WCLC 2016: First-Line Ceritinib Reduces Risk of Disease Progression in ALK-Positive NSCLC vs Chemotherapy
Patients who received first-line ceritinib experienced a 45% risk reduction for advanced anaplastic lymphoma kinase (ALK)–positive on–small cell lung cancer (NSCLC) compared to a control group that received chemotherapy, according to research presented at the IASLC 17th World Conference on Lung Cancerin Vienna, Austria (Abstract PL03.07).
Ceritinib is an ALK inhibitor that was approved in 2014 by the U.S. Food and Drug Administration for the treatment of ALK-positive metastatic NSCLC following treatment with crizotinib. ALK gene rearrangement is found in about 2% to 7% of patients with NSCLC, which makes up about 85% of all lung cancer.
Gilberto De Castro Jr, MD, PhD, of the Instituto do Cancer do Estado de Sao Paulo, Brazil and his co-researchers established a clinical trial and randomized 376 patients with advanced, nonsquamous NSCLC patients to ceritinib or chemotherapy. Patients in the trial were treated for a median 66 weeks on ceritinib and 29 weeks for chemotherapy.
Study Findings
The study met its primary objective, with ceritinib demonstrating statistically significant improvement in progression-free survival of more than 16 months, compared to 8 months in the chemotherapy arm. Overall objective response to the drug was significantly higher in the ceritinib group (72.5%) compared to the chemotherapy group (26.7%).
Fewer patients (5.3%) in the ceritinib arm discontinued treatment due to adverse events compared to the chemotherapy-treated patients (11.4%).
“In addition to the risk reduction in terms of disease-progression these patients experienced, ceritinib achieved high and durable systemic responses and high overall intracranial responses in patients with measurable brain metastases,” concluded Dr. De Castro.
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