ARVO 2024: Extended treatment outcomes and the potential for Q20W dosing with faricimab in nAMD


Philip P. Storey, MD, shares the highlights of his ARVO presentation on a post hoc analysis of the pivotal TENAYA/LUCERNE trials.

Philip P. Storey, MD, sat down with Modern Retina to discuss extended treatment outcomes and the potential for Q20W dosing with faricimab in nAMD from a post hoc analysis of the pivotal TENAYA/LUCERNE trials. He shares some of the highlights here with Group Editorial Director Sheryl Stevenson.

Video Transcript

Editor's note - This transcript has been edited lightly for clarity.

Sheryl Stevenson: We are joined today by Dr. Philip Storey, who will be presenting at ARVO this year. Welcome! So delighted to have you. We'd love to hear more about the post hoc analysis regarding the TENAYA and LUCERNE trials. What can you tell us?

Philip P. Storey, MD: First of all, thank you so much for having me. I really appreciate being on. We did a post hoc analysis looking at outcomes from TENAYA and LUCERNE [NCT03823287 and NCT03823300], which of course is the pivotal phase 3 clinical research study looking at faricimab, the first bispecific antibody used for wet macular degeneration.

And first of all, we looked at those patients. As you all know, this was a 2-year study that looked at faricimab versus aflibercept [Q8W aflibercept]. And then the faricimab patients were extended pretty aggressively actually to a very impressive point. Over almost 80% of patients (77% of patients) were able to get to a Q12W or Q16W interval by the end of this study. The point of this analysis was really to look at patients who had been extended, who'd completed all the way up to that Q16W extension and say, hey, if we applied the same treatment criteria that we used previously to extend patients, how many of these patients could we potentially have gotten to Q20W dosing for wet macular degeneration, which is sort of an unheard of interval for clinical studies.

The results were pretty impressive. What we did...the first year of the study had a fixed-interval dosing. Patients were either treated at Q12W or Q16W, then they have very specific algorithms for patients that need to be moved backwards. Basically, if the fluid increased or the vision dropped or there was new hemorrhage on the back of the eye, then that interval was decreased. The patients who were stable were increased. Whenever we got to the second year, treat-and-extend period, that's when we could see more of an extension.

This study looked at patients who had successfully completed...had one complete interval of the Q16W dosage, and we looked to see could these patients have been extended longer? The answer is 'yes' for quite a few of them: 56% of patients in this post hoc analysis would have qualified for extension to a once every 20 week dosing, which was pretty impressive. About 44% of patients still didn't qualify for that extension. That was usually because of anatomical changes, increase in CST [central subfield thickness]. But the majority of patients could.

Then we took another look at who are the patients who are more likely to be extended...could have been extended to that every 20 week interval? And the answer was patients with less fluid and lower PEDs [pigment epithelial detachments], which makes a whole lot of sense. You have less fluid. There's a greater chance of getting rid of that fluid and therefore extending the patient.

This was really impressive data. They of course didn't have a Q20W arm in the study but it looks like they could have and they could have been quite successful with over half of patients. So very impressive data with faricimab and I'm thrilled to present it at ARVO.

Stevenson: Thanks for that update. That's really fascinating. What does this research mean for retina specialists and their patients?

Storey: Yeah, good question. This means that we have good data that we can go longer between intervals than we ever thought we could...that if we're able to get a patient dry and maintain their vision. Historically, with first-generation medications a lot of us weren't really comfortable extending past 12 weeks—risk of hemorrhage or risk of loss of vision. This is good strong data that says maybe particularly with the second-generation medications, specifically faricimab, we can go longer than we ever have before. You know, coming to see your doctor once a month...I love seeing my patients but they hate coming to see me. It's a burden. A lot of our patients are elderly. They can't drive. They rely on family members. So the longer we can go between injections, the better it is for our patients.

Stevenson: Fantastic. Anything else to add that we haven't touched upon?

Storey: It's exciting times in retina. We are making big leaps forward, and I'm just excited to continue to provide amazing care for our patients. Thank you very much for having me on.

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