An independent data monitoring committee said the interim results of the trial of Novocure's tumor-treating fields should be accelerated. The TTFs are electric fields designed to disrupt cell division in stage 4 non-small-cell lung cancer.
After reviewing the interim analysis report, the panel concluded that the trial “should continue with no evidence of increased systemic toxicity,” Novocure said.
The panel's recommendations "support the potential for TTFields to make a significant difference in treatment outcomes for patients with non-small-cell lung cancer, whether used together with immune checkpoint inhibitors or docetaxel,” Novocure Executive Chairman William Doyle said in a statement.
Novocure shares at last check jumped 53% to $201.84. They have traded on Tuesday up as much as 61% at a 52-week high $211.79. The stock had been down about 20% year to date before Tuesday's rally.
Novocure has notified the U.S. Food and Drug Administration of the data-monitoring committee's recommendations and of the company intent to submit an -investigational-device exemption supplement, which would permit the company to use the device in a clinical study.
The panel also said that it was likely unnecessary and possibly unethical to keep admitting patients randomized into the control group. That was the panel's only recommendation for changes to the design of the trial.
The primary endpoint of the trial is a superior overall survival rate when patients are treated with TTFields plus immune checkpoint inhibitors.
“Combination therapy is a cornerstone of cancer care, and we believe using TTFields together with other cancer treatments, including immunotherapies, may lead to better outcomes for some patients,” said Doyle.