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Positive Phase 3 results for Roche's melanoma drug

Sep. 29, 2014 7:28 AM ETRoche Holding AG (RHHBY) StockRHHBYBy: Douglas W. House, SA News Editor
  • At the European Society of Medical Oncology (ESMO) Congress today, Roche (OTCQX:RHHBY) announced positive from a Phase 3 clinical trial evaluating the safety and efficacy of the combination of cobimetinib plus Zelboraf (vemurafenib) compared to Zelboraf alone in patients with advanced melanoma.
  • The results showed that patients with previously-untreated BRAF V600 mutation-positive advanced melanoma who received the combination lived significantly longer that those who received Zelboraf alone. Median progression-free survival in the combination therapy cohort was 9.9 months compared to 6.2 months in the monotherapy cohort.
  • The data is currently under European Medicines Agency review. Roche plans to submit an NDA to the FDA later this year.

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