Summary
Large Degree of Innovation in NSCLC Pipeline
The NSCLC pipeline currently has 389 products in active development across all stages, but a stark contrast between the mechanisms of action employed in the current market and the pipeline is evident. Where the market comprises primarily ineffective chemotherapies that target tubulin or DNA replication, the pipeline shows an incredibly diverse range of therapies targeting multiple signaling pathways and molecules integral to cancer development. This diversity is partially due to the presence of 122 first-in-class products, which accounts for 38% of the overall pipeline therapies that disclosed their target. In an industry, market and development landscape that favors first-in-class over non-first-in-class development in many ways, such as through faster approval or greater revenue, this finding has strategic implications for a wide array of market participants, both large and small. Despite a high attrition rate in NSCLC, first-in-class therapies that reach the market have the potential to transform and improve the NSCLC treatment landscape.
Alignment of First-in-Class Molecular Target with Disease Causation
The method of characterizing NSCLC tumors is currently shifting from the traditional histology-based characterization to a more specific molecule-based method of characterization. This has resulted in the identification of key oncogenic mutations in NSCLC and has coincided with the rise of targeted pipeline therapies, which are designed to target proteins in signaling pathways that are frequently mutated, amplified or overexpressed in NSCLC. Aligning the molecular target with disease-causing signaling pathways and frequently mutated pathways therapies can benefit from reduced systemic cytotoxic effects while still inhibiting tumor-promoting signaling. Therefore, targeted therapies often display superior safety and efficacy to chemotherapies.
GBI Researchs proprietary analysis showed substantial variation in how well NSCLC first-in-class targets align to frequent gene mutations. Further in-depth analysis identified the most promising first-in-class targets based on various scientific and clinical parameters. Examining scientific and clinical data of promising first-in-class targets showed that first-in-class status is not, in its own right, enough for a successful product; however, the first-in-class products substantiated by scientific and clinical evidence will be exciting future prospects with the potential to transform the NSCLC market.
First-in-Class Products in Licensing and Co-development Deals
The NSCLC deals landscape appears relatively quiet for such a large indication. However, analysis showed that of the therapies with disclosed deal values there is significant range in the value of NSCLC deals. Concerning first-in-class specifically, only five licensing or co-development deals have been made since 2006. Despite the low sample size, it is clear that the first-in-class NSCLC products offer an attractive investment prospect as they command much higher deal values and, on average, deals occur earlier in development compared to non-first-in-class counterparts. Both trends were substantiated by industry-wide data that showed that, particularly in Phase I, first-in-class products would attract larger mean and median total deal values. The data highlight that the first-in-class deals landscape is different and indicates a greater chance of becoming much more lucrative than the deals landscape for addition-to-class or advance-in-class therapies.
A total of 117 first-in-class products that are currently in development have not yet been entered into a licensing or co-development deal. In a transforming market that will favor innovative, targeted therapies with a strong clinical record, there are numerous
