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ONYX Pharmaceuticals, AŞ Message Board

  • ahhaha2 ahhaha2 Nov 2, 2012 11:53 PM Flag

    The CC, in the clinic

    Barbara Klencke

    Let's start with our proteasome inhibitor franchise. Our comprehensive development program is well underway to evaluate Kyprolis across all lines of therapy in multiple myeloma. We have 3 ongoing global Phase III trials and are on track to initiate a fourth Phase III trial in front-line patients in the first half of next year.

    For relapsed and refractory patients, as we recently announced, we completed patient enrollment in the FOCUS trial, one quarter ahead of projection. This randomized trial is being conducted under scientific advise from the EMA and is intended to support marketing approval outside of the United States, and importantly, to demonstrate a survival advantage with Kyprolis. This study incorporates a planned interim analysis, and depending on the rate of event accrual, it is possible that we could have top line results from an interim analysis as early as the second half of 2013.

    Turning to ASPIRE, which is a primary endpoint of progression-free survival, we continue to monitor the accrual of events in this trial. We are observing the patients who are not progressing as rapidly as projected. So given the current rate of overall event accrual, we now expect results from an interim analysis could be available by the fourth quarter of 2013 or later.

    While we await results from FOCUS and ASPIRE, we also are executing a head-to-head comparison strategy to evaluate Kyprolis' superiority versus VELCADE. To this end, we began enrollment in the Phase III ENDEAVOR study in mid-2012 to compare Kyprolis in combination with low-dose dexamethasone to VELCADE with low-dose dexamethasone in 880 patients. In addition, we plan to initiate a second head-to-head comparison trial of Kyprolis versus VELCADE in the first half of 2013, this trial in the front-line setting.

    Finally, with an objective of covering the multiple myeloma treatment landscape, we are also advancing the development of our oral proteasome inhibitor, oprozomib. We have completed additional formulation work for this compound and are introducing a tablet, rather than in a powder and capsule formulation, into the ongoing Phase Ib/II trial this month. We look forward to presenting the early stage safety and efficacy data from the powder and capsule formulation at the ASH Meeting in December. In fact, at ASH this year, we are excited that we will have 7 oral presentations, including both company-sponsored and investigator-sponsored trial data for both Kyprolis and oprozomib. The oprozomib data with the split-dose regimen in hematologic malignancies was accepted as an oral presentation, and there will be 6 additional oral presentation on Kyprolis.

    Turning our attention to the kinase inhibitor franchise. Onyx and Bayer expect to report top line results from the Phase III DECISION study in differentiated thyroid cancer patients before the end of the year, potentially providing a new indication opportunity for Nexavar. If the data are favorable, we would quickly pursue a supplemental regulatory submission for Nexavar in what would be a third potential indication. And in the advanced breast cancer setting, we expect to complete patients enrollment in the Phase III RESILIENCE trial in the first half of next year.

    Moving to Stivarga. We recently announced that Bayer received priority review based on its supplemental NDA for a second potential indication in the gastrointestinal stromal tumors, which was submitted in August of this year.

    So with the ongoing Phase III trials across our portfolio and for both franchises, we look forward to multiple data readout with the goal of potentially benefiting even more patients with cancer.