1042O - Durvalumab for recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC): preliminary results from a single-arm, phase 2 study

Date 11 September 2017
Event ESMO 2017 Congress
Session Head and neck cancer, excluding thyroid
Topics Cancer in Adolescents
Cancer Immunology and Immunotherapy
Head and Neck Cancers
Presenter Dan Zandberg
Citation Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374
Authors D. Zandberg1, A. Algazi2, A. Jimeno3, J.S. Good4, J. Fayette5, N. Bouganim6, N. Ready7, P.M. Clement8, T. Goswmi9, A. Jarkowski9, J.M. Armstrong9, K. Asubonteng9, G. Melillo9, R. Mesía10
  • 1Hematology/oncology, University of Maryland Greenebaum Comprehensive Cancer Center, 21201-1595 - Baltimore/US
  • 2Oncology, University of California San Francisco, CA 94115 - San Francisco/US
  • 3Departments Of Medicine/oncology And Otolaryngology, University of Colorado Cancer Center and Gates Center for Regenerative Medicine, CO 80045 - Colorado/US
  • 4Oncology, Institute of Head and Neck Studies and Education, Queen Elizabeth Hospital, B15 2TH - Birmingham/GB
  • 5Clinical Oncology, Cancer Center "Centre Léon Bérard," University of Lyon, 69008 - Lyon/FR
  • 6Department Of Oncology, McGill University Health Centre, H4A 3J1 - Montreal/CA
  • 7Medical Oncology, Duke University Medical Center, NC 27710 - Durham/US
  • 8Department Of Oncology, University Hospitals Leuven, Leuven/BE
  • 9Immuno-oncology Gmd, AstraZeneca, Gaithersburg/US
  • 10Medical Oncology, Catalan Institute of Oncology, University of Barcelona, Barcelona/ES

Abstract

Background

R/M HNSCC patients (pts) who have progressed on platinum-based chemotherapy have a poor prognosis and limited therapeutic options. Programmed cell death 1 (PD-1) and its ligand 1 (PD-L1) are frequently up-regulated in several tumor types, including HNSCC. The global, single-arm, Phase 2 HAWK study (NCT02207530) evaluated the anti-PD-L1 immunotherapy durvalumab as monotherapy in PD-L1 high pts with R/M HNSCC who have failed platinum-based chemotherapy.

Methods

Immunotherapy-naïve pts aged ≥18 years with confirmed PD-L1 high protein expression (≥25% of tumor cells [TCs] using the Ventana SP263 assay) who had progression or recurrence during/after 1 platinum-based regimen for R/M HNSCC received durvalumab 10 mg/kg IV every 2 weeks up to 12 months or until progression, starting another anticancer therapy, consent withdrawal, or unacceptable toxicity. The primary endpoint was objective response rate (ORR; blinded independent central review, RECIST v1.1); secondary endpoints included progression-free survival (PFS) and overall survival (OS).

Results

As of Sept 26, 2016, 112 pts from 12 countries had received treatment (median age 60 years, 71.4% male, 34.7% human papillomavirus [HPV]+, and 61.6% current/former smokers). Median durations of treatment and follow-up were 3.45 and 5.96 months, respectively. Among evaluable pts (n = 111), ORR was 13.5% (95% CI 7.8–21.3) overall and 26.5% (95% CI 12.9–44.4) and 7.9% (95% CI 2.6–17.6) for HPV+ and HPV- pts, respectively; among responders (n = 15), 12 (80%) had an ongoing response at data cutoff (DCO). 35 pts (31.5%) had stable disease ≥8 weeks. Median PFS was 2.3 months (95% CI 1.9–3.7) and 34 pts (30.4%) were alive at DCO (OS data were immature). The incidence of grade ≥3 treatment-related adverse events (AEs) was 9.8% and no treatment-related AEs led to death. 88 pts (78.6%) discontinued initial study treatment, 65 (58%) due to progressive disease and 10 (8.9%) due to all-causality AEs.

Conclusions

Durvalumab demonstrated promising antitumor activity with an acceptable safety profile in PD-L1 high pts with R/M HNSCC, supporting its potential use, and the opportunity to improve efficacy, in combination therapy.

Clinical trial identification

NCT02207530 (release date: August 1, 2014)

Legal entity responsible for the study

AstraZeneca PLC

Funding

AstraZeneca PLC

Disclosure

D. Zandberg: PI at UMGCCC for trials by Medimmune, AstraZeneca, Merck, Macrogenics, Bristol-Myers Squib, Gliknik. A. Algazi: UCSF receive research funding on my behalf from AstraZeneca, Merck, Bristol-Myers Squib, MedImmune, Acerta, OncoSec, Novartis. A. Jimeno: Consultant for AstraZeneca, one presentation at research meeting in January 2016 J.S. Good: Corporate sponsored research: AstraZeneca and Honoraria: Eisai, Bayer, Sirtex, BTG J. Fayette: Honoraria: Bristol-Myers Squib, AstraZeneca. N. Ready: Consultant: AstraZeneca, Bristol-Myers Squib, Merck, Celgene, Abbvie and Honoraria: Bristol-Myers Squib, Abbvie. P.M. Clement: Speakers’ Bureau and Corporate sponsored research: AstraZeneca. T. Goswmi, A. Jarkowski, J.M. Armstrong: Employee & Shareholder of AstraZeneca. K. Asubonteng: Employee & Shareholder of AstraZeneca. Corporate sponsored research: AstraZeneca. G. Melillo: Employee & Shareholder of AstraZeneca. R. Mesía: Speakers’ Bureau: Merck, SL and Consultant: Merck, SL, MSD, Bayer, AstraZeneca, Bristol. All other authors have declared no conflicts of interest.