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A phase I study of Novartis' ceritinib found that the ALK inhibitor shrank non-small-cell lung cancers in slightly more than half of patients given the drug, as researchers led by Massachusetts General Hospital's Jeffrey Engelman report in the New England Journal of Medicine.

As a related editorial from the University of Cologne's Roman Thomas points out, many people treated for cancers with ALK rearrangements relapse as the tumor becomes resistant to the effects of the drug and that treatments for recurrent tumors are "urgently needed."

Preclinical studies, the Engelman and his colleagues note, indicate that ceritinib is some 20 times as potent as crizotinib, an ALK inhibitor marketed by Pfizer as Xalkori, against ALK rearrangements.

In this study, which was funded by Novartis, the researchers conducted a dose-escalation experiment followed by an expansion phase in which some 114 patients with NSCLC received the drug. Engelman and his colleagues report that the response rate among those patients was 58 percent and the median progression-free survival was seven months.

Further, the response rate was 56 percent among the 80 patients who had previously received crizotinib, the researchers say. Thomas calls this finding "striking."

"[P]atients appear to have a second chance of response after relapse occurs following crizotinib treatment," he adds.

The Wall Street Journal notes that Novartis isn't the only one going after this target: Ariad Pharmaceuticals, Chugai Pharmaceutical in conjunction with Roche, and Pfizer are all pursing drugs in this area.

The Journal adds that this study's results form the basis of an application that Novartis has filed with the US Food and Drug Administration to review the drug under the agency's "breakthrough therapy designation."