ALTA-1L trial results : Takeda’s ALUNBRIG continues to show superiority over crizotinib
ALTA-1L trial results : Takeda Pharmaceutical says that ALUNBRIG (brigatinib), its tyrosine kinase inhibitor (TKI), is continuing to show superiority over crizotinib in the phase 3 ALTA-1L trial.
The Japanese pharma company released updated data from the late-stage trial involving adult patients having advanced anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who did not receive a prior ALK inhibitor.
After more than two years of follow-up, investigators found that ALUNBRIG has brought down the risk of disease progression or death by 76% in newly diagnosed patients whose disease had spread to the brain at the time of enrollment.
In all patients, the tyrosine kinase inhibitor also showed a 57% reduction in risk of disease progression or death. Takeda Pharmaceutical plans to present the data during the Presidential Session at the 2019 European Society for Medical Oncology (ESMO) Asia Congress on 23 November in Singapore.
Commenting on the ALTA-1L trial results, Phil Rowlands – Takeda Pharmaceutical Oncology Therapeutic Area Unit Head 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.”
According to the Japanese pharma company, ALUNBRIG has been designed to target and block the anaplastic lymphoma kinase (ALK) fusion protein in non-small cell lung cancer.
In April 2017, the tyrosine kinase inhibitor was granted accelerated approval from the US Food and Drug Administration (FDA) for anaplastic lymphoma kinase-positive (ALK+) metastatic NSCLC patients whose disease has progressed on or are intolerant to crizotinib.
ALUNBRIG’s approval for the indication is under accelerated approval, which was based on tumor response rate and duration of response. Continued approval for the indication could be subject to verification and description of clinical benefit in a confirmatory trial.