Poniard said that the Phase 2 trial enrolled 32 men. The trial was designed to evaluate the efficacy and safety of intravenous Picoplatin (120mg/meter squared) administered every three weeks in combination with full doses of Docetaxel (75mg/meter squared) with twice daily prednisone (5mg) as a first-line treatment in chemotherapy-naive patients with metastatic CRPC.
In the trial, the treatment continued for up to 10 cycles of therapy, as specified in the protocol. PSA response was the primary endpoint. Secondary endpoints include duration of PSA response, radiologic response, PFS, overall survival and safety. Results from the study included:
The study results showed that Median overall survival was 21.4 months in 29 patients who received Picoplatin in combination with Docetaxel and Prednisone. Data from published literature report a median overall survival of 18.9 months for patients who received docetaxel 75mg/meter squared and prednisone 5mg alone. Progression free survival was 7.4 months.
PSA response was achieved in 78% of evaluable patients. Data report a PSA response of 45% in patients who received Docetaxel 75mg/meter squared and prednisone 5mg alone. In addition, 30% of these patients experienced PSA level normalisation following treatment with the Picoplatin, Docetaxel and Prednisone combination.
The final data showed that Picoplatin, in combination with Docetaxel and Prednisone, the current standard of care for CRPC, produced a clinically meaningful benefit in patients as measured by overall survival, progression-free survival (PFS) and prostate specific antigen (PSA) response rate. These results also demonstrated that Picoplatin can be safely administered with full doses of Docetaxel and Prednisone.
Ronald Martell, CEO of Poniard, said: “We believe these results reflect the promise of Picoplatin as a safe and effective platinum chemotherapeutic agent in prostate cancer, and suggest Picoplatin could play a significant role in the treatment of other tumor types where platinum and taxane chemotherapies are currently used, further supporting Picoplatin’s value proposition to potential partners.
“We intend to consult with our clinical advisory board and the FDA to finalise registration strategies in prostate cancer while simultaneously exploring potential partnership opportunities to support the continued development of Picoplatin in multiple solid tumor indications.”