An Inside Look at Diagnostics
This case study illustrates the evolution of the diagnostic industry across different continents, diagnostic companies' evolving business models, stak...
What does the future hold for PD-L1? Who will advance or move into the space? Peter Keeling of Diaceutics provides his insights on this hot topic.
And so it begins, the rolling regulatory approvals of anti PD-1 therapy, an oncology drug class likely to become the biggest in history. Leading oncologists at the American Society of Clinical Oncology and the European Society for Medical Oncology have been highly impressed with the data reported for both Merck’s drug Keytruda and BMS’s Opdivo. Regardless of which drug they prefer, they are united in one opinion, namely that these drugs will increase patient survival by adding second and first line drug options as monotherapy or in combination with other drugs.
However, look at this from a different angle and the pharmaceutical company strategies used to deploy these new therapies reveal an intriguing set of chess-like moves. Speculation is high among PD-1/PD-L1 watchers as to which opening will take control of the board. Will it be:
The truth is we don’t yet know, but analogues of previous great drug wars in new categories tell us that competitors tend to benefit from patient share in the first few years, with revenues often neck and neck as the marketplace develops and strategic battles are fought, but there will inevitably be one clear winner. There will be one relative strategic advantage which, in the final analysis, will show how one company gained control. It might be a simple but powerful marketing message, as was seen in the case of Zantac versus Tagamet, or maybe the strength of data in first line and combination versus monotherapy and second line indications, as it was with Erbitux versus Vectibix. It could also be the ability to leverage the testing space, as it was in the beginning with Herceptin versus Tykerb.
Why this particular chess game is so intriguing though is that it could become three-dimensional, directly impacting the PD-L1 or, more correctly, the immuno-oncology business model. In academic medical centres most cancer tumors are being actively genetically profiled, in effect an integration of those mutations currently targeted by approved therapies with other ‘likely driver mutations’ being explored in clinical trials. So what has historically been a series of guideline-driven treatment choices is rapidly becoming a personalized treatment cocktail based on real time genetic and molecular data.
Consider, for example, the bold, unequivocal and category-shaping announcements of Foundation Medicine[v] (which we were told was acquired by Roche for research purposes) to enable clinical treatment choices (often off label) based on extensive molecular level evidence. Such genetic profiling is no longer confined to organizations like Foundation Medicine. Instead, the unprecedented uptake of NGS platforms from the likes of Illumina and Life Technologies (our data suggests 65 per cent of leading oncology labs in all the key markets now have access to NGS platforms[vi]) is delivering this ‘Foundation-like’ interpretation capability to oncologists globally.
Diaceutics will be the first to bemoan the lack of infrastructure investment throughout the diagnostic landscape. Our lab data tells us that currently less than 7 per cent of oncology labs globally[vii] offer PD-L1 testing despite the likely imminent demand. In short, integrating testing into treatment pathways in line with rapid regulatory approvals is a messy business requiring investment, preparation and deep domain knowledge. However, as we continue to run competitive scenarios on the PD-L1 and immuno-oncology space here at Diaceutics, we come largely to the same conclusion. The therapy company which recognizes immuno-oncology patient profiling as a central communication channel, engineering smart bridges from often incomplete and disruptive testing strategies to truly personalized patient management will, in our view, step over the competition[viii]. We call this the Knight’s Move and it may be the deciding tactic in the long PD-L1 chess game.
[vi] Source: Labceutics Lab Mapping NGS 2015
[vii] Source: Labceutics Lab Mapping PD-L1 2015
[viii] [php snippet=34 param=”title=The PD-L1 case – Immune checkpoint inhibitors and the lack of robust biomarkers&id=972″]