Palonosetran: Phase III

MOGN and Helsinn presented data from study 99-03, an international Phase III double-blind trial in 563 patients receiving high or low-dose palonosetron 5-HT3 serotonin receptor antagonist or ondansetron, a marketed 5-HT3 antagonist to prevent CINV. During the first 24 hours following chemotherapy, 81% of patients receiving a single intravenous 0.25 mg palonosetron dose (the low dose) achieved complete response compared to 68.6% of patients receiving 0.32 mg ondansetron (p<0.025). During the period 2-5 days following chemotherapy, 74.1% of patients receiving 0.25 mg palonosetron had a complete response compared to 55.1% of patients receiving odansetron (p<0.025). For the entire 120-hour period following chemotherapy, 69.3% of palonosetron patients had a complete response compared to 50.3% of ondansetron patients. The two drugs had similar tolerability. The most frequent side effect was headache. ...