Loading viewer...
investor_presentation
Format: PDF investor_presentation
Study 202 Overall Results and Stage 2 Results January 5, 2017 1 Copyright © 2017 Halozyme, Inc.
Study 202 Overall Results
1 Copyright © 2017 Halozyme, Inc.Study 202 Design Overview
2•Phase 2, randomized, multicenter study
•Patients with stage IV (metastatic ), previously untreated PDA
•Primary & Secondary PFS Endpoint:
–80% power at 2- sided alpha level of 0.1
CR, complete response; DCR, disease control rate; DoR, duration of response; HA, hyaluronan; KPS, Karnofsky performance status; ORR, objective response rate; OS, overall survival;
PDA, pancreatic ductal adenocarcinoma; PFS, progression- free survival; PR, partial response; SD, stable disease.Halozyme/Ventana HA Companion Diagnostic (CDx)
3Determining HA Status
•Novel CDx to identify patients with HA-High PDA tumors
•An affinity histochemistry assay with a scoring algorithm based on the HA
staining pattern area in the extracellular matrix (ECM) over the entire tumor
•PDA tumors are HA -High when the HA score is ≥50%Study 202 Study Timeline
Mar April Aug Feb Dec
• Training Set for CDx
• Develop Ventana HA scoring algorithm and
• ~40% HA High patients treated on PAG arm
discontinued PEGPH20 at the clinical hold
• Presented at ASCO 2016
•Validation Set for CDx
•Prospectively validate Ventana HA scoring
algorithm and cut -point used in Phase 3 study
•To be presented at Scientific Forum 2017
Follow up Data ReadoutStudy 202: Modifications Since Stage 1 Clinical Hold
5Statistical Analysis
Plan Planned Analysis Populations:
-Intent -to-Treat: Combined Stage 1 + Stage 2 efficacy analyses
-Efficacy Evaluable (requires post baseline assessment): Primary
-Treated population: Separate analyses of Stage 1 and Stage 2
PFS event definition to include deaths occurring within 14 days of last
Preview truncated — download the full document for the complete content.
conference
20 Pages
investor_presentation
20 Pages
Honeywell International Inc.