Dr Robert Petit, Vice President of Clinical Operations and Medical Affairs, Advaxis joined us at the World Vaccine Congress Washington 2012 to answer the following question:
Why does patient selection matter?
Simply, because each patient factor can impact the outcome. Patient factors can include: age, performance status, gender, race, disease status etc. Critical patient selection factors can vary by disease type, disease stage, therapeutic intent, alternative therapy, class of therapeutic, potential for combination therapy, stage of clinical trial; and could also be inherited from current SOC.
Special considerations must be taken into account in accordance with whether or not the vaccine in question is prophylactic or therapeutic.
For Prophylactic vaccines, it is important to consider:
– Strain specificity and valence
– Geographic location vs. projected prevalence – Seasonal Variations
– Route of administration vs. compliance
– Social Considerations
– Feasibility of 100% immunization
– Public health cost impact
– Size of clinical trials, data in sub-populations
For therapeutic vaccines it is important to consider:
– Expression of target (Her2, PAP, HCV, HPV-16)
– Multiple Infection/epitopes vs. valence (HPV 16, 18, 45, ; Her 2 heterogenicity, etc…)
– Tumor Heterogeneity
â¢ Marker +, ++, +++; selection for target negative clones
– Combination with conventional treatments â¢ Toxicity, Synergy, Sequence
Â· – Time to treatment effect vs. stage of disease
Â· – Development of resistance to vector
Â· – Geographic SOC vs. Immunotherapy
– Patient factors / Response criteria inherited from prior/approved treatments
The takeaways from this presentation are:
â¢ Patient selection, based on patient factors, is critical to a successful vaccine trial. Even one patient factor can have a large impact on outcomes and all trials incorporate multiple factors and outcomes.
â¢ Critical patient factors vary by therapeutic intent, indication, stage of clinical development, historical and competitive reference, and the reviewer's role in the development process.
â¢ Successful trial outcomes require careful consideration and accommodation of patient factors from scientific, medical, and sponsor perspectives.
â¢ A successful vaccine trial design should include an evaluation of lessons learned from other programs and potential extrapolation to your specific agent, disease setting, potential indication, MOA, regulatory and competitive environment.
â¢ Proper Patient Selection Will Lead to Successful Outcomes