Recurrent Ovarian Cancer
April 25, 2016
Morphotek reported results of a phase III trial of farletuzumab (MORAb-003) in combination with a platinum standard chemotherapy regimen (carboplatin plus taxane) in platinum-sensitive ovarian cancer patients in first relapse. All subjects received carboplatin plus paclitaxel or docetaxel (for six cycles combined with randomized test product 1:1:1 farletuzumab 1.25mg/kg, farletuzumab 2.5mg/kg, or placebo), and single-agent test product was continued weekly until disease progression. Neither farletuzumab dose met the study’s primary progression-free survival (PFS) endpoint when compared to placebo, with PFS of 9.0, 9.5 (hazard ratio [HR]=0.99) and 9.7 months (HR=0.86) for the placebo, farletuzumab 1.25mg/kg, and farletuzumab 2.5mg/kg arms, respectively. There was no difference in overall survival. Prespecified subgroup analyses demonstrated that subjects with a low CA125 level (less than three times the upper limit of normal) correlated with longer PFS (HR=0.49) and OS (HR=0.44) for farletuzumab 2.5mg/kg versus placebo. Subjects with higher farletuzumab exposure also showed superior PFS and OS compared to placebo. The most common adverse events were those known to be associated with chemotherapy, including alopecia, nausea, neutropenia, fatigue, thrombocytopenia and neuropathy. Morphotek has initiated a phase II trial to investigate the potential clinical benefit observed in patients with a low CA125 level.
July 1, 2013
Amgen reported results from a phase III trial of trebananib plus paclitaxel v. placebo plus paclitaxel for the treatment of recurrent ovarian cancer. This global, multicenter, randomized, double-blind, placebo-controlled study enrolled 900 women with recurrent partially platinum-sensitive or -resistant (platinum-free interval of 12 months or less) epithelial ovarian, primary peritoneal or fallopian tube cancer. Patients were randomized 1:1 to receive either 15mg/kg of intravenous trebananib weekly plus 80mg/m of intravenous paclitaxel weekly (three weeks on, one week off) or weekly intravenous placebo plus 80mg/m of intravenous paclitaxel weekly (three weeks on, one week off). The trial met its primary endpoint of progression-free survival (PFS). A statistically significant difference was observed in PFS with a 34% reduction in the risk of disease progression or death (HR = 0.66, 95% CI, 0.57, 0.77, p<0.001). The median PFS was 7.2 months in the trebananib arm v. 5.4 months in the control arm.
September 24, 2007
Pfizer released positive preliminary results from a phase II trial of sunitinib for the treatment of non-small cell lung cancer (NSCLC). The trial was designed to compare sunitinib (37.5 mg/day) in combination with erlotinib (150 mg/day) in previously treated subjects with advanced NSCLC. The primary endpoint was safety and tolerability. Secondary endpoints included anti-tumor activity. The combination treatment was generally safe and well tolerated, with all adverse events mild to moderate in nature. Two subjects had partial response; one which was maintained for >3 months and one which was currently ongoing. In addition, stable disease up to or more than 16 weeks was observed in two subjects. The randomized portion of this trial is currently underway.