Researchers at the Moores UCSD Cancer Center are gearing up for a late-stage trial of Pfizer's crizotinib, preparing a pivotal test to see if the promising therapy can help a unique subgroup of patients with treatment-resistant lung cancer.
Scientists want to test how effective the therapy is among patients whose ALK gene has fused with the EML4 gene, which generates a protein that fires up cancer cell growth. About four percent of all patients with non-small cell lung cancer develop the enzyme. In early and mid-stage trials 57 percent of patients had their tumors reduced and at eight weeks of treatment 87 percent showed disease stabilization. The data dump on the drug at ASCO recently stirred intense interest in the drug. Mark Kris at Memorial Sloan-Kettering Cancer Center called it an "absolutely huge deal."
"The results of the first two trials have been very encouraging," said Lyudmila Bazhenova, MD, assistant clinical professor at UC San Diego School of Medicine and a member of the Moores UCSD Cancer Center. "The Phase III clinical trials will be critical in determining if this drug goes to market."
In the Phase III trial, treatment-resistant patients will either be treated with crizotinib or a standard chemotherapy. And patients in the chemo arm will be given crizotinib if they don't respond to standard therapy.
- here's the release for more