Avax Technologies, Inc., has released 9-year
follow-up data of stage III melanoma patients from company-sponsored
phase II studies of M-Vax, an individualized cell-based vaccine for
cancer. Ernest W. Yankee, PhD, the companys executive vice-president,
presented the data at the 26th annual meeting of the Clinical
Oncological Society of Australia in Melbourne. Australia has the
highest incidence of melanoma in the world, three times the rate in
the United States.
David Berd, md, professor of medicine, Thomas Jefferson University,
and the inventor of M-Vax, began studies of the vaccine in 1989 and
now has data from a sufficient number of patients to conduct a
long-term analysis. At the conference, Dr. Yankee highlighted the
results from 71 patients who were melanoma free for at least 2 years
following treatment with M-Vax and then were monitored for up to 9.8
years (median follow-up, 5.3 years). The 9-year overall survival rate
was approximately 85% in this group of patients, demonstrating that
the clinical response to M-Vax therapy is long lasting. The 9-year
relapse-free survival rate in these patients was 80%. No serious or
long-term toxic effects of M-Vax were observed in any patient.
Confirming earlier findings, a patients clinical outcome was
strongly influenced by the development of cell-mediated immunity to
the patients own melanoma cells. Cell-mediated immunity is
measured by a simple skin test (delayed-type hypersensitivity [DTH]
test) administered to the patient after the vaccine treatment is completed.
Of the 71 patients, all had received M-Vax after surgical debulking
of bulky regional lymph node metastases, and over half had entered
the studies with one or more widely recognized indicators of poor
prognosis. These included in-transit metastases or metastases to
multiple lymph nodes.
Immune Response and Survival
There are several experimental vaccines administered
post-surgically that claim prolonged survival rates in stage III
melanoma patients, said Dr. Yankee. These survival rates
are generally calculated on the basis of estimates and not on actual
observations. We believe that AVAX is the only cancer vaccine company
with strongly positive survival data that extend to 5 years and
beyond in a group of patients that were given very little hope for
Characterizing the data as extremely encouraging, Dr.
Yankee emphasized that the investigators have noted a direct
correlation between the development of an immune response to the
patients melanoma cells and survival. We &ldots;.believe
that these vaccines, which are made from a patients own tumor
cells, provide potential therapies for patients with other
cancers, he said.