WHAT IS THE MIMOSA TRIAL?
MIMOSA is a demanding multinational trial that will be carried out
over the next 9 years with 900 patients with ovarian cancer who
have responded well to the initial treatment (surgery + chemotherapy).
Its purpose is to verify the efficacy and safety of the vaccination
with Abagovomab for the prevention or delay of recurrences of the
disease.
WHAT IS ABAGOVOMAB?
Abagovomab is an antibody to be used as a therapeutic vaccine for
the prevention of recurrences of ovarian cancer.
HOW DOES ABAGOVOMAB WORK?
Abagovomab stimulates the patient’s immune system to recognize
the ovarian cancer cells as foreign to the organism and to kill
them.
FOR WHICH DISEASE IS ABAGOVOMAB STUDIED?
Abagovomab is being studied for the treatment of ovarian cancer
and, more precisely, for the prevention of the tumour’s regrowth,
which unfortunately is very frequent and highly aggressive with
this type of tumour.
WHAT
THERAPEUTIC RESPONSE IS EXPECTED WITH ABAGOVOMAB?
Even though the data obtained so far is not yet conclusive, it indicates
that Abagovomab helps the patient’s immune system to fight
the tumour’s regrowth. This hypothesis will be studied in
detail during the MIMOSA trial.
WHICH
PATIENTS CAN USE ABAGOVOMAB?
Patients included in the trial will have a prior diagnosis of advanced-stage
ovarian tumour and on entering the trial will be in apparent remission
after radical surgery and chemotherapy. The purpose for administering
the vaccine is to maintain patients disease-free by preventing the
tumour’s regrowth and thus extending survival.
HOW IS THIS VACCINE ADMINISTERED?
Similar to many other vaccines, the vaccine is administered subcutaneously
using a small syringe; this is usually completely painless. At the
beginning, the vaccination must be repeated every two weeks, followed
by monthly administrations in order to induce and maintain the immune
response against the tumour cells.
WHAT ADVANTAGES DOES ABAGOVOMAB OFFER COMPARED TO TRADITIONAL TREATMENTS?
There are actually NO treatments for the prevention of the regrowth
of ovarian tumours; Abagovomab would therefore be an absolute novelty
for these patients. In any case, since this is a vaccine and not
a classic anti-tumour drug, Abagovomab will not cause the typical
side effects of common chemotherapies (e.g. nausea, fever, hair
loss, etc.), but at most a slight local reaction typical of all
vaccinations.
DOES
THE VACCINE HAVE TO BE REPEATED FOR THE PATIENT’S ENTIRE LIFE?
We do not yet know for how long Abagovomab will have to be given.
During the MIMOSA trial it will be administered continuously for
2-4 years, because we know that in this way we will maintain an
adequate antibody reaction against the tumour’s regrowth.
However, the patients will be followed for much longer (up to 5
years) after the end of the treatment in order to verify its benefits
even for the long-term and after suspension of the therapy.
ARE PARTICULAR EXAMINATIONS NEEDED TO VERIFY THE EFFICACY OF TREATMENT
WITH ABAGOVOMAB?
No, the patients of the MIMOSA trial will be followed very closely
and frequently, but using the clinical and radiological examinations
usually used for the follow-up without the need for any particular
invasive examinations that might cause discomfort to the patients.
|