Combo conundrums
What new approaches are needed to speed trials of cancer drug combinations
The development of combinations of investigational agents for cancer gained steam in 2009 with a deal between Merck & Co. Inc. and AstraZeneca plc. At least six more companies have joined forces since and many combination studies are underway; but there is still work to be done to speed development, including earlier vetting of candidate combinations, greater access to early-stage compounds and increased use of adaptive trials.
The pace has quickened in the face of the known hurdles to combining two novel agents: companies are hesitant to do so until they can properly assess the efficacy and toxicity of each agent separately. Partnerships with institutions can be delayed by institutional review boards. And FDA has not entirely resolved uncertainty about the regulatory requirements for such combinations...