- 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.
- 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.
- 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%.
- Open-label, single-group study.