Bristol-Myers Squibb (NYSE:BMY) is a leader in the space of immune checkpoint inhibitors, despite competition from other pharma giants like Genentech, Pfizer, and AstraZeneca. It has cemented the position of its lead compound nivolumab (Opdivo) through approvals in lung cancer, melanoma, kidney cancer, and Hodgkin's lymphoma.
Now BMY is looking to add yet another gem to its crown.
Immune Checkpoint Inhibitors in Bladder Cancer
Currently, the management of bladder cancer that has progressed beyond where a surgeon can simply excise the tumor is a pretty bad road. Some patients can benefit from local chemotherapy, but once the disease has metastasized, options are very limited.
However, bladder cancer is known to be highly immunogenic. That is, it is an organ that is subject to a lot of tissue damage (since it comes in contact with almost all chemicals leaving the body, including carcinogens from activities like smoking), and the resulting mutations can be recognized by the immune system.
Genentech took the early roll on bladder cancer with atezolizumab, and they were rewarded with approval back in May 2016. This agent was approved for patients with advanced or metastatic disease that has progressed on prior platinum-based chemotherapy.
On Monday, BMY was granted breakthrough designation for nivolumab in previously treated metastatic bladder cancer. This may sound like a retread now, since atezolizumab operates under very similar principles, but I think it's worth noting two key differences:
1) Atezolizumab targets the ligand of PD-1, PD-L1. Nivolumab directly antagonizes the PD-1 receptor itself. At this time, it is unknown whether there is a more beneficial target in these tumors. Therefore, approval of a PD-1 inhibitor should create some inroads, especially since...
2) BMY has the market dominance in a number of tumors, even in the case of lung cancer where pembrolizumab was approved first. Of course, its ability to capture the market is due in part to the requirement of PD-L1-positive tumors for pembrolizumab prescription. Still, it shows that BMY is able to carve out a market for its drugs.
When you consider that nivolumab was already approved for renal cell cancer (a genitourinary tumor), there will be some clinicians already familiar with its use. This may also swing the market in favor of nivolumab, allowing both drugs to share this space.
At this time, because it has so few options, it is difficult to estimate the market size for bladder cancer. Of the 60,000 new cases of urothelial tumors per year, something like 50% to 60% will eventually relapse after initial treatment. This means the number of patients who could potentially benefit each year numbers in the tens of thousands. Considering the pricing for nivolumab in other disease areas (65,000 - 130,000 depending on the payor), the market size for bladder cancer could reach over a half a billion dollars per year, conservatively.
So the stakes are high. I think BMY is well positioned to capitalize if they can translate this breakthrough designation into an approval and marketing.
Disclosure: I/we have no positions in any stocks mentioned, and no plans to initiate any positions within the next 72 hours.
I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.