WEEKLY IMPORTANT NEWS FROM MEDSCAPE AND OTHER SOURCES
Κυριακή, 10 Απριλίου 2016
NO USE OF FARLETUZUMAB FOR OVARIAN CANCER
Addition of the antifolate receptor-α antibody farletuzumab to carboplatin/taxane did not improve progression-free survival in patients with ovarian cancer in first platinum-sensitive relapse, reported Vergote et al in the Journal of Clinical Oncology. However, benefit was observed in patients with lower CA-125 levels and in those with higher farletuzumab exposure.
In the phase III double-blind trial, 1,100 women with relapse at 6 to 24 months after initial surgery and platinum/taxane treatment from 274 sites in North America, Europe, the Asia Pacific region, Latin America, and Japan were randomly assigned to receive six cycles of carboplatin/taxane plus weekly farletuzumab at 1.25 mg/kg (n = 370) or 2.5 mg/kg (n = 366) or placebo (n = 364) until disease progression. The primary endpoint was progression-free survival.
Median progression-free survival was 9.5 months in the farletuzumab 1.25-mg/kg group (hazard ratio [HR] = 0.99, P = .9025) and 9.7 months in the 2.5-mg/kg group (HR = 0.86, P = .1521) vs 9.0 months in the placebo group. Median overall survival was 28.7 months (HR = 0.99, P = .9646) and 32.1 months (HR = 0.88, P = .3231) vs 29.1 months, respectively. The most common adverse events were mainly those associated with chemotherapy.
Among patients with baseline CA-125 levels ≤ 3 times the upper limit of normal (ULN), median progression-free survival was 10.0 months in the farletuzumab 1.25-mg/kg group (HR = 0.92, P = .7235) and 13.6 months in the 2.5-mg/kg group (HR = 0.49, P = .0028) vs 8.8 months in the placebo group, and median overall survival was not estimable (HR = 0.87, P = .6464) and not estimable (HR = 0.44, P = .0108) vs 29.1 months, respectively.
Patients with average minimum serum concentrations of farletuzumab above the median (HR = 0.679, P = .002) and those with area under the curve levels above the median (HR = 0.77, P = 0.012) had prolonged progression-free survival vs the placebo group.
The investigators concluded: “Neither farletuzumab dose met the study’s primary [progression-free survival] end point…. [S]ubgroup analyses demonstrated that patients with CA-125 levels not more than three times the ULN and patients with higher farletuzumab exposure showed superior [progression-free survival] and [overall survival] compared with placebo.”
They noted: “Based on the results of this phase III study, a follow-on study in patients… who have low CA-125 levels is planned using a modified farletuzumab dosing regimen.”
Morphotek, a subsidiary of Eisai Co, funded the study.