The medical director manager of neuroscience at Genentech offered her perspective on the mountain of data presented at MS Virtual 2020 on the recently approved NMOSD treatment.
Kathleen Hawker, MD
This is the second of a 2-part interview. For part 1, click here.
At MS Virtual 2020, the 8th Joint ECTRIMS-ACTRIMS meeting, September 11–13, 2020, a number of posters representing datasets from both clinical development programs and independent analyses were presented on 2 major therapies developed by Genentech: the multiple sclerosis (MS) agent ocrelizumab (Ocrevus) and the neuromyelitis optica spectrum disorder (NMOSD) therapy satralizumab (Enspryng).
Satralizumab recently won FDA approval for the treatment of NMOSD, making it just the third option for patients, and the first to offer at-home administration. Its approval was based on robust data from the phase 3 SAkuraStar (NCT02073279) and SAkuraSky (NCT02028884) clinical trials, which combined included more than 170 patients who were randomly assigned to receive satralizumab 120 mg or placebo. In SAkuraSky, patients added treatment to baseline immunosuppressive therapy.
Notably, at MS Virtual, data from the open-label extension and a substudy of the SAkuraSky and SAkuraStar trials revealed that patients with NMOSD—regardless of treatment status—had a reduced risk of relapse with treatment with satralizumab.1,2 To learn more about these data, NeurologyLive spoke with Kathleen Hawker, MD, Medical Director Manager, Neuroscience, Genentech.
Kathleen Hawker, MD: Obviously, we were going to be collecting data long-term, but I was very excited about it. Anytime you get out into longer-term data and show no changes in the safety and the efficacy maintained, that's really what everybody wants to see. So, the data between Ocrevus and satralizumab are very similar. We don't have as much long-term data with satralizumab, but they're both showing the same thing: that patients are still continuing to do well.
I think what's exciting about our data as well, too, is that these were patients who were on other immunosuppressants and we were not seeing an uptick in safety issues in them, despite the fact that they were on a variety of other medications. So not only the drug is safe by itself, but we can see that safety is as good when you combine it with drugs with no safety profile concerns and the relapse rate is staying down. The other big and exciting part, too, is the patients are feeling better according to the patient-related outcomes. We always talk about MRIs and about a lot of different things, but the biggest thing when you get in the clinic is you say, “How are you doing?” Patients are very good about that. Those patient-related outcomes, the fact they are really improved and staying that way, is also great given the longevity of the drug and the great benefit without the safety issues.
Even beside COVID, when you take a look at a subcutaneous injection, patients with NMOSD can be much more disabled in terms of their vision when it comes to trying to get around, and also their walking ability. More so than patients with MS. The fact they can do it at home is a huge boon to them, even besides the times of COVID-19. If you can't see it's very hard to get to appointments—really, to get places—and it raises the burden upon families, caregivers, and patients. This at-home administration, I think, is really tremendous. Long-term as well, and during COVID, even though nobody likes COVID, it's been a boon for them as well.
As I said, I'm really excited that there are some options for patients that’re on other drugs that satralizumab—it's got a very unique mode of action, so I think that's really important that we're not doing the same old, same old that we’ve done before. That's really crucial.
I've always been excited about ocrelizumab. I've been in the development program for a long period of time, and I think it's one of the drugs that is high efficacy without some of the safety issues that a lot of the other high efficacy therapies that we developed. And the fact that we're hearing from patients, too. Again, coming back to the patients, when we talk to them about them, they're feeling better, they're doing better, they're getting on with their lives. I'm really proud of a lot of stuff based on what's been going on.
We've got some new studies that are probably going to be planned, in trying to push the envelope even further to treat even earlier in the CHIMES study. That's crucial because it’s very under-represented In most of our studies. So, to try to understand what we can do to help in these cases is important. There’s more to come.
Transcript edited for clarity. For more coverage of MS Virtual 2020, click here.