Takeda Pharmaceutical Company Limited announced that data from the pivotal Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) clinical trial evaluating ALUNBRIGTM (brigatinib) in patients with locally advanced or metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib will be presented in an oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer (WCLC) on Monday, October 16, 