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:
- PD-L1 status is combined with other actionable NSCLC biomarkers in half of all Phase II/III NSCLC trials.
- PD-L1 integration will lead to complex interpretation of trial outcomes.
- All competitors are exploring the value of combining PD-L1 with known NSCLC biomarkers.
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:
- In Germany there are 10 different antibody clones available for testing, but early harmonization, driven by pathologists, made the choice of antibodies easier, with heavy adoption of one antibody.
- In Italy there are 4 different antibody clones available for testing but there is still a lack of consensus as to which should be used, and harmonization studies started later than in Germany.
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.