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Genitourinary tumours, non-prostate

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

Date

09 Sep 2017

Session

Genitourinary tumours, non-prostate

Presenters

Chung-Han Lee

Citation

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

Authors

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
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Abstract 3765

Background

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).

Methods

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).

Results

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.

Conclusions

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:

847O

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

NCT02501096

Legal entity responsible for the study

Eisai Inc

Funding

Eisai Inc

Disclosure

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.

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