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Exelixis, Inc. Message Board

  • erniewerner erniewerner May 15, 2013 2:26 PM Flag

    Scher abstract

    Obviously this is the abstract getting the most attention tonight. I pointed out several months ago that Exelixis had released HCC and RCC survival data, but not any CRPC data. At the time it concerned me, sometimes what is not said is more important than what is said. It appears as if EXEL was just waiting for the right opportunity and perhaps the last ASCO annual meeting in advance of topline results from the Comet trials is the big stage. We'll see.

    The data to be released is survival data from the nonrandomized expansion cohort that was started in January 2011. The RDT (randomized discontinuation trial) cohort was capped at 168 and enrollment began in the NRE (nonrandomized expansion) with a different set of entry criteria. At ASCO 2012 EXEL reported the following:

    "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. "

    At some point, enrollment at the 100mg dose was discontinued and restarted at 40mg. Last September, Dr. DeBono reported on 51 NRE 40mg dosed patients. I believe tonights abstract will be an update on the 93 patients in the 100mg cohort, but we will see for sure in a few hours.

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