Real-World Results

Sections

Real-world survival and QoL results

3 real-world studies in over 2,000 patients show that the Optune Gio pivotal efficacy and safety was maintained in practice^33-35

Efficacy meta-analysis: Consistent efficacy results across multiple real-world studies³³

A systematic literature review identified 9 clinical studies that reported on OS—including the EF-14 clinical trial
Pooled results from the 6 real-world studies show a 5-month benefit in mOS when adding Optune Gio to the Stupp protocol,* consistent with pivotal trial results
Median OS: 22.6 months with Optune Gio + Stupp protocol vs 17.4 months with Stupp protocol alone

Table of OS comparison for Optune Gio + SOC vs SOC alone, with pooled median, 2-year, and 4-year OS rates.

~5-month increase in median OS with Optune Gio was consistent between the real-world setting and the pivotal EF-14 trial³³

Extend past the clinical trial to the real-life setting

TIGER: the largest, prospective real-world study of Optune Gio: Robust OS and PFS results across real-world patients with a broad range of clinical characteristics that was consistent with EF-14³⁴

Median OS: 19.6 months for Optune Gio + TMZ
Median PFS: 10.2 months for Optune Gio + TMZ

While 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. No deaths were associated with device-related SAEs^1,34

Only SAEs (grade 3-5) were measured in the TIGER study. The rates of mild-to-moderate AEs (grade 1-2) were not recorded. In the EF-14 trial, the most common AEs associated with Optune Gio device use were skin related and mild to moderate

Limitations:

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 caution³⁴
The TIGER study is not yet fully published. There may be additional study details and/or limitations other than those included in the poster

The TIGER study showed Optune Gio is both effective and well-tolerated in the real-world clinical setting^1,34

QoL real-world study: Data from over 1,000 patients showed real-world QoL can be maintained while on Optune Gio³⁵

To assess QoL in patients actively using Optune Gio for treatment of GBM, EQ-5D-5L and EQ-VAS questionnaires were sent to 2,182 patients in the US and 633 patients in the EU, 1106 of whom were included in the final analysis³⁵
Mean time on Optune Gio in this real-world study was 13.5 months and in EF-14 was 12.5 months^2,35
The current Optune Gio model is half the size and weight of the model used in this study

HR-QoL was positively associated with longer time on Optune Gio^35†‡

Overall Health Score^§

2.63

(higher values indicate improved self-rated health)

Self-care

-0.17

(lower values indicate less impairment)

Mobility

-0.12

(lower scores indicate improved self-rated health)

Usual Activities

-0.17

(lower values indicate less impairment)

Limitations³⁵:

While the study was designed for ease of completion, patient privacy, and compliance with approved labeling, that meant some details remain unknown about each patient’s disease, treatment, or supportive care that could impact HR-QoL
Because all information was self-reported, it was not possible to verify responses with medical records
There may be a response bias, as patients who decided to respond to the survey may not be representative of all patients receiving Optune Gio in the US and the EU

Real Patient Cases

*Predominantly included maximal surgical resection followed by standard RT + concurrent TMZ and adjuvant TMZ.³³

^†In the univariate analysis based on log (time on Optune Gio).

^‡As measured by EuroQol’s EQ-5D-5L questionnaire and EuroQol’s visual analogue scale (EQ-VAS), a standard questionnaire in which patients can rate their overall health score.

^§As measured by EQ-VAS.

GBM, glioblastoma; mOS, median overall survival; OS, overall survival; QoL, quality of life; RT, radiation therapy; TMZ, temozolomide. AEs, adverse events; EQ-5D-5L, EuroQol 5-dimensional, 5-level survey; EU, European Union; HR-QoL, health-related quality of life; PFS, progression-free survival; SAEs, serious adverse events; TIGER, TTFields In GErmany in Routine Clinical Care (NCT03258021); US, United States.

Real-World Results

Sections

Real-world survival and QoL results

Extend past the clinical trial to the real-life setting

Real Patient Cases

Indications For Use

Important Safety Information

Contraindications

Warnings and precautions

Please click here to see the Optune Gio^®Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.

References

Real-World Results

Sections

Real-world survival and QoL results

Extend past the clinical trial to the real-life setting

Real Patient Cases

Indications For Use

Important Safety Information

Contraindications

Warnings and precautions

Please click here to see the Optune Gio® Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.

References

Please click here to see the Optune Gio^®Instructions For Use for complete information regarding the device’s indications, contraindications, warnings, and precautions.