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Poniard Announces Positive Incremental Efficacy and Safety Data from Phase 2 Picoplatin Trial in Patients With Metastatic Colorectal Cancer
Date:10/22/2008

Design and Preliminary Results

The randomized, controlled, Phase 2 study enrolled 101 patients who had not received prior chemotherapy. The trial is comparing the safety and efficacy of intravenous picoplatin given once every four weeks in combination with bi-weekly 5-fluorouracil and leucovorin (the FOLPI regimen) with oxaliplatin given in combination with 5-fluorouracil and leucovorin in the FOLFOX regimen, which is the current standard of care. Severe neuropathy is commonly seen in CRC patients treated with oxaliplatin in combination with 5-fluorouracil and leucovorin as part of the FOLFOX regimen at cumulative doses above 800 mg/m squared.

Interim Phase 2 results presented at the Symposium showed that 65 percent of 37 evaluable FOLFOX-treated patients showed evidence of neurotoxicity with 5 percent of these patients exhibiting severe Grade 3 or 4 neurotoxicities. This is in contrast to 18 percent of 34 evaluable patients treated with FOLPI who exhibited resolvable low-grade (Grade 2 or lower) neurotoxicities. In addition, the FOLPI-treated patients did not show any severe Grade 3 or 4 neurotoxicities. Nephrotoxicities and ototoxicities were rare and mild with the FOLPI regimen.

Non-neurologic tolerability was similar between the two treatment groups. Acute gastrointestinal toxicity was similar in the two groups, while thrombocytopenia and neutropenia were more frequent and severe in the FOLPI- treated patients, but considered to be manageable. These findings confirm and extend earlier results presented at the 44th Annual Meeting of the American Society of Clinical Oncology in May.

Anti-tumor activity also was found to be similar in the FOLPI and FOLFOX groups. Of the 35 evaluable patients in the FOLPI arm, 20 achieved disease control (partial response combined with stable disease), including six with partial responses (or 17 percent of evaluable patients). Fifteen patients in the FOLPI arm were not evaluable or too early to evaluate.
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SOURCE Poniard Pharmaceuticals, Inc.
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