ASCO study will provide molecularly targeted drugs to patients with advanced cancers

Abstract

The American Society of Clinical Oncology (ASCO) recently announced its first-ever clinical trial aimed at providing patients with advanced cancer access to molecularly targeted cancer drugs. The study also will collect “real-world” data regarding clinical outcomes to learn about applications for these drugs outside the indications approved by the US Food and Drug Administration. Known as the Targeted Agent and Profiling Utilization Registry (TAPUR), the prospective, nonrandomized trial will involve major pharmaceutical companies that will contribute drugs free of charge. TAPUR will gather information regarding the antitumor activity and toxicity of commercially available targeted drugs for a range of cancer types, including any advanced solid tumor, multiple myeloma, or non-Hodgkin lymphoma with a genomic variation known to be a drug target—a broader patient population than is normally included in clinical trials. Oncologists often use therapies approved for a specific cancer indication to treat individuals with other types of advanced cancer, but they rarely learn from that experience to benefit other patients, says Peter Paul Yu, MD, a past president of ASCO. TAPUR aims to do just that by documenting the realworld experience of patients who receive these targeted drugs. ASCO will organize operations for the study, including coordinating all collaborators. Among them will be oversight committees, pharmaceutical companies, technology firms, and community-based study sites. The participants represent an innovative, inclusive approach to studying targeted cancer drugs, according to ASCO. TAPUR not only will reach the many patients with cancer who receive their care through community-based treatment centers, but it also will provide education and support to community oncologists to help them interpret complex genomic tests. As the study proceeds, an Institutional Review Board will review the study protocol and consent form. In addition, ASCO has established 3 oversight committees, each of which will include patient representatives, clinical oncologists, statisticians, and genomic specialists. Physicians will select a drug from available TAPUR study drugs that target the identified genomic variation in the patient's tumor. If a relevant drug target match is unavailable, a physician may consult the molecular tumor board and request a review of the clinical and genomic features of the patient's case. Patients will be monitored for side effects and outcomes, including tumor response, progression-free and overall survival, and duration of treatment. At least 13 drugs that target more than 15 unique genomic variants will be provided by pharmaceutical companies. The trial will be launched at the Michigan Cancer Research Consortium, the Cancer Research Consortium of West Michigan, and the Carolinas Healthcare System, all of which run trials for the NCI and industry. Leaders hope to expand the study nationally.