KEYNOTE-028: pembrolizumab shows efficacy in ovarian cancer

  • Varga A & et al.
  • Gynecol Oncol
  • 3 Dec 2018

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • Pembrolizumab is well tolerated in patients with programmed death ligand 1 (PD-L1)-positive advanced recurrent ovarian cancer.
  • The overall response rate was 11.5%; nearly 27% of patients had stable disease.

Why this matters

  • Advanced ovarian cancer has a poor prognosis.
  • Encouraging findings call for further investigation.

Study design

  • Multicenter phase 1B KEYNOTE-028 study of 26 patients (median age, 57.5 years) with PD-L1-positive advanced ovarian epithelial, fallopian tube, or primary peritoneal carcinoma who failed previous therapy.
  • 38.5% had metastatic disease; 73.1% previously received ≥3 lines of therapy.
  • Patients received pembrolizumab (10 mg/kg every 2 weeks) for ≤24 months or until disease progression/intolerable toxicity.
  • Funding: MSD.

Key results

  • Median follow-up duration, 15.4 months.
  • 73.1% of patients experienced treatment-related adverse events (TRAEs); the most common were arthralgia (19.2%), nausea (15.4%), pruritus (15.4%), diarrhea (11.5%), and rash (11.5%).
  • 1 grade ≥3 TRAE (increased plasma transaminase level) was reported.
  • The overall response rate was 11.5% (1 complete response, 2 partial responses), and 26.9% of patients achieved stable disease.
  • Median PFS was 1.9 (95% CI, 1.8-3.5) months, and OS was 13.8 (95% CI, 6.7-18.8) months, respectively.

Limitations

  • Open-label design.

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