GVAX® is an investigational allogeneic cancer vaccine platform based on the local production of granulocyte-macrophage colony stimulating factor (GM-CSF) at the vaccine site to generate a systemic tumor-specific immune response.
GVAX® is being investigated in several cancers including pancreatic, colorectal, neuroblastoma clinical trials in combination with other agents including PD-1 checkpoint inhibitors.
The goal of cancer vaccines is to enable the immune system to mount an effective and durable response against the cancer cells when a low tumor burden exists. To date, cancer vaccines have mostly been used in various settings to prevent disease relapse.
The myeloma GVAX® vaccine consists of two multiple myeloma cell lines plus K562 cells modified to express GM-CSF which serves as an adjuvant to attract antigen-presenting cells and subsequently generate long-standing immunity.
GVAX® is advancing in clinical trials to evaluate the efficacy of this investigational cancer vaccine for patients with multiple myeloma that have entered in a complete remission.
Over 32,000 people are diagnosed with multiple myeloma annually and the average life expectancy is 5 years. The majority of multiple myeloma patients experience repeated relapse following initial therapy, which includes a variety of combination therapies and the common use of autologous stem cell transplant. Multiple myeloma can change genetically with treatment, and more aggressive clones can evolve over time, making relapsed myeloma more difficult to treat.
GVAX® is being tested in a Phase II three-arm randomized clinical trial comparing the efficacy of the allogeneic GM-CSF secreting myeloma vaccine in combination with lenalidomide (with or without Prevnar) compared to lenalidomide and placebo. Patients in the study must be in a near complete response (M-spike negative with persistence of immunofixation) or complete response (M-spike negative, negative immunofixation, and <5% clonal plasma cells on bone marrow) and must be MRD positive by next generation sequencing.
Prior to enrollment, patients must be on a lenalidomide-containing regimen for a minimum of 6 cycles. The depth of response to therapy in myeloma correlates with improved progression free survival. Lenalidomide can augment vaccine responses and current studies seek to examine its use in combination with GVAX® for myeloma patients in near complete response or complete response to deepen clinical response to determine whether it can generate measurable myeloma-specific immunity and longer progression-free and overall survival.