New therapy on the horizon for ALK-positive non-small cell lung cancer
Early signs of activity seen also in patients who no longer respond to crizotinib
A new compound that targets anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer is well-tolerated by patients and is already showing early signs of activity, including in patients who no longer respond to crizotinib, the only FDA approved ALK inhibitor. Results of this study were presented by a researcher from Fox Chase Cancer Centre during the 2012 Annual Meeting of the American Society of Clinical Oncology (ASCO), 1-5 June, Chicago.
The compound LDK378, developed by Novartis, targets ALK—a key cancer gene in a subset of lung cancer, lymphoma and the childhood cancer neuroblastoma, and may be associated with other cancers, including breast and colorectal cancer. The study's authors looked at patients with ALK+ lung cancer, as well as other ALK+ solid tumours. Early data from the phase I study show that the majority of patients treated with active doses of LDK378 responded, including those who had progressed after treatment with crizotinib.
Results are encouraging in patients who have tumours with alterations involving ALK, even if they have relapsed from previous treatments
In its first test in patients, designed to determine the compound's safety and optimal dose, 56 patients with various types of ALK+ solid tumours (primarily lung cancer) were enrolled, receiving doses between 50 to 750 mg/day. LDK378 was well-tolerated in most patients up to 750 mg/day, with the most common side effects being nausea, vomiting, and diarrhoea.
The study researchers consider these results as definitely encouraging, and with a positive signal to go forward with additional research looking at whether LDK378 is effective in various types of cancers that have alterations involving ALK.
The fact that patients appeared to tolerate LDK378 at doses up to 750 mg/day is also encouraging, since preclinical research has suggested this dose would have therapeutic effects.
In the meantime investigators around the world are continuing to enrol patients in the trial. The next phase of the study will test the maximum tolerated dose of LDK378 in all patients enrolled.
This study was sponsored and funded by Novartis.
Other researchers involved are from the University of Colorado, Denver; Huntsman Cancer Centre, Salt Lake City; Vall d'Hebron University Hospital, Barcelona; National Cancer Centre, Singapore; University Hospital Gasthuisberg, Leuven; European Institute of Oncology, Milan; Seoul National University Hospital, Seoul; Humanitas Cancer Centre, Rozzano; Princess Margaret Hospital, Toronto; Novartis; and Massachusetts General Hospital Cancer Centre, Boston.
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