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Backups Shown

Backups Shown. Comparison of Overall Survival versus BSC in 2nd line NSCLC. TAX317 HR (Docetaxel vs. BSC) = 0.56 95% CI : (0.35,0.88). JMEI HR (Alimta vs. historical BSC) = 0.55 95% CI : (0.33,0.90). ID : 138. Status:. Content Owner:. Overall Survival. SubCat:. SubSubCat. Reddigari.

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Backups Shown

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  1. Backups Shown

  2. Comparison of Overall Survival versus BSC in 2nd line NSCLC TAX317 HR (Docetaxel vs. BSC) = 0.56 95% CI : (0.35,0.88) JMEI HR (Alimta vs. historical BSC) = 0.55 95% CI : (0.33,0.90) ID : 138 Status: Content Owner: Overall Survival SubCat: SubSubCat Reddigari StudyID Backup

  3. Post Study Crossover Chemotherapy • Time varying covariate analysis • Compares Alimta to docetaxel within groups that have similar post study chemo • Estimates effect of post study chemotherapy • Among patients with no post study chemo • Alimta to docetaxel HR = 0.84 (0.65, 1.08) • Effect of post study chemo (interaction p=0.10) • On docetaxel HR = 1.12 (0.81, 1.53) • On Alimta HR = 1.58 (1.17, 2.12) ID : 138 Status: Content Owner: Survival by Post Study SubCat: SubSubCat Reddigari StudyID Backup

  4. 2 % T75 Weight Loss During TreatmentPercent of Patients with Weight Loss >10% TAX 317B JMEI 25 % 25% 25% 20% 20% 15% 15% 10% 10% 5% 5% 0.8 % 0.4 % 0% 0% BSC75 T75 Alimta p<0.001 p=ns ID : 138 Status: Content Owner: Non Lab, CTC, Hosp SubCat: SubSubCat Reddigari StudyID Backup

  5. Overall Survival of JBR 21 ___ Erlotinib, _____ Placebo *HR 0.71, p <0.0001 31% 22% Months * *Adjusted for stratification factors (except centre) AND EGFR status ID : 138 Status: Content Owner: TAX 317/320 SubCat: SubSubCat Reddigari StudyID Backup

  6. Concern about “Only One Small Historical Study” • No therapy could be non-inferior to docetaxel based on historical comparisons, even if many large studies show equality: • So docetaxel would not be non-inferior to itself! • Imprecision of the benefit of docetaxel over best supportive care limits any comparison • Rothmann analysis accounts for imprecision in historical data, even if study is small • If (i) no possibility of comparing with historical studies & (ii) unable to compare with best supportive care: studies will require many thousands of patients ID : 138 Status: Content Owner: NI Method SubCat: SubSubCat Swain StudyID Backup

  7. JMEI: Summary of Efficacy 1.00 0.75 0.50 0.25 0.00 0 3 6 9 12 15 18 21 Overall Survival Mo 1.00 0.75 Survival Distribution Factor 0.50 0.25 0.00 17.5 20 0 2.5 5 7.5 10 12.5 15 Post Progression Survival Survival Distribution Factor 1.00 0.75 0.50 0.25 0.00 0 3 6 9 12 15 18 21 Time to Progressive Disease Mo Version: Modified by: ; Date: ID : 135 Status: Content Owner: Overall Survival SubCat: SubSubCat Reddigari StudyID Backup

  8. Third Line Chemotherapy for the Treatment of NSCLC TAX 317 Trial Massarelli et al. Lung Cancer 2003; 39:55.700 patients43 treated 3rd-line 3rd-Line RR: 2.3%Median Survival: 3.96 mo

  9. Consistency of Secondary Endpoints in 2nd Line NSCLC Trials ID : 845 Status: Content Owner: Secondary Efficacy SubCat: SubSubCat Bunn StudyID Core

  10. JMEI: Performance Status 0/1 Patients Alive One Month after Discontinuation without Post-Study Chemotherapy ID : 743 Status: Content Owner: Survival by Post Study Objectives SubSubCat Reddigari StudyID Backup

  11. Tax 317 90% confidence interval Likelihood estimate is many times more likely than the confidence bound Likelihood based on Tax 317 90% 0.56 Hazard ratio 0.82 0.38 ID : 726 Status: Content Owner: Statistical Results Objectives SubSubCat Horan StudyID Backup

  12. 95% confidence interval Likelihood estimate is many times more likely than the confidence bound Likelihood based on JMEI 95% 0.99 Hazard ratio 1.20 0.82 ID : 725 Status: Content Owner: Statistical Results Objectives SubSubCat Horan StudyID Backup

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