Takeda Pharmaceutical has reported positive results from the Phase III ALTA-1L clinical trial of Alunbrig (brigatinib) in patients with anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC).
Alunbrig is a selective tyrosine kinase inhibitor (TKI) of the ALK fusion protein in NSCLC. The ALTA-1L trial assessed the drug in 275 adult patients who did not receive previous treatment with an ALK inhibitor.
In newly diagnosed participants whose cancer had spread to the brain at baseline, risk of disease progression or death decreased by 76% with Takeda’s drug compared to crizotinib.
The drug led to a 57% reduction in overall patient population.
At the data cut-off date of 28 June 2019, a second interim analysis showed a 51% decrease in the risk of disease progression or death on the primary endpoint of progression-free survival (PFS).
Long-term analysis involving a follow-up period of two years found a positive response with Alunbrig in newly diagnosed patients with or without brain metastases at baseline.
The drug demonstrated superior efficacy over crizotinib in patients with baseline brain metastases.
Takeda Oncology Therapeutic Area Unit head Phil Rowlands said: “We are proud of the progress made thus far, including these updated results from the ALTA-1L trial, which show that Alunbrig delayed disease progression by more than two years and significantly reduced the risk of disease progression in patients with baseline brain metastasis.
“We look forward to submitting these data to regulatory authorities around the globe with the goal of making Alunbrig available to ALK+ NSCLC patients worldwide.”
In a recent announcement, Takeda said that the vaccine’s efficacy was 73.3% at 18 months. The company noted that additional data is required to fully understand the profile of TAK-003.