3 Things In Biotech You Should Learn Today: June 19, 2017

by: Zach Hartman

Regeneron bolsters its grip on rheumatoid arthritis.

But AbbVie might just be a strong contender in rheumatoid arthritis, too.

BeiGene sneaks in with a BTK inhibitor for lymphoma.

Welcome to another edition of "3 Things in Biotech You Should Learn Today," a daily digest dedicated to helping you sort through the noise and identify potentially actionable news that may not have been on your radar.

Today, we're going to focus a bit on rheumatoid arthritis competition, an increasingly crowded therapeutic space, before veering off into some lymphoma stuff.

Let's get started!

Regeneron bolsters its grip on rheumatoid arthritis

Back in May, I covered the approval of Regeneron's (NASDAQ:REGN) and Sanofi's (NYSE:SNY) sarilumab on the same day I touched on Merck's approval of pembrolizumab in MSI-high tumors. For me, nothing was going to top the Merck news!

But REGN continue to strengthen its argument for including sarilumab in the treatment armamentarium. At the European Congress of Rheumatology, REGN and SNY presented patient-reported outcomes from their MONARCH study, the pivotal trial that led to sarilumab approval in this space.

In essence, across a broad range of patient questionnaires, including those relating to disability index and pain, sarilumab produced statistically superior improvement over adalimumab.

Looking forward: When it comes to getting approval, the heavy-hitting results from the pivotal study are going to be the main drivers. However, patient-reported outcomes data will give a sense of how they are responding to therapy. If you're going to analyze how a new drug will be taken up into the market, you must consider patient preference, especially in light of this increasingly connected world we live in. Patients can talk to one another about their experience, and if one drug is performing better than another in the real-world setting, doctors are now more likely to hear from their patients about it. So, while these follow-on data are not meteoric in their impact, they do represent an important move forward!

But AbbVie might just be a strong contender in rheumatoid arthritis, too!

That's not to say that REGN and SNY won't be facing competition in the near future. AbbVie's (NYSE:ABBV) Belgian partner, Ablynx, is currently working on a nanobody that targets the same signaling axis as sarilumab, i.e., the interleukin-6 receptor signaling pathway.

The ABBV/Ablynx entry into this space is called vobarilizumab, and results for this agent were also presented at the European Congress of Rheumatology. In this phase 2b study, the ACR20 (patients achieving at least 20% improvement in American College of Rheumatology criteria) rate ranged from 73% to 81%, and the more stringent ACR70 rate ranged from 16% to 24%.

Therapy was well tolerated with no unexpected safety events.

Looking forward: While we can't make direct comparisons of these results with the MONARCH study (sarilumab), these ACR20 and ACR70 rates do appear to be in the same ballpark as the already approved sarilumab. So, it seems likely that ABBV and Ablynx are on track to get vobarilizumab to the finish line. Of course, time will tell!

BeiGene sneaks in with a BTK inhibitor for lymphoma

The last time we saw BeiGene (NASDAQ:BGNE), it was jumping the gun in China with a PD-1 inhibitor, and it may, in fact, receive the first approval for this class of therapy in that massive market. Thus, it's easy to see BeiGene as a sort of "also-ran" making similar versions of established drugs in a notoriously challenging market for foreign companies to break into.

And this news might not change your mind if you think that! BGB-3111 is a small-molecule inhibitor of Bruton's tyrosine kinase (BTK), which you may recognize as the principle target of ibrutinib, a firmly entrenched agent for several forms of lymphoma in the US and Europe.

At the 14th International Conference on Malignant Lymphoma, BGNE presented findings from a phase 1b/2 study enrolling patients with Waldenstrom's macroglobulinemia, chronic lymphocytic leukemia (CLL), or follicular lymphoma, to receive BGB-3111.

The findings were quite encouraging, with high response rates, including a relatively high proportion of patients achieving complete remission - something that has been notoriously challenging for ibrutinib.

Now, BGEN is initiating several trials, most notably a direct comparator phase 3 study to assess whether BGB-3111 is superior to ibrutinib in patients with Waldenstrom's macrogloobulinemia.

Looking forward: In light of these results, it wouldn't be fair to call BGEN an also-ran in this heme space, as its agent might just end up being superior. Achieving complete remission in patients with CLL and non-Hodgkin lymphoma remains a pretty serious unmet need, even though patients can maintain disease control for a long time with ibrutinib. But failure to eradicate the disease means the patient can never stop taking the drug, which presents toxicity issues as well as cost issues. So, the field is inching ever forward to find more powerful agents.


So, we have some potentially serious competition brewing in the rheumatology space. Ablynx and ABBV are not quite ready for prime time, so sarilumab may be a lone dog for a while before that particular competitor steps up.

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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.