Novocure (NSDQ:NVCR) touted today the final analysis of a pivotal Phase III trial that evaluated Optune combined with temozolomide in newly-diagnosed glioblastoma patients.
The analysis, published today in the Journal of the American Medical Association (JAMA), showed that Novocure’s Optune-temozolomide combo extended overall survival and progression-free survival by 37% compared to temozolomide alone.
The drug-device therapy’s benefit was seen in all pre-specified patient subgroups, regardless of factors like age and extent of resection, the company reported.
“This is the first positive Phase III trial in newly diagnosed GBM since the efficacy of temozolomide was demonstrated in 2005,” investigator Dr. Jay-Jiguang Zhu said in prepared remarks. “The introduction of Optune with temozolomide gives newly diagnosed GBM patients the potential for long term survival. The results demonstrated that tumor treating fields are an effective antimitotic treatment modality, which could change the way we treat a variety of solid cancers in the future.”
According to data from the 695-patient trial, people treated with Optune plus temozolomide had an overall survival of 20.9 months compared to 16 months for those treated with just the drug. The company also noted that patients’ five-year survival rate jumped from 5% to 13% for the combo treatment arm compared to the comparator group.
“GBM is a very difficult to treat disease where over 20 large randomized Phase III studies have failed to show a survival benefit over the past decade. We are proud of the EF-14 final analysis and what it means to patients living with GBM,” Novocure CEO Asaf Danziger added. “We are honored to have the final analysis published in such a prestigious medical journal and believe it will help us to continue to effectively educate the medical community about the benefits of Optune with temozolomide for the treatment of newly diagnosed GBM.”
Novocure’s Optune system delivers low-intensity, intermediate frequency, alternating electric fields, called ‘Tumor Treating Fields,’ to inhibit cancer cell replication.
Glioblastoma is an especially vicious type of cancer – 85% of patients diagnosed with GBM are dead within five years. And Novocure’s Optune tech has not proven to be curative. In fact, of the 466 patients originally enrolled in the company’s trial, just five of them are still alive, according to STAT.
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