NovoCure touts JAMA publication of Optune trial data

NovoCure (NSDQ:NVCR) said today data from the pivotal phase 3 trial of its Optune device, in combination with standard-of-care temozolomide, for treating newly diagnosed glioblastoma has been published in the Journal of the American Medical Association.

The results from the EF-14 trial reported that Optune along with temozolomide significantly extended progression-free survival and overall survival compared to temozolomide alone in treating newly diagnosed glioblastoma.

“The EF-14 data are spectacular. They support Tumor Treating Fields as a new standard of care for patients suffering from glioblastoma. These results establish a proof-of-principle of an entirely new cancer treatment modality,” principal investigator Dr. Roger Stupp of Switzerland’s University of Zurich said in prepared remarks.

Optune is a mobile device that delivers low-intensity, intermediate frequency, alternating electric fields, referred to as “tumor treating fields” to inhibit cancer cell replication and cause cancer cell death.

“We are pleased the EF-14 trial results have been published in JAMA, one of the most highly recognized and respected peer-reviewed medical journals. We believe the data will give physicians even greater confidence in the value and importance of Optune as an effective and safe treatment option for newly diagnosed GBM patients. We believe EF-14 is the first trial in glioblastoma to be stopped at the interim analysis because of clear superiority. The findings inspire us at NovoCure to continue our robust research program investigating TTFields therapy in more than a dozen other solid tumor types,” chief science officer Eilon Kirson said in a prepared statement.

Last November, NovoCure halted the trial after data from only 315 patients in the 700-patient trial showed enough data at 18 months for an independent data monitoring committee to recommend that the trial be terminated early for success.

After halting the trial, patients in the control group were offered TTField therapy prior to progression.

Results from the trial indicated, after 38 months, that patients treated with TTFields and temozolomide showed significant increases in progression-free survival at 7.1 months versus 4 months in the control group, an increase in overall survival of 20.5 months versus 15.6 in the control group, and a 2-year survival rate 50% greater than standard-of-care treatment alone.

Earlier this month, NovoCure said that a retrospective analysis of its Tumor Treating Fields therapy showed it safe in adult glioblastoma patients with implanted non-programmable shunts.

The FDA removed a pre-existing contraindication in October based on the safety data that contraindicated the therapy for patients with non-programmable shunts, NovoCure said.

The data was presented last month at the Society for Neuro-Oncology’s annual meeting in San Antonio, Texas.

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