MGCD265: Updated Phase II data
MethylGene reported updated preliminary data from the ongoing, 2-part, open-label, dose-escalation Phase II Trial 103 trial evaluating once-daily oral MGCD256 for 21 days in combination with either Tarceva erlotinib or Taxotere docetaxel. In 4 patients with metastatic stage IV NSCLC, MGCD265 plus Taxotere produced 1 partial response and 3 cases of stable disease. Mean and median PFS were 34 and 33 weeks, respectively. All 4 patients experienced tumor shrinkage, with a 98% reduction in carcinoembryonic antigen (CEA) levels in the patient experiencing a partial response. One patient with pancreatic cancer also experienced stable disease.
In patients receiving MGCD265 plus Tarceva, 1 patient with gastric cancer experienced significant clinical benefit as demonstrated by the removal of an indwelling catheter to drain ascites and a decrease in gastric wall thickening. One patient with metastatic medulloblastoma also experienced stable disease. The Tarceva and Taxotere arms have enrolled 16 and 21 patients, respectively. MethylGene reported preliminary data from the trial in June (see BioCentury, June 28). ...