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January 14, 2019

TRIO Enrolls First Patient Into PHASE III NATALEE Clinical Trial

– Timely Enrolment Signifies Milestone in TRIO-

EDMONTON, Alberta (January 14, 2019) – Translational Research In Oncology (TRIO), in collaboration with Novartis and under the direction of Dennis Slamon, MD, PhD, TRIO Chairman/Executive Director and Director of Clinical Translational Research at the University of California, Los Angeles Jonsson Comprehensive Cancer Center, announces enrollment of the first patient into its newest clinical trial, NATALEE (New Adjuvant TriAl with LEE).

NATALEE is a randomized, phase III clinical trial testing the efficacy and safety of ribociclib and endocrine therapy in the adjuvant treatment of Hormone Receptor-positive, HER2-negative early breast cancer. The trial will test a daily 400 mg dose of ribociclib on a three week on, one week off cycle with endocrine therapy, against endocrine therapy alone. The combination of ribociclib with endocrine therapy has shown to be effective in previous advanced breast cancer clinical trials, leading to the approval of ribociclib in this setting. The primary endpoint of NATALEE is invasive disease-free survival (iDFS) using STEEP (Standardized Definitions for Efficacy End Points in Adjuvant Breast Cancer Trials) criteria.

“The speed with which we’ve enrolled our first patient reflects the energy we put into every one of our clinical trials. It also reflects the strength of our relationship with our investigator network and in particular, the efficiency of the TRIO-US team who enrolled our first patient,” says Launa J Aspeslet, PhD, CEO of TRIO. “We deeply appreciate the sacrifices every breast cancer patient makes to help us achieve our goal of a world where all patients with breast cancer can be cured.”

This patient marks the first of more than 4,000 patients expected to enroll in NATALEE, TRIO’s largest clinical trial to date. NATALEE is projected to include hundreds of international sites within TRIO’s network and Novartis recommended sites. NATALEE will be conducted over the next seven years. TRIO has extensive experience with breast cancer clinical trials, most notably in the development of trastuzumab for HER2-positive breast cancer and more recently with CDK 4/6 inhibitors.

“NATALEE is an exciting culmination of TRIO’s efforts in translating our past preclinical results into clinical trials, especially with regards to breast cancer and the role of CDK 4/6 inhibition in that disease,” says Dr. Slamon. “Our collaboration with Novartis and our global network of investigator sites will be a great collective effort over the next few years.”

For more information on NATALEE, visit https://clinicaltrials.gov/ct2/show/NCT03701334.

Ribociclib was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.