Delcath Systems, Inc. · NASDAQ:DCTH

Delcath Systems — Technical Presentation (2012)

24 slides from Delcath Systems's technical presentation, 2012

  1. Slide 1: Exploratory Survival Analysis of BAC Cross-over

    Percutaneous Hepatic Perfusion (PHP) Compared with Best Available Care (BAC) for Metastatic Melanoma in the Liver Exploratory Survival Analysis of BAC Cross-over Versus Non-Cross-over Patients For the PH-III Randomized US Multi-Center Trial Investigators APCCVIR 2012; Abstract #00131

  2. Slide 2: Phase 3 Study Investigators

    PHASE 3 STUDY INVESTIGATORS Marybeth Hughes, National Cancer Institute, Bethesda, MD H. Richard Alexander, U. of Maryland School of Medicine, Baltimore, MD Mark Faries, John Wayne Cancer Institute, Santa Monica, CA James F. Pingpank, U. of Pittsburgh, Hillman Cancer Center, Pittsburgh, PA Jonathan S

  3. Slide 3: Chemosaturation Therapy (CS-PHP)

    CHEMOSATURATION Therapy (CS- PHP) Isolation Saturatio Filtratio n n A PERCUTANEOUS ALTERNATIVE to IHP

  4. Slide 4: Filtration Procedure

    Filtration Procedure Chemo Filtration Chemo Isolation & Circuit Delivery Circuit

  5. Slide 5: Melphalan

    MELPHALAN  A bi-functional alkylating agent (nitrogen mustard)  Not cell-cycle specific – binds DNA strands  Cytotoxic effects are related to concentration and duration of exposure  Non-toxic to normal hepatocytes  Track record with surgical IHP

  6. Slide 6: Phase III: CS-PHP vs. BAC Study Design Elements

    PHASE III: CS-PHP VS. BAC STUDY DESIGN ELEMENTS • Conducted under Special Protocol Assessment (SPA) of US- FDA: • Primary Endpoint: Hepatic Progression Free Survival (hPFS) • Cross-Over: of BAC patients at hepatic progression • Stratification: Cutaneous vs. Ocular • Lead Center: National Cancer Inst

  7. Slide 7: Phase III: Statistical Analysis Plan

    PHASE III: PHP-CS VS. BAC STATISTICAL ANALYIS PLAN • Sample size: 46 patients per arm • Alpha: p≤0.05 (2-sided ) • Power: 80% to detect a difference of 4 months Hepatic PFS • Expected Hepatic PFS (used for sample size determination) • PHP (Treatment): 7.73 months • Best Alternative Care (Control): 4

  8. Slide 8: PHP-CS Arm Treatment Schema

    PHP-CS Arm Treatment Schema On Study Post Treatment Follow-up Evaluation/Randomization Interval Evaluation* (Baseline, 6-weeks, 12 weeks, 20 weeks, 28 weeks, 36 weeks) Treatments 1 through 6 - Melphalan - Angiogram (Celiac, SMA) - GDA assessment (Treatment #1) 4-5 Weeks 4-5 Weeks 4-5 Weeks 4-5 Weeks

  9. Slide 9: Phase III Preliminary Results

    PHASE III PRELIMINARY RESULTS*

  10. Slide 10: Randomization and Treatment Schematic

    Randomization and Treatment SchematicH Total Accrual: 93 patients (PHP: 44; BAC: 49, Crossover: 28) E P A T R PHP ARM I FOLLOW-UP A (N= 44) C N Cross over to D P CHEMOSATU MELANOM O R RATIOIN PHP A M O (n=28, 57%) METASTA I G TIC Z R TO LIVER E E (N = 93) BAC S 1: ARM S FOLLOW-UP 1 I (N = 49) O Scan

  11. Slide 11: Patient Demographics

    Patient Demographics Baseline Category PHP BAC P value* Characterist N=44 (%) N=49 (%) ic Age (years) Mean 55 55 NS Gender Male 23 (52) 22 (45) NS Female 21 (48) 27 (55) Race White 44 (100) 48 (98) NS Non-White 0 (0) 1 (2) ECOG Missing 3 (7) 4 (8) NS 0 37 (84) 42 (86) 1 4 (9) 3 (6) Primary Ocular 39

