BioCentury
ARTICLE | Clinical News

Tetraxetan clivatuzumab: Final Phase Ib/II data

June 11, 2012 7:00 AM UTC

Final data from 90 evaluable patients with advanced inoperable pancreatic cancer in an open-label, dose-escalation, U.S. Phase Ib/II trial showed that multiple cycles of clivatuzumab plus gemcitabine (n=31) led to a combined median overall survival (OS) of 9.3 months, which the company said is comparable to other pancreatic cancer regimens. In 38 patients in the Phase Ib portion of the trial, 6.5 or 9 mCi/m 2 weekly clivatuzumab plus fixed-dose 200 mg/m 2 gemcitabine produced a disease control rate (DCR) of 50%, while 12 or 15 mCi/m 2 once-weekly clivatuzumab plus 200 mg/m 2 gemcitabine produced a DCR of 73%. In 52 patients in Phase II portion of the trial, fixed-dose 12 mCi/m 2 weekly clivatuzumab plus escalating doses of 200, 600 or 1,000 mg/m 2 gemcitabine produced a DCR of 72% at 200 mg/m 2, 63% at 600 mg/m 2 and 68% at 1,000 mg/m 2. In the Phase II portion, multiple cycles of clivatuzumab plus gemcitabine led to a median OS of 8.7 months vs. 4.2 months for a single cycle of treatment. Data were presented at the American Society of Clinical Oncology meeting in Chicago. ...