US regulators have green-lighted the use of Novartis Zykadia as a first-line treatment option for some patients with non-small cell lung cancer.
The decision allows physicians to prescribe the drug in treatment-naiive patients with metastatic NSCLC whose tumours are anaplastic lymphoma kinase (ALK)-positive, following clearance in 2014 as a second line option for patients who progressed on or are intolerant to crizotinib.
In the Phase III ASCEND-4 trial, patients treated with first-line Zykadia (ceritinib) had a median progression-free survival (PFS) of 16.6 months compared to 8.1 months for those given standard first-line pemetrexed-platinum chemotherapy with pemetrexed maintenance.
Also of note, the overall intracranial response rate (OIRR) in patients with measurable brain metastases was 57 percent for patients treated with Zykadia, versus 22 percent for those treated with chemotherapy, while the whole body overall response rate (ORR) observed with Novartis’ drug was 73 percent.
The most common adverse events, occurring in more than 25 percent of Zykadia patients, were found to be diarrhoea (85 percent vs. 11 percent with chemotherapy), nausea (69 percent vs. 55 percent), vomiting (66 percent vs. 36 percent) and an increase in the liver enzymes ALT (60 percent vs. 22 percent) and AST (53 percent vs. 19 percent).
Bruno Strigini, chief executive of Novartis Oncology, said expanding Zykadia’s reach brings “this important medication to a patient population where a need still exists”.
Around 3-7 percent of all patients with NSCLC have an ALK gene rearrangement.