The numbers are staggering in the race to find the perfect combination of drugs to destroy cancer using the human body's own immune system. Last year 469 clinical trials were launched to test combination candidates in immuno-oncology (IO), bringing the total number of trials currently underway to 1,105. By comparison, in 2010 there were only five such trials.
Valuations for viable candidate drugs are astronomical. In July, 2017, Merck & Co. (MSD) announced it will pay up to USD 8.5 billion to co-develop and co-commercialize AstraZeneca’s Lynparza in combinations with their respective checkpoint inhibitors, programmed death 1 [PD-1] and programmed death-ligand 1 (PD-L1) medicines.
"The IO space is huge, there are different targets and different ways to get at those targets. It is growing rapidly with an increasingly rich pipeline and doing things that we have not seen before," said Jeffrey Bockman from Defined Health, who organized a panel discussion on IO at BIO-Europe Spring® 2018.
Is this a frenzy, an irrational exuberance? he asked pharma executives on the panel.
"IO is here to stay, it is not a bubble or a passing fad," said Khatereh Ahmadi, who is the Executive Director for Business Development and Licensing at MSD. "IO is so broad, spanning epigenetics to metabolism to microbiome, so there is yet a lot to explore for a while longer. We have taken a very empirical approach to this with more than 400 combinations and 700 trials."
Debi Watson, VP for Johnson & Johnson's Janssen Business Development Oncology agreed, saying, "We are so early in this space with our knowledge of what IO can bring to patients. We are at the very tip of the iceberg as to where this is going to go. If there is a bubble it concerns certain specific target areas where the upfront deals were incredible. As we move to the combination trials with companies generating data, we are still very much in the heat of that now. We have not even touched the potential in cold tumors or where vaccines can go. So IO is here to stay for a very long time. There is not one answer, not one patient population. There are a lot of variables to finding success and it will take time to figure it out."
Rogier Rooswinkel, Principal at Forbion, said, "There are so many targets, and some of the early targets have made a lot of sense. Some of them have disappointed in the clinical setting, but assuming there will be further scrutiny we can see there is such excitement for the benefit to patients that we can expect to see much more for quite a while."
The same day as the panel discussion, the Copenhagen-based clinical-stage biopharmaceutical company IO Biotech announced it had entered into a collaborative agreement with MSD focused on the clinical evaluation of its lead candidate IO102 with Keytruda (pembrolizumab) in patients with non-small cell lung cancer (NSCLC).
Speaking on the panel, the CEO of IO Biotech Mai-Britt Zocca said, "Being a newco, we think it is great that we have some many years to look forward to because we do not yet really understand the full potential. We have since 2008 been working on known targets PD-L1 and indoleamine-dioxygenase (IDO) with a vaccine, meaning we are generating T cells based on identified antigens and we have tested in the clinic. We saw early on that we need to target not only the tumors but the tumor micro-environment."