Insight wanted to get the lay of the I/O landscape, so who better to speak with than Jeff Bockman, Vice President of Defined Health. Not only was Jeff kind enough to share his insights with us, but he also had an extensive slide deck on “Immuno-Oncology Partnering: Tipping Point or Tip of the Iceberg?” Below we feature some of his slides along with some of his top line comments.
There has been a full-fledged stampede by the BioPharma industry into immuno-oncology. The promise of higher ORR and durable remissions among selected cancers and subsets of patients has resulted in an increasingly crowded market with significant FDA events.
The advances in melanoma with checkpoint inhibitors like nivolumab and pembrolizumab, plus ipilimumab, have been dramatic, creating the second major paradigm change after the approval of the BRAF and MEK inhibitors, with their high ORRs but poor durability, but with a meaningful proportion of patients having sustained remissions.
Advances with precision medicine around PD-L1 expression are enabling better patient selection and management, especially in NSCLC where Keytruda has shown clinically meaningful improvement compared to chemotherapy in PD-l1 overexpressors.
The rush into checkpoint inhibitors (PD-1/L1), for example, has generated increasing benchmarks of competition. Most biotechs want to use melanoma, for example, for POC, but the challenge is in showing Proof of Relevance, POR. The intense competition may result in an uncertain regulatory landscape. To what degree a drug label will protect each PD-1 therapy is a major question mark.
Oncology has always been a combination market, and so too is the burgeoning I/O space. Most combinations rely on the backbone of a checkpoint inhibitor, either anti-PD-1 or anti-PD-L1. Next gen agents include other checkpoints, costimulatory agonist, innate immunity targets, and additional cell types in the immune system-tumor microenvironment interplay, such as MDSCs, TAMs, etc.
The pace of clinical advancement and regulatory approvals is quite amazing.
An examination of 2015 I/O deals clearly shows the land grab mentality in this market. Not only is the market vibrant with many early stage deals, the deals are also priced to perfection. The justification is the view that checkpoint inhibitors are like classic oncology backbone therapies, i.e., Taxol, but will this indeed turn out to be the case?
The departure from the past as represented by recent I/O deal flow is the expectation of combinations of high-priced agents that companies are hoping will result in a new dimension of price/value.
While the I/O market is working towards the peak of the interest/hope/hype curve, it is worth keeping in mind that the majority of oncology deals are non-I/O and that I/O is still in its infancy and “learning on the job” and empiric therapy is, by and large, the name of the game at present.
Jeff Bockman will lead a panel at BIO-Europe Spring® 2017 called “The immuno-oncology universe” Meet with Bockman and the Defined Health team at BIO-Europe Spring 2017 springtime partnering conference taking place in Barcelona, Spain March 20–22, 2017. Find out more.
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Editor-in-Chief, InsightFollow on Twitter More Content by Erin Righetti