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Genentech reacts to DRCR.net Protocol T data
In a company-issued statement, Genentech responds to data regarding the DRCR.net Protocol T:
Genentech thanks the Diabetic Retinopathy Clinical Research Network (DRCR.net) for bringing this important data to patients and physicians.
The preliminary 1-year results of the DRCR.net Protocol T trial reinforce the safety and efficacy of Lucentis for diabetic macular edema (DME). The trial studied Lucentis 0.3 mg given less than monthly compared with other anti-VEGF agents in DME.
On average, Lucentis patients saw robust visual acuity gains consistent with those seen with monthly dosing in our pivotal trials, RIDE and RISE. The primary endpoint showed a two-letter difference between Lucentis and Eylea, which is clinically comparable.
We believe that the findings of a single trial at 1 year must be viewed in context of the totality of evidence establishing the efficacy and safety profile of Lucentis.
During the first year of the Protocol T trial, patients in all study arms received a similar number of injections and experienced no significant difference in the percentage of serious adverse events including hospitalizations, death or endpoints as represented by the Anti-Platelet Trial Collaboration (APTC) (non-fatal stroke, non-fatal myocardial infarction and vascular death) criteria.
These preliminary data include a new and not yet validated endpoint of “Any Cardiovascular Event,” which contains a broad range of symptoms with unclear relationship to anti-VEGF drug use. This endpoint indicates a potential difference in cardiovascular events among the three medicines. Whether this is a real or chance finding is uncertain.
However, according to the study, a higher event rate of “Any Cardiovascular Event” for Lucentis did not translate into increased serious adverse events, including hospitalization or death. Our view is that a standardized approach to safety information for clinical trial reporting allows greater transparency and comparability with historical data. Genentech looks forward to better understanding these data.
Caution is warranted with interpretation of the preliminary efficacy and safety results ahead of a full presentation and final peer-reviewed publication by the DRCR.net.”
Genentech is a leader in ophthalmology. Lucentis has been studied for 14 years in 23 trials and in more than 9,200 patients in wet AMD, DME and macular edema after retinal vein occlusion (RVO). Lucentis was the first approved medicine in all three of these indications and has had a tremendous impact on the lives of patients with these potentially blinding conditions.
Genentech will continue our efforts to bring more information to patients regarding this complex and dynamic disease state.