Ceritinib, Developed by Novartis, Provides Promising Results in Phase 1 Trials of ALK-Rearranged NSCLC Patients

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Ceritinib, which received a 'breakthrough therapy' status from the FDA last year, was highly active in patients with advanced, ALK-rearranged NSCLC, including those who had had disease progression during crizotinib treatment, regardless of the presence of resistance mutations in ALK.

Although the targeted cancer treatment drug crizotinib is very effective in causing rapid regression of a particular form of lung cancer, patients' tumors inevitably become resistant to the drug. Now a new drug called ceritinib appears to be effective against advanced ALK-positive non-small cell lung cancer (NSCLC), both in tumors that have become resistant to crizotinib and in those never treated with the older drug. The results of a phase 1 clinical trial conducted at centers in 11 countries are reported in the March 27


New England Journal of Medicine

"Crizotinib has become a standard treatment agent for patients with advanced, ALK-rearranged NSCLC, but patients invariably develop resistance, leaving their treatment options limited," says Alice Shaw, MD, PhD, of the



lead author of the report. "We found ceritinib to be highly effective in the majority of crizotinib-resistant patients, as well as those who had never received the drug, with mostly mild and managea

ble side effects."

Read the MGH press release here:

Massachusetts General Hospital (MGH) Cancer Center

Source: Massachusettes General Hospital