Novocure announces the EF-14 phase 3 pivotal clinical trial stopped for early success at interim analysis.

In 2014, Novocure faced unanswered questions from the scientific, medical and investment communities regarding the potential of its innovative therapy. That changed when Bill Doyle, Novocure’s Executive Chairman, learned that the EF-14 Independent Data Monitoring Committee recommended the trial be stopped for early success.

“If I had to put my finger on one really transformational moment for the company, I would pick the announcement that the EF-14 trial achieved statistical significance at the interim analysis and was terminated early for success,” Bill said.

The EF-14 study was designed to test the safety and efficacy of adding Tumor Treating Fields to standard of care chemotherapy compared to standard of care chemotherapy alone in patients with newly diagnosed GBM. The trial achieved statistically-significant and clinically meaningful results in overall survival and progression-free survival in a planned interim analysis of the first 315 patients enrolled.

Two months later, the trial data were presented by Dr. Roger Stupp as a late-breaking abstract at the 2014 Society for Neuro Oncology Annual Meeting. The EF-14 results gave Novocure’s leadership team confidence that FDA approval would be granted and that a business could be established helping patients with newly diagnosed GBM.

“We now had superiority data in one of the most difficult to treat cancer indications,” Bill said. “This was the foundation that allowed us to move forward to build the Novocure we know today.”