Newly Diagnosed Safety
In newly diagnosed GBM,
Optune Gio™ + TMZ was well tolerated
No significant increase in serious AEs compared with TMZ alone1,2
- The most common (≥10%) AEs involving Optune Gio in use with TMZ were thrombocytopenia, nausea, constipation, vomiting, fatigue, asthenia, medical device site reaction, headache, convulsion, hemiparesis, and depression3
- A slightly higher incidence of grade 1 to 2 AEs was seen in some of the systems in the Optune Gio + TMZ arm of the study. This is most likely a reflection of the longer duration of TMZ treatment due to the increase in PFS seen in the treatment group1
- The rate of grade 1/2 medical device site reaction was 52% for Optune Gio + TMZ compared with 0% for TMZ alone, and severe (grade 3) skin involvement occurred in 2% of patients treated with Optune Gio + TMZ2
- Grade 3 to 4 AEs were well balanced between arms. None of the systemic grade 3 to 4 AEs were considered related to Optune Gio by any of the investigators1
- Mild-to-moderate skin irritation, the most common device-related side effect with Optune Gio, was typically manageable, reversible, and did not result in treatment discontinuation2,3
Learn about the pivotal trial study design
AEs, adverse events; GBM, glioblastoma; TMZ, temozolomide.
References: 1. Optune Gio. Instructions For Use. Novocure; 2023. 2. Stupp R, Taillibert S, Kanner A, et al. Effect of tumor-treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial. JAMA. 2017;318(23):2306-2316. 3. Novocure Data on File OPT-103.