>>Preliminary Results from a Phase IIIb Study Showed Patients With Wet AMD Treated With Lucentis Quarterly Experienced a 16-Letter Benefit Over the Control Group at One Year
Friday June 2, 9:00 am ET
Lucentis Groups Showed Initial Increase in Vision from Baseline With Monthly Dosing and Returned to Baseline With Quarterly Treatments
SOUTH SAN FRANCISCO, Calif., June 2 /PRNewswire-FirstCall/ -- Genentech, Inc. (NYSE: DNA - News) announced today that a Phase IIIb clinical study of a quarterly dosing regimen of the investigational drug Lucentis(TM) (ranibizumab) for the treatment of wet age-related macular degeneration (AMD) met its primary efficacy endpoint by preventing vision loss as measured by mean change in visual acuity from baseline to month 12. In this study, called PIER, patients receive Lucentis (0.3 mg or 0.5 mg respectively) or sham injections once per month for the first three months followed thereafter by doses once every three months for a total of 24 months. One-year data from this study were presented today at the Retinal Physician Symposium in the Bahamas. The pivotal Phase III studies of Lucentis (MARINA and ANCHOR) evaluate a monthly treatment schedule.
In the PIER study, patients treated with Lucentis, on average, demonstrated an initial increase in mean visual acuity compared to baseline after three monthly injections. At month three, patients treated with Lucentis, on average, gained 2.9 letters and 4.3 letters (0.3 mg and 0.5 mg dose groups, respectively) compared to a loss of 8.7 letters among patients in the sham group. After month three, patients treated with Lucentis received additional doses at months six, nine and 12. On average, patients treated with Lucentis returned to baseline visual acuity by month 12, while patients in the sham group experienced significant vision loss. At month 12, patients treated with Lucentis lost 1.6 letters and 0.2 letters (0.3 mg and 0.5 mg) compared to a loss of 16.3 letters in the sham group, on average [p less than or equal to 0.0001].
"The results of the Lucentis pivotal studies have changed the expectations for the treatment of wet AMD," said Hal Barron, M.D., Genentech senior vice president, Development and chief medical officer. "While the PIER regimen provided a 16-letter benefit compared to sham, the data suggest that treating patients on a quarterly basis may be less effective than monthly or individualized dosing. Data from ongoing Phase IIIb studies and emerging results from our Investigator Sponsored Trials should help us learn more about the optimal dosing regimen for patients."
Consistent with earlier trials of Lucentis, common side effects that occurred more frequently in the Lucentis groups than in the control group at one year were mild to moderate and included conjunctival hemorrhage, eye pain and increased intraocular pressure. There were no reported cases of endophthalmitis, serious intraocular inflammation or other key ocular serious adverse events. There were no deaths, myocardial infarctions or cerebral vascular events in the first year of the study.
The one-year data from this study were submitted to the U.S. Food and Drug Administration (FDA) for consideration as the FDA reviews the Biologics License Application (BLA).
Additional one-year study findings include:
-- Among patients treated with Lucentis, 83 percent (0.3 mg) and
90 percent (0.5 mg) lost fewer than 15 letters in visual acuity
compared to baseline, a secondary endpoint of the study, compared
with 49 percent in the control group.
-- 12 percent (0.3 mg) and 13 percent (0.5 mg) of those treated with
Lucentis improved vision by a gain of 15 letters or more, a secondary
endpoint of the study, compared with approximately 10 percent of
those in the control group.
-- 30 percent (0.3 mg) and 28 percent (0.5 mg) of those treated with
Lucentis achieved 20/40 vision at 12 months, an exploratory endpoint
of the study, compared to 11 percent in the sham group.
About the Filing
Genentech submitted a BLA to the FDA for Lucentis on December 29, 2005 and was granted a Priority (six-month) Review. The FDA has until the end of June 2006 to take action on the filing. The submission was based on one-year clinical efficacy and safety data from two pivotal Phase III trials, MARINA and ANCHOR, as well as one-year clinical data from the Phase I/II FOCUS trial. Two-year data from the MARINA study and one-year data from the PIER study were submitted to the FDA after the initial BLA submission. Data from these studies demonstrate that Lucentis is the first investigational therapy to have improved vision in patients with wet AMD in two pivotal Phase III clinical trials. In addition, Lucentis is the first investigational therapy to have demonstrated a clinical benefit compared to verteporfin (Visudyne®) photodynamic therapy (PDT) in a head-to-head clinical study (ANCHOR).
About the Study
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) is a study of 184 patients in the United States with predominantly classic, minimally classic or occult with no-classic wet AMD. In this study, patients were randomized 1:1:1 to receive Lucentis (0.3 mg or 0.5 mg) or sham injections once a month for the first three months followed thereafter by doses once every three months for a total of 24 months. 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.<<
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Despite this, OSIP share price is hanging in there, even up a bit as I type. So is DNA share price. It would appear from the ANCHOR results and these, that monthly dosing works better. Patients retained their vision gains instead of returning to baseline on the quarterly regime. OK, now as I type, the market and both stocks go red, which actually makes more sense to me.
Cheers, Tuck |
