National Cancer Institute initiates NCI-MATCH study of targeted therapy in cancer.

June 2015- The National Cancer Institute (NCI),starts a Phase II study, part of President Obamas precision medicine initiative, aimed at matching the most appropriate targeted therapy or combinations of treatments to patients based on the molecular profile of their tumors. Investigators for the nationwide trial, NCI-MATCH: Molecular Analysis for Therapy Choice (EAY131) announced at the annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago that the precision medicine trial will open to patient enrollment in July. The trial seeks to determine whether targeted therapies for people whose tumors have specific gene mutations will be effective regardless of their cancer type. NCI-MATCH will incorporate more than 20 different study drugs or drug combinations, each targeting a specific gene mutation, in order to match each patient in the trial with a therapy that targets a molecular abnormality in their tumor. The study was co-developed by the National Cancer Institute (NCI), part of the National Institutes of Health, and the ECOG-ACRIN Cancer Research Group, part of the NCI-sponsored National Clinical Trials Network (NCTN). It is being led by ECOG-ACRIN.

NCI-MATCH is a phase II trial, the largest precision medicine clinical trial in history, with numerous small sub-studies (arms) for each treatment being investigated. It will open with approximately 10 sub-studies, moving to 20 or more within months. The study parameters for the first 10 arms are being sent to 2,400 participating sites in the NCTN for review in preparation for patient enrollment beginning in July. The exact date for the opening of patient enrollment will be decided shortly after the ASCO meeting. Additional sub-studies are in development and will be added over time as the trial progresses.

The MATCH trial is expected to start out with eight drugs. The initial drugs in the study are Pfizer's Xalkori (crizotinib) and Sutent (sunitinib); GlaxoSmithKline's Mekinist (trametinib) and Tafinlar (dabrafenib); Boehringer Ingelheim's Gilotrif (afatinib); AstraZeneca's AZD9291; Genentech's Kadcyla's (ado- trastuzumab emtansine); and Verastem's VS6063.

The primary endpoint of the NCI-MATCH trial is overall response rate, or the proportion of patients in the study whose tumors shrink by a predefined amount over a specific time period. The secondary endpoint is six-month progression-free survival.