NOVO

U RE

NovoCure EF-11 Recurrent GBM Pivotal Trial Summary of Results Presented at ASCO 2010
Presented by Roger Stupp, M.D. of CHUV

Protocol
A Prospective, Randomized, Multi-center Trial of NovoTTF-100A Compared to Best Standard of Care in Patients with Progressive or Recurrent GBM.

Key Parameters
237 patients from 28 centers in the US and Europe. 1:1 randomization (50% each arm) between using the NovoTTF-100A device alone or using a best physicians choice chemotherapy (control group) Primary endpoint of overall survival and toxicity

Patient Characteristics
53% were second or greater recurrence 20% had failed bevacizumab prior to the trial 25% were re-operated for recurrence prior to the trial Mean tumor diameter was 5.4cm on the control arm and 6.1cm on the NovoTTF-100A arm 185 patients received at least one dose (see note below) of treatment on the trial (Per Protocol (PP) population) Patients on the control arm (n=117) received: Nitrosureas or PCV or Procarbozine (33%) Bevacizumab (13%) Platinum based (11%) TMZ (11%) CPT-11 (6%) Miscellaneous (5%) Dropped from study immediately after randomization (21%)

Key Data Overall survival

Median of 6.6 months on the NovoTTF-100A versus 6.0 months on the control for the Intent to Treat population (ITT, n=237) Median of 7.8 months on the NovoTTF-100A versus 6.1 months on the control for the Per Protocol population (PP, n=185, p<0.05)

Response rate (per MacDonald, 50% or greater reduction in area)

11.7 % on the NovoTTF-100A versus 5.9% on the control for the ITT population (p=0.07) 15.1% on the NovoTTF-100A versus 7.6% on the control for the PP population (p=0.03) 3 complete responses on the NovoTTF-100A versus no complete responses on the control

NOVO

U RE

Progression-free Survival At 6 Months

24% on the NovoTTF-100A versus 17% on the control for the ITT population (p=0.27) 28% on the NovoTTF-100A versus 14% on the control for the PP population (p=0.04)

One Year Survival Rate

23.6% on the NovoTTF-100A versus 20.7% on the control for the ITT population 29.5% on the NovoTTF-100A versus 19.2% on the control for the PP population

Adverse Events (AEs)

AEs common to chemotherapy such as hematological toxicity and gastro-intestinal problems were signicantly lower in the NovoTTF-100A arm AEs related to central nervous system such as seizures and headaches were not different between arms The only AE reported more frequently in the NovoTTF-100A arm was a skin irritation under the electrodes reported in 17% of the NovoTTF-100A patients

Overall Survival in Patients Who Failed Bevacizumab Prior to The Trial

4.0 months on the NovoTTF-100A versus 3.1 months on the control arm in the ITT population (n=44, p=0.022) 6.3 months on the NovoTTF-100A versus 3.3 months on the control arm in the PP population (n=29, p=0.001) Note: One dose on the NovoTTF-100A arm is dened as greater than 70% compliance for at least four weeks of treatment. One dose on the control arm is dened as one standard cycle for the selected agent. The Per Protocol Population is dened as those patients receiving at least one dose of treatment.

www.novocuretrial.com

For more information see