While the debate rages over ONXX, here's an AGEN abstract from ASH, which seems underwhelming to me:
>>[3343] Safety and Efficacy of Heat Shock Protein-Peptide 96 Complex (HSPPC-96) Vaccine Therapy in Patients with Relapsed or Previously Untreated Low-Grade Non-Hodgkin Lymphoma. Session Type: Poster Session 563-III
Anas Younes, Luis Fayad, Barbara Pro, Peter McLaughlin, Frederick Hagemeister, Paul Mansfield, Gary Clayman, L. Jeffrey Medeiros, John Manning, Jonathan Lewis, Pramod Srivastava
Lymphoma, Surgery, and Hematopathology, M. D. Anderson Cancer Center, Houston, TX, USA; Antigenics, Inc, New York, NY, USA; Immunology, University of Connecticut, Farmingham, CT, USA
Considerable laboratory and clinical data show that vaccination with autologous HSPPC-96 is a promising treatment for cancer. HSPPC-96 isolated from a patients specific tumor induces a T-cell and an anti-tumor response in a proportion of patients with diverse cancers. This phase II study evaluated the feasibility, efficacy and safety of autologous HSPPC-96 vaccination in patients with low-grade indolent non-Hodgkin lymphoma. Eligibility: (1) newly diagnosed or relapsed follicular lymphoma grade 1 or 2, small lymphocytic lymphoma, or marginal zone/MALT lymphoma; (2) bidimensionally measurable disease; (3) no bulky disease ( < 10 cm) (4) Absolute peripheral blood lymphocyte count of at least 1000/ mm3 with no gross evidence of circulating lymphoma cells; (5) no HIV infection. Patients were not allowed to receive concomitant steroids or growth factors. Twenty patients were enrolled. Vaccine was successfully prepared from excisional lymph node biopsy specimens in 17 patients (follicular: N = 9, small lymphocytic: N = 6, marginal zone : N = 2), of whom 14 are evaluable for safety and treatment response. Seven patients received 1 to 6 prior treatment regimens, and 10 were previously untreated patients. Patients were vaccinated with 25 microgram HSPPC by subcutaneous injections every week x 4 weeks, then every other week until they ran out of vaccine or disease progression. Response to therapy was evaluated by CT scans every three months while on therapy and after completion of therapy until disease progression. Nine women and 7 men were vaccinated, with a median age of 58 years (range, 45-83 y). Pretreatment LDH was elevated in 3 patients, and beta-2 microglobulin was higher than 3 in 7 patients. Patients received a median of 4 vaccine doses (range 1 - 14). Vaccination was well tolerated without significant adverse effects. Three patients responded. One patient with relapsed marginal zone lymphoma had a PR, and 2 patients had a minor response (1 with relapsed follicular lymphoma and 1 with previously untreated small lymphocytic lymphoma). The duration of response was 13, 8, and 12+ months respectively. Five additional patients had stable disease. Two patients are too early to evaluate. All responding patients were either previously untreated or received only one prior treatment regimen. We conclude that HSPPC-96 vaccination is feasible, safe and may be effective in patients with minimally treated or newly diagnosed patients with low-grade lymphoma. This preliminary data demonstrate encouraging clinical activity of HSPPC-96 vaccine in patients with lymphoma and warrants studying the activity of this novel vaccine in patents with minimal residual disease
Abstract #3343 appears in Blood, Volume 102, issue 11, November 16, 2003<<
Cheers, Tuck |
