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
|
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
rn| Nivolumab | Investigator’s Choice | Hazard Ratio (95% CI) | rn|
|---|---|---|---|
| Overall Survival, median (95% CI), months | rn|||
| Global | rn7.5 (5.5–9.1) | rn5.1 (4.0–6.1) | rn0.70 (0.51–0.96)a P = 0.0101 | rn
| Asian countries | rn9.5 (9.1–NR) | rn6.2 (2.6–NR) | rn0.50 (0.17–1.48) | rn
| Progression-Free Survival, median (95% CI), months | rn|||
| Global | rn2.0 (1.9–2.1) | rn2.3 (1.9–3.1) | rn0.89 (0.70–1.1) P = 0.3236 | rn
| Asian countries | rn1.9 (1.6–7.5) | rn1.8 (0.4–6.1) | rn0.57 (0.25–1.33) | rn
a97.73% CI. NR, not reached.
rnClinical 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.