Full Press Release Details
Phase 2 trial of CVac for the
treatment of ovarian cancer patients in first or second remission
Supplemental information to management
presentation on October 2, 2013
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CAN-003 Study Design
CVac group - 10 doses (60 million cells ea.) in 56 weeks
Control - observation only (standard of care)
63 patients enrolled
first 7 non randomized (to establish manufacturing comparability)
56 patients randomized 1:1
43 in 1st remission / 20 in 2nd remission
enrolled w/in 12 weeks of complete remission after 1st or 2nd line
CVac dosing started within 10 weeks of enrollment
2 year observation period
Progression determined
by GCIC criteria (CA-125) & RECIST
Primary - Safety and Progression-free survival
Secondary - Overall survival and Immune monitoring
Safety population: all 63 patients
population: 56 randomized patients
CAN-003 Data Analysis Summary
CVac was well tolerated and non-toxic
CVac induced a mucin 1 specific
No antibody response generated by CVac
No statistically significant differences observed
Divergent trends observed between first and second remission groups
8 deceased out of 58 evaluable patients
CAN-003 Statistical Considerations
not powered to detect a statistically significant difference in PFS
This sample size considered adequate on
clinical grounds to evaluate rates of tumor progression, trends in immunological outcomes, disease markers, and other clinical outcomes for the purpose of planning future trials.
The Intent-to-Treat (ITT) population includes all subjects randomized to treatment with CVac or SOC, excluding the 7
subjects assigned to CVac at the start of the study.
Serious Adverse Events (SAE)
Total of 10 SAEs in three years
SAEs by causality (9 Not Related, 1 Unlikely Related)
- Unlikely related event was small bowel obstruction
SAEs by country (7 Australia / 3 USA)
category (9 hospitalizations / 1 death)
- Death was unrelated to study agent and resulted from reported events
of respiratory failure and subdural hematoma
SAEs by outcome (8 recovered, 1 ongoing, 1 fatal)
All Adverse Event (AE) Data
definitely related included:
symptoms at injection site (localized pain, erythema, redness, swelling, burning)
events of fatigue, lethargy, and dizziness were also reported as related to study agent
Majority of events were mild (grade 1) and resolved same day
All severe events resolved except for 1 event of bunion
Severe events were mostly unrelated.
except for 1 event of widespread itch which was deemed as probably related
1 event of headache which was deemed as possibly related
CVac was well tolerated and non-toxic
Immune Monitoring - anti Mucin 1
response generated by treatment with CVac
Patient data points are
Anti mucin 1 [light intensity]
T cell Immune Monitoring Summary
patients best immune responses)
CVac induced a mucin 1 specific T cell response
Kaplan-Meier Estimates of Progression-Free Survival (ITT)
Data of all 56 patients combined showed no difference in PFS
OSC: median PFS 10.18 months
CVAC: median PFS 10.87 months
Hazard ratio 1.04 (95% CI: 0.53, 2.02)
P=0.9 by log-rank test (2-sided)
Progression Probability
Kaplan-Meier Estimates of Progression-free Survival by Randomization Strata (ITT)
While not statistically significant, different PFS trends were observed in first remission as compared to second remission
OSC: median PFS not reached yet (>20.73 months)
CVAC: median PFS 10.87 months
Progression Probability
Hazard ratio 1.90 (95%
P=0.16 by log-rank test (2-sided)
OSC: median PFS 5.14 months
CVAC: median PFS 7.69 months
Hazard ratio 0.50 (95% CI: 0.17, 1.50)
P=0.2 by log-rank test (2-sided)
OS data is immature; observation
As of September 9, 2013:
5 patients had withdrawn consent => 58 patients
8 have been confirmed as deceased
48 have been confirmed as
alive (28 CVac / 20 SOC)
Multinational manufacture and
distribution of CVac, an autologous-DC therapy, was feasible
CVac was very well tolerated & induces
cellular immune activity
Similar to many recent trials of immunotherapy for solid cancer, there appears to be
no clinically significant effect of CVac on PFS
It will be important to observe signals in Overall Survival to