A novel complex targeting mesenchymal lymphoma kinase-positive (ALK+) non-small cell lung cancer is available that is well tolerated by patients, including those resistant to crizotinib (the only proven ALK inhibitor), and has shown early signs of efficacy. A researcher from the Fox Chase Cancer Center presented the results of the Novartis-sponsored study at the 2012 American Society of Clinical Oncology Annual Meeting. The compound LDK378 was developed by Novartis and targets ALK, a key oncogene in lung cancer, lymphoma, pediatric tumor neuroblastoma, and possibly other cancers including breast and colorectal cancers. The study authors looked at patients with ALK+ lung cancer and other ALK+ solid tumors. early data from the phase I study showed effects in most patients treated with active doses of LDK378, including those who progressed after crizotinib treatment. ”These results are encouraging,” said study author Ranee Mehra, M.D., Fox Chase Medical Oncologist and Assistant Professor. “They offer hope for patients who have tumors containing ALK variants, even those who have relapsed after prior treatment.” In the first human trial, 56 patients with different types of ALK+ solid tumors (mainly lung cancer) were included in order to clarify the safety and optimal dose of the complex, with doses ranging from 50-750 mg/d. Most patients tolerated LDK378 well at up to 750 mg/d, with the most common side effects being nausea, vomiting and diarrhea. ”Whenever you conduct a drug trial, even if that trial is designed only to look at safety and dosing, you’re interested in whether the patient responds to the drug,” Mehra said, “These results are definitely encouraging and mean we can move on to the next studies to see if LDK378 is effective in different types of tumors containing ALK variants.” The fact that patients tolerated LDK378 at doses up to 750 mg/d is also encouraging, she added, as preclinical studies have suggested a therapeutic effect at that dose. In the meantime, Mehra and investigators at other centers around the world are continuing to recruit patients for the trial. The next phase of the study will test the maximum tolerated dose of LDK378 in all patients enrolled.