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A stumble, but not a fall – what’s next for Opdivo?

Blue Latitude Health's Louis Perdios talks about the daunting challenges faced by BMS after Opdivo's disappointing results.
Bristol-Myers Squibb's (BMS, $BMY) immunotherapy wonder drug Opdivo (nivolumab) was poised for lasting success. The immuno-oncology treatment won an accelerated FDA approval for metastatic melanoma in December 2014, and has since proved to be a thriving sensation. Until things took a turn for the worse. 


Opdivo’s promising start

Opdivo works via PD-1 immune checkpoint inhibition, which involves reactivating T-cells (a subtype of white blood cell) and decreasing tumor growth. In this manner, it can crucially target several cancers, a property that was successfully exploited by BMS and resulted in securing FDA nods for treating non-small cell lung cancer (NSCLC) and renal cell carcinoma (kidney cancer). Impressively, Opdivo consistently outperformed Merck & Co.'s ($MRK) Keytruda (pembrolizumab), racking up $1.58 billion in sales during the first half of 2016 compared to $563 million earned by its main rival. Observers of its soaring trajectory projected Opdivo to be second in order of top selling pharmaceutical products in Europe in 2022, with €2.4 billion in sales.

A series of unfortunate events

Their success story wasn’t to remain untarnished forever. Some chinks in the Opdivo armor were evident back in June 2016, but were largely overlooked. Back then, the UK’s cost-effectiveness watchdog NICE deemed Opdivo too pricey for renal cell carcinoma when taking into account the availability of Pfizer's Inlyta at a markedly lower price. Then, in August 2016, BMS announced disappointing results from a Phase III clinical trial – Opdivo had failed to significantly improve progression-free survival (PFS) when used as a first-line treatment for NSCLC. Their share price plunged by 17%, while competitor Merck & Co.'s surged by more than 10%. Rubbing salt into BMS’s wounds, Merck's Keytruda snagged a new FDA approval in head-and-neck cancer.As tremors of uncertainty reverberated in the global markets, analysts dramatically slashed Opdivo’s profit forecasts and doctors and drug executives unfavorably recalibrated their expectations for Opdivo. ...


Read the full article on the Blue Latitude Health website

25th August 2016

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Blue Latitude Health

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