Ongoing Studies with GM.CD40L Bystander-Based Vaccines

Excerpt

Drs Kobayashi and colleagues are correct in pointing out that patient selection, sample size, heterogeneity of patient characteristics (e.g., pathology, performance status, and tumor burden), and length of follow-up are all important factors that may affect the outcome of a cancer immunotherapy clinical trial. Our phase-I study was designed to demonstrate feasibility, safety, lack of toxicity, and proof of principle with regard to the generation of an immune response after vaccination. We agree that further clinical trials with larger sample sizes and longer follow-up are necessary to evaluate T cell-mediated immunotherapy. In fact, we have three separate phase-II trials currently underway to address outcomes such as immune response, tumor response, and survival after treatment of homogeneous populations of cancer patients with our GM.CD40L bystander-based vaccine. The three trials deal with different cancer diagnoses: metastatic melanoma, mantle cell lymphoma (MCL), and metastatic adenocarcinoma of the lung. Each trial will treat 40 patients with an ECOG performance status of 0 or 1. Each protocol is unique, based on the biology of the disease, ease of tumor harvest, and standard of care treatment options available to those patients. We believe that these trials, with larger sample sizes, homogeneous patient characteristics, and longer follow-up, will help generate data that can address questions of immune response, tumor response, and survival. …