360O_PR - Efficacy and safety of nivolumab for recurrent or metastatic (R/M) squamous cell carcinoma of the head and neck (SCCHN) in Asia: CheckMate 141 subg...

Date 16 December 2016
Event ESMO Asia 2016 Congress
Session Head and neck cancer
Topics Cancer Immunology and Immunotherapy
Head and Neck Cancers
Presenter Yasuhisa Hasegawa
Citation Annals of Oncology (2016) 27 (suppl_9): ix112-ix122. 10.1093/annonc/mdw587
Authors Y. Hasegawa1, N. Kiyota2, S. Takahashi3, T. Yokota4, C. Yen5, S. Iwae6, Y. Shimizu7, R. Hong8, M. Goto9, Y. Namba10, R.L. Ferris11, M. Monga12, M. Lynch13, S. Hagihara14, M. Tahara15
  • 1Head And Neck Surgery, Aichi Cancer Center Hospital, 464-8681 - Nagoya/JP
  • 2Department Of Medical Oncology And Hematology, Kobe University Hospital, 650-0017 - Kobe/JP
  • 3Cancer Chemotherapy Center, Cancer Institute Hospital of JFCR, 135-8550 - Tokyo/JP
  • 4Division Of Gastrointestinal Oncology, Shizuoka Cancer Center, 411-8777 - Shizuoka/JP
  • 5Department Of Internal Medicine, National Cheng Kung University Hospital, 704 - Tainan/TW
  • 6Department Of Head And Neck Surgery, Hyogo Cancer Center, 673-8558 - Akashi/JP
  • 7Department Of Medical Oncology, Hokkaido University Hospital, 060-8648 - Sapporo/JP
  • 8Department Of Oncology, National Taiwan University Hospital, 100 - Taipei/TW
  • 9Cancer Center, Cancer Chemotherapy Center, Osaka Medical College, 569-8686 - Takatsuki/JP
  • 10Clinical Development, ONO Pharmaceutical CO.,LTD., 541-8564 - Osaka/JP
  • 11Department Of Otolaryngology, University of Pittsburgh Medical Center Cancer Center, 15232 - Pittsburgh/US
  • 12Global Clinical Resarch Oncology, Bristol-Myers Squibb, 08543 - Princeton/US
  • 13Oncology Global Clinical Research, Bristol-Myers Squibb, 06492 - Wallingford/US
  • 14Statistical Analysis Data Science, ONO Pharmaceutical CO.,LTD., 541-8564 - Osaka/JP
  • 15Department Of Head And Neck Medical Oncology, National Cancer Center Hospital East, 277-8577 - Kashiwa/JP

Abstract

Background

The median overall survival (OS) for patients (pts) with platinum-refractory R/M SCCHN is ≤ 6 months (mo). Nivolumab (nivo), an anti-PD-1, fully human IgG4 monoclonal antibody, demonstrated OS benefit compared to investigator’s choice (IC) therapy in CheckMate 141 (pts with platinum-refractory R/M SCCHN). Here we present a subgroup analysis of CheckMate 141 in Asian countries.

Methods

The phase 3, open-label CheckMate 141 trial enrolled pts aged ≥18 years with R/M SCCHN and ECOG performance status ≤1. Pts were randomized 2:1 to receive nivo or IC (methotrexate, docetaxel, or cetuximab) until disease progression or toxicity. Primary endpoint was OS; secondary endpoints included progression-free survival (PFS), objective response rate per RECIST 1.1, and quality of life.

Results

Globally, 361 pts were randomized, 34 (9.4%) of whom were in Asia (27 in Japan, 5 in Taiwan, 1 in Korea, 1 in Hong Kong). At the time of analysis, globally there were 133 (55.4%) and 85 (70.2%) deaths in the nivo and IC arms, respectively, and in Asia 7 (30.4%) and 6 (54.5%) deaths, respectively. OS and PFS are reported in the table. In the nivo arm, the incidence of treatment-related adverse events (TRAEs) of any grade was 58.9% globally and 69.6% in Asia; grade 3–4 TRAEs occurred in 13.1% and 8.7% of pts, respectively. No treatment-related deaths were reported in Asia.

Conclusions

The efficacy and safety profiles of nivo in platinum-refractory R/M SCCHN in Asian countries were similar to those in the global population. Nivo is the first immunotherapy to demonstrate a significant improvement in survival for pts with R/M SCCHN who progress after platinum-based therapy and is likely to become a standard of care option for R/M SCCHN in Asia.rn

Table: 360O_PR Overall survival and progression-free survival in CheckMate 141: Globally and in Asian countries

rnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrnrn
NivolumabInvestigator’s ChoiceHazard Ratio (95% CI)
Overall Survival, median (95% CI), months
Global7.5 (5.5–9.1)5.1 (4.0–6.1)0.70 (0.51–0.96)a P = 0.0101
Asian countries9.5 (9.1–NR)6.2 (2.6–NR)0.50 (0.17–1.48)
Progression-Free Survival, median (95% CI), months
Global2.0 (1.9–2.1)2.3 (1.9–3.1)0.89 (0.70–1.1) P = 0.3236
Asian countries1.9 (1.6–7.5)1.8 (0.4–6.1)0.57 (0.25–1.33)
rn

a97.73% CI. NR, not reached.

rn

Clinical trial indentification

NCT02105636;Study start date, May 2014

Legal entity responsible for the study

Ono Pharmaceutical

Funding

Funded by BMS and Ono Pharmaceutical

Disclosure

N. Kiyota: Personal fees from ONO (honorarium and research funding) during the conduct of the study payment for seminar presentation from Bristol-Meyers Squibb, Merck Serono and Bayer. Y. Namba, S. Hagihara: Employee of Ono Pharmaceutical. R.L. Ferris: Grants and other from AstraZeneca, grants and other from Merck, other from Pfizer, grants and other from BMS, outside the submitted work. M. Monga: Employee of BMS. M. Tahara: Personal fees from Bristol-Myers Squibb, Merck Sharp & Dohme, Bayer, Otsuka, grants from, Boehringer Ingelheim, Novartis, NanoCarrier, grants and personal fees from Ono Pharmaceutical, Astra Zeneca, Pfizer, Eisai. All other authors have declared no conflicts of interest.