Snip from recent GS report on DNA:
4. EARLY PHASE II DATA
ON AMGN/ABGX EGF BLOCKER LIKELY TO BE POSITIVE
Amgen and its partner, Abgenix, are developing ABX-EGF, a fully human antibody to the EGF
receptor. A series of Phase II studies are underway in renal, colorectal and prostate cancers and
NSCLC. Initial data on colorectal cancer are expected in May.
Two open-label trials with ABX-EGF in colorectal cancer are ongoing. The first trial, initiated at
the end of 2001, will include up to 100 patients who will receive monotherapy intravenous infusions
of 2.5 mg/kg of ABX-EGF weekly over an 8-week treatment cycle, for up to 6 cycles. The patients
enrolled are refractory to chemotherapy, including the Saltz regimen. Some patients may also be
refractory to oxaliplatin. The endpoints of the trial are tumor response rates and time to progression.
We expect data on a subset of patients from this study to be presented as a poster at the ASCO
meeting on Saturday, May 31 at 1:30pm CDT. We believe the preliminary data will likely be
favorable.
In the second trial, initiated in January 2002, up to 84 patients will receive weekly intravenous
infusions of 2.5 mg/kg of ABX-EGF in combination with standard doses of irinotecan, leucovorin,
and 5-fluorouracil (Saltz regimen) over a 6-week treatment cycle, for up to eight cycles.
In January 2002, Abgenix initiated a 50-patient, multi-center, open-label Phase II study of
ABX-EGF in prostate cancer. In this trial, patients will receive intravenous infusions of 2.5 mg/kg
of ABX-EGF weekly over an 8-week treatment cycle, for up to 5 cycles. The primary efficacy
endpoint of the study will be measured by prostate specific antigen (PSA) response rates (decrease
of PSA level by >50% compared to baseline).
Positive initial Phase II data on ABX-EGF as monotherapy in 88 advanced kidney cancer patients
were reported in May, 2002. At 8 weeks, stable disease was achieved in 50% of the patients. We
believe this is a strong start given the severity of the patients studied, and the fact that ABX-EGF
was studied as monotherapy. |
