The American Society of Clinical Oncology, more commonly known as ASCO, has flipped the traditional clinical trial model on its head, seeking to give greater access to new treatments to patients as well as understand the complex genetics involved. The clinical trial is called TAPUR
, and the key difference is identifying a treatment by a patient’s tumor type, regardless of the tumor’s location.
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Dr. Laura Porter, MD, stage IV colon cancer survivor and Colon Cancer Alliance Patient Advocate Medical Consultant.[/caption]
And, in an almost unprecedented show of cooperation, seven major pharmaceutical companies have agreed to participate, including: AstraZeneca, Bayer, Bristol-Myers Squibb, Eli Lilly and Company, Genentech, Merck and Pfizer.
What makes this trial different?
- It looks at specific genetic variants that already have drugs that can target them
- Enrollment criteria is not as strict as other clinical trials in that they are taking all solid tumors based on the variant that is present.
- TAPUR does not randomly assign patients –all patients that are enrolled will receive the available drug at no cost for as long as they continue to respond
- They are already in 55 sites across 15 states, and are opening new sites regularly, many of which are in community clinics.
Currently 17 drugs are included in the TAPUR study and there are over 100 participants already enrolled with multiple tumor types. The study is designed to evaluate targeted therapies outside of the disease that they are FDA approved for. The tumor type does not matter, just the genomic variant.
Genomic testing or molecular profiling of the tumor must be done prior to enrollment. You and your physician can choose the test that is right for you either tumor or blood. Another positive aspect of the TAPUR study is that patients are not randomly assigned. Any patient who is enrolled on TAPUR and whose tumor contains an actionable genomic variant that matches a particular drug will receive the matched drug at no cost and will continue to receive the drug for as long as they continue to benefit.
Precision medicine—tailoring therapy to individual people's genes, environments, and lifestyles—is here to stay and playing an increasing role in cancer treatment.