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Opdivo moves closer to head and neck cancer approval

Possible US verdict by November for BMS’ ‘breakthrough’ SCCHN therapy

BMSRegulators in the US and EU have started reviews of Bristol-Myers Squibb's PD-1 inhibitor Opdivo as a treatment for patients with an aggressive form of head and neck cancer.

Immuno-oncology therapy Opdivo (nivolumab) has been filed as a treatment for patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), a form of cancer with a particularly poor prognosis if it progresses after first-line chemotherapy.

In the US Opdivo already has breakthrough as well as a priority review status in this indication, setting up a possible approval in November, while in Europe the EMA has now started a standard, centralised review.

The applications are based on the results of the CheckMate-141 trial, which was stopped early in January after an interim look at the data revealed a 30% overall survival benefit for Opdivo compared to the comparator arm.

In absolute terms, patients taking BMS' drug lived for a median of 7.5 months compared to 5.1 months for those given the investigator's choice methotrexate, docetaxel, or Eli Lilly's Erbitux (cetuximab).

BMS' Jean Viallet - who is global clinical research lead, oncology - claims Opdivo "is the first and only PD-1 inhibitor to show an overall survival benefit in a Phase III trial in these patients".

Opdivo's filings in SCCHN come shortly after rival PD-1 inhibitor Keytruda (pembrolizumab) was submitted for approval in this indication by Merck & Co with an FDA action date of 9 August.

Immuno-oncology drugs like Opdivo and Keytruda are expected to quadruple the value of the head and neck cancer market to $1.53bn by 2024 in seven major pharma markets, according to recent figures from GlobalData.

Their analysis suggests Keytruda will claim the market leader spot in the head and neck cancer space - with $500m in 2024 sales - thanks to an anticipated earlier launch as a first-line therapy for SCCHN.

This will allow Merck's drug "to garner a larger target patient pool compared with Opdivo, which is anticipated to launch only in the second-line setting".

Head and neck cancer is the seventh most common cancer, with estimated 400,000-600,000 new cases and 223,000-300,000 deaths each year. The five-year survival rate is said to be less than 4% for metastatic advanced-stage disease.

Article by
Phil Taylor

19th July 2016

From: Regulatory

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