ESMO Asia 2016: Asian Patients With Head and Neck Squamous Cell Carcinoma Live Longer With Immunotherapy Than Overall Population
Asian patients with head and neck cancer live longer with pembrolizumab (Keytruda) immunotherapy than the overall population, according to a subanalysis of the KEYNOTE-012 trial presented at the ESMO Asia 2016 Congress in Singapore.
“Head and neck squamous cell carcinoma is the seventh most common cancer worldwide,” said lead author Makoto Tahara, MD, PhD, Chief of the Department of Head and Neck Medical Oncology, National Cancer Centre Hospital East, Chiba, Japan. “The overall incidence of [head and neck squamous cell carcinoma] in the Asia Pacific region is approximately 300,000 new cases per year, which is more than half of the total cases worldwide.”
Recurrent/metastatic head and neck squamous cell carcinoma is commonly treated in the first line with cetuximab (Erbitux), platinum, and fluorouracil, known as the EXTREME regimen, which has demonstrated a median overall survival of 10 months. Patients with disease progression on first-line therapy or with platinum-refractory disease have a median overall survival of less than 6 months.
The initial KEYNOTE-012 trial in 60 patients showed the clinical activity of pembrolizumab administered at 10 mg/kg every 2 weeks. A fixed dose of 200 mg every 3 weeks was then evaluated in 132 patients. “A fixed dose has several advantages, including safety, convenience, reduction of waste, and adherence,” said Dr. Tahara.
Subanalysis Results
At ESMO Asia, researchers reported the results of a subanalysis of the safety and efficacy of pembrolizumab in the 26 Asia Pacific patients who received the fixed dose for 24 months until disease progression or adverse events. Median overall survival was better in Asians than the overall population (11.5 vs 8.4 months). Disease control rate was better in Asians (50.5% vs 37.9% overall). The tumor shrank in a smaller proportion of Asians (50%) than the overall group (61%).
There was no significant difference in overall response rate between the two populations (19.2% in Asians vs 18.2% overall). Responses lasted for more than 12 months in 80% of Asian patients, which was similar to the overall population (86%). Median durations of response were not reached in both populations. The safety profile and incidence of treatment-related adverse events were generally similar between the two groups. There were no treatment-related deaths.
Dr. Tahara said, “The fixed dose of pembrolizumab was well-tolerated in Asia Pacific patients with recurrent/metastatic head and neck cancer. Although the Asian population was small, our findings suggest that they have better median overall survival with pembrolizumab than a mixed population. The clinical benefit of the fixed dose of pembrolizumab in the first- and second-line treatment of recurrent/metastatic head and neck cancer is being evaluated head-to-head with standard-of-care chemotherapy in phase III trials around the world, including Asia Pacific.”
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