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OPT-0088
In newly diagnosed GBM
5-year survival data from a phase 3, randomized, clinical trial now published in JAMA

Effect of tumor treating fields plus maintenance temozolomide vs maintenance temozolomide alone on survival in patients with glioblastoma: a randomized clinical trial

The Journal of the American Medical Association.
2017;318(23):2306-2316.
Roger Stupp, MD, Sophie Taillibert, MD, Andrew Kanner, MD, et al.
Proven superior long-term survival with Optune® + TMZ vs TMZ alone with 5 years of clinical evidence1

cta01_20171231
At 5 years, Optune + TMZ had consistently superior results vs TMZ alone1
5-Year OS: 13% vs 5% (P=0.004)
•  Median OS: 20.9 months vs 16.0 months (P<0.001)
•  Median PFS: 6.7 months vs 4.0 months (P<0.001)
•  Increased OS, regardless of age, KPS, MGMT promoter methylation status, extent of resection, or gender

Optune + TMZ was safely combined for 5 years1
•  No late-emerging serious AEs were seen in the 5-year follow-up

Study Design: Optune was studied in the EF-14 trial, a large, prospective, open-label, randomized, phase 3 trial in newly diagnosed GBM patients comparing Optune + TMZ with TMZ alone (N=700). The primary endpoint was PFS and OS was a powered secondary endpoint. The 5-year survival analysis included all
695 evaluable patients, with a median follow-up of 40 months and a minimum follow-up of 24 months.


Indications For Use

Optune is intended as a treatment for adult patients (22 years of age or older) with histologically-confirmed glioblastoma multiforme (GBM).

Optune with temozolomide is indicated for the treatment of adult patients with newly diagnosed, supratentorial glioblastoma following maximal debulking surgery, and completion of radiation therapy together with concomitant standard of care chemotherapy.

Important Safety Information

Contraindications

Do not use Optune in patients with an active implanted medical device, a skull defect (such as, missing bone with no replacement), or bullet fragments. Use of Optune together with implanted electronic devices has not been tested and may theoretically lead to malfunctioning of the implanted device. Use of Optune together with skull defects or bullet fragments has not been tested and may possibly lead to tissue damage or render Optune ineffective.

Do not use Optune in patients that are known to be sensitive to conductive hydrogels. In this case, skin contact with the gel used with Optune may commonly cause increased redness and itching, and rarely may even lead to severe allergic reactions such as shock and respiratory failure.

Warnings and Precautions

Optune can only be prescribed by a healthcare provider that has completed the required certification training provided by Novocure™ (the device manufacturer).

Do not prescribe Optune for patients that are pregnant, you think might be pregnant or are trying to get pregnant, as the safety and effectiveness of Optune in these populations have not been established.

The most common (≥10%) adverse events involving Optune in combination with temozolomide were thrombocytopenia, nausea, constipation, vomiting, fatigue, medical device site reaction, headache, convulsions, and depression.

Use of Optune in patients with an inactive implanted medical device in the brain has not been studied for safety and effectiveness, and use of Optune in these patients could lead to tissue damage or lower the chance of Optune being effective.

If the patient has an underlying serious skin condition on the scalp, evaluate whether this may prevent or temporarily interfere with Optune treatment.

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

AEs, adverse events; KPS, Karnofsky Performance Status; MGMT, O-6-methylguanine–DNA methyltransferase; OS, overall survival; PFS, progression-free survival; TMZ, temozolomide.
Reference: 1. 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.
cta02_20171231


Sincerely,

Pritesh Shah
Sr. Vice President of the Americas


novocure

     Novocure · 195 Commerce Way · Portsmouth, NH 03801 · USA
©2018 Novocure. All rights reserved. Optune and Novocure are trademarks of Novocure. OPT-1287.1


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