Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2017

A phase 1b/2 trial of lenvatinib+pembrolizumab in patients with renal cell carcinoma (#236)

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


Lenvatinib (LEN), an inhibitor of VEGFR 1−3, FGFR 1−4, PDGFRα, RET, and KIT, was approved in combination with everolimus to treat advanced renal cell carcinoma (RCC) after 1 prior VEGF-targeted treatment. We report results for the RCC cohort of a phase 1b/2 trial of LEN+pembrolizumab in patients with selected solid tumors.


This was a multicenter open-label study. Patients had metastatic clear cell RCC, measurable disease per immune-related RECIST (irRECIST) and ECOG PS ≤1. LEN 20 mg/d plus pembrolizumab 200 mg intravenously every 3 weeks was assessed as the MTD and recommended phase 2 dose in phase 1b. Tumor assessments were performed by trial investigators using irRECIST. The primary phase 2 endpoint was ORR at 24 weeks. Secondary endpoints included ORR, PFS, and DOR.


Thirty patients were enrolled in either the phase 1b (n=8) or phase 2 cohort (n=22). Data cutoff was February 15, 2017. Eleven (37%) patients had 0, 11 (37%) had 1, and 8 (27%) had ≥2 prior anti-cancer therapies. Of patients who received prior medication (n=19, 63%), 16 (53%) received prior VEGF-targeted therapy. Efficacy outcomes are in the table. At data cutoff, 17 (57%) patients were receiving treatment, 8 (27%) completed treatment due to disease progression, and 5 (17%) discontinued. Most common any-grade TEAEs were diarrhea, fatigue, hypothyroidism, nausea, and stomatitis. Toxicities were manageable with dose interruption and/or modification, and no new safety signals were found. Updated data will be presented.


LEN+pembrolizumab combination treatment showed promising antitumor activity and an acceptable safety profile. A phase 3 trial of LEN+pembrolizumab and LEN+everolimus, vs sunitinib in first-line treatment for metastatic clear cell RCC is ongoing. 



95% CI

ORR, n (%)

19 (63.3)


Median PFS, mos



Median DOR, mos



 NE, not estimable.