Lenvatinib-pembrolizumab shows benefit in endometrial cancer

  • Makker V & et al.
  • Lancet Oncol
  • 25 Mar 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • The interim results of phase 2 study point to safety and antitumor activity with lenvatinib plus pembrolizumab in biomarker-unselected patients with advanced or recurrent endometrial cancer.

Why this matters

  • Lenvatinib plus pembrolizumab received breakthrough therapy designation from the FDA and a phase 3 trial is underway.

Study design

  • Interim results of phase 2 study.
  • 53 biomarker-unselected patients with metastatic endometrial cancer received lenvatinib plus pembrolizumab every 3 weeks.
  • Funding: Eisai; Merck & Co., Inc., Kenilworth, NJ, USA.

Key results

  • Median study follow-up was 13.3 months.
  • At 24 weeks, the objective response rate was 39.6%.
  • Median follow-up for PFS was 7.7 months; median PFS was 7.4 months (95% CI, 5.0-not estimable).
  • The most common any-grade treatment-related adverse events were hypertension (58%), fatigue (55%), diarrhea (51%), and hypothyroidism (47%).
  • Most common grade 3 treatment-related adverse events were hypertension (34%) and diarrhea (8%).
  • No grade 4 treatment-related adverse events were reported.
  • 30% of patients experienced serious treatment-related adverse events, and 1 treatment-related death was reported.
  • Toxicity-related discontinuation rate was 9%.

Limitations

  • Open-label, single-group study.

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