On May 10, 2017 Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company innovating the development of highly selective medicines for patients with genetically defined cancers, reported that the first patient has been enrolled in the Phase 1 clinical trial of LOXO-292, an investigational, highly potent and selective RET inhibitor (Press release, Loxo Oncology, MAY 10, 2017, View Source [SID1234518973]). RET gene alterations are thought to play a key role in the development of certain cases of lung, thyroid, colon and other cancers. Schedule your 30 min Free 1stOncology Demo! "We are excited to put a second, purpose-built precision medicine into clinical development," said Josh Bilenker, M.D., chief executive officer of Loxo Oncology. "We believe that patients with RET-altered lung, thyroid and other cancers have highly actionable genetic events that are not well addressed by existing therapies. LOXO-292 was designed to deliver potent RET inhibition, while avoiding off-target activities that can compromise dose intensity and contribute to toxicity. If our hypothesis is correct, LOXO-292 could have meaningful single agent anti-tumor activity in RET-altered cancers, and the ability to address key resistance mutations that could otherwise limit the clinical potential of RET inhibition in affected patients. In advancing our larotrectinib program, we have worked closely and creatively with patients and their doctors to deliver on the promise of precision medicine. We hope that LOXO-292 opens a new and exciting chapter in this story."
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This first-in-human, global, multi-center Phase 1 trial will evaluate LOXO-292 as a single agent in patients with advanced solid tumors. The primary objective of the trial is to determine the maximum tolerated dose or recommended dose for further study. Key secondary objectives include measures of safety, pharmacokinetics, and anti-tumor activity (i.e. Objective Response Rate and Duration of Response, as determined by RECIST v1.1). The trial includes a dose escalation phase and dose expansion phase. During the dose escalation phase, up to 30 patients with advanced solid tumors may be enrolled to inform the selection of a dose and schedule for the expansion phase. In the expansion phase, five cohorts are planned to allow for the characterization of preliminary activity of LOXO-292 in the following genetically-defined populations: 1) RET-fusion lung cancer patients with prior RET inhibitor experience; 2) RET-fusion lung cancer patients with no prior RET inhibitor experience; 3) RET-mutant medullary thyroid cancer patients with prior RET inhibitor experience; 4) RET-mutant medullary thyroid cancer patients with no prior RET inhibitor experience; and 5) other RET-altered solid tumors. Loxo Oncology anticipates that approximately 15 patients will be enrolled to each of the expansion cohorts.
About LOXO-292
LOXO-292 is a potent, oral and selective investigational new drug in clinical development for the treatment of patients with cancers that harbor abnormalities in the rearranged during transfection (RET) kinase. RET fusions have been identified in approximately 2% of non-small cell lung cancer, 10-20% of papillary thyroid cancer, and a subset of colon and other cancers. RET point mutations account for approximately 60% of medullary thyroid cancer. Both RET fusion and select RET mutated cancers are primarily dependent on this single activated kinase for their proliferation and survival. This dependency, often referred to as "oncogene addiction," renders such tumors highly susceptible to small molecule inhibitors targeting RET. LOXO-292 was designed to inhibit native RET signaling as well as anticipated acquired resistance mechanisms that could otherwise limit the activity of this therapeutic approach. LOXO-292 is currently being studied in a Phase 1 trial. Interested patients and physicians can contact the Loxo Oncology Physician and Patient RET Clinical Trial Hotline at 1-855-RET-4-292 or email [email protected].