Novocure (NVCR) Announces Significant Data from Optune Combo Phase 3 in GBM

September 12, 2016 7:08 AM EDT
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Novocure (Nasdaq: NVCR) announced that long-term survival analysis of the full 695 patient dataset from the phase 3 pivotal EF-14 trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) will be presented as a late-breaking oral presentation at the 21st Annual Scientific Meeting of the Society for Neuro-Oncology (SNO) in Scottsdale, Arizona, on Friday, Nov. 18, 2016.

The long-term survival analysis of the full and mature dataset confirms the interim analysis results published in the Journal of the American Medical Association (JAMA)1 in December 2015, showing significant extension of both progression free and overall survival in newly diagnosed GBM patients receiving Optune with temozolomide compared to temozolomide alone. The long-term analysis shows survival rates were significantly higher four years from randomization in patients receiving Optune with temozolomide compared to patients receiving temozolomide alone. The safety profile in the mature analysis was consistent with the interim analysis of the EF-14 trial.

“The analysis of the mature dataset provides an impressive confirmation of the improvement in both progression free and overall survival we saw in the trial’s interim analysis results, and demonstrates the trial met its prespecified endpoints at both interim and long-term analyses,” said Roger Stupp, M.D., Professor at the University of Zurich and Director of Department of Oncology at the Zurich University Hospital, Zurich, Switzerland and EF-14 Principal Investigator. “I look forward to sharing the data with the scientific community in November.”

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