Poniard Announces Positive Preliminary Efficacy and Safety Data From Ongoing Phase 2 Trial of Picoplatin in First-Line Treatment of Colorec...(hase 2 study is comparing thesafety and ...),Health

Preliminary data suggest that FOLPI and FOLFOX may have similar anti-tumor activity in metastatic CRC. Preliminary data representing 61 patients will be presented. Of 11 evaluable patients in the FOLPI arm, 10 achieved disease control (partial response combined with stable disease), including two partial responses. Of 13 evaluable patients in the FOLFOX arm, 10 achieved disease control, including one partial response. A total of 37 patients across both arms are too early for evaluation.

Expanded and Updated Phase 1 CRC Study Results

In the Phase 1 dose-escalation study, 70 patients were treated with FOLPI with picoplatin treatment administered either every two or four weeks. Patients have received a total picoplatin exposure of between 85 mg/m2 and 1,350 mg/m2, representing up to 28 cycles of picoplatin therapy.

The dose limiting toxicity (DLT) for the every-four-week regimen at 180 mg/m2 was hematologic with neutropenia and thrombocytopenia as the most frequent adverse events. The maximum tolerated dose (MTD) in the every-four-week FOLPI schedule was previously reported to be hematologic and occurred at 150 mg/m2. The MTD in the every-two-week FOLPI schedule of picoplatin when infused with 5-fluorouracil and leucovorin has not yet been reached, and the trial is ongoing at a dose of 135 mg/m2.

None of the Phase 1 patients treated with picoplatin exhibited severe neuropathy (Grade 3 or 4), as is commonly seen in metastatic CRC patients treated with oxaliplatin in combination with 5-fluorouracil and leucovorin as part of the FOLFOX regimen. Neurotoxicities were not related to cumulative exposure of picoplatin. Nephrotoxicities and ototoxicities were rare and mild
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