Download File - JOHN J. HADDAD, Ph.D.
Download File - JOHN J. HADDAD, Ph.D.
Download File - JOHN J. HADDAD, Ph.D.
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Personalized Cancer Vaccines 75<br />
CANCER VACCINES: ONGOING PHASE 3 STUDIES<br />
Favld 1 (Favrille; San Diego, CA, U.S.)<br />
Favld is an autologous active cancer immunotherapy in which recombinant<br />
patient-specific idiotype protein isolated from tumor biopsy is conjugated to keyhole<br />
limpet hemocyanin (KLH) and administered in combination with the immunostimulatory<br />
factor GM-CSF. Favld is currently undergoing a phase 3 clinical<br />
study to determine its ability to extend time to progression (TTP) in patients with<br />
follicular B-cell non-Hodgkin’s lymphoma following treatment with Rituxan 1 .The<br />
primary end point is disease-free survival at three years. At the time of the prospectively<br />
planned interim analysis conducted on 233 out of 349 randomized<br />
patients who had been followed for 12 months or more (25), there was no significant<br />
difference between FavId-treated and control groups in a secondary end point of<br />
response improvement; final data are expected at the end of 2007 (26).<br />
MyVax 1 (GTOP; Genitope Corporation, Fremont, CA, U.S.)<br />
MyVax personalized immunotherapy is an autologous active cancer immunotherapy<br />
consisting of recombinant patient-specific idiotype that is conjugated to<br />
KLH, an immunogenic carrier protein, and administered along with GM-CSF<br />
adjuvant. Results from a phase 2 study showed that 9 of the 21 patients in the<br />
study remained progression-free in their last clinical follow-up at 56 to<br />
78 months following chemotherapy. A pivotal phase 3 study to measure PFS in<br />
patients with follicular non-Hodgkin’s lymphoma is underway and scheduled to<br />
be completed by December 2007 (27).<br />
Stimuvax 1 (Biomira; Edmonton, AB, Canada/Merck KGaA,<br />
Darmstadt, Germany)<br />
Stimuvax, a non-patient-specific vaccine, consists of a synthetic peptide derived<br />
from the tumor-associated antigen MUC-1 encapsulated in a liposome (a phospholipid<br />
shell intended to facilitate and improve treatment delivery). It is designed<br />
to neutralize the immunosuppressive effect of MUC-1 to better enable the immune<br />
system to target the cancer.<br />
A phase 2, randomized, open-label trial evaluated Stimuvax in patients<br />
with stage IIIB or IV non-small cell lung cancer (NSCLC) whose disease was<br />
stable or had responded to treatment following completion of first-line standard<br />
chemotherapy, with or without radiation treatment. Final analysis of the trial,<br />
which involved 171 patients, showed a survival advantage associated with<br />
vaccination for patients with stage IIIB disease (earlier-stage disease and<br />
therefore associated with better prognosis; n ¼ 65) but not for patients with stage<br />
IV disease (advanced-stage disease, worse prognosis; n ¼ 106) (28,29). In the<br />
study, median survival was 30.6 months for stage IIIB patients who received<br />
vaccine compared with 13.3 months for stage IIIB patients in the control arm