Efficacy and Safety
Real-world data consistent with EF-14 study results1-3
Review the efficacy data from multiple real-world studies of Optune Gio:
From the efficacy meta-analysis
OS benefit maintained across real-world studies1
To assess the consistency of the survival benefit observed in EF-14, a systematic literature review was conducted of clinical studies that reported on OS in patients with newly diagnosed GBM1
- The pooled meta-analysis included 7 studies (1430 total patients) that reported on OS of Optune Gio when added to the Stupp protocol* vs Stupp protocol* alone
Meta-analysis limitations1
- All studies included in the analysis were retrospective and lacked randomization between treatment groups
- Additional prognostic factors beyond those routinely captured for patients with GBM and reported here may exist
- Patterns related to how long patients sustain treatment with Optune Gio could not be evaluated and remain unknown
Results of the meta-analysis showed Optune Gio + Stupp protocol* was associated with improved survival vs Stupp protocol* alone1-3
- 37% reduction in the risk of death with Optune Gio + Stupp protocol* vs Stupp protocol* alone (HR: 0.63 [95% CI, 0.53-0.75])1
*Predominantly included maximal surgical resection and TMZ-based standard chemoradiotherapy.1
Optune Gio survival benefit pooled across real-world results1,†
*Predominantly included maximal surgical resection and TMZ-based standard chemoradiotherapy.1
†Pooled analysis of just the 6 real-world comparative datasets from the meta-analysis.1
~5-month increase in median OS with Optune Gio was consistent between the real-world setting and the pivotal EF-14 trial1
From the prospective real-world study
Additional OS and PFS results from the largest, prospective real-world study of Optune Gio
To evaluate the OS and PFS and to assess the safety of Optune Gio in patients with newly diagnosed GBM, a prospective, noninterventional study that assessed routine clinical visits was conducted in Germany.2
- The TIGER Study included 429‡ patients from 81 centers and assessed results for over 4 years (median follow-up was 56.2 months)
Prospective real-world study limitations2
- The TIGER Study was an observational and nonrandomized study conducted in Germany, and did not include a control group. As with all observational research, comparisons to other interventional and noninterventional studies should be made with caution
- The TIGER study is not yet fully published. There may be additional study details and/or limitations other than those included in the poster
‡Initially, 710 patients agreed to participate in the TIGER Study.
Safety results from the TIGER Study showed Optune Gio was well tolerated in real-world patients2,4
- While serious adverse events (SAEs) were observed in TIGER, the vast majority were not attributed to Optune Gio. Only 3 SAEs (0.7%) were attributed to Optune Gio, and all were considered mild to moderate in severity. 0 deaths were associated with device-related SAEs
- Only SAEs (serious adverse events, grade 3-5) were measured in the TIGER Study. The rates of mild to moderate AEs (adverse events, grade 1-2) were not recorded. Based on clinical data from the EF-14 trial, the most common AEs associated with the Optune Gio device use were skin-related and mild to moderate
GBM, glioblastoma; IDH1, isocitrate dehydrogenase-1; ITT, intent-to-treat; MGMT, O-6-methylguanine-DNA methyltransferase; OS, overall survival; PFS, progression-free survival; SAE, serious adverse event; TIGER, TTFields In GErmany in Routine Clinical Care.
References: 1. Ballo MT, Conlon P, Lavy-Shahaf G, Kinzel A, Vymazal J, Rulseh AM. Association of tumor treating fields (TTFields) therapy with survival in newly diagnosed glioblastoma: a systematic review and meta-analysis. J Neurooncol. 2023;164(1):1-9. doi:10.1007/s11060-023-04348-w 2. Bähr O, Tabatabai G, Fietkau R, Goldbrunner R, Glas M. Tumor Treating Fields Therapy in Patients With Newly Diagnosed Glioblastoma: Long-Term Survival Results From TTFields in Germany in Routine Clinical Care (TIGER) Study. Poster presented at: American Society of Clinical Oncology; May 31-June 4, 2024; Chicago, IL. 3. Palmer JD, Chavez G, Furnback W, et al. Health-related quality of life for patients receiving tumor treating fields for glioblastoma. Front Oncol. 2021;11:772261. doi:10.3389/fonc.2021.772261 4. Optune Gio. Instructions For Use. Novocure; 2023.