GS Take: ABGX (IL/N)/AMGN (OP/N): ASCO update on
ABX-EGF in cancer. No Surprise.
At ASCO, complete data from an ABX-EGF phase II study in second and third line colon
cancer, and interim data from a Phase II trial in first line lung cancer were reported. In the
colon cancer study, the primary endpoint of overall response rate was 10%, in line with
the interim analysis on 40 patients. Lung cancer data were encouraging but early.
ABX-EGF is in phase III studies in colon cancer with a 50/50 collaboration between
ABGX & AMGN. We believe progress on this program will be a main valuation driver
for ABGX but one of many projects at AMGN. While we expect there will be room for
many players, competition is intense with avastin and erbitux already launched and timing
of ABX- EGF trial is unclear. We maintain ratings (outperfrom for AMGN & In Line for
ABGX) and Neutral coverage view. Key risks include slower sales, development failures,
reimbursement, patent disput and manufacturing.
I. Colon cancer data in line with expectations
Complete data were reported from a phase II study on 148 patients with second and third
line colon cancer, who were treated with ABX-EGF monotherapy. 96% of patients had
previous treatment with irinotecan and 49% had previous treatment with oxaliplatin. The
primary endpoint of overall response rate was 10%, which was in line with data reported
in the interim analysis on 40 patients. Secondary endpoints of median time to
progression and median overall survival was 2.0 months and 7.9 months, respectively.
II. Phase III study underway in colon cancer
Earlier this year Amgen and Abgenix began phase III studies to study ABX- EGF
monotherapy in third line colon cancer. With the approvals of Genentech's avastin and
Bristol Myer's and Imclone's erbitux, competition in colon cancer is increasing. In
addition, oral EGFR inhibitors, including Genentech's tarceva and AstraZeneca's Iressa,
two oral agents, have increased competition in the EGFR field.
III. Early but encouraging data in lung cancer
Data were reported from interim data from a trial with ABX-EGF in combination with
paclitaxel and carboplatin for first-line non-small cell lung cancer. Nineteen patients were
evaluated of which there was one complete response and four partial responses. We
regard this data as encouraging but early. |
