novocure Optune - Page 13

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7 What Studies Have Been Conducted with Optune
®
?
A second clinical study tested Optune together with temozolomide compared to temozolomide alone. The study
included 695 subjects with newly diagnosed GBM (466 subjects with Optune and temozolomide and 229 subjects
with only temozolomide).
In the clinical study using Optune with temozolomide before patients’ tumors reappeared, the time from the start of
treatment to death was measured when half of the patients had joined the study as well as at the time when all of the
total 695 patients had joined the study. The table below shows the amount of time that patients who used Optune
with temozolomide were observed to be alive longer than patients who used temozolomide alone.
Benefit of Optune + Temozolomide
Half of Patients in Study All Patients in Study
Correct use Almost 5 months longer Almost 8 months longer
All subjects 3 months longer Almost 5 months longer
In addition, more patients who used Optune with temozolomide were alive after 2 years than patients using
temozolomide alone:
Patients Alive 2 Years After the Start of Treatment
(Optune + Temozolomide vs. Temozolomide Alone)
Half of Patients in Study All Patients in Study
Correct use 48% vs. 32% 44% vs. 25%
All subjects 48% vs. 34% 43% vs. 31%
The number of subjects with digestive problems, blood problems, or infections was similar in the group treated with
Optune and temozolomide compared to the group treated with temozolomide alone.
235 out of 456 Optune subjects had mild or moderate skin reaction under the transducer arrays (red rash, small sores
or blisters). This was expected. None of these cases of skin irritation caused damage to the skin that could not be fixed.
The reaction went away after being treated with steroid cream and moving the transducer arrays. In all cases, the rash
went away after stopping treatment. Seven out of 456 Optune subjects had a larger open sore under their transducer
arrays, which needed surgery to fix.
The clinical study in patients using Optune with temozolomide before their tumor reappeared found that Optune was
more eective than temozolomide alone in treating GBM. Treatment with Optune increased the time until the tumor
reappeared and also increased the time patients lived.
Ask your doctor for more details about the clinical studies of Optune. For more information, visit our website:
www.Optune.com
What Studies Have Been Conducted with Optune?