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Array BioPharma Inc. Message Board

  • dcaf7 dcaf7 Oct 7, 2013 8:53 AM Flag

    ARRY-380 phase 1 results

    SEATTLE, WA, Oct. 7, 2013 /PRNewswire/ - Oncothyreon Inc. (ONTY) today announced the presentation of final results from the first Phase 1 trial of ONT-380 at the American Association for Cancer Research Special Conference on Advances in Breast Cancer Research in San Diego. The results were presented by Virginia F. Borges, M.D., Associate Professor in the Division of Medical Oncology, University of Colorado School of Medicine. ONT-380 (also known as ARRY-380) is an orally active, reversible and selective small-molecule HER2 inhibitor being developed by Oncothyreon in collaboration with Array BioPharma Inc. (Nasdaq: ARRY), Boulder, Colorado.
    The first-in-human Phase 1 trial, with both dose-escalation and expansion components, enrolled a total of 50 patients, 43 of whom had HER2+ metastatic breast cancer. In this study, ONT-380 demonstrated an acceptable safety profile; treatment-related adverse events were primarily Grade 1. Because ONT-380 is selective for HER2 and does not inhibit EGFR, there was a low incidence and severity of treatment-related diarrhea, rash and fatigue, side effects which have been associated with EGFR inhibition. A single patient experienced Grade 2 treatment-related diarrhea and no patient developed treatment-related Grade 3 diarrhea; one patient had a Grade 3 rash. Additionally, there were no treatment-related cardiac events or Grade 4 treatment-related adverse events reported. The maximum tolerated dose of ONT-380 established in this Phase 1 trial was 600 mg twice daily. The dose-limiting toxicity was reversible elevation in liver enzymes.

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    • Nice decaf Thanks again for your input and knowledge. Another question I know its ONTY PR but why has ARRY been so quite on their successes ? Do you believe there might be a buyout in the works ?

    • continued
      In this trial, 22 HER2+ breast cancer patients with measurable disease were treated with ONT-380 at doses greater than or equal to 600 mg BID. In this heavily pretreated patient population, there was a clinical benefit rate (partial response [n = 3] plus stable disease for at least 6 months [n = 3]) of 27%. Notably, two of the patients with partial responses during treatment with ONT-380 had confirmed progressions while on prior lapatinib- and trastuzumab-containing regimens.

      "We believe that ONT-380's selectivity for HER2, without also targeting EGFR, positions ONT-380 as a potential best-in-class small molecule HER2 inhibitor," said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. "Results from this first-in-human trial provide preliminary evidence of activity against HER2+ breast cancer with a low incidence of EGFR-related side effects. We are looking forward to the initiation of Oncothyreon's planned Phase 1b trials of ONT-380, which we currently expect to begin before year end."

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