Novartis today announced new data from two Phase II studies of Zykadia™ (ceritinib), as well as one Phase II study of Tafinlar® (dabrafenib) in combination with Mekinist® (trametinib) in certain patients with non-small cell lung cancer (NSCLC). Data from these studies were presented at the 51st Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
The results of the Zykadia studies – ASCEND-2 and ASCEND-3 – reinforce the efficacy of the medicine in patients with anaplastic lymphoma kinase-positive (ALK+) NSCLC who had received previous treatment with an ALK inhibitor and in those receiving an ALK-targeted therapy for the first time. Overall response rates (ORR) seen in these trials were 38.6% and 63.7%, respectively, based upon investigator assessment. Comparable ORR results were observed in patients with ALK+ NSCLC who entered the studies with brain metastases (33% and 58%, respectively).
Separately, the study of dabrafenib in combination with trametinib in patients with metastatic BRAF V600E-mutation positive NSCLC who had failed at least one round of chemotherapy demonstrated an ORR of 63% in this population.
"As our lung cancer portfolio and pipeline continue to mature and grow, we are impressed by the level of activity these targeted treatments demonstrate in patients with specific genetic mutations in NSCLC," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "Our continued studies of Zykadia and the Tafinlar and Mekinist combination, other targeted medicines, as well as our partnerships with the oncology community to develop practice-changing immunotherapy combinations, demonstrate our strong commitment to patients living with lung cancer."
Novartis Pharmaceuticals Corporation