Please note that I am affiliated with Avisol Capital Partners and their Total Pharma Tracker service. They have also covered the companies in this article in their writings, and I wanted to make readers aware of the potential for overlapping coverage.
It almost goes without saying that the immune checkpoint inhibitors targeting the PD-1 axis have made their impact almost exclusively in the realm of solid tumors. Advancement of antibodies like nivolumab and pembrolizumab has been much slower in the hematologic malignancies, limited mainly to Hodgkin lymphoma, at least at this time.
On the other hand, Seattle Genetics (SGEN) has made its entire case in the heme cancers, with its CD30-directed antibody-drug conjugate brentuximab vedotin becoming a staple in Hodgkin lymphoma across most treatment lines. For a while, the discussion about Hodgkin disease centered around whether Bristol-Myers Squibb's (BMY) nivolumab would be able to supplant brentuximab vedotin in certain treatment lines.
But the enterprising researchers chose to focus on combining the two drugs, as well. Nivolumab plus brentuximab vedotin has been shown to be highly active in classical Hodgkin lymphoma. Unsurprisingly, this is not the end of the collaborative efforts between the two companies.
BMY and SGEN presented new data for their nivolumab-brentuximab combo at the 2018 American Society for Hematology (ASH) Meeting. The disease of interest here is primary mediastinal B-cell lymphoma, which used to be considered as part of a subgroup of the non-Hodgkin lymphoma called diffuse large B-cell lymphoma (DLBCL). These forms of lymphoma are known to be aggressive, and the prognosis for patients is poor once they exhaust their relatively meager treatment options.
The companies gave a presentation of phase 2 data highlighting 30 patients treated with the combination for relapsed, CD30-positive primary mediastinal B-cell lymphoma. In all, 21 of the 30 had an objective response (70% rate), with a 27% complete response rate. A median duration of response has not been reached at this time.
The toxicity profile of the combination wasn't particularly surprising, with a risk of neutropenia (reduction of a certain type of white blood cell called a neutrophil) and peripheral neuropathy being the most frequent complications.
This study provides a very encouraging early look at the use of this combo in a very specific subset of non-Hodgkin lymphoma patients. At this time, the best patients can hope for is to switch to a different multi-agent chemoimmunotherapy regimen, such as R-ICE. But this only has the chance to work in patients who had a response to first-line chemotherapy.
Moreover, you have to remember that patients will experience a heavy toxicity burden from these multiagent regimens. So a well-tolerated salvage therapy option that has efficacy could represent an important innovation for patients with this lymphoma subset.
Of course, we shouldn't get too far ahead of ourselves, either, as this is still early-stage data, no matter how encouraging it is. It needs to be confirmed in a larger patient population before the nivolumab-brentuximab combination could be considered a worthy addition to the treatment arsenal. It's clear that the combo is active here, and it is definitely an area of need, but it's not going to supplant the current standard of care just yet.
Key investment takeaways
Of the two companies involved here, SGEN is definitely the party that has more to gain from changing the game in primary mediastinal B-cell lymphoma. Its main path forward for several years has been widening the role of brentuximab vedotin in the management of lymphoma. To date, it's been very successful at just that, but it has struggled to garner approvals for other projects in its pipeline.
A new approval outside of the realm of classical Hodgkin lymphoma helps its multifront attack.
As for BMY, every little bit helps for nivolumab, which has struggled and fallen behind in 2018 as Merck (MRK) grew the pembrolizumab annual sales past nivolumab's for the first time. However, this form of lymphoma won't, on its own, yield a turnaround.
In conclusion, the news is positive for both BMY and SGEN, but I feel that the positive impact will be felt more acutely for SGEN, assuming the companies can move quickly to confirm these results and get it approved for this disease subset. As such, I re-affirm my conviction that SGEN is a company you should check out, especially as it pulls out of the skid that it's found itself in in the latter half of 2018.
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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.