Bristol-Myers Squibb (NYSE:BMY) has been one of the most important developers of immune checkpoint inhibitors in cancer since its flagship PD-1 inhibitor Opdivo was approved for melanoma, lung cancer, and kidney cancer.
Now the company is adding another jewel to the crown. Opdivo was conditionally approved for the treatment of relapsed/refractory Hodgkin lymphoma on May 17 by the FDA.
This news comes on the heels of very promising trial results, such as a New England Journal of Medicine publication last year. This trial featured patients who had received every possible therapy, including a technique called allogeneic stem cell transplant. The latter is a very risky procedure where your body's bone marrow is wiped out using high-dose chemotherapy before rescuing with another person's stem cells.
Despite this heavy pre-treatment, 87% of patients responded to therapy. For many, it improved their overall outcome. 11 of the 23 patients were still in the trial after the publication of results.
For this, Opdivo was given breakthrough designation by the FDA for relapsed/refractory Hodgkin lymphoma. The accelerated approval is provided under the condition that BMY conducts a randomized phase 3 trial. But if the results are similar between what we've seen in the preliminary studies and the bigger trial, full approval is almost assured.
What this means for patients
Hodgkin lymphoma is already a highly treatable disease using standard chemoimmunotherapy. Many patients can go their whole lives without relapse.
However, once patients do relapse, the picture gets grim. Brentuximab vedotin has been the only recent approval shown to be effective in this setting. If patients develop resistance to that, there is no standard treatment option available to them.
Opdivo now provides a new mode of attack to prolong the benefit to patients. Though it should be noted that the FDA has required a warning:
Transplant-related deaths have occurred, and health care professionals should follow patients closely for early evidence of transplant-related complications, such as hyperacute graft-versus-host disease (GVHD), severe acute GVHD, steroid-requiring febrile syndrome, hepatic veno-occlusive disease, and other immune-mediated adverse reactions. FDA has required the manufacturer to further study the safety of allogeneic HSCT after nivolumab.
At this point, it's largely precautionary to include this warning. The technique of allogeneic stem cell transplant already carries this risk of graft-versus-host disease. BMY will need to watch carefully to make sure that activation of the immune system doesn't increase the risk of hyperacute reactions.
What this means for investors
Undoubtedly, this approval opens up the gates just a little more for the big bully on the immunotherapy block. It also establishes the proof of concept that immune checkpoint inhibitors can work in hematologic cancers. Certainly, Hodgkin lymphoma is special in its tendency to express PD-1, but there was some skepticism about whether non-solid tumors would respond well to this strategy.
Now, we can worry no longer. It may signal further exploration in other tumor types.
In terms of nickels and dimes, consider the case of Takeda's (OTCPK:TKPYY) Adcetris. It commands over $210 million in worldwide revenue for relapsed/refractory Hodgkin lymphoma. This represents another important step for BMY, and while it's not as lucrative as lung cancer and melanoma, Opdivo is definitely going to provide some boost to revenue.
So, though it doesn't represent the biggest market in cancer, this approval provides a hopeful sign for the future of Hodgkin lymphoma and for hematologic cancers in general. It would not surprise me at all to see BMY move toward trying to get approval for Opdivo in first-line management. As it turns out, studies combining Adcetris and Opdivo are already recruiting. This would represent a major shift in the treatment of Hodgkin lymphoma, and it would certainly mean a larger market position for Opdivo in this disease state.
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