Opdivo shows biggest survival increase for head and neck cancer in 20 years in Phase III trials

pharmafile | April 19, 2016 | News story | Research and Development, Sales and Marketing Bristol-Myers Squibb, Cancer, blockbuster, head and neck cancer, nivolumab, oncology, opdivo, potential, squamous 

Opdivo (nivolumab) showed the biggest increase in survival for patients with head and neck cancer for 20 years, according to new Phase III clinical trial data presented by Bristol-Myers Squibb (NYSE: BMS) at the American Association for Cancer Research congress.

In the CHECKMATE Phase III clinical trial, In patients with current or metastatic platinum-refractory squamous cell carcinoma of the head and neck, more than double the number of patients treated with Opdivo were still alive at one year vs. the comparator arm (36% vs. 16%). Furthermore, the study also demonstrated a 30% reduction in the risk of death in favour of Opdivo (7.5 months vs. 5.1 months).

Opdivo has been heralded widely for its ability to fight certain forms of cancer. It recently received EU approval to treat patients with advanced lung and advanced kidney cancer. Also, UK patients were granted early access to BMS’s drug under the Early Access to Medicines Scheme.

Head and neck cancer is becoming an increasingly prevalent form of cancer in the UK, with 11,300 new cases diagnosed each year and data showing that almost a third of newly diagnosed patients died from the disease in 2012.

Due to the survival benefits observed with Opdivo, the CHECKMATE-141 trial was stopped early based on the recommendation from an independent monitoring committee. All remaining patients on the comparator chemotherapy arms in the trial were given the option to switch to Opdivo.

Professor Kevin Harrington, UK principal investigator on the trial, says: “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. 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.”

Jean Viallet, global clinical research lead in oncology at Bristol-Myers Squibb, comments: “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.”

Sean Murray

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