A Randomized Placebo Controlled Study of Erlotinib (OSI-774, Tarceva

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1 A Randomized Placebo Controlled Study of Erlotinib (OSI-774, Tarceva ) ) versus Placebo in Patients with Incurable Non-Small Cell Lung Cancer Who Have Failed Standard Therapy for Advanced or Metastatic Disease FA Shepherd, J Pereira, T Ciuleanu, E Tan, V Hirsh, S Thongprasert, A Bezjak, D Tu, P Santabárbara, L Seymour for the National Cancer Institute of Canada Clinical Trials Group

2 Background & Rationale EGFR expression is common in NSCLC Expression has been associated with: increased tumour cell motility increased adhesion increased metastatic potential increased vascularity chemotherapy resistance reduced survival EGFR mutations have been described in NSCLC

3 Phase II Activity of EGFR TKIs Number Result Erlotinib Gefitinib IDEAL 1 250mg 500mg Gefitinib IDEAL 2 250mg 500mg Response Rate 12.3% 18% 19% 12% 9% Median Survival 8.4 m 7.6 m 8.0 m 7.0 m 6.0 m 1-Yr Survival 40% 35% 29% 27% 24%

4 NCIC CTG BR.21 Study Design Prospectively randomized Phase III trial Placebo controlled Led by the National Cancer Institute of Canada Clinical Trials Group Canadian and International Member Centre participation

5 BR.21 Study Design - 2 Stratified by: Centre PS, 0/1 vs 2/3 Response to prior Rx (CR/PR:SD:PD) Prior regimens, (1 vs 2) Prior platinum, (Yes vs no) R A N D O M I S E Erlotinib* 150 mg daily Placebo 150 mg daily *2:1 Randomization

6 BR.21 Study Endpoints Primary Overall survival Secondary Time to deterioration of cough, dyspnea and pain (QoL, QLQC30 & QLQCLC13) Progression-free survival Response rate & duration of response Toxicity & tolerability

7 BR.21 Statistical Considerations Median survival of untreated patients was estimated to be 4 months Original HR 0.67 Revised HR 0.75 (before any analyses) Goal: detect an improvement in median survival of 33% 90% power and a 2-sided 5% level test 700 patients required to enter the study over 14 months with 6 months follow-up; 582 events required

8 BR.21 Key Eligibility Criteria Prior chemotherapy for NSCLC 1 or 2 prior regimens (at least 1 a combination regimen) Elderly patients may have received 1 or 2 single agent regimens Performance status 0-3 Adequate hematology and biochemistry Signed informed consent

9 BR.21 Key Exclusion Criteria Prior treatment with any EGFR inhibitor Prior breast cancer or melanoma at any time, other prior cancers within last 5 years Significant ocular or GI disorders Significant co-morbid diseases Symptomatic CNS metastases

10 BR.21 Results BR.21 Results 731 patients randomized Aug/01 Jan/03 22 ineligible >2 regimens (9) Only single agent in young patient (2) CT or RT given within 2-4 weeks, concurrent CT (5) Biochemical abnormalities (4) Symptomatic CNS metastases (2) Efficacy analyses All 731 patients included Only 7 (<1%) patients lost to follow-up All treated patients (727) included in safety analyses

11 BR.21 Patient Characteristics Erlotinib (N=488) Placebo (N=243) Median Age (yrs) Gender ECOG PS (%) Histology Male 65% 66% Female 0 35% 34% 13% 14% 1 52% 54% 2 26% 23% 3 9% 9% Adenocarcinoma 50% 49% Other 50% 51%

12 BR.21 Patient Characteristics Erlotinib (N=488) Placebo (N=243) Measurable Disease 88% 87% Prior Chemotherapy Best Response to Prior Chemotherapy 1 regimen 50% 50% 2 regimens 49% 49% 3 regimens 1% 1% Prior platinum 93% 92% CR/PR 40% 40% SD 39% 39% PD 21% 21%

13 NCIC CTG BR.21: Best Response 638 patients had measurable disease 9% of erlotinib patients had objective response (CR or PR): duration 7.9 months Best response of disease progression: 57% for placebo 38% for erlotinib

14 BR.21 Progression Free Survival Erlotinib: 2.2 m Placebo: 1.8 m *HR 0.61, p < Months * *Adjusted for stratification factors (except centre) AND EGFR status

15 BR.21 Overall Survival Erlotinib: 6.7 m Placebo: 4.7 m g 60 *HR 0.71, p < % 22% Months * *Adjusted for stratification factors (except centre) AND EGFR status

16 BR.21 Adverse Events Erlotinib (N=485) Placebo (N=242) Total % G 3 or 4 % Total % G 3 or 4 % Fatigue 79% 19% 74% 23% Rash 76% 9% 17% 0% Anorexia 69% 9% 56% 5% Diarrhea 55% 6% 19% <1% Nausea 40% 3% 34% <1% Infection 34% 10% 21% 5% Ocular 28% 1% 9% <1% Vomiting 25% 3% 23% 2%

17 BR.21 Adverse Events (2) Erlotinib (N=485) Placebo (N=242) Total % G 3 or 4 % Total % G 3 or 4 % Hemoptysis 24% 1% 22% <1% Constipation 23% 2% 27% 2% Stomatitis 19% <1% 3% 0% Dehydration 7% 4% 6% 3% Pulm Fibrosis 3% <1% 3% 0% Pneumonitis/ Pulmonary Infiltrate 3% <1% 3% <1%

18 BR.21 Time to Deterioration of QoL Symptoms Erlotinib Placebo P* N Median (95%CI) N Median (95%CI) Cough m 153 ( m) 3.7 m ( m) 0.04 Dyspnea m ( m) m ( m) 0.01 Pain m ( m) m ( m) 0.02 *unadjusted

19 BR.21 Summary This is the first placebo controlled randomized trial to confirm that an oral tyrosine kinase inhibitor of EGFR can prolong survival Treatment with erlotinib was associated with significantly longer overall survival longer progression free survival improved lung cancer-related symptoms improved QoL

20 Acknowledgements Support: National Cancer Institute of Canada OSI Pharmaceuticals Thank you to the NCIC CTG central office staff in Kingston, Ontario, Canada, and..

21 Thank you to all patients and investigators from around the globe USA Mexico Sweden Germany Romania Greece Israel Hong Kong Thailand Singapore Brazil South Africa Australia Chile Argentina New Zealand

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