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Poniard's investigational colorectal cancer drug meets trial endpoint, yields lower overall survival, data reveal
Tuesday, March 02 2010 | Comments
What's This?
Poniard Pharmaceuticals Inc.'s investigational cancer drug, picoplatin, met the primary endpoint in a recent midstage trial but led to lower overall survival than did a comparative treatment. The Phase II study evaluated picoplatin as a neuropathy-sparing alternative to oxaliplatin for the first-line treatment of metastatic colorectal cancer in 101 patients who had not received prior chemotherapy. The trial's main objective was to compare the relative incidence and severity of neuropathy with the FOLPI regimen (picoplatin in combination with 5-fluorouracil and leucovorin) versus that of the FOLFOX regimen (oxaliplatin in combination with 5-fluorouracil and leucovorin).
The primary endpoint of the trial was met, as the FOLPI regimen was associated with a statistically significant reduction in neurotoxicity compared with the FOLFOX regimen.
However, the overall survival rate among the patients who received the FOLPI regimen was 13.6 months, which was lower than the overall survival rate of 15.6 months among those who received the FOLFOX regimen.
In addition, thrombocytopenia and neutropenia occurred more frequently among the patients who received the regimen containing picoplatin. Complications were rare, Poniard noted, with only 1 patient experiencing febrile neutropenia and 2 patients experiencing minor bleeding issues.
"We plan to schedule an end of Phase II meeting with the Food and Drug Administration to discuss these data and a potential registration strategy for picoplatin in colorectal cancer," said Jerry McMahon, chief executive officer of Poniard. "Our ultimate goal is to secure a strategic partnership to support further development of picoplatin in colorectal cancer and other solid tumor indications, including prostate and ovarian cancers."
These data were presented recently in Orlando, Fla., at the American Society of Clinical Oncology's 2010 Gastrointestinal Cancers Symposium.
This information concerns a use that has not been approved by the FDA.
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