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Weekly AMG 386 + Paclitaxel Well Tolerated in Recurrent Ovarian CA

Treatment shows some evidence of antitumor activity and dose-response effect

MONDAY, Dec. 19 (HealthDay News) -- For patients with recurrent ovarian cancer, AMG 386, an investigational peptide-Fc fusion protein, combined with weekly paclitaxel is well-tolerated, according to a study published online Dec. 19 in the Journal of Clinical Oncology.

Beth Y. Karlan, M.D., from the Cedars-Sinai Medical Center in Los Angeles, and colleagues assessed the efficacy and toxicity of AMG 386 and paclitaxel in patients with recurrent ovarian cancer. A total of 161 patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer were randomly allocated to receive once-weekly treatment of paclitaxel plus 10 mg/kg intravenous AMG 386 (arm A), 3 mg/kg AMG 386 (arm B), or placebo (arm C). Progression-free survival (PFS) was the primary end point.

The investigators found that the median PFS was 7.2, 5.7, and 4.6 months in arms A, B, and C, respectively. Compared with arm C, the hazard ratio for arms A and B combined was 0.76 (P = 0.165). An exploratory dose-response effect was seen for PFS across the arms in a further analysis (Tarone's test, P = 0.037). For arms A, B, and C, the objective response rates were 37, 19, and 27 percent, respectively, and the incidence rates of grade 3 or worse adverse events (AEs) were 65, 55, and 64 percent, respectively. Common AEs included peripheral edema, hypokalemia, and hypertension. Linear pharmacokinetic properties were seen with AMG 386 at the tested doses.

"Treatment with once-weekly AMG 386 plus paclitaxel may result in prolonged median PFS. The therapy was well tolerated with a distinct and manageable toxicity profile," the authors write.

Several authors disclosed financial ties with Amgen, which funded the study and manufactures AMG 386.

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