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Immunotherapy: Big Pharma’s Seductive Embrace

 
• By Mark Ratner, Olivier Lesueur, and Rachel Laing

The oncology community believes that immunotherapy will be foundational, in the same way that combination chemotherapy became the backbone of treatment in the 1970s. The marching order is to trial broadly, quickly, making clinical development particularly well-suited for Big Pharma.

The emergence of Merck & Co. Inc.’s Keytruda (pembrolizumab), granted an accelerated FDA approval in September 2014 based on data from more than 400 patients in an initial Phase I study started in early 2011, makes a compelling argument for Big Pharmas with the resources to rapidly develop fast followers to enter the race to commercialize cancer immunotherapies. Companies are doing just that, in many cases setting up combination trials early in clinical development, either with additional immunotherapies or with targeted agents.

Merck followed in the footsteps of Bristol-Myers Squibb Co., whose Yervoy (ipilimumab), approved in 2011, validated decades of effort in immuno-oncology. BMS’ second entry into the field, Opdivo (nivolumab),...

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• By David Wild

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• By Ashley Yeo

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UK Bets On Regulatory Innovation As Competitive Advantage In Synthetic Biology

 
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