Ceritinib produced clinically meaningful, durable responses in patients who had advanced non–small-cell lung cancer and a history of multiple treatments with chemotherapies and crizotinib, according to investigators.

Ceritinib was effective even in patients with brain metastases, and it both reduced a high tumor burden and improved lung symptoms, said Lucio Crino, MD, of the University Medical School of Perugia (Italy) and his associates.

They assessed ceritinib in a single-arm, open-label, phase II trial involving 140 adults with advanced ALK-rearranged non–small-cell lung cancer at 51 sites worldwide who had received at least two lines of antineoplastic chemotherapy and had progressed while taking crizotinib. A total of 100 patients (72%) had brain metastases.

After a median follow-up of 11 months (range, 0-19 months), the overall response rate was 38.6% and the disease control rate was 77.1%. Tumor burden was significantly reduced in 75.2% of patients. Treatment response was rapid, occurring at a median of 1.8 months, and durable, lasting for a median of 9.7 months. Median progression-free survival was 5.7 months, median overall survival was 14.9 months, and the 1-year overall survival rate was 63.8%.

Treatment response was similar in the subgroup of patients who had brain metastases at baseline: Their overall response rate was 33.0%, the disease control rate was 74.0%, the median duration of response was 9.2 months, and median progression-free survival was 5.4 months (J Clin Oncol. 2016 July 17. doi: 10.1200/JCO.2015.65.5936).

No new or unexpected adverse events occurred. All patients reported at least one adverse event, most commonly nausea, diarrhea, and vomiting. Most adverse events were managed without dose interruption or reduction. There was a trend toward improvement in lung symptoms such as cough, pain, and dyspnea, and both health-related quality of life and functional capacity were generally maintained throughout ceritinib treatment, Dr. Crino and his associates said.