Roche’s double antibody treatment of DME reached two endpoints
Roche’s double antibody treatment of DME reached two endpoints. Roche’s double antibody treatment of DME reached two phase III clinical endpoints, showing strong durability.
Genentech is expected to submit a marketing application for the drug for the treatment of DME in February 2020. On December 21, 2020, Roche’s Genentech announced the positive top-line results of two global phase III clinical trials of the same design, YOSEMITE and RHINE. The study evaluated the bispecific antibody Faricimab in diabetic macular edema (DME). Role in patients.
Both studies reached the primary endpoint. Compared with aflibercept, which was administered every 8 weeks, Faricimab, which was administered every 8 weeks and with a personalized dosing interval of up to 16 weeks, showed non-inferior effects in improving vision. Sex.
In terms of secondary endpoints, more than half of the subjects who received the personalized administration of Faricimab in the first year extended the treatment interval to 16 weeks. In the Phase III clinical trial for the treatment of DME, it is the first time that any drug under investigation can achieve such a level of durability.
In addition, Faricimab was well tolerated overall, and no new safety signals were found.
DME is a vision-threatening complication of diabetic retinopathy (DR), affecting approximately 750,000 people in the United States, and is the main cause of vision loss for adults working at the right age. DR occurs when blood vessels are damaged and new blood vessel formation causes blood and/or fluid to leak to the retina. This can cause swelling and blockage of blood supply to certain areas of the retina. DME occurs when damaged blood vessels leak and cause swelling of the macula in the central area of the retina. As the incidence of diabetes increases, the number of people suffering from DME is expected to increase. If left untreated, it can lead to blindness.
Although anti-VEGF single-drug injections have greatly reduced vision loss caused by DME, frequent eye injections and the burden of treatment related to medical treatment may lead to insufficient treatment, which may not bring the best vision results. It has been nearly ten years since the last drug with a new mechanism of action for the treatment of DME was approved, and there is still a need for more effective and durable therapies to address unmet clinical needs.
Faricimab is the first research bispecific antibody designed for the eye, targeting Angiopoietin 2 (Ang-2) and Vascular Endothelial Growth Factor A (VEGF-A). These two pathways can drive a variety of retinal diseases. Including DME. Ang-2 and VEGF-A can make blood vessels unstable, promote the formation of new leaky blood vessels and increase inflammation, which ultimately leads to vision loss. Faricimab stabilizes blood vessels by blocking these two pathways, thereby helping patients with retinal diseases improve vision.
YOSEMITE and RHINE are two randomized, multicenter, double-blind global phase III clinical trials that evaluated the effectiveness and safety of Faricimab compared with aflibercept in 1891 patients with DME. Among them, the YOSEMITE study involved 940 people. There are 951 people in the RHINE study.
Each study has three treatment groups. After the loading phase, subjects are randomly assigned to receive 6.0 mg Faricimab doses at a personalized interval of up to 16 weeks; or 6.0 mg Faricimab doses are given every 8 weeks. The drug is given once; or aflibercept at a fixed dose of 2.0 mg is administered once every 8 weeks.
The primary endpoint of the study was the average change in the best corrected visual acuity (BCVA) score from baseline after one year. Secondary endpoints include:
- At week 52, the proportion of subjects in the personalized treatment group who received medication every 4, 8, 12, and 16 weeks; at week 52, subjects who achieved two or more improvements in
- the severity of diabetic retinopathy compared with baseline Ratio
- The proportion of subjects whose BCVA has increased by at least 15 letters from baseline;
- The proportion of subjects who avoided a reduction of at least 15 letters of BCVA compared to baseline;
- And the change of retinal thickness in the center of the macula from the baseline.
In addition to YOSEMITE and RHINE, the phase III clinical trial Rhone-X also studied the long-term safety and tolerability of Faricimab in the treatment of DME. Phase III clinical trials of TENAYA and LUCERNE are studying Faricimab for the treatment of neovascular or “wet” age-related macular degeneration (nAMD), which is an advanced form of AMD that can cause rapid, severe, and irreversible vision loss. The detailed results of the YOSEMITE and RHINE studies will be announced in February 2021, when Genentech will submit a marketing application for the drug for the treatment of DME.