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  • parsnipsnbeets parsnipsnbeets Apr 25, 2013 5:22 PM Flag

    2012 NRE mCRPC abstract update - Dr. Scher

    Cabozantinib in Chemotherapy-Pretreated Metastatic CRPC: Interim Results from a Phase 2 Non-Randomized Expansion Cohort

    The interim results reported today include data from 93 men enrolled in the ongoing non-randomized expansion (NRE) 100 mg cohort of the company’s phase 2 randomized discontinuation trial. All patients had bone metastases on bone scan and 46% had measurable soft tissue disease. All patients had received prior docetaxel, 35% had prior abiraterone or MDV3100, and 24% had received prior cabazitaxel. Bone directed therapies such as zoledronic acid, denosumab and alpharadin were used in 57%, 14% and 1% of patients, respectively. Seventy-three percent of patients had received at least 2 prior lines of therapy for CRPC. Clinically significant pain, defined as baseline pain score by Brief Pain Inventory (BPI) ≥4, was present in 44% of patients, with the majority requiring chronic narcotic administration.

    Bone Scan Response (BSR). Computer-assisted evaluation of bone scan lesion area (BSLA) was determined by an Independent Radiology Committee (IRC) and showed an overall BSR rate (complete response + partial response) of 67%. Another 16% of patients had stable disease and 8% had a best response of progressive disease. Median best BSLA change was a reduction of 60%, and reductions were observed in patients with prior abiraterone, MDV3100, cabazitaxel, and/or radionuclide therapy. The median duration of bone scan response was 5.4 months (range 5.0 – 6.9 months).

    Pain Palliation. In 39 patients with clinically significant baseline pain, the median maximal reduction in pain from baseline was 46%. A clinically significant reduction of pain, defined as a ≥30% decrease in pain score, was observed in 25 patients (64%). Fifty-six percent of patients decreased their use of narcotics, including 31% who discontinued narcotics. These improvements were observed in patients with a variety of prior therapies.

    Circulating Tumor Cells. Robust reductions in circulating tumor cells (CTCs) were observed regardless of prior therapy in 62 patients with baseline CTC counts ≥5/7.5 mL of blood and a week 6 and/or week 12 assessment. Fifty-seven patients (92%) had ≥30% decrease in their CTC count. Thirty-nine percent of evaluable patients converted to

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