

Takeaway

  • Nivolumab shows durable response and manageable safety in patients with recurrent/metastatic cervical, vaginal, or vulvar cancer.
  • No new safety signals were reported.

Why this matters

  • Promising data call for further prospective evaluation.

Study design

  • Phase 1/2 CheckMate 358 study evaluated nivolumab in 24 patients with recurrent/metastatic cervical, vaginal, or vulvar carcinoma.
  • Funding: Bristol-Myers Squibb.

Key results

  • Cervical cancer cohort (n=19):
    • 84.2% of patients had stage IV disease and 78.9% had prior systemic therapy;
    • median follow-up: 19.2 months;
    • median duration of treatment: 5.6 months;
    • objective response rate (ORR): 26.3% (95% CI, 9.1%-51.2%);
    • disease control rate: 68.4% (95% CI, 43.4%-87.4%);
    • treatment-related adverse event rate (AER): any grade, 63.2%; grade 3-4, 21.1%.
    • 3 patients were continuing treatment at data cutoff.
  • Vaginal/vulvar cohort (n=5):
    • 3 patients had stage IV disease and 4 had prior systemic therapy;
    • median duration of treatment: 6.7 months;
    • median follow-up was 10.3 months;
    • ORR: 20.0% (95% CI, 0.5%-71.6%);
    • disease control rate: 80.0% (95% CI, 28.4%-99.5%);
    • treatment-related AER: any grade, 100.0%; grade 3-4, 0%.
  • No new safety signals or treatment-related deaths were reported.

Limitations

  • Small number of patients with vaginal/vulvar cancer.