With another FDA approval for Merck’s Keytruda, this time for gastric cancer, we see the onward march of PD-L1 therapy development. This time the therapy has been approved alongside the Agilent Technology companion diagnostic 22C3 pharmDx kit to test for PD-L1 IHC.
When a therapy is approved for a new indication, pharma companies can benefit from an in-depth landscape analysis of a particular companion diagnostic market in order to understand the testing options for an advanced disease, the sample availability, the sample journey and where their drug plays a role.
Let’s look at the EU market, for example. A company may already be aware of the diagnostic landscape for its initial therapy indication there, and which laboratories can run with the companion diagnostic testing. However, when a new indication is approved it is likely that landscape will change, because that analysis may not necessarily translate to another biomarker or test. So, it is important for pharma companies to have regular, up-to-date information regarding testing options.
Another reason for assessing the companion diagnostic landscape regarding any new biomarker or indication relates to the national or regional regulations around therapies or testing. In Italy, for example, for some types of cancer the biomarker should be included in the guidelines, so pharma companies need to be aware of pathology society guidelines. It is here where a landscape analysis can be of great value. It can also help when considering the test platform needed. The PD-L1 22C3 pharmDx kit needs the Dako platform but in some countries validation studies are trying to assess its reliability on another platform, which could be less costly and more widely available in the EU. This does, however, require an extra effort by labs that have to run an internal or national validation study. This can have a negative impact on the time taken to adopt a new test. Even so, could this alternative approach offer a greater coverage of diagnostic testing for pharma?
It is important for laboratories to have solid evidence for a biomarker’s utility when introducing it into routine practice, and now there are a number of studies showing the PD-L1 22C3 pharmDx kit to be clinically reliable with good results. Since the scientific community is convinced of the utility of PD-L1 in lung cancer, the main barriers to test adoption for other indications are easier to remove. So the ideal scenario is to have an operational lab network ready to start testing at the earliest opportunity.
In the fast-paced marketplace of precision medicine, having an efficient lab network in place to test for any new biomarker or disease indication could provide a competitive edge. Diaceutics can provide this deeper understanding of the companion diagnostic testing landscape for pharma as we have invested in a global laboratory network, can access updated lab data and have regional teams on the ground with expertise to provide insights relating to a particular country’s testing capabilities. We can also advise on country-specific guidelines as we have strong links with key advisors and many national pathology societies.
You might know your diagnostic landscape for one indication but will you be able to see it in sharp focus when the next one comes along?