Oops, you're using an old version of your browser so some of the features on this page may not be displaying properly.

MINIMAL Requirements: Google Chrome 24+Mozilla Firefox 20+Internet Explorer 11Opera 15–18Apple Safari 7SeaMonkey 2.15-2.23

Genitourinary tumours, non-prostate

3765 - A Phase 1b/2 Trial of Lenvatinib Plus Pembrolizumab in Patients With Renal Cell Carcinoma


09 Sep 2017


Genitourinary tumours, non-prostate


Cytotoxic Therapy;  Immunotherapy;  Renal Cell Cancer


Chung-Han Lee


Annals of Oncology (2017) 28 (suppl_5): v295-v329. 10.1093/annonc/mdx371


C. Lee1, V. Makker1, D. Rasco2, M. Taylor3, C. Dutcus4, R. Shumaker4, E.V. Schmidt5, D. Stepan6, D. Li7, R.J. Motzer1

Author affiliations

  • 1 Genitourinary Oncology, Memorial Sloan-Kettering Cancer Center, 10065 - New York/US
  • 2 Medical Oncology, START, 78229 - San Antonio/US
  • 3 Oregon Health And Science University, Knight Cancer Institute, Portland/US
  • 4 Eisai, Inc., 07677 - Woodcliff Lake/US
  • 5 Merck & Co., Inc., Kenilworth/US
  • 6 Eisai, Inc., 07677 - Woodcliff lake/US
  • 7 Eisai, Inc., Woodcliff Lake/US


Login to access the resources on OncologyPRO.

If you do not have an ESMO account, please create one for free.

Abstract 3765


Lenvatinib (LEN) is a multikinase inhibitor of vascular endothelial growth factor (VEGF) receptor 1 − 3, fibroblast growth factor receptor 1 − 4, platelet-derived growth factor receptor α, RET, and KIT. LEN 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 (pembro) in patients (pts) with selected solid tumors (NCT02501096).


This was a multicenter open-label study. Pts had metastatic clear cell RCC, measurable disease according to immune-related Response Evaluation Criteria in Solid Tumors (irRECIST), and Eastern Cooperative Oncology Group performance status ≤1. LEN 20 mg/d plus pembro 200 mg intravenously every 3 weeks was assessed as the maximum tolerated dose and recommended phase 2 dose in phase 1b. Tumor assessments were performed by trial investigators using irRECIST. The primary phase 2 endpoint was objective response rate (ORR) at 24 weeks. Secondary endpoints included ORR, progression-free survival (PFS), and duration of response (DOR).


30 Pts were enrolled in either the phase 1b (8 pts) or phase 2 cohort (22 pts). Data cutoff Feb 15, 2017. 11 (37%) Pts had 0, 11 (37%) pts had 1, and 8 (27%) pts had ≥2 prior anti-cancer therapies. Of pts who received prior medication (n = 19, 63%), 16 (53%) received prior VEGF-targeted therapy. Efficacy outcomes are summarized in the Table. At data cutoff, 17 (57%) pts were still receiving treatment, 8 (27%) completed treatment due to disease progression, and 5 (17%) discontinued treatment. The most common any-grade treatment-emergent adverse events 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.


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


Outcomen = 3095% CI
ORR, n (%)19 (63.3)43.9%–80.1%
Median PFS, mosNE9.9–NE
Median DOR, mosNE8.4–NE
NE, not estimable.

Clinical trial identification


Legal entity responsible for the study

Eisai Inc


Eisai Inc


C-H. Lee: Research funds to institute from Eisai, Bristol-Myers Squib, Pfizer, Exelixis, Calithera, and consulting fees from Exelixis. D. Rasco: Research funding from Aeglea, Asana, Ascentage, Bayer, Celgene, Eisai, Five Prime Therapeutics, GlaxoSmithkline, Macrogenics, Merck, Millennium Pharmaceuticals, OncoMed Pharmaceuticals, Pharmacyclics, Rexahn Pharmaceuticals, Santa Maria Biotherapeutics. M. Taylor: Honoraria from/held consulting advisory role with: Eisai, Bristol-Myers Squib, Blueprint Medicine, and Trillium Pharma; participated in speakers\' bureau for Eisai Inc. C. Dutcus, R. Shumaker, D. Stepan, D. Li: Employee of Eisai Inc. E.V. Schmidt: Employee of/stockholder: Merck Research Labs. R.J. Motzer: Grants from Pfizer, Eisai, Exelixis, Novartis, and Bristol-Myers Squib. Served as a consultant to Pfizer, Eisai, Exelixis, and Novartis. All other authors have declared no conflicts of interest.

This site uses cookies. Some of these cookies are essential, while others help us improve your experience by providing insights into how the site is being used.

For more detailed information on the cookies we use, please check our Privacy Policy.

Customise settings
  • Necessary cookies enable core functionality. The website cannot function properly without these cookies, and you can only disable them by changing your browser preferences.