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Ceritinib improves PFS in patients with ALK–positive NSCLC
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The ASCEND-4 trial — designed to evaluate ceritinib in patients with advanced anaplastic lymphoma kinase–positive non–small cell lung cancer — met its primary endpoint, according to the drug’s manufacturer.
Ceritinib (Zykadia, Novartis) is a selective inhibitor of anaplastic lymphoma kinase (ALK), a gene that can form an abnormal “fusion protein” with other genes that promotes the growth of cancer. Two percent to 7% of patients diagnosed with NSCLC harbor the ALK rearrangement.
The phase 3 trial included 376 ALK–positive patients with stage IIIB to IV NSCLC who had not been previously treated for their advanced disease. Researchers randomly assigned patients to receive 750 mg daily of oral ceritinib or standard pemetrexed-based platinum doublet chemotherapy with pemetrexed maintenance.
Results showed ceritinib conferred a clinically significant improvement in PFS, the study’s primary endpoint, according to a press release. The trial also met its secondary endpoints of improvement in overall response rate and duration of response.
The researchers observed no new adverse events.
“Ceritinib has proven to be an important treatment option for ALK–positive NSCLC patients who have progressed following treatment with crizotinib [Xalkori; Pfizer Oncology, EMD Serono],” Alessandro Riva, global head of oncology development and medical affairs at Novartis Oncology, said in the release. “We are pleased to see these topline results show promise in untreated patients with advanced disease, and look forward to sharing these data with regulatory authorities in the coming months.”