Ignyta, Inc., a biotechnology company focused on precision medicine in oncology, announced that EORTC, the European Organisation for Research and Treatment of Cancer, is expanding its collaborative agreement with Ignyta. Under this collaboration, Ignyta will serve as a diagnostic laboratory performing fusion testing for EORTC's SPECTA (Screening Patients for Efficient Clinical Trial Access) initiative.
Part of the testing will include identifying patients who harbor a gene fusion for the NTRK, ROS1 or ALK genes for potential inclusion of these patients in Ignyta's global STARTRK-2 phase 2 clinical study of entrectinib. The genetic data obtained from this screening will also be available for potential future academic research as part of EORTC's SPECTA initiative.
"EORTC's SPECTA network includes a broad pool of clinical trial sites, tissue samples and patient data, which is helping us identify patients with a variety of tumor histologies across Europe who could potentially be enrolled in our STARTRK-2 clinical trial, and may benefit from entrectinib, our CNS-penetrant, targeted Trk, ROS1 and ALK inhibitor," said Zachary Hornby, COO at Ignyta. "We are happy to work with EORTC to demonstrate the value of biomarker-driven clinical trials to bring forward innovative, targeted cancer medicines."
EORTC's SPECTA program is a pan-European biobank and molecular profiling platform for patients in colorectal, brain, lung, melanoma and rare cancers, which aims to optimize drug access, help advance the development of targeted treatments and accelerate new healthcare delivery. Built as a collaborative network, SPECTA provides access to large sets of patient-level clinical and biological data for international, multidisciplinary clinical research.
"Identification of specific genetic mutations provides opportunities for improving treatment efficacy in cancer patients," said Vassilis Golfinopoulos, Medical Director at EORTC. "This is at the heart of our SPECTA program, which helps oncologists find trials that are adapted to their patients' needs. The collaboration with Ignyta is allowing more patients to be screened, and providing more data to advance the development of precision medicine in cancer."
The Ignyta STARTRK-2 phase 2 study is evaluating the effectiveness of entrectinib, a selective tyrosine kinase inhibitor targeting tumors that harbor NTRK, ROS1 or ALK gene fusions. The STARTRK-2 trial is actively enrolling and working with leading cancer centers worldwide, including nine countries throughout Europe.
The European Organisation for the Research and Treatment of Cancer (EORTC) brings together European cancer clinical research experts from all disciplines for trans-national collaboration. Both multinational and multidisciplinary, the EORTC Network comprises more than 4,600 collaborators from all disciplines involved in cancer treatment and research in more than 640 hospitals in over 37 countries. A unique pan-European clinical research infrastructure, EORTC offers an integrated approach to drug development, drug evaluation programs and medical practices through translational and clinical research.
Entrectinib is a novel, orally available, selective tyrosine kinase inhibitor targeting tumors that harbor activating alterations to NTRK1/2/3 (encoding TrkA/ TrkB/TrkC), ROS1 or ALK. Entrectinib is the most potent Trk inhibitor in the clinic, without undesirable off-target activity, and the only Trk inhibitor with clinically demonstrated activity against primary and metastatic CNS disease. This product candidate is in a phase 2 clinical trial called STARTRK-2, which is the second of the "Studies of Tumor Alterations Responsive to Targeting Receptor Kinases." The trial is a global, multicenter, open label, potentially registration-enabling phase 2 clinical trial of entrectinib that utilizes a basket design with screening of patient tumor samples for the relevant targets. Such a basket design takes full advantage of entrectinib's demonstrated preliminary clinical activity across a range of different tumor types and molecular targets.