CheckMate 141 highlights potential of nivolumab for recurrent or metastatic head and neck cancer

Roshini Claire Anthony
27 Dec 2016
CheckMate 141: Nivolumab a potential therapy for recurrent or metastatic HNSCC

Nivolumab has emerged as a potential therapy for patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) previously treated with platinum-based therapy, based on results of a subgroup analysis of Asian patients in the CheckMate 141* trial.

In the global cohort, nivolumab more than doubled the 1-year overall survival (OS) rate compared with the investigator’s choice of drug (36.0 percent vs 16.6 percent, hazard ratio [HR], 0.70, 97.73 percent confidence interval [CI], 0.51–0.96; p=0.0101). Nivolumab also improved OS in the Asian subgroup (HR, 0.50, 95 percent CI, 0.17–1.48). [ESMO Asia 2016, abstract 360O_PR]

Six-month progression-free survival was also superior in patients on nivolumab compared with investigator’s choice in both the global cohort (19.7 percent vs 9.9 percent; HR, 0.89, 95 percent CI, 0.70–1.1; p=0.3236) and Asian subgroup (HR, 0.57, 95 percent CI, 0.25–1.33).

“Nivolumab is the first agent to demonstrate a significant improvement in survival in patients with [HNSCC] who progress after platinum-based therapy in a global, phase III, comparative trial,” said Dr Yasuhisa Hasegawa from the Aichi Cancer Center Hospital, Nagoya, Japan who presented the findings at the European Society for Medical Oncology (ESMO) Asia 2016, held in Singapore.

“The survival benefit favouring nivolumab was also observed in the Asian subgroup, despite a smaller number of patients in this study population,” he said.

Among nivolumab-treated patients, treatment-related adverse events of any grade occurred in 58.9 and 69.6 percent of the global and Asian populations, respectively, while grade 3–4 adverse events were more common in the global cohort compared with the Asian subgroup (13.1 percent vs 8.7 percent). However, skin toxicities of any grade appeared to be more common in Asians (43.5 percent vs 15.7 percent), though none were grade 3–4.

In CheckMate 141, individuals (aged ≥18 years; n=361) with recurrent or metastatic HNSCC and ECOG performance status ≤1 who had progressed on or within 6 months of the last dose of platinum-based therapy were randomized 2:1 to receive either intravenous nivolumab (3 mg/kg Q2W) or investigator’s choice of therapy (intravenous dose of either methotrexate [40 mg/m2 weekly], docetaxel [30 mg/m2 weekly], or cetuximab [400 mg/m2 once followed by 250 mg/m2 weekly]). Treatment was continued until disease progression or toxicity.

Thirty-four patients (9.4 percent) from the global cohort were from Asia (predominantly Japan, n=27), 23 and 11 in the nivolumab and investigator’s choice groups, respectively. Seven patients are still on treatment (all nivolumab). Sixteen patients (69.6 percent) in the nivolumab group discontinued treatment compared with 11 patients (100 percent) on investigator’s choice of drug, mainly due to disease progression (56.5 percent vs 81.8 percent in the nivolumab and investigator’s choice groups, respectively), while one patient in each arm withdrew due to study drug toxicity.

According to Hasegawa, prognosis for platinum-refractory recurrent or metastatic HNSCC is poor with a median OS of six months or less, and new treatments are required to improve survival in this patient population.

“Nivolumab is a new standard-of-care option for patients with [recurrent or metastatic HNSCC] after platinum-based therapy, based on results from a large global phase III study, with similar findings in an Asian subgroup,” he said.


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