Patients to be Treated Based on Tumor Genomics, Not Disease Type, in ASCO’s First Clinical Trial

The American Society of Clinical Oncology (ASCO) is testing what will happen if patients are treated according to the genomics of their tumors, rather than on the basis of their disease types, such as breast or colorectal cancers.

Through an ASCO clinical trial, physicians will have the option of prescribing oncology drugs that are approved by the U.S. Food and Drug Administration, but not in a patient’s specific cancer type — as long as the genomics of the patient’s tumor match the drug’s target.

The trial — known as TAPUR, or Targeted Agent and Profiling Utilization Registry — is the first run by ASCO in its 50-year history. The study’s aim is to simplify patient access to cancer treatments across many tumor types. ASCO unveiled the trial June 1 in a press briefing during its 2015 Annual Meeting of nearly 30,000 oncology professionals in Chicago.

The nonrandomized TAPUR trial will involve patients with any advanced solid tumor, multiple myeloma or non-Hodgkin lymphoma that has a genomic variation known to be the target of an existing approved drug.

The primary objectives of TAPUR are twofold, explained ASCO’s chief medical officer, Richard L. Schilsky, at the press briefing: to improve access to potentially effective therapies for a much broader population than is typically enrolled in clinical trials, and to gather important information on the antitumor and toxicity of targeted drugs across multiple cancers.

“Increasingly, we find that patients with advanced cancer who no longer have any standard treatment options are having a genomic profiling test performed,” noted Schilsky in explaining the rationale for the initiative. “These tests are now readily available…and sometimes what’s known as ‘a potentially actionable variant’ is detected.” Estimates in the literature are highly variable, he added, but about 40 percent to 70 percent of the time these tests are likely to turn up something that the doctor might be able to act on:

“The question that the doctor and the patient then face is, ‘How do I get the drug that is suggested by my tumor’s profile?’”

Although in some cases the drug will be investigational and thus best administered in the context of a conventional clinical trial, “in other cases, given the large number of targeted therapies that are now commercially available, the best option for the patient might be to receive a commercially available targeted drug, but one that would have to be prescribed outside of its FDA-approved indication,” a process that can be very complicated and burdensome.

Even when patients do get access to these agents, said Schilsky, “we have no mechanism right now to learn the experience of that patient — how the patient did, whether they responded or not, whether they had side effects. That information is never captured in any organized way that we as an oncology community can learn from.”

A Collaborative Effort

Five pharmaceutical companies (AstraZeneca, Bristol-Myers Squibb, Eli Lilly and Company, Genentech and Pfizer) have signed on to provide their currently marketed targeted drugs at no charge to participants, and more are expected to join the effort, noted ASCO President Peter Paul Yu in a statement. He added that “at least 13 drugs that target more than 15 genomic variants will be provided by these companies.”  

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