Poster Presentation Clinical Oncology Society of Australia Annual Scientific Meeting 2018

A phase 1b/2 trial of lenvatinib plus pembrolizumab in patients with squamous cell carcinoma of the head and neck   (#366)

Matthew H Taylor 1 , Drew W Rasco 2 , Marcia S Brose 3 , Nicholas J Vogelzang 4 , Stephen L Richey 4 , Allen L Cohen 4 , Donald A Richards 4 , Daniel E Stepan 5 , Corina E Dutcus 5 , Matthew Guo 5 , Robert C Shumaker 5 , Emmett V Schmidt 6 , Louise Young 7 , Lori J Wirth 8
  1. Knight Cancer Institute, Oregon Health and Science University, Portland, OR, USA
  2. South Texas Accelerated Research Therapeutics, San Antonio, Tx, USA
  3. Department of Otorhinolaryngology, Head and Neck Surgery, Abramson Cancer Center of the University of Pennsylvania, Philadelphia, PA, USA
  4. US Oncology Network, McKesson Specialty Health, Fort Worth, Tx, USA
  5. Eisai Inc., Woodcliff Lake, New Jersey, United States of America
  6. Merck & Co., Inc., Kenilworth, NJ, USA
  7. Eisai Australia Pty Ltd, Melbourne, VIC, Australia
  8. Massachusetts General Hospital Cancer Center, Boston, MA, USA

Aims: Lenvatinib is a multikinase inhibitor of vascular endothelial growth factor receptor 1−3, fibroblast growth factor receptor 1−4, and other targets. Pembrolizumab is an anti-PD-1 antibody approved for the second-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), with an objective response rate (ORR) of 16%.1

Methods: In this multicenter, open-label, phase 1b/2 study (NCT02501096), patients with measurable, confirmed metastatic SCCHN and ECOG PS ≤1 received lenvatinib (20 mg/day orally) + pembrolizumab (200 mg Q3W, IV). Patients were not preselected based on PD-L1 status. Tumor assessments were by study investigators using immune-related RECIST (irRECIST). The phase 2 primary endpoint was ORR at 24 weeks (ORRWK24). Secondary endpoints included ORR, progression-free survival (PFS), and duration of response (DOR).

Results: At data cutoff of August 1, 2017, 22 patients with SCCHN (regardless of PD-L1 status) were enrolled; 86% had ≥1 prior anticancer therapy. Median follow-up for PFS was 7.6 months (95% CI, 4.2–12.6). Efficacy outcomes are summarized in the table. Grade 3/4 AEs occurred in 91% of patients (grade 4 in 14%). 4 (18%) Patients discontinued study treatment due to AEs. The most common AEs were fatigue (55%), decreased appetite (41%), hypertension (41%), diarrhea (36%), and nausea (36%). Updated data will be presented.

Conclusions: Lenvatinib+pembrolizumab demonstrated promising clinical activity and manageable toxicities, supporting further evaluation of the lenvatinib+pembrolizumab combination in patients with SCCHN.


irRECIST (N = 22)

ORRWK24, n (%)*

95% CI

8 (36.4)


ORR, n (%)

95% CI

8 (36.4)


Median DOR, months (95% CI)

8.2 (2.2–not estimable)

Median PFS, months (95% CI)

8.2 (4.3–not estimable)

PFS rate at 12 months, % (95% CI)

37.2 (12.8–62.2)

*8 Partial responses (PRs). †7 PRs, 1 complete response.

4/8 (50%) Responders achieved a DOR of >6 months.