| Relapse risk in cancer of the ovary |
|
Many patients with cancer of the ovary suffer a relapse, a so-called
recurrence, within one to two years despite an apparently successful
treatment with surgery and chemotherapy that led to a complete removal
of the tumour.
Until now, there was no scientifically-based therapy for the prevention
of this possible relapse; thus, there was no evidence that an extension
of the chemotherapy as the maintenance therapy prolonged the survival
time.
If a relapse occurs, then therapeutic possibilities are limited
and the disease is, in most cases, considered no longer curable.
|
| Ovarian Tumor –
Standard Treatment |
| Treatment
1st line |
‘Watch
and Wait’
(waiting and observation,
no treatment approved) |
Chemotherapy
2nd line |
Surgery+ Chemotherapy
|
Complete
response
~18 months
|
Relapse |
|
|
Mortality of 50% 5 years after diagnosis;
with late diagnosis, mortality reaches 90% |
|
|
A new therapeutic principle: vaccination with the Abagovomab antibody
A completely new therapeutic approach is a vaccination to prevent
relapse. The active substance, Abagovomab, is a monoclonal antibody
that can trigger the immune system to produce tumour-specific
antibodies. The tumour cells of the ovarian carcinoma display
the CA 125 antigen on their surface.
|
Abagovomab presents
the female immune system with a protein that “mimics”
the tumour antigen, but differs from it in such a way that the female
immune system recognises it as an antibody and stimulates an immune
reaction by which specific antibodies are formed that recognise
and fight the CA 125 protein, typical of ovarian
cancer.
This means that the body helps itself to not re-contract the disease.
International researchers are setting their hopes
high on this therapeutic principle and the active substance Abagovomab,
which is still being tested clinically and is not yet authorised
for commercial use.
In a Phase II study on 119 patients with advanced ovarian carcinoma
in which the standard therapies already proved ineffective, treatment
with Abagovomab led to a formation of antibodies against the tumour
in 70 % of patients.
This again led to a prolongation of survival time from 4.9 months
to 23.4 months.
As these results are very promising, the development to market readiness
is intended to be very rapid in order that, if it further meets
expectations, all women affected can benefit from the vaccine as
quickly as possible. |
|
|
|
|
Patients can participate in the MIMOSA study
The MIMOSA (Monoclonal antibody
Immunotherapy for Malignancies of the
Ovary by Subcutaneous Abagovomab)
study, tests the efficacy of the administered vaccine against a
placebo. The objective of the study is to test to what extent the
period of remission and overall survival can be prolonged.
Furthermore, the tolerability of repeated administrations of Abagovomab
is studied and it is intended proof be obtained that the vaccine
causes the immune system to form antibodies. Abagovomab
has been shown to be well-tolerable to date. Up to now, no serious
side effects have been observed in clinical studies with this active
substance.
About 900 women with cancer of the ovary can be
included in the study that is being conducted worldwide in 151
clinics.
The MIMOSA study is a placebo-controlled study in which the effect
of Abagovomab is compared with that of placebo. The allocation of
the treatment group (Abagovomab or placebo) is decided randomly.
The probability of treatment with Abagovomab is twice as high as
the allocation into the control arm.
Neither the attending physician, nor the patient knows whether Abagovomab
or placebo is being administered. The injection of the substances
is subcutaneous; that means, the vaccine or placebo is injected
with a small needle under the skin of the rear-end, upper thigh,
abdomen, or arm.
If no serious side effects occur or the cancer does not relapse,
the treatment lasts at least 21 months and at the most up to 45
months. In the induction phase, the vaccine (or placebo) is injected
four times at two-week intervals. In the maintenance phase, the
patients receive one shot at monthly intervals.
Physical examinations are conducted routinely during every treatment.
To further document the status of health, the patients should also
regularly consult their physician after concluding the treatment.
Further information on the MIMOSA
study: www.clinicaltrials.gov
|
|
Specific antibodies
Attack against 
Immune response (n=81)
NO Immune response (n=38)
