The study is being presented at the 50th Annual Meeting of the
"Ceritinib demonstrated a high level of activity in patients with ALK+ NSCLC regardless of whether or not they were previously treated with an ALK inhibitor," said lead investigator
Among a combined population of 246 NSCLC patients, ceritinib achieved an overall response rate (ORR) of 58.5% and a median progression-free survival (PFS) of 8.2 months. Of these, 124 patients entered the trial with brain metastases and achieved an ORR of 54.0% and a median PFS of 6.9 months. The most common adverse events, occurring in more than half of patients, were diarrhea, nausea, vomiting, abdominal pain and fatigue(1).
Approximately 2-7% of patients with NSCLC harbor the ALK gene rearrangement, which causes cancer growth(3). These patients are candidates for treatment with a targeted ALK inhibitor. Patients with ALK+ NSCLC are often younger than the average NSCLC patient, and in many cases have never smoked(4).
"We are encouraged that ceritinib has demonstrated consistent activity as we analyze data from additional patients with longer follow-up, further supporting the potential of ceritinib to make a difference in the lives of patients with ALK+ NSCLC," said
The study presented at ASCO served as the basis for the
About the study and ceritinib clinical trial program The 246 patients with ALK+ NSCLC in this Phase I single-arm study received ceritinib 750 mg daily and had a 7-month median duration of follow-up. Of these, 166 (67%) had received at least two prior regimens and 163 (66%) had been previously treated with an ALK inhibitor. Findings from the study showed that patients treated with ceritinib achieved an ORR of 58.5% [95% CI, 52.1-64.8%] and a median PFS of 8.2 months [95% CI, 6.7-10.1 months]. The median duration of response was 9.7 months [95% CI, 7.0-11.4 months], with a median time to first response of 6 weeks after starting treatment(1).
Among 163 patients receiving 750 mg of ceritinib daily and who were previously treated with the commonly prescribed ALK inhibitor crizotinib, ORR was 54.6% [95% CI, 46.6-62.4%] and PFS was 6.9 months [95% CI, 5.4-8.4 months]. In 83 patients who had not received prior treatment with an ALK inhibitor, ORR was 66.3% [95% CI, 55.1-76.3%] and PFS had not been reached (NR) at the time of data cutoff as the majority of patients were still receiving treatment with ceritinib(1).
In the 124 patients who started the study with brain metastases, ceritinib achieved an ORR of 54.0% [95% CI, 44.9-63.0%] and a median PFS of 6.9 months [95% CI, 5.4-8.4 months]. Tumor shrinkage was seen in 50.0% of patients [49 of 98 patients; 95% CI, 39.7-60.3%] with brain metastases who had received previous ALK inhibitor therapy, while 69.2% of patients [18 of 26 patients; 95% CI, 48.2-85.7%] with brain metastases who were not previously treated with an ALK inhibitor achieved tumor shrinkage following treatment with ceritinib(1).
Discontinuation of treatment due to adverse events occurred in 10% of patients(1).
Among 255 patients treated with ceritinib, including 246 patients with NSCLC and nine patients with other types of cancer, 150 (59%) required at least one dose reduction. The most frequent adverse events (incidence >50%) among 255 patients were diarrhea (86%), nausea (80%), vomiting (60%), abdominal pain (54%) and fatigue (52%). The most common lab abnormalities (incidence >50%) were decreased hemoglobin (84%), increased ALT (80%), AST increased (75%) and increased creatinine (58%). The most common Grade 3/4 lab abnormalities (incidence >10%) were increased ALT (27%), increased AST (13%) and increased glucose (13%)(1).
This study is part of the ongoing
Keywords for this news article include: Pharmaceutical Companies, Cancer, Oncology, FDA Actions,
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