Lymphoma Vaccine Shows Promise
A pivotal phase III trial of BiovaxID shows promising results in follicular lymphoma.
6/24/2009
Lymphoma vaccines have been in development for more than 20 years, with mixed results. However, promising data from a recent phase III clinical trial testing the BiovaxID vaccine were presented at the 2009 American Society of Clinical Oncology (ASCO) annual meeting in Orlando, FL.
Vaccines used to treat lymphoma are different from traditional vaccines that are used for the prevention of infection. Lymphoma vaccines are designed to treat a tumor after it has developed and are therefore labeled therapeutic vaccines.
Therapeutic vaccines are designed to stimulate a patient's own immune system to recognize and destroy cancer cells, while sparing healthy cells. BiovaxID is a personalized vaccine that specifically targets cancerous B-cells (a type of white blood cell). To make the vaccine specific to each patient, it is necessary to obtain a sample of the patient's tumor through a biopsy. Unique identifiers are then extracted from the surface of the tumor sample and combined with several molecules to create a vaccine that can easily recognize cancerous cells and stimulate the body to recruit cancer-killing immune cells to the tumor.
The phase III multi-center trial, initiated by the National Cancer Institute and subsequently sponsored by Biovest International Inc., was designed to determine the effectiveness of the BiovaxID vaccine in patients with follicular lymphoma. Patients with previously untreated, advanced stage follicular lymphoma (stage 3 or 4) were enrolled in the study. Patients first underwent a lymph node biopsy to obtain tumor tissue for vaccine generation. Patients then received six to eight cycles of a standard chemotherapy regimen called PACE (prednisone, doxorubicin, cyclophosphamide and etoposide). After six months, patients that achieved and maintained a complete remission (117 out of 234 patients) were randomized and either received five monthly doses of the vaccine formulation or a non-specific immune stimulant. The patients were then followed for an average of 56.6 months after the randomization process. For those receiving the vaccine the average time to relapse was 44.2 months compared to 30.6 months for those receiving the non-specific immune stimulant. The vaccine was very well-tolerated and did not have many side effects or major toxicities.
"This is the first vaccine trial in lymphoma which has shown that vaccine therapy can improve the duration of remission in patients with follicular lymphoma," says Sattva S. Neelapu, MD, Assistant Professor at the University of Texas, MD Anderson Cancer Center and co-author of the ASCO abstract. "However, during the 10 years it took to complete the trial, the standard of care for follicular lymphoma has changed. Patients with follicular lymphoma now routinely receive rituximab along with their chemotherapy. Therefore, BiovaxID needs to be tested in patients that have received rituximab containing chemotherapy."
Due to the success BiovaxID has achieved, it is anticipated that the vaccine will be tested with various treatment combinations, including rituximab, and in other types of B-cell cancers such as marginal zone lymphoma, diffuse large B-cell lymphoma and mantle cell lymphoma. |
