By Harley Everett Wilcox, MBA
Senior Scientific Advisor
Historical clinical cancer studies lack efficiency and
require significant time for often an overall survival improvement of only 60
days versus standard treatment. The inefficiencies may be related to the need
for adequate safety evaluation, single agent studies, and limited tumor
biological information for individual patients.
Approval of a new oncological agents require 10-15 years of clinical
drug development and in rarer cancers, patient populations available for study
are lacking .New investigation drugs require evaluation in diseased patients
prior to approval and often before combination with other attractive agents.
With the advancements in biological test procedures, and better understanding
of cancer biology, an individual tumor may be profiled to determine the
theoretical optimum drugs, combination of drugs and dosing schedule.
The I-SPY program is a novel personalized cancer treatment
study supported by the FDA, NIH and a consortium of pharmaceutical companies
via the Foundation for the National Institutes of Health (FNIH). The design
allows for investigating new drug therapies with standard treatment and
flexibility to modify treatment protocols on the fly, saving time, money, and optimal
treatment regimens for breast cancer patients.
Multiple company intellectual property have been combined in a single phase
II like program to access the best therapy based on tumor biology and proof
concept of activity prior to surgery in resistant tumor types. The goal will be
to bring effective treatments to market with fewer patients and in less time.
Targeting another type of cancer in an adaptive trial
approach is MD Anderson and the recently announced AGILE study. Glioblastoma multiform has yet to see a new
chemical treatment option in ~10 years with the standard chemotherapy Tremodar
and radiation providing an overall survival improvement of just 2 months. MD Andersons’ Mitchel Burger, MD states the
uniqueness of the study, like the I-SPY uses biological tumor profiling and Bayesian statistics to
limit the number of clinical patients. The
statistical method allow for a probability approach to advance drug winners
more quickly. As stated earlier, one issue with rare cancers is adequate
patient populations for supporting multiple clinical studies. With~10,000 GBM cases
a year combined with aggressive disease, brain cancer clinical programs often
require longer time to complete enrollment.
These adaptive clinical trial programs will hopefully
provide more meaningful outcome for clinical trial participants and more rapid
approval for needed treatment options.
References:
Target Oncology (targetdonc.com)
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