SNTA's goal in its latest trial was to limit phase III risk by finding those patients who have the highest probability for strong outcomes in phase III...essentially, personalized medicine! This is significant. The trial had some issues, with Eastern European patients from two countries entering in the final six months, which likely skewed the data so it wasn't as robust as the drug had performed in earlier trials. But, the fact is that the idea being finding a homogeneous group of trial patients is the future of biotech trial work.
You will see going forward, an increasing use of genomics data to screen patients to find the proper group of patients to enter into late stage clinical trials based on earlier stage trial work. As screening tests continue to proliferate for all sorts of cancers and demographic, geographic and timing effectiveness (i.e. the SNTA drug is only effective when given after 6 months of first line effort) get factored into trial design, you will see significant increases in drug outcomes vs. placebo. A more targeted trial cohort is a major step forward in finding effective drugs to treat specific patient populations.
Very forward thinking trial work. Worth adding here...
I don't see how you'll get significant increases in drug outcomes with the phase III results when they already separated phase II results into the target sub group. One would expect similar results, which weren't horrible but weren't spectacular either.
Also, narrowing the patient population also diminishes the revenues you can earn from the drug.
I think pre-Eastern European increase in hazard ratio of 35-40% and 13 weeks increased life expectancy is fairly spectacular in a disease like this. And its just the beginning. First line treatment will follow along with 15 other cancers.
Excellent post! So I am trying to decipher that you are looking beyond the Lung cancer trials to other indications (for future success). What exactly is your take on any success with the Lung cancer trials (too late to get this rectified)? Increased patient enrollment may be the right fix to the European outliers patient issue?
Highly specific treatments result in highly specific application for approval. The FDA recognizes this and will approve highly specific therapies as long as the safety profile is established.
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