Phase III trial results for Optune in glioblastoma published in JAMA Oncology.- Novocure.

Novocure announced that a detailed quality of life analysis of Novocure�s EF-14 phase III pivotal trial of Optune in combination with temozolomide for the treatment of newly diagnosed glioblastoma (GBM) has been published in JAMA Oncology. This secondary endpoint analysis demonstrated that the addition of Optune to temozolomide did not negatively impact health-related quality of life, except for itchy skin under Optune�s transducer arrays. The analysis also demonstrated that a higher proportion of patients treated with Optune and temozolomide reported stable or improved quality life for global health status, pain, physical functioning and leg weakness.

The analysis concluded that the use of Optune in combination with temozolomide extended progression free and overall survival in patients with newly diagnosed glioblastoma, without negatively influencing their quality of life. More patients treated with the combination of Optune and temozolomide reported stable or improved scores on: global health status (53 percent versus 38 percent, p=.001), pain (57 percent versus 36 percent, p<.0001), physical functioning (54 percent versus 38 percent, p=".001)" and leg weakness (59 percent versus 42 percent, p=".001)" when compared to patients treated with temozolomide alone. deterioration-free survival (the time until quality of life declined by more than 10 points or disease progression) was longer (p><.01) for patients treated with the combination of optune and temozolomide versus patients treated with temozolomide alone for: global health (4.8 versus 3.3 months), physical (5.1 versus 3.7 months) and emotional functioning (5.3 versus 3.9 months), pain (5.6 versus 3.6 months) and leg weakness (5.6 versus 3.9 months).>

Time to deterioration (the time until quality of life declined by more than 10 points, excluding disease progression) did not significantly differ between treatment arms, except for itchy skin (8.2 months for patients treated with Optune plus temozolomide versus 14.4 months for patients treated with temozolomide alone, p<.001), and pain (13.4 months for patients treated with optune plus temozolomide versus 12.1 months for patients treated with temozolomide alone, p><.001).>

See: "Influence of Treatment With Tumor-Treating Fields on Health-Related Quality of Life of Patients With Newly Diagnosed GlioblastomaA Secondary Analysis of a Randomized Clinical Trial." Martin J. B. Taphoorn et al. JAMA Oncol. Published online February 1, 2018. doi:10.1001/jamaoncol.2017.5082