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