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.
Bristol-Myers Squibb (BMS) has announced results from the pivotal CheckMate -141 Phase III clinical trial which showed that treatment with nivolumab, which is investigational in head and neck cancer, achieved superior survival rates compared with current standard chemotherapies.
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.”
Related News
-
News BioNTech to begin mRNA vaccine manufacturing in Rwanda by 2025
German biotechnology company BioNTech has stated their intentions to begin production at their mRNA vaccine factory in Rwanda by 2025, which will mark the first foreign mRNA vaccine manufacturing site on the continent of Africa. -
News Identifying Alzheimer’s Disease biomarker proteins with whole blood tests
A University of Manchester spin-out pharmaceutical company, PharmaKure, has reported successful study results for the quantification of Alzheimer’s Disease biomarker proteins with a whole blood test. -
News Bill & Melinda Gates Foundation to boost mRNA vaccine initiatives in Africa with USD $40m
To address vaccine inequality and accessibility issues, the Bill & Melinda Gates Foundation aims to deliver USD $40m to various biotech companies and vaccine manufacturers in support of mRNA vaccine development. -
News CPHI Podcast Series: Exploring neurological frontiers in Alzheimer's and beyond
The next episode of the CPHI Podcast Series delves into the science and background behind some recent developments in the field of Alzheimer's disease and neurological disorders. -
News Is patient centricity the future of pharmaceutical manufacturing?
In this interview with Sandra Sánchez y Oldenhage, President of PharmAdvice, she speaks to the importance of considering patients in the manufacturing stages of the pharmaceutical supply chain, and how it can redefine healthcare. -
News CPHI Podcast Series: How to leverage AI for Drug Discovery
Artificial intelligence is the topic of debate in the latest episode from the CPHI Podcast Series, where Digital Editor Lucy Chard speaks with Bill Whitford of DPS Group about the integration of AI in healthcare. -
News Pfizer forges ahead with blood cancer therapy after approval from FDA
Pfizer gains accelerated approval from the US FDA for their new bispecific antibody therapy for multiple myeloma, set to address an unmet need for patients. -
News Alzheimer's drug donanemab deemed effective in landmark clinical trial
Results from the TRAILBLAZER-ALZ 2 Randomised Clinical Trial into the use of donanemab to treat early symptoms of Alzheimer’s disease have been analysed.
Position your company at the heart of the global Pharma industry with a CPHI Online membership
-
Your products and solutions visible to thousands of visitors within the largest Pharma marketplace
-
Generate high-quality, engaged leads for your business, all year round
-
Promote your business as the industry’s thought-leader by hosting your reports, brochures and videos within your profile
-
Your company’s profile boosted at all participating CPHI events
-
An easy-to-use platform with a detailed dashboard showing your leads and performance