Strata, Mirati Therapeutics Partner on Tumor-Agnostic Clinical Trial of Novel KRAS G12C Inhibitor

NEW YORK – Ann Arbor, Michigan-based Strata Oncology on Thursday announced that it has entered into a partnership with Mirati Therapeutics to identify and enroll patients with KRAS GI12C mutations into Mirati's Phase I/II study of MRTX849 as a treatment for patients with advanced solid tumors.

For its part of the partnership, Strata will identify patients with solid tumors harboring KRAS G12C mutations who are taking part in the ongoing observational Strata Trial across a network of over 20 health systems in the US. The Strata Trial aims to pair patients with biomarker-guided clinical trials based on the results of molecular profiling using StrataNGS, the company's next-generation sequencing test designed specifically for use on small tissue samples. In accordance with this new partnership, Mirati's MRTX849 study will become one of the biomarker-guided trials to which patients are matched.

Patients with KRAS G21C mutations who go on to enroll in Mirati's Phase I/II trial will receive MRTX849, an oral, selective small molecule G12C inhibitor. The trial is designed with multiple expansion cohorts, some stratifying patients by tumor histology and others evaluating the drug in combination with other agents including pembrolizumab (Merck's Keytruda), cetuximab (Eli Lilly's Erbitux), and afatinib (Boehringer Ingelheim's Gilotrif). The primary aims of the trial, dubbed KRYSTAL-1, will be to evaluate the safety and tolerability of the agent as well as its pharmacokinetics according to patients' blood plasma concentrations and its activity according to patients' objective response rates.

"Our partnership with Mirati Therapeutics is reflective of our shared goal to develop new medicines not by tissue type but by molecular profile, producing superior outcomes for patients and potentially faster drug approvals," Dan Rhodes, Strata Oncology's CEO, said in a statement. "We are confident our network of health systems, standardized on the Strata Trial, will bring additional support to help broaden enrollment of this important clinical trial."