Opinion
Video
Efficacy of Faricimab in Clinical Trails
Author(s):
Experts discuss clinical trials on the efficacy of faricimab and how they utilize this therapy in their practice.
Transcript
Ehsan Rahimy, MD: All right, this is a fun section here. We get to talk about what’s new and upcoming in our field, so all the advances to hopefully improve care for our patients. We’ve touched on this earlier in the conversation, but there are obviously a lot of things in the pipeline and a lot of changes we’ve already seen come to the market in the last year. Veeral, let’s start with faricimab. We’ve had 4 major trials across 2 indications come out. We’ve seen 2-year data presented through both of them. Do you want to tell us a bit about TENAYA, LUCERNE, YOSEMITE, and RHINE?
Veeral Sheth, MD, MBA, FASRS, FACS: We’ve had just 2 landmark DME [diabetic macular edema] studies, 2 landmark AMD [age-related macular degeneration] studies. They achieved their end point, which is noninferior efficacy to every 8-week aflibercept, but in a way that was durable to a point where almost 60% in all of those studies got to 16 weeks of interval between their injections. Almost 80%, If you look across these studies, got to 12 weeks or beyond.
We’ve talked about it a number of times, but the Holy Grail now is not just efficacy, because we’ve set that bar pretty high already. It’s now getting that efficacy with fewer injections over time, so that in the real world we get results that approach what we get in clinical trials. And so it’ll be interesting to see what plays out. They’re doing extensions on those studies, so we’ll see how those go.
Also on top of that, when you talk about faricimab in particular, there are real-world data being shown. There’s the TRUCKEE study, which is a consortium of groups showing that the real-world data are also good and not just safe. I think now more than ever, and we’ve talked about it, safety is so important now, if not as important as efficacy, right there next to it. And we’re seeing after thousands of real-world injections, no significant safety signals. I think all that is reassuring, we’re a year into the usage of it, and it’s been a step forward for patients, especially in terms of mechanism of action and those types of thoughts.
Jonathan Jonisch, MD: I think the community was so pleasantly surprised with the clinical outcome of faricimab, we’re seeing that in our practice, and it’ has raised the conversation about the role of Ang-2 [angiopoietin-2] in all these diseases and what’s contributing to the increased durability. I think you just look at some of the patients who can get out to 4 months. It’s so much better than what we’ve seen with ranibizumab alone, no matter what dosage, even at some of the higher doses, that it certainly lends evidence that Ang-2 is a driver in at least some of these patients in both of these disease spectrums. I think that’s been a pleasant advance for our field.
Ehsan Rahimy, MD: Ali, what has your experience been like with faricimab? Where have you been integrating it into your practice, with what types of patients, and what have you seen?
Ali Khan, MD, FACS, FASRS: Initially the experience was kind of like our previous discussion about suboptimal responders, people with persistent fluid despite monthly or near monthly treatment with other agents, and switching to faricimab to look for an improved response. I think this is a more difficult patient population to get a huge improvement because they’ve been somewhat resistant to anti-VEGF treatment already. But I have had some good cases where I’ve been able to at least extend or go a bit longer while maintaining the same level of exudation, which I think the patients appreciate.
I’m now going to a second group of patients, like we also talked about, who were stable on their current treatments, and I’m just trying to see if they can go longer. So this is a second group of patients for whom I’m more interested in seeing what happens, to see if I can really get [longer intervals]. Some of the trials did show that a lot of patients could get out to 12 [weeks] and even up to 16 weeks as well. I’m excited to see that. The difficult part with step therapy and biosimilars and these other things is it’s not always easy to get a treatment-naive patient started on this drug right away, and that’s what the trial data reflect. I think that’s a less common scenario. But so far the TRUCKEE data have shown some good response. I think in my limited experience as far as those 2 types of patients, they have had at least as good of a response as previously, and if not, more durability.
Ehsan Rahimy, MD: I’m curious for you guys, have you been following the extension protocols for faricimab, like was done in the studies? People say different things here. Are you comfortable now extending in 4-week increments for neovascular AMD and DME, assuming it’s driven by the medicine, or are you still doing your standard treat and extend? I see Veeral’s already saying no.
Veeral Sheth, MD, MBA, FASRS, FACS: Yes, you alluded to that they used a 4-week kind of extension. I still go by 2 weeks at a time, more because I’m curious. I want to know what happens with these patients. I do think I would consider it now based on, especially in our diabetics, what we see as far as the data that they got and some of the cases they’ve shown from the data. I’m not closed off to it by any means, but I still consider myself a 2-weeker.
Jonathan Jonisch, MD: Same here. I need to be really comfortable with the drug at this point, whether it’s evidence-based or not, to go 4 weeks.
Ali Khan, MD, FACS, FASRS: Four weeks is a long time. I agree, I’m going 1 to 2 weeks still. I’m using my usual treat and extend.
Ehsan Rahimy, MD: But I think we’re all old enough to remember even when aflibercept came out. After the monthly loading dose, we were being told to go to 8 weeks. There were a lot of patients who did recur at 6-week marks. We saw people come in with hemorrhages all the time. I’m constantly reminded of that, and I’m with you guys. I’m going with 2-week increments, at least for now, until we gather more experience under our belt.
Transcript edited for clarity.
