medwireNews: The ASCEND-5 trial results establish ceritinib as a valid option for pretreated non-small-cell lung cancer (NSCLC) patients harboring anaplastic lymphoma kinase (ALK) translocations.
Among 231 patients who had received one to two prior chemotherapy regimens as well as crizotinib, treatment with ceritinib 750 mg/day significantly reduced the risk of progression or death by half relative to chemotherapy (either docetaxel 75 mg/m2 or pemetrexed 500 mg/m2).
During a median follow-up of 16.5 months, progression-free survival, as assessed by blinded independent review, was a median of 5.4 months for the 115 ceritinib-treated patients and 1.6 months for the 116 patients randomly assigned to receive chemotherapy.
The objective response rate was also significantly higher with the second-generation ALK inhibitor than with chemotherapy, at 39.1% versus 6.9%.
Reporting the confirmatory phase III results at the ESMO 2016 Congress in Copenhagen, Denmark, Giorgio Scagliotti (University of Torino, Italy) noted that the adverse event profile was as expected, with gastrointestinal and liver toxicities observed most commonly in the ceritinib group and hematological side effects in the chemotherapy group.
He concluded that ceritinib demonstrated “superior efficacy” to standard chemotherapy in ALK-rearranged NSCLC, establishing “ceritinib as a preferred treatment option in this patient population.”
By Shreeya Nanda
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