MedNews
SYDNEY, AUSTRALIA - Prima BioMed Ltd (ASX: PRR; NASDAQ: PBMD; ISIN:
US74154B2034) (“Prima”, the “Company”) today announced top-line analysis
of the CAN-003 phase 2 study of CVac for treatment of epithelial
ovarian cancer patients in first or second remission.
Results
indicate that CVac was generally well tolerated, with no Serious
Adverse Events (SAEs) considered related to protocol therapy. The
majority of non-Serious Adverse Events (AEs) were considered mild and
transient in nature.
While variable, immune monitoring data indicate that CVac induces a T
cell response which may be beneficial for patients with ovarian cancer.
No evidence was seen of a humoral (or antibody) response after CVac
administration which is also considered a positive signal.
Although this study was not adequately powered to detect statistical
significance, the estimate of median progression-free survival (PFS) for
all randomized patients resulted in no observed difference between the
CVac and control groups.
The median PFS was also estimated separately for patients in first
and second remission. In first remission, the median PFS favored the
control arm when compared to the CVac treated patients. In second
remission, the median PFS favored CVac as compared to patients on the
control group. However, neither of these trends was statistically
significant.
It is considered too early to make conclusions based on Overall
Survival (OS) data. Prima will continue to monitor patient outcomes on
the CAN-003 trial until overall survival data matures.
As previously advised, further study information will be presented by
Dr. Jeffrey Goh at the European Cancer Congress in Amsterdam on October
1st, 2013. Prima’s management will hold a teleconference to discuss
results in more detail after Dr. Goh’s presentation.
Inconclusive PFS data are consistent with the trial results of a
number of cancer immunotherapy products. Trials of sipuleucel-T and
ipilimumab, and the recently reported trial of MAGE-A3 immunotherapy,
indicate that PFS (and similar endpoints like disease-free survival) may
not be useful markers of clinical benefit for cancer
immunotherapeutics. Importantly, however, several immunotherapies
demonstrate the ability to extend overall survival and OS was the basis
for marketing approvals for sipuleucel-T and ipilimumab.
Prima will engage with regulators to make appropriate amendments to
the clinical development plan for CVac in ovarian cancer and identify
the most appropriate endpoints for evaluation of clinical benefit. Until
then, Prima has temporarily suspended enrollment on its CAN-004
(“CANVAS”) clinical trial, which had been designed with PFS as the
primary endpoint. Patients currently enrolled on the CANVAS trial may
continue on the protocol as currently designed.
Matthew Lehman, Prima’s CEO: “All of us at Prima want to thank the
patients, their families, and the physicians for their involvement in
the CAN-003 trial. We are pleased that CVac has continued to demonstrate
a favorable side effect profile and positive immune activity. We are
committed to progressing our CVac clinical trials – in ovarian cancer as
well as other cancer types – in an expeditious manner.”
About the CAN-003 trial
CAN-003 is a 63-patient phase 2 study evaluating the effects of CVac,
as compared to an observation-only control arm, in epithelial ovarian
cancer patients in complete remission after first or second line
treatment. The primary objectives of the trial are to determine the
safety of CVac administration and to determine CVac’s effect on
progression-free survival. Secondary objectives of the trial are to
determine CVac’s effect of overall survival and to evaluate host
immunologic responses to CVac. In accordance with the protocol design,
the first seven patients on the trial were all assigned to receive CVac
in order to test the comparability of product manufacturing in a new
facility. The subsequent 56 patients were randomized in a 1:1 fashion
and assigned to either the CVac group or observational control group.
PDF (150 K)
Cancer is a disease in which cells in the body grow out of control.
Cancer is always named for the part of the body where it starts, even if
it spreads to other body parts later. When cancer starts in the
ovaries, it is called ovarian cancer. Women have two ovaries that are
located in the pelvis, one on each side of the uterus. The ovaries make
female hormones and produce eggs.
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