Delcath Bullish After Melphalan Drug/Device Combo Scores In Phase III
This article was originally published in The Gray Sheet
Executive Summary
Delcath Systems is confident about the prospects for its combination drug/device product for patients with unresectable melanoma metastases to the liver after better-than-expected Phase III trial results
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Delcath Systems drug/device combo
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Delcath Systems drug/device combo
ASCO Meeting In Brief
Brain cancer device makes headway: Israel-based NovoCure plans a near-term PMA submission for its NovoTTF brain cancer device, a portable headgear-based system that relies on low intensity electric fields to disrupt cell division, based on data from a 237-subject trial of recurrent glioblastoma patients reported June 5 at the American Society of Clinical Oncology annual meeting. In the full "intent-to-treat" population, the NovoTTF arm showed statistically similar survival times to "best available" chemotherapies (6.6 months vs. 6.0 months), researchers reported at the Chicago meeting. In the "per-protocol" population - the 80% of patients that completed at least one course of device or drug treatment - NovoTTF patients experienced a statistically significant survival advantage (7.8 months vs. 6.1 months) and a large advantage in response rate (15.1% vs. 5.1%). The CE-marked device, which a patient can wear throughout the day while toting a battery pack in an over-the-shoulder bag, was associated with three to four times fewer infections than standard chemotherapy, plus a reduction in other common side effects. NovoCure is conducting another pivotal trial assessing the impact of combining the device with chemotherapy for newly diagnosed glioblastomas. The firm recently raised funds from Pfizer, Johnson & Johnson and other investors to help fund its clinical trial program (1"The Gray Sheet" Oct. 12, 2009)