Bristol-Myers Squibb (NYSE:BMY) is the current leader in the marketing of immune checkpoint inhibitors, with its properties like ipilimumab, tremelimumab, and nivolumab. Recent approvals for nivolumab in areas like lung cancer and renal cancer have led to rapid changes in the standard of care for these tumor types.
Back in May, BMY received accelerated approval for nivolumab in a new area: Hodgkin lymphoma. This approval was based on the results of CheckMate 205 and another single-arm study in patients with relapsed/refractory disease.
Updated results from EHA 2016
BMY has provided an updated picture of the benefit of nivolumab at the European Hematology Association's annual meeting.
The investigators divulged that, at approximately 9 months of follow-up, the overall response rate was 72.5%, and the 6-month PFS rate was 76.9%. Of 43 patients who had no response to Adcetris, 72% had response to nivolumab.
Overall, these findings signal a strong likelihood of success for nivolumab in Hodgkin lymphoma, and the inevitable confirmatory trial would appear to stand a good chance of netting full approval for this drug. Of course, nothing is guaranteed there, but with high response rates and durable remissions, it appears that nivolumab is providing substantial benefit to patients in this difficult-to-treat disease subset.
Revenue impact of nivolumab in Hodgkin lymphoma
The sales that BMY can expect to accumulate from this approval are not quite as high as can be expected from bigger, more deadly tumor areas like lung cancer. Currently, SGEN's Adcetris commands about $200 million in revenue annually. Nivolumab is approved for patients who have failed Adcetris therapy.
This could change in the future, as the company has already launched a phase 1/2 trial combining Adcetris and nivolumab in patients who failed frontline therapy. It would seem intuitive also that BMY will conduct a head-to-head study against Adcetris at some point, though there have been no plans to do so to date.
What's more, the success of nivolumab in this setting provides proof of concept that PD-1 inhibition can help patients with hematologic malignancies. Ongoing studies are tackling other blood cancers, such as non-Hodgkin lymphoma.
The approval and continuing success of nivolumab in Hodgkin lymphoma is a boon for patients in this setting, where few options currently exist. But it also signals a higher proof of principle for immune checkpoint inhibitors in general.
What do I mean? Essentially, if the tumor in question has a component (in this case, the Reed-Sternberg cells) that expresses PD-L1, one of the ligands for PD-1, then there is a strong likelihood that the tumor will respond to immune checkpoint inhibition. This has consequences for any diligent investor looking at companies developing these molecules.
Essentially, if you can find pathologic studies in a tumor type suggesting a preponderance of tumors to express PD-L1, then you can be reasonably assured that drugs like nivolumab or pembrolizumab are going to have an impact. So if you look into the tumor areas that have significant therapeutic unmet needs, you can use the current success to speculate on which agents might be approved next. To date, no trial investigating nivolumab has failed due to efficacy. That could change, but it is a very enticing finding.
The track record of immune checkpoint inhibitors has pointed to as close to a slam dunk as we have seen in oncology for a very long time. If it looks like it COULD work, then the evidence suggests it will. Therefore, take these findings from BMY at face value, and also add them to your own due diligence when looking at any company that is touching PD-1/PD-L1 inhibition.
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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.