, have led to a major amendment in a phase 3 Children's Oncology Group clinical trial, which has incorporated lorlatinib for newly diagnosed ALK-driven
"The profound clinical responses seen in this trial, in a highly therapy-resistant, relapsed pediatric cancer population, allows us to now offer lorlatinib into frontline care for newly diagnosed patients with ALK mutated or amplified neuroblastoma, a population known to have inferior survival with standard-of-care, high-risk therapy," said the study's first author and co-chair of the trial Kelly Goldsmith, MD, Co-Leader of the Discovery & Developmental Therapeutics Program at...
After screening numerous anti-ALK agents, the researchers discovered in preclinical tests that lorlatinib, an ALK and ROS-1 inhibitor, surpassed results seen with crizotinib. Leveraging that data, the researchers were able to test the safety, tolerability, and anti-tumor activity of lorlatinib in a first-in-child NANT Consortium Phase 1 trial in children, adolescents and adults with ALK-driven refractory/relapsed neuroblastoma.
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