BMS Opdivo trial scores early goal

pharmafile | January 14, 2015 | News story | Research and Development, Sales and Marketing BMS, Merck, cancer nsclc, keytruda, nivolumab, opdivo 

A late-stage trial of Bristol-Myers Squibb’s lung cancer drug Opdivo has been stopped early after showing promising results – but Merck is hot on its heels with its own competing treatment.

The Phase III CheckMate -017 study was testing Opdivo (nivolumab) against established medicine docetaxel in patients with advanced non-small cell lung cancer (NSCLC), the most common form of the disease.

It was ended after an assessment conducted by the independent Data Monitoring Committee (DMC) concluded that the study met its endpoint, demonstrating superior overall survival in patients receiving the drug.

Opdivo belongs to a new class of cancer drugs called PD-1 inhibitors, which help the body’s own immune system recognise and kill cancerous cells. It is currently only approved for treating melanoma, but BMS has been chasing approval in the lucrative market of lung cancer, the leading cause of cancer deaths worldwide.

Opdivo is not the only PD-1 drug looking to enter this market however – Merck’s Keytruda (pembrolizumab) is racing to be the first to get the green light for this indication.

Last year Keytruda became the first PD-1 drug on the US market for any indication when it was approved for treating melanoma, beating Opdivo to the post.  Merck has now said that it hopes to speed up its submission for a lung cancer indication and have the application filed by the middle of the year.

Keytruda and Opdivo have also been submitted to the EMA with decisions expected later in 2015, although it remains to be seen which one will be the first PD-1 medicine on the European market.

Both companies also announced yesterday that they would be testing their drugs in combination with several cancer compounds from Lilly in a series of clinical trials, in the hopes of finding novel ways to treat cancer by targeting multiple pathways.

The growing rivalry between BMS and Merck in the PD-1 market – estimated to be worth up to $30 million – has even led to a lawsuit, in which BMS accused Merck of patent violation.

Meanwhile, Merck is also looking to fast track its application for its new hepatitis C treatment grazoprevir/elbasvir, as a new class of drugs for the disease reignite the market following the success of Gilead’s Sovaldi (sofosbuvir).

George Underwood

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