Genomic Testing for Trial Participation and Access

Leonard Lichtenfeld, MD: The question about doing routine genetic testing in patients on tumor samples is an interesting one, and it’s one of those questions that’s going to come to the forefront—it’s coming into the forefront right now. Not only do we have advances in looking at the genome of tumors and looking at what we call the germlinethe native DNAof patients, but we also have self-free DNA and we’re trying to figure out where that fits into this whole picture. If it’s a predicted test, does it help us understand that the cancer’s recurring? There has been some research reported recently in that regard.

In order to try a drug on a patient today, genomic data are going to be critical for targeted therapy. It’s an interesting point, because if you go back in the relatively recent history of targeted therapies, there was a watershed moment, in my opinion, that happened with 1 of the drugs that was useful to treat lung cancer. It turned out that there were 2 drugs in the market—they were both targeted therapies—and they were both effective, but 1 drug seemed more effective than the other. So, the second drug got put aside.

But, to get the 10% of patients who responded, you had to treat 100%. Well, an interesting question was, if a genetic test came along that predicted response, what would the pharmaceutical companies do? That was the beginning of the biomarker requirement—it wasn’t the beginning, but in my view of the world, it was one of the first examples. I actually wrote an opinion piece at the time saying, “How are they going to move?” because it was their economic interest to treat 100 patients, not to treat the 10 patients.

Eventually, the mutation was discovered. The companies did treat only those patients who had the mutation, and we were off on a whole new path to the point today where a biomarker is almost a requirement before the medication goes into clinical trial—particularly for the targeted therapies. Immunotherapies are still under discussion in most diseases. So, to the company, it doesn’t make sense to have a biomarker, but that’s what they’ve done—not every company, but most. I think having that information is critical to having successful trials and successful treatments.

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