More OGIX data to review
2008 Annual Meeting of the Quebec Urological Association (QUA)
Cuog Phase II Randomized Study of Custirsen (Ogx-011) Combination Therapy in Patients with Poor-Risk Hormone Refractory Prostate Can- Cer (Hrpc) Who Relapsed on or within 6 Months of First-Line Docetaxel Therapy
Saad Fred (1), Hotte S�bastien J (2), North Scott (3), Eigl Bernie (4), Chi K (5), Czaykowski P (6), Pollak M (7), Wood L (8), Winquist Eric (9)
Objective: There is no standard of care when patients with metastatic HRPC manifest disease progression (PD) after first-line docetaxel. Custirsen is an antisense oligonucleotide targeting clusterin which in preclinical studies increased response of taxane-resistant cell lines to chemotherapy. This study evaluated the safety and efficacy of custirsen in combination with either docetaxel or mitoxantrone as second-line therapy (Rx).
Materials and methods: Patients were eligible if they had PD while receiving or within 6 month of discontinuing first-line docetaxel. All patients received 640 mg of weekly IV custirsen following 3 loading doses. Patients were randomized to standard doses of docetaxel/prednisone (DPC) or mitoxantrone/prednisone (MPC) on a 21-day cycle for up to 9 cycles. Protocol defined PD was based on RECIST, pain and performance score but not solely on PSA. Results: Analysis as of Jan. 3, 2008; median follow-up: 13.3 (8.4-17.1) months.
Forty-two patients received at least 1 cycle of combined therapy (DPC-20, MPC-22). Prior outcomes with first-line docetaxel were similar in both arms. The median time to PD for all patients was 1.8 months; 16 (38%) patients had PD while receiving first-line Rx. Following custirsen therapy: median number of cycles delivered: DPC-7.5, MPC-6.0; 40% of patients completed 9 cycles. Best PSA response (> 90, > 50, > 30%): DPC-20/40/55%, MPC-0/27/32%. Predetermined pain response: DPC-8/12 (67%), MPC-7/14 (50%); median duration in both arms: 6 months. KM estimate of PFS: DPC-4.7, MPC-2.6 months.
At a median follow-up of 13.3 months, 60% of patients are still alive in both arms. Both regimens were well tolerated; there were more grade 3/4 AEs with MPC (68%) than DPC (50%) + 1 patient died of CHF following 8 cycles of MPC. Conclusion: In patients who progressed during or soon after first-line docetaxel, both custirsen combination regimens were well tolerated and associated with impressive PSA + pain responses and better than expected survival. Custirsen/docetaxel/prednisone appeared superior to custirsen/mitoxantrone/prednisone in both efficacy and safety.
Phase 3 studies are planned utilizing chemotherapy plus custirsen as second-line therapy in patients progressing after a first-line docetaxel regimen.
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