ANCHOR results are out; Lucentis does not stumble:
>>SOUTH SAN FRANCISCO, Calif., Nov. 7 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) announced today that a second Phase III clinical study of the investigational drug Lucentis(TM) (ranibizumab), ANCHOR, met its primary efficacy endpoint of maintaining vision in patients with the wet form of age- related macular degeneration (AMD). Approximately 94 percent of patients treated with 0.3 mg of Lucentis and 96 percent of those treated with 0.5 mg of Lucentis maintained or improved vision (defined as a loss of less than 15 letters in visual acuity) compared to approximately 64 percent of those treated with verteporfin (Visudyne®) photodynamic therapy (PDT) [p<0.0001] during the first year of the two-year study. The Lucentis treatment groups further demonstrated a statistically significant difference from the control arm in an important secondary endpoint: mean change in visual acuity from baseline to month 12. On average, patients treated with Lucentis improved, while patients treated with PDT declined. One-year data from the ANCHOR study will be presented at an upcoming medical meeting.
Preliminary safety findings were consistent with those observed in the other Phase III pivotal study of Lucentis, MARINA. Data from both Phase III studies will be submitted to the U.S. Food and Drug Administration (FDA) as part of the Biologics License Application (BLA) for Lucentis that the company plans to file in December 2005. Genentech will request Priority Review designation at the time of submission.
"Lucentis is the first potential therapy for wet AMD to improve vision in two pivotal Phase III trials and demonstrate a clinical benefit over PDT in a head-to-head study," said Hal Barron, M.D., Genentech senior vice president, Development and chief medical officer. "Based on these compelling results and current unmet medical need, all patients in the ANCHOR study will have access to Lucentis during the remainder of the trial."
ANCHOR (ANti-VEGF Antibody for the Treatment of Predominantly Classic CHORoidal Neovascularization in AMD) is a Phase III randomized, multi-center, double-masked, active-treatment controlled study comparing two different doses of Lucentis to PDT in 423 patients with predominantly classic wet AMD. Patients were randomized 2:1 to receive intravitreal Lucentis injections (0.3 mg or 0.5 mg dose) once a month or PDT every three months for two years. Exclusion criteria included prior subfoveal laser treatment, PDT or experimental treatments for wet AMD. Visual acuity was measured using the Early Treatment of Diabetic Retinopathy (ETDRS) chart, the standard method of quantifying visual acuity. The study is ongoing in the United States, Europe and Australia.
Common ocular adverse side effects that occurred more frequently in the Lucentis arms than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain, increased intraocular pressure and vitreous floaters. Serious ocular adverse events that occurred more frequently in the Lucentis-treated arms were uncommon and included endophthalmitis (approximately 1 percent). Among non-ocular serious adverse events, the frequency of cerebral vascular events was equal across all three arms. The frequency of myocardial infarctions was slightly higher in patients treated with 0.5 mg of Lucentis than in the other two arms, although this difference was not statistically significant.
Lucentis is a humanized antibody fragment developed at Genentech and designed to bind and inhibit Vascular Endothelial Growth Factor A (VEGF-A), a protein that is believed to play a critical role in angiogenesis (the formation of new blood vessels).
Additional Phase III Studies
SAILOR
SAILOR (Safety Assessment of Intravitreal Lucentis for AMD) is a Phase IIIb clinical study of Lucentis for patients with all subtypes of new or recurrent active subfoveal wet AMD. It is a one-year study designed to evaluate the safety of two different doses (0.3 mg and 0.5 mg) of Lucentis administered once a month for three months and thereafter as needed based on criteria-based re-treatment options. The study will be conducted at more than 100 sites in the United States and will enroll approximately 5,000 patients. Enrollment in the SAILOR study began in November 2005.
PIER
Genentech is also conducting PIER (A Phase IIIb, Multicenter, Randomized, Double-Masked, Sham Injection-Controlled Study of the Efficacy and Safety of Ranibizumab in Subjects with Subfoveal Choroidal Neovasularization with or without Classic CNV Secondary to Age-Related Macular Degeneration) with 184 patients in the United States. In this trial, Lucentis is administered once per month for the first three months followed thereafter by doses once every three months for a total of 24 months. Enrollment in this study is complete and preliminary results are expected in the first half of 2006.
MARINA
Earlier this year, Genentech announced positive preliminary one-year Phase III data on Lucentis from MARINA (Minimally classic/occult trial of the Anti- VEGF antibody Ranibizumab In the treatment of Neovascular AMD), a two-year study of 716 patients with minimally classic or occult wet AMD. Nearly 95 percent of patients treated with Lucentis maintained or improved vision at 12 months. Additional one-year results include:
* Twenty five percent (59/238) of patients treated with 0.3 mg of
Lucentis and 34 percent (81/240) treated with 0.5 mg of Lucentis
improved vision by a gain of 15 letters or more compared to
approximately 5 percent (11/238) of patients in the control group as
measured by the ETDRS eye chart.
* Nearly 40 percent (188/478) of Lucentis-treated patients achieved a
visual acuity score of 20/40 or better compared to 11 percent
(26/238) in the control group.
* Patients treated with Lucentis gained an average of seven letters in
visual acuity compared to study entry, while those in the control
group lost an average of 10.5 letters.
* The majority of patients treated with Lucentis (74.8 percent in the
0.3 mg group and 71.3 percent in the 0.5 mg group) experienced a
letter improvement of zero or more compared to 28.6 percent in the
sham group.
In October, Genentech announced that patients in the sham arm of the MARINA study would be crossed over to active treatment with Lucentis.
An analysis of the one-year data showed that adverse events were similar to those seen in earlier trials of Lucentis. Common side effects that occurred more frequently in the Lucentis arms than in the control group were mild to moderate and included conjunctival hemorrhage, eye pain and vitreous floaters. Serious ocular adverse events occurring more frequently in Lucentis-treated patients were infrequent (<1 percent) and included uveitis and endophthalmitis. There appeared to be no imbalance in serious non-ocular adverse events.<<
Unless the AE profile is worse than expected, but I don't think so. Confirms OSI's stupidity in buying EYET, IMO. No longer have trading position in DNA, but have an OSIP position, that I have hedged with sold calls.
Edit: I guess they're saving the 3 line improvement data for that medical meeting, unless some analyst gets it out of them on a CC.
Cheers, Tuck |
