MGI reports Aloxi alone, in combination cuts side effects of chemotherapy

New York, June 5 - MGI Pharma, Inc. reported a series of presentations at the American Society of Clinical Oncology annual meeting including two showing that Aloxi either alone or in combination reduced the side effects of chemotherapy.

A phase 2 multi-center study to assess the efficacy and safety of Aloxi injection in patients with germ cell tumors receiving multiple-day cisplatin-based chemotherapy found the treatment provided comparable or better overall protection from nausea and emesis than the previous standard five-day ondansetron-based regimen in patients receiving this highly emetogenic multiple day cisplatin-based chemotherapy.

The results of this trial, along with other data, will support a submission of a label supplement to the Food and Drug Administration for the dosing and administration of Aloxi in multi-day chemotherapy regimens.

Forty-one adult men receiving five consecutive days of cisplatin-based chemotherapy were administered 0.25 mg Aloxi intravenously 30 minutes prior to chemotherapy on days 1, 3 and 5 plus dexamethasone on days 1, 2, 6, 7 and 8.

MGI said the majority of patients had no emesis and no moderate or severe nausea on each of the nine study days. Most patients reported no significant interference with functioning due to nausea on days 1-4 of chemotherapy (72%) and days 5-9 (85%).

The combination of Aloxi plus dexamethasone was well tolerated, and the most common treatment-related adverse events in this study were mild-moderate headache (17%) and constipation (10%).

For the combination, a phase 2 trial examining the safety and efficacy of the combination of olanzapine, Aloxi and dexamethasone for the prevention of chemotherapy-induced nausea and vomiting in chemotherapy-naive patients demonstrated that the treatment was a safe and effective option.

Olanzapine, an atypical antipsychotic agent, has been studied as an adjunct to standard 5-HT(3) receptor antagonists and dexamethasone for the prevention of acute and delayed chemotherapy-induced nausea and vomiting, and has been shown to be safe and effective in prior studies.

The 40 evaluable patients undergoing chemotherapy in this study received a combination of 0.25 mg intravenous Aloxi, 10 mg oral olanzapine, and dexamethasone on the day of chemotherapy administration followed by 10 mg per day of oral olanzapine on days 2 through 4 following chemotherapy.

The complete response rate (no emesis, no rescue) was 100% for the acute period, defined as the 24-hour period following chemotherapy; 75% for the delayed period (days 2-5 post chemotherapy); and 75% for the overall period (days 1-5) for the eight patients who received highly emetogenic, cisplatin-based chemotherapy regimens.

Among this group of patients, the percentage of patients without nausea was 100% in the acute period, 50% in the delayed period and 50% in the overall period. Of the 32 patients receiving moderately emetogenic chemotherapy, the complete response rate was 97% for the acute period, 75% for the delayed period, and 72% for the overall period. The percentage without nausea was 100% in the acute period, 78% in the delayed period and 78% in the overall period.

There were no grade 3 or 4 toxicities associated with the combination of Aloxi, olanzapine and dexamethasone.

MGI also announced that enrollment is now complete in its multi-center phase 2 alternate dosing trial of Dacogen in patients with myelodysplastic syndromes. This trial, called Adopt (Alternate Dosing for Outpatient Treatment), is designed to evaluate a five-day Dacogen dosing regimen of intravenous one hour infusions at a dose of 20 mg/m(2).

MGI Pharma is a Minneapolis oncology- and acute care-focused biopharmaceutical company.

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