Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

A phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with endometrial carcinoma (#235)

Vicky Makker 1 , Drew Rasco 2 , Corina Dutcus 3 , Daniel Stepan 3 , Di Li 3 , Emmett Schmidt 4 , Robert Shumaker 3 , Louise Young 5 , Matthew Taylor 6
  1. Memorial Sloan Ketting Cancer Center, New York, USA
  2. START, San Antonio, Texas, USA
  3. Eisai Inc., Woodcliff Lake, NJ, USA
  4. Merck Co. Inc, Kenilworth, New Jersey, USA
  5. Eisai Australia Pty Ltd, Melbourne, VIC, Australia
  6. Oregon Health and Science University, Portland, Oregon, USA


Lenvatinib is a multikinase inhibitor of VEGFR 1−3, FGFR 1−4, PDGFRα, RET, and KIT. Pembrolizumab, an antibody targeting PD-1, prevents T cell deactivation. In addition to its antiangiogenic effects, lenvatinib may act, in part, by preventing VEGF-mediated immune suppression, suggesting combination with pembrolizumab could improve its activity. From a phase 1b/2 trial of lenvatinib+pembrolizumab, we report results in pts with endometrial carcinoma.


In this multicenter, open-label study, pts had confirmed metastatic endometrial cancer that progressed after approved therapy, measurable disease, and ECOG PS ≤1. Pts received oral lenvatinib 20 mg/day + pembrolizumab 200 mg intravenously every 3 weeks, with tumor assessments by the investigator. ­­­­­The primary phase 2 endpoint was ORR based on irRECIST. Secondary endpoints included PFS, DCR (complete response [CR]+ partial response [PR]+ stable disease [SD]), CBR (CR + PR + durable SD), and duration of response (DOR), all by irRECIST, and safety.


Twenty-three patients enrolled (phase 2: 21; phase 1b: 2); median age was 64 years (range: 51−80); 87% were white; and all had ≥1 prior anticancer therapy. Confirmed ORR was 48% (all PR). Median PFS and DOR were not estimable (NE; see table). All pts had treatment-emergent adverse events, with hypertension, fatigue, arthralgia, diarrhea, and nausea as the most common. Toxicities were manageable with dose interruption and/or modification and no new safety signals occurred. Updated data will be presented.


Promising efficacy was observed in pts receiving lenvatinib+pembrolizumab, and toxicities were generally expected and manageable with dose modification. These results warrant further study of lenvatinib+pembrolizumab in patients with endometrial carcinoma.


Patients (n=23)

95% CI

ORR, n (%)

11 (48%)


DCR, n (%)

22 (96%)


CBR, n (%)

17 (74%)


Median PFS, months



Median DOR, months*



*For patients with CR or PR

CI, confidence interval.