Keryx Biopharmaceuticals Inc fka KERX

[califax]

KERX @ ASCO (Tuesday, June 8, 2010)

http://ih.advfn.com/p.php?pid=nmona&article=42926420&symbol=N^KERX

Gastrointestinal (Colorectal) Cancer

Abstract Title: Final results of a randomized phase II study of perifosine in combination with capecitabine (P-CAP) versus placebo plus capecitabine (CAP) in patients (pts) with second- or third-line metastatic colorectal cancer (mCRC).

Presentation Date/Time: Tuesday, June 8, 2010; 8:00 AM - 12:00 Noon with poster discussion from 11:45 am – 12:00 Noon

Author: Donald A. Richards, MD, PhD, Texas Oncology

Discussion Presenter: Wells Messersmith, MD, University of Colorado

Permanent Abstract ID: 3531

Location: S403, Poster Board #22, with discussion in S406

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Abstract:

Background:
Perifosine (P), a synthetic alkylphospholipid, inhibits or modifies signal transduction pathways including AKT, MAPK and JNK. We previously reported initial results of a phase II randomized study of P-CAP vs. CAP which demonstrated improved clinical activity of P-CAP over CAP in pts with mCRC. We now report the final safety, overall response rate (ORR), time to progression (TTP) and overall survival (OS) results.

Methods:
Pts with 2nd or 3rd line mCRC and no previous CAP in metastatic setting were randomized to P-CAP (P 50 mg PO QD + CAP 825 mg/m2 PO BID d1-14) or CAP (placebo + CAP 825 mg/m2 PO BID d 1-14). Cycles were 21 days.

Results:
38 pts were randomized (20 P-CAP/18 CAP). Median age 67 (32-83); 61% male. Median prior Rx = 2 (1-5). Prior Rx of P-CAP arm vs. CAP arm: FOLFIRI (90% vs. 87%); FOLFOX (75% vs. 73%); bevacizumab (75% vs. 80%); EGFR antibody (45% vs. 60%); progressed on prior 5-FU-based Rx (70% vs. 73%). All 38 pts were evaluable for toxicity. Most frequent AEs (P-CAP vs. CAP): G3 /4: hand/foot syndrome (HFS) (30% vs. 0%), anemia (15% vs. 0%), fatigue (0% vs. 11%), bowel obstruction (0% vs. 11%); G1/2: diarrhea (65% vs. 28%), nausea (45% vs. 28%), fatigue (50% vs. 33%), HFS (25% vs. 22%). 35/38 pts were evaluable for response (3 CAP pts off study for AE). Results for P-CAP vs. CAP: ORR: 20% vs. 7%; Median TTP: 28 vs. 11 wks (p=0.012); and OS: 18 vs. 11 mos (p=0.0136). Subset analysis in pts with 5-FU refractory disease is shown in the Table.

Conclusions:
P-CAP is a well-tolerated regimen that has promising activity over CAP as 2nd or 3rd line therapy for pts with metastatic colorectal cancer. This improvement is consistent for the subset of pts with 5-FU refractory disease. A randomized phase III trial of P-CAP vs. CAP is planned for refractory colorectal cancer pts.

http://abstract.asco.org/AbstView_74_48640.html