Patients with metastatic non-small cell lung cancer (NSCLC) who have a rearrangement in the anaplastic lymphoma kinase (ALK) gene now have a first-line option: ceritinib.
Patients with metastatic non-small cell lung cancer (NSCLC) who have a rearrangement in the anaplastic lymphoma kinase (ALK) gene, as detected by an FDA-approved test, and who are treatment naïve can now be treated with the tyrosine kinase inhibitor ceritinib (Zykadia). The approval follows a priority review received in January 2017 for first-line in patients with ALK-positive metastatic NSCLC.
Results from the randomized, open-label, multicenter ASCEND-4 trial in patients newly diagnosed with ALK-positive NSCLC were the basis of the current approval. The rearrangement was detected using the VENTANA ALK (D5F3) test.
ASCEND-4 recruited 376 patients who were randomized 1:1 to receive once-daily ceritinib till disease progression or platinum-pemetrexed doublet chemotherapy (either cisplatin or carboplatin).
Patients were evaluated based on a blinded independent review committee assessment. Ceritinib treatment improved progression-free survival (PFS) by 8.5 months: median PFS was 16.6 months in the ceritinib arm (95% CI, 12.6 to 27.2) compared with 8.1 months in the chemotherapy arm (95% CI, 5.8 to 11.1). Patients treated with ceritinib had an objective response rate of 73% (95% CI, 66% to 79%) as opposed to 27% (95% CI, 21% to 34%) in the chemotherapy arm. The median duration of response was significantly greater among patients treated with ceritinib: 23.9 months (95% CI, 16.6 to not estimable), versus 11.1 months in those receiving chemotherapy.
Ceritinib also had an overall intracranial response rate of 57% in patients with brain metastases (95% CI, 37 to 76), versus 22% in those receiving chemotherapy (95% CI, 9 to 42).
It’s still too early to estimate overall survival in the enrolled population.
The most common adverse events (AEs) in patients receiving ceritinib were diarrhea, nausea, vomiting, fatigue, abdominal pain, decreased appetite, and cough. While serious AEs were noted in 38% of patients, a little over 10% of patients dropped out of the treatment arm because of AEs. Seventy-seven percent patients had a dose interruption while 66% required a dose reduction.
“Today's approval represents the next step in the development of Zykadia as a treatment option for ALK-positive metastatic NSCLC, bringing this important medication to a patient population where a need still exists,” said Bruno Strigini, CEO, Novartis Oncology, which has developed the drug.
Ceritinib was first approved in 2014 for late-stage NSCLC whose disease advanced on crizotinib or who were intolerant to crizotinib.
Lack of Mutations Associated With Favorable Prognosis in MPN-U
April 25th 2024While the Dynamic International Prognostic Scoring System and bone marrow blasts may predict overall survival, the lack of certain mutations is also associated with a better prognosis for myeloproliferative neoplasm, unclassifiable (MPN-U).
Read More
Examining Low-Value Cancer Care Trends Amidst the COVID-19 Pandemic
April 25th 2024On this episode of Managed Care Cast, we're talking with the authors of a study published in the April 2024 issue of The American Journal of Managed Care® about their findings on the rates of low-value cancer care services throughout the COVID-19 pandemic.
Listen
HOPE-CAT Can Identify Maternal Cardiovascular Risk 2 Months Earlier Than Doctors, Study Says
April 25th 2024In a retrospective study, the machine learning tool was able to screen for potential risks of cardiovascular disease nearly 60 days before the patient's medical record showed any signs of a related condition or before they were officially diagnosed or treated for it.
Read More
Data Back Neoadjuvant Combo vs Chemo Alone for Early-Stage NSCLC
April 24th 2024For patients with early-stage non–small cell lung cancer (NSCLC), combining neoadjuvant immune checkpoint inhibitors and platinum-based chemotherapy improves 2-year outcomes over chemotherapy alone, suggest findings of an extensive literature review and meta-analysis.
Read More