Slide 1: Analysis Phase 2 trial of CVac for ovarian cancer patients in first or second remission
Analysis Phase 2 trial of CVac for the treatment of ovarian cancer patients in first or second remission Supplemental information to conference call on 3rd June, 2014 ASX:PRR; NASDAQ:PBMD; ISIN:US74154B2034
Slide 2: Introductions
Introductions Dr Bradley J. Monk Professor Division Director Division of Gynecologic Oncology Department of Obstetrics and Gynecology University of Arizona Cancer Center Dr Heidi Gray Associate Professor University of Washington Medical Center Fred Hutchinson Cancer Research Center
Slide 3: Progression-free survival in second remission improved with mucin 1 autologous dendritic cell therapy (CAN-003)
PROGRESSION-FREE SURVIVAL IN OVARIAN CANCER PATIENTS IN SECOND REMISSION IS IMPROVED WITH MUCIN 1 AUTOLOGOUS DENDRITIC CELL THERAPY (CAN-003) Heidi J. Gray, MD Data presented at the 50th ASCO Annual Meeting May 31, 2014
Slide 4: CAN-003
CAN-003: Randomized open label, phase 2 trial Purpose: – Determine the safety and efficacy of CVac vs Observational Standard of Care in patients with First or second remission Primary Objectives: Safety Progression-free survival (PFS) Secondary Objectives: Overall survival (OS) Immunologic response
Slide 5: Study Design
Study Design Patient R Population: Maintenance CVac A 9 Previously 10 doses (60 x 10 cells/dose) N Efficacy ITT Cytoreduced, Over 56 weeks (N = 29) Run-in* D Stage 3-4 EOC, (N= 7) Population O (N=56) First or Second M Control Arm Remission I Observational Standard of Care Within Z (N = 27) 12 weeks
Slide 6: Results: Demographics
Results: Demographics Characteristic CVAC SOC (N=29) (N=27) Remission status Achieved after first-line therapy 19 (66%) 17 (63%) Achieved after second-line therapy 10 (34%) 10 (37%) Disease stage III 24 (83%) 20 (74%) IV 5 (17%) 7 (26%) Histology subtype Serous 25 (86%) 23 (85%) Endometrioid 1 (3%)
Slide 7: Serious Adverse Events
Serious Adverse Events Event Outcome Causality Treatment group Recovered with 1.Small bowel obstruction Unrelated CVac treatment 2. Abdominal pain, dehydration, Recovered with Unrelated SOC nausea, vomiting treatment 3. Abdominal pain Recovered Unlikely Related CVac 4. Respiratory failure Fatal Unre
Slide 8: Progression-Free Survival (ITT, n=56)
Progression-Free Survival (ITT, n=56) 1.00 OSC: median PFS 8.64 months CVAC: median PFS 12.89 months Haz ard ratio 0.72 (95% CI: 0.38, 1.38) ity l 0.75 P=0.33 by log-rank tes t (2-s ided) Probabi sion 0.50 Progre s 0.25 0.00 0 6 12 18 24 30 Months OSC 10/27 5/15 1/10 4/9 0/0 CVAC 6/29 7/20 2/13 2/8
Slide 9: Comparison of PFS First Remission vs Second Remission
Comparison of PFS First Remission HR1.18 Second Remission HR0.32 Hazard ratio 0.32 (95% CI: 0.10, 1.03) Hazard ratio 1.18 (95% CI:0.51, 2.71) P=0.69 by log-rank test (2-sided) P=0.04 by log-rank test (2-sided) 1.00 1.00 OSC: median PFS 18.20 months OSC: median PFS 4.94 months CVAC: median PFS 12.89
Slide 10: Overall Survival First Remission vs Second Remission
Overall Survival First Remission HR0.63 Second Remission HR0.17 1.00 1.00 Probability 0.75 0.75 0.50 OSC: median OS not reached yet 0.50 OSC: median OS 26.25 months CVAC: median OS not reached yet CVAC: median OS not reached yet Survival Hazard ratio 0.63 (95% CI: 0.14, 2.82) Hazard ratio 0.17 (95%
Slide 11: Conclusions
Conclusions Feasibility - Multinational manufacture and distribution of CVac was possible Safe - CVac was well tolerated with minimal toxicity Immunogenic - Positive mucin 1-specific T cell response in CVac treated patients PFS signal in second remission Interim OS signal in second remission
Slide 12: Acknowledgements
Acknowledgements Patients & their families for participation My fellow collaborators in CAN-003 Goh J1, Mason J2, Chan J3, Bottino J4, Berek J5, Beningno B6, Mileshkin L7, Recio F8, Tchabo N9, Del Priore G10, Eisenberg P11, Rose P12, Mitchell P13, Young J14, Matos M15, Secord A16, Davy M17, Gargosky
Slide 13: Q&A
Q&A Dr Bradley J. Monk Professor Division Director Division of Gynecologic Oncology Department of Obstetrics and Gynecology University of Arizona Cancer Center Dr Heidi Gray Associate Professor University of Washington Medical Center Fred Hutchinson Cancer Research Center