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Dr. Shaw on LDK378 and Alectinib for ALK+ NSCLC

Alice T. Shaw, MD, PhD
Published Online: Monday, February 10, 2014
Alice T. Shaw, MD, PhD, an attending physician in the Center for Thoracic Cancers at Massachusetts General Hospital, discusses the two most advanced next-generation ALK-inhibitors for the treatment of non-small cell lung cancer (NSCLC): LDK378 and alectinib (AF802). Both agents currently have Breakthrough Therapy designation status.

LDK378 has the most data available and has gone through phase I testing. In a phase I trial, LDK378 demonstrated a response rate of about 60% and median progression-free survival of 8.3 months in ALK-positive patients who had relapsed on crizotinib. This “impressive activity,” Shaw says, has given way to phase II and III trials. Shaw says Novartis, the manufacturer of the drug, has stated that it will file for an accelerated approval.

Alectinib has been studied in a crizotinib-naïve population in Japan. Shaw says a 93% response rate was reported in this population. Alectinib is being analyzed in crizotinib-resistant patients and early data is showing a 50-60% response rate.

Both LDK378 and alectinib have also shown activity in brain metastases and leptomeningeal disease, which are typically difficult to treat.

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