Results with Optune Gio

RESULTS WITH OPTUNE GIO

Proven to help people with newly diagnosed GBM live longer

The safety and efficacy of Optune Gio in people with newly diagnosed GBM was studied in a large, randomized clinical trial. This trial compared the effectiveness and safety of people treated with Optune Gio and chemotherapy to those treated with chemotherapy alone. In this study, those with newly diagnosed GBM who used Optune Gio in addition to chemotherapy had a greater chance to live longer than people who used chemotherapy alone.

Jeanneane, an Optune Gio user and Patient Ambassador, and Jenny, her care partner

WITH OPTUNE GIO + CHEMOTHERAPY*:

Nearly half of people using Optune Gio + chemotherapy were alive at 2 years

Compared with 31% of people using chemotherapy alone.

WITH OPTUNE GIO + CHEMOTHERAPY*:

Better survival at 5 years

13% of people using Optune Gio + chemotherapy were alive compared with 5% of people using chemotherapy alone.

WITH OPTUNE GIO + CHEMOTHERAPY*:

Tumor growth was delayed an average of 2.7 months longer

than in people using chemotherapy alone (6.7 months vs 4 months).

WITH OPTUNE GIO + CHEMOTHERAPY*:

On average, people lived 4.9 months longer

than those using chemotherapy alone (20.9 months vs 16 months).

WITH OPTUNE GIO + CHEMOTHERAPY*:

People maintained their quality of life

including mental, emotional, and physical health, for up to 12 months.

Craig, an Optune Gio user and Patient Ambassador

*Temozolomide, also known as TMZ or Temodar^®.

RESULTS IN NEWLY DIAGNOSED GBM

RESULTS IN RECURRENT GBM

Who should not use Optune Gio?

Optune Gio is not for everyone. Talk to your doctor if you have:

An implanted medical device (programmable shunt), skull defect (missing bone with no replacement), or bullet fragment. Optune Gio has not been tested in people with implanted electronic devices, which may cause the devices not to work properly, and Optune Gio has not been tested in people with skull defects or bullet fragments, which may cause Optune Gio not to work properly

A known sensitivity to conductive hydrogels (the gel on the arrays placed on the scalp like the ones used on EKGs). When Optune Gio comes into contact with the skin, it may cause more redness and itching or may rarely cause a life-threatening allergic reaction

Do not use Optune Gio if you are pregnant or are planning to become pregnant. It is not known if Optune Gio is safe or effective during pregnancy.

What should I know before using Optune Gio?

Optune Gio should only be used after receiving training from qualified personnel, such as your doctor, a nurse, or other medical staff who have completed a training course given by Novocure^®, the maker of Optune Gio.

Do not use any parts that did not come with the Optune Gio Treatment Kit sent to you by Novocure or given to you by your doctor

Do not get the device or transducer arrays wet

If you have an underlying serious skin condition on the scalp, discuss with your doctor whether this may prevent or temporarily interfere with Optune Gio treatment

What are the possible side effects of Optune Gio?

Most common side effects of Optune Gio when used together with chemotherapy (temozolomide, or TMZ) were low blood platelet count, nausea, constipation, vomiting, tiredness, scalp irritation from the device, headache, seizure, and depression. The most common side effects when using Optune Gio alone were scalp irritation (redness and itchiness) and headache. Other side effects were malaise, muscle twitching, fall and skin ulcers. Talk to your doctor if you have any of these side effects or questions.

Please click here for the Optune Gio Instructions For Use (IFU) for complete information regarding the device’s indications, contraindications, warnings, and precautions.

Results with Optune Gio