New survival data for nivolumab in head and neck cancer

Phase III data for nivolumab in head and neck cancer show biggest increase in survival for 20 years.

In patients with recurrent or metastatic platinum-refractory squamous cell carcinoma of the head and neck, more than double the number of patients treated with nivolumab were still alive at one year vs. the comparator arm (36%, [95% CI: 28.5-43.4] vs. 16.6%, [95% CI: 8.6-26.8]). The study also demonstrated a 30% reduction in the risk of death in favour of nivolumab (median overall survival (OS) 7.5 months (95% CI: 5.5-9.1) for nivolumab vs. 5.1 months (95% CI: 4.0-6.0) for the comparator arm (HR=0.70 [95% CI: 0.51, 0.96] p=0.0101). Four centres in the UK took part in this study and the results were presented in a late-breaking presentation at The American Association for Cancer Research (AACR) Annual Meeting 2016 in New Orleans. Head and neck cancer is the seventh most common cancer in the UK and almost a third of newly diagnosed patients died from the disease in 2012. With incidence rates having risen by over 30% in the last 15 years in Europe, this group of cancers represents a growing health burden.

“We don’t have effective treatments for advanced head and neck cancers — these cancers are notoriously difficult to treat. So it’s exciting that this Phase III trial has been the first to show a significant survival benefit with an immunotherapy,” said UK principal investigator Professor Kevin Harrington, Professor of Biological Cancer Therapies at The Institute of Cancer Research, London, and consultant oncologist at The Royal Marsden NHS Foundation Trust. “Nivolumab was not only more effective than chemotherapy for patients with head and neck cancer but also had fewer side-effects, and has the potential to significantly extend life and increase quality of life.”

Due to the survival benefit observed with nivolumab, the Checkmate-141 trial was stopped early based on a recommendation from an independent monitoring committee. All remaining patients on the comparator chemotherapy arms in the trial were then given the option of receiving treatment with nivolumab. Nivolumab is the first in a new class of medicines, called PD-1 immune checkpoint inhibitors. This type of approach has an innovative mode of action that works by harnessing the ability of the immune system to fight head and neck cancer. This means it works quite differently and offers a different side effect profile that is considered manageable compared with some traditional chemotherapies.

In the CheckMate -141 study, the safety profile of nivolumab was consistent with prior studies and no new safety signals were identified. Grade ≥3 treatment-related adverse events (side effects) were seen in 13.1% of patients receiving nivolumab vs. 35.1% of patients on standard chemotherapies. The most frequently reported treatment related adverse events of any grade occurred in 58.9% of patients on nivolumab vs. 77.5% of patients on the investigators choice of standard chemotherapy; two treatment-related deaths were reported as related to nivolumab (pneumonitis and hypercalcemia), and one Grade 5 event of lung infection on the investigator’s choice arm.

Jean Viallet, Global Clinical Research Lead, Oncology, BMS, commented: “We are excited to share, for the first time, data from the CheckMate -141 trial with the oncology community at the 2016 AACR Annual Meeting. We are encouraged by the overall survival results seen with this investigational use of nivolumab versus three standards of care for patients with recurrent or metastatic squamous cell carcinoma of the head and neck, who often face poor survival rates. These findings are supportive of our Immuno-Oncology research goal to study potential treatment options for their ability to help patients with difficult-to-treat cancers achieve long-term survival.”