Implementation of biomarker testing is key to the success of precision medicine. The success of therapies based on immuno-oncology, with over six indications in recent years (predominantly lung cancer), has highlighted the need for PD-L1 biomarker testing and the challenges it raises for implementation. In our February 2017 webinar we discuss the adoption of PD-L1 testing in Europe using Germany and Italy as examples, to understand how different environments can generate different adoption rates, and look at how the process could be optimized.
The PD-L1 testing market is dynamic with 3 new entities, 6 indications, 14+ approvals and 3+ tests all in 3 years, so it’s clear that PD-L1 is going to play a major role in the biomarker and diagnostic landscape. The Diaceutics PM Readiness Report 2016 found that around 40 per cent of all NSCLC trials, regardless of the phase (I-IV), require determination of PD-L1 status:
As with all test adoption there are barriers on the route to diagnostic enablement and these can cause problems such as patient leakage, loss of post-market data integrity, erosion of coverage and, ultimately, reduced profit. But as we have demonstrated before, the barriers can vary in different markets.
For instance, Europe can be viewed as one market but individual European countries may encounter different diagnostic enablement barriers. The webinar looks closely at Germany and Italy to highlight this predicament. One example concerns the restricted availability of antibodies:
The webinar goes on to discuss how a combination of barriers can reduce therapeutic opportunity and dramatically reveals how much one of these countries has lost in both revenue and treatment opportunities.