Novartis’s Zykadia prolongues advanced non-small lung cancer (ALK+) patients’ life for 16.6 months, compared to 8.1 months in patients treated with standard chemotherapy.
Novartis on Tuesday announced results at International Association for the Study of Lung Cancer (IASLC), in Vienna, from its Phase III open-label, randomized, active-controlled, multi-center ASCEND-4 study. This equated to a 45% reduction in the risk of disease progression.
“These data demonstrate the potential to more than double a patient’s progression-free survival when they take Zykadia as their first ALK inhibitor rather than undergoing treatment with chemotherapy,” said lead investigator Dr. Gilberto de Castro Jr., head of Thoracic Oncology and Head and Neck Cancer clinic in the Clinical Oncology Service of the Institute of Cancer of São Paulo (ICESP), in São Paulo, Brazil. “For clinicians, who are constantly working to extend a patient’s response to treatment in the first-line setting, the ASCEND-4 results are very compelling.”
Overall survival data were immature; however, a positive trend in favor of Zykadia was observed, despite 72.4% of patients in the chemotherapy arm receiving an ALK inhibitor as their first treatment after discontinuing chemotherapy, Novartis said.
Patients getting Zykadia reported improvement in lung-cancer symptoms
Patients taking Zykadia had an ORR of 72.5% compared to 26.7% in patients treated with standard chemotherapy. Further, patients with measurable brain metastases experienced an OIRR of 72.7% with Zykadia compared to 27.3% with standard chemotherapy. Patients without brain metastases at screening experienced a median PFS of 26.3 monthswith Zykadia compared to 8.3 months with standard chemotherapy. Additionally, patients taking Zykadia demonstrated a DCR of 84.7% and DoR of 23.9 months. Study results were measured by a blinded independent review committee (BIRC). Patients treated with Zykadia also reported better overall general health status and improvement in lung cancer-specific symptoms compared to patients treated with standard chemotherapy.
“The patient response to treatment is high and durable in the first-line setting,” said Bruno Strigini, CEO, Novartis Oncology. “Based on these results, Novartis is initiating discussions with regulatory authorities worldwide regarding this potential use of Zykadia to further improve outcomes for patients with ALK+ advanced NSCLC.”