  12. Slide 12: PH-III Randomized US Trial Primary End Point

    PH-III Randomized US Trial Primary End Point

  13. Slide 13: Hepatic Progression-free Survival (ITT)

    Hepatic Progression-free Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 0.6 0.35 (CI: p<0.0001 0.23-0.54) 8.0 1.6 0.4 0.2 0.0 0 5 10 15 20 25 30 35 Months 3/31/11 Pingpank JF, et al. ECCO-ESMO 2011

  14. Slide 14: PH-III Randomized US Trial Secondary End Points

    PH-III Randomized US Trial Secondary End Points

  15. Slide 15: Overall Progression-free Survival (ITT)

    Overall Progression-free Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 0.6 0.36 (CI: p<0.0001 0.23-0.57) 6.7 1.6 0.4 0.2 0.0 0 5 10 15 20 25 30 35 Months Pingpank JF, et al. ECCO-ESMO 2011

  16. Slide 16: Overall Survival (ITT)

    Overall Survival (ITT) Survival probability 1.0 CS-PHP BAC 0.8 Hazard Ratio: 0.6 1.08 (CI: p=0.74 0.69-1.68) 9.8 9.9 0.4 55% crossover 0.2 0.0 0 5 10 15 20 25 30 35 40 45 50 55 Months 3/31/11 Pingpank JF, et al. ECCO-ESMO 2011

  17. Slide 17: Factors Associated with Survival

    Factors Associated with Survival Survival was Highly Associated with Use of Melphalan with CS-PHP Pingpank JF, et al. ASCO 2010

  18. Slide 18: Efficacy (Randomized to CS-PHP versus BAC)

    EFFICACY (PATIENTS RANDOMIZED TO CS-PHP VERSUS RANDOMIZED TO BAC) CS-PHP BAC HR Endpoint (N=44) (N=49) (95% CI) P value 0.35 Median hPFS, months 8.0 1.6 p<0.0001 (0.23–0.54) 1.08 Median OS, months 9.8 9.9 p=0.7403 (0.69–1.68) ORR, % 32 2 – p=0.0001 ITT population Data as of 31 March 2011

  19. Slide 19: Efficacy (CS-PHP and by BAC Subset)

    EFFICACY (CS-PHP AND BY BAC SUBSET) CS-PHP BAC-to-PHP randomized BAC only crossover Endpoint (N=44) (N=21) (n=28) Median hPFS, months 8.0 1.6 8.8 HR (crossover vs BAC-only) 0.32 Median overall survival, months 9.8 4.1 13.1 HR (crossover vs BAC-only) 0.33 Still alive as of 31 March 2011 4 3* 7 Follow

  20. Slide 20: Overall survival (ITT population)

    Overall survival (ITT population) PHP randomized v PHP crossover v BAC only 1.0 PHP randomized BAC crossover* 0.9 BAC only* 0.8 Censored observations Proportion of subjects surviving 0.7 0.6 0.5 0.4 0.3 0.2 0.1 4.1 9.8 13.1 0.0 0 12 24 36 48 60 Time (months) * Similar patient characteristics and dem

  21. Slide 21: Overall survival: Total PHP versus BAC only

    Overall survival (ITT population) Total PHP versus BAC only 1.0 Total PHP incl. crossover BAC only 0.9 Censored observations 0.8 Proportion of subjects surviving 0.7 0.6 0.5 0.4 0.3 0.2 0.1 4.1 11.4 0.0 0 12 24 36 48 60 Time (months) Overall Survival Tail For Treated Patients

  22. Slide 22: Phase III Results & Conclusions

    PHASE III RESULTS & CONCLUSIONS*  Primary endpoint exceeded, o P = 0.0001, Hazard Ratio = 0.35 o CS/PHP median hPFS of 8.0 months compared to 1.6 months for BAC o Five times gain in hPFS o 86% overall clinical benefit (CR + PR + SD)  Gen 1 Safety profile – consistent with currently approved US lab

  23. Slide 23: Phase III Results & Conclusions

    PHASE III RESULTS & CONCLUSIONS*  Secondary endpoints o OS Secondary endpoint – No difference in Kaplan-Meier curves due to cross over o 9.8 months compared to 10.0 months o CS/PHP median overall PFS of 6.7 months vs. 1.6 months for BAC  OS exploratory analysis o Median survival of 9.8 months for

  24. Slide 24: Thank you

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