Dive Brief:
- The National Cancer Institute (NCI) is initiating a trial in which it will test numerous drugs against tumors with various mutations.
- This study—NCI-Match—is the largest, most rigorous 'precision' oncology trial to date.
- At least 10 pharmaceutical companies will contribute 20 different drugs to be tested.
Dive Insight:
What makes this NCI-Match special besides its size and scope (which is impressive in and of itself? The strategy behind this trial is based on the idea that the same cancer-causing molecular traits are often found in various types of tumors. For example, HER-2 is expressed in large levels not only in breast cancer, but also in gastric cancer. Therefore, Roche's Herceptin is approved for treatment of both of these solid-tumor types. The goal is to test the effect of targeting a patient's tumor mutations regardless of where the cancer is in his or her body.
Because the cost of DNA sequencing has dropped and continues to drop, there are now huge repositories of genetic data, including data from advanced cancer patients with various types of genetic mutations, available to researchers. All told, NCI-Match will harness data from 1,000 advanced cancer patients, who have given permission to use tissue from their fresh tumor biopsies. With 2,400 study sites nationwide, this study is designed to capture a wide variation of genetic inputs from various types of cancers and various populations of patients.
Primary endpoints in NCI-Match include both overall survival and tumor shrinkage, with a threshold of 16% shrinkage representing "success." Undoubtedly, NCI-Match will be a major step in advancing a personalized approach to cancer treatment.