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

Head and neck cancer, excluding thyroid

4202 - Long-Term Safety and Clinical Outcomes of Atezolizumab in Head and Neck Cancer: Phase Ia Trial Results

Date

11 Sep 2017

Session

Head and neck cancer, excluding thyroid

Presenters

Rastislav Bahleda

Citation

Annals of Oncology (2017) 28 (suppl_5): v372-v394. 10.1093/annonc/mdx374

Authors

R. Bahleda1, F.S. Braiteh2, A.S. Balmanoukian3, I. Braña4, F..S. Hodi5, L. Garbo6, B. Liu7, L. Molinero8, C. O'Hear9, X. Shen10, M. Fasso10, A.D. Colevas11

Author affiliations

  • 1 Early Drug Development Department, Gustave Roussy, 94805 - Villejuif/FR
  • 2 Medical Oncoloy, Comprehensive Cancer Centers of Nevada, 89169 - Las Vegas/US
  • 3 Research, The Angeles Clinic and Research Institute, 90025 - Los Angeles/US
  • 4 Medical Oncology, Vall d’Hebron Institute of Oncology, Barcelona/ES
  • 5 Medical Oncology, Dana–Farber Cancer Institute, Boston/US
  • 6 Hematology, New York Oncology, Albany/US
  • 7 Biostatistics, Genentech, Inc., 94080 - South San Francisco/US
  • 8 Oncology Biomarker Development, Genentech, Inc., South San Francisco/US
  • 9 Product Development Oncology, Genentech, Inc., South San Francisco/US
  • 10 Product Development Oncology, Genentech, Inc., 94080 - South San Francisco/US
  • 11 Medicine, Stanford University, Stanford/US
More

Resources

Abstract 4202

Background

Checkpoint inhibitors have shown efficacy in pts with recurrent and/or metastatic head and neck cancer (HNC). Atezolizumab (atezo; anti–PD-L1) inhibits binding of PD-L1 to PD-1 and B7.1, thereby restoring tumor-specific T-cell immunity. Here, we examine single-agent safety and clinical activity of atezo in pts with advanced HNC.

Methods

Pts with HNC received atezo IV q3w (15 or 20 mg/kg or 1200 mg) in a Ph Ia study (NCT01375842). Pts were initially enrolled non-selectively (n = 10); once PD-L1 was identified as a potential biomarker, pts were selected by PD-L1 status (> 5% PD-L1 expression on IC [IC2/3]; centrally evaluated by VENTANA SP142 IHC assay, n = 22). HPV status was assessed by PCR. Treatment was originally for 16 cycles or up to 1 y; pts were subsequently treated until loss of clinical benefit. Primary endpoint was safety; tumor responses were evaluated by RECIST v1.1.

Results

As of 31 Dec 2016, with follow-up of ≥ 14 mo, 32 pts were safety and efficacy evaluable. 84% were male; 66% had ECOG PS of 1. Median age was 62 y (range, 32-78 y), pts were heavily pre-treated (53% had ≥ 2 prior lines of therapy) and 66% were current/previous tobacco users. Most common primary tumor sites were oropharynx (50%), oral cavity (22%) and nasopharynx (19%). Median treatment duration was 3.4 mo; 21/32 pts (66%) had a treatment-related AE. 3 pts (9%) had Gr 3 treatment-related AEs (tumor lysis syndrome, hyponatremia, pruritus, colitis). 1 pt (3%) had Gr 4 treatment-related cardiac tamponade. No Gr 5 treatment-related AEs were seen. In all pts (IC0/1, n = 7; IC2/3, n = 25), confirmed ORR was 22%, mPFS was 2.6 mo (range, 0.5-48.4 mo) and mOS was 6.0 mo (range, 0.5-51.6+ mo). Clinical activity by PD-L1 subgroups is shown in the Table. Preliminary analyses indicate that there was no association between HPV status and clinical outcomes.

Conclusions

In advanced HNC, atezo was well tolerated. Encouraging response and long-term survival were seen independently of PD-L1 IHC or HPV status and warrant further investigation.Table:

1044O Clinical Activity per RECIST v1.1 in PD-L1 Subgroups

IC0/1aIC2/3a
(n = 7)(n = 25)
ORR, n (%)1 (14%)6 (24%)
CR00
PR1 (14%)6 (24%)
DCR, n (%)3 (43%)7 (28%)
mDOR, mo (range)b7.426.2 (2.8-45.8)
mPFS, mo (range)5.7 (0.5-13.5)2.6 (0.5-48.4)
mOS, mo (range)9.0 (0.5-26.5)5.6 (1.1-51.6+)
1-year OS rate43%34%
2-year OS rate29%18%
3-year OS rateNE18%
+

indicates a censored value.

a

Data by PD-L1 expression on TC will be presented.

b

n = 1 for IC0/1, no estimate for mDOR; n = 6 for IC2/3.

IC0 = PD-L1 expression on 

Clinical trial identification

NCT01375842

Legal entity responsible for the study

F. Hoffmann-La Roche Ltd.

Funding

F. Hoffmann-La Roche Ltd.

Disclosure

F.S. Braiteh: Speaking and consulting fees received from Genentech. A.S. Balmanoukian: Speaker\'s bureau for Merck, Bristol-Myers Squib, Genentech, and AstraZeneca. F.S. Hodi: Consultant Merck, Bristol‐Myers Squibb, Genentech, EMD Serono, Amgen; Research support to institution from Bristol‐Myers Squibb. B. Liu, L. Molinero, X. Shen: Genentech employee and stock. C. O\'Hear: Genentech employee and Roche stock. 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.