Personalised immunotherapy shows promise

Genitope Corporation from San Diego, CA,has announced results of a Phase 2 clinical trial evaluating MyVax personalised immunotherapy for the treatment of aggressive non-Hodgkin's lymphoma, including mantle cell lymphoma (MCL).

The study examined two dosing strategies of MyVax, with the results suggesting an accelerated schedule with more doses of MyVax may be a safe and effective treatment following chemotherapy in individuals with aggressive lymphoma, including mantle cell lymphoma. 'Patients with mantle cell lymphoma typically respond well to chemotherapy, but the disease has the shortest median survival of all lymphoma subtypes and generally recurs quickly,' says Dr John Leonard, the study's co-ordinator. 'This study is an important step in the right direction, as we need to find an effective treatment for this difficult disease.'

The study involved 27 patients with aggressive non-Hodgkin's lymphoma, in complete or partial remission following CHOP chemotherapy. Each patient received one of two treatment schedules of MyVax. Fourteen patients on Schedule A (five with MCL) received five immunisations over 24 weeks, starting three months after completing chemotherapy. The median time to disease progression for the mantle cell patients on Schedule A was 254 days following completion of chemotherapy. In an attempt to improve clinical responses, an accelerated and extended administration regimen was developed. Thirteen patients on Schedule B (11 with MCL) began receiving MyVax three months following completion of chemotherapy. Patients were immunised with MyVax every two weeks for seven doses, with an eighth dose administered at week 18. In the MCL population on Schedule B, the median time to disease progression was 477 days following completion of chemotherapy.

'There is no clearly curative therapy for mantle cell lymphoma, and it is a particularly challenging lymphoma to treat. Though the number of patients in the study is limited, we are encouraged that patients treated with the accelerated schedule of MyVax Personalised Immunotherapy may have more extended remissions than otherwise expected with this disease,' commented Dr Leonard. 'We continue to watch these patients closely and hope to further evaluate the potential benefit of this treatment for mantle cell and other aggressive lymphomas.'

Mantle cell lymphoma is a B-cell non-Hodgkin's lymphoma, and accounts for about 6% of all non-Hodgkin's lymphoma cases in the United States. It primarily affects men over age 50.

MyVax Personalized Immunotherapy is a patient- and tumour-specific therapy based on the unique genetic makeup of a patient's own tumor. It consists of a patient-specific and tumour-specific cell surface idiotype protein (Id), combined with keyhole limpet hemocyanin (KLH), an immunogenic carrier protein. It is co-administered with granulocyte macrophage-colony stimulating factor (GM-CSF). The therapy is currently being investigated in a pivotal, Phase III clinical trial at 34 leading North American oncology centres for the potential treatment of follicular non-Hodgkin's lymphoma.

For more information www.genitope.com.