New initiatives will seek to better target therapies for cancer patients with the use of both treatments that are based on the genetic makeup of the disease, as well as an educational effort intended to help physicians in their clinical decisions.
Two new clinical trials will look to prove the efficacy of molecularly targeted treatments for cancer patients. The announcement was made at a Monday morning news briefing at the American Society of Clinical Oncology's 2015 Annual Meeting in Chicago.
One will be conducted by the National Cancer Institute, known as NCI-MATCH, which is scheduled to begin in July and involve around 3,000 patients across 2,400 sites nationwide.
The study will involve sequencing the DNA of patient tumors in order to match them with treatment from one or more of 20 approved but experimental cancer drugs that will used based on how effective those therapies are against the genetic defect causing the tumor in the individual as opposed to the how well they treat a particular form of cancer.
“What we're trying to do is sequence their tumor for various cancer drivers,” said Dr. Barbara Conley, associate director of the NCI's Cancer Diagnosis Program in a statement. “If they have that driver, they will be able to get the drug that was chosen to attack that driver.”
Of the 3,000 patients the trial plans to sequence, around 1,000 will be placed in groups of up to 35 patients who will receive drug treatment for their tumors based on how well they respond to the drugs being used in the study.
Eligible trial participants include adults 18 years of age and older with solid tumors or lymphomas that have advanced following at least one line of standard systemic therapy, or with tumors for which there is no standard treatment. At least one-fourth of those slated to receive treatment will be patients with rare forms of cancer.
“It is the first study in oncology that incorporates all of the tenets of precision medicine.” said Dr. Doug Lowy, acting director for the NCI in a statement. “There are no other cancer clinical trials of this size and scope that truly bring the promise of targeted treatment to patients whose cancers have specific genetic abnormalities. It holds the potential to transform cancer care.”
Investigators will look at what proportion of trial participants experience a shrinking of their tumor and whether their disease remains stable after six months.
The second clinical trial announced Monday is the first one ever to be led by ASCO, which will look to collect data on the outcomes of patients with advanced cancers who receive molecularly-targeted drugs for uses not approved by the Food and Drug Administration. The medical society's Targeted Agent and Profiling Utilization Registry, or TAPUR, study includes participation from five pharmaceutical firms who will provide free access to at least 13 drugs for the purpose of the study.
“Oncologists often use therapies approved for a specific cancer indication to treat people with other types of advanced cancer, but we very rarely learn from that experience to benefit other patients,” said ASCO President Dr. Peter Yu in a statement. “TAPUR will document the real-world experience of patients who receive commercially available targeted anti-cancer drugs and will describe the effectiveness and side effects of a range of targeted agents available in this study.”
Also announced was the launch of ASCO's health information technology initiative, called CancerLinQ, which will provide oncologists with a large database of previously inaccessible information on cancer care using millions of electronic health records. The purpose is to uncover patterns in patient treatment and outcomes for a more personalized approach in making clinical treatment decisions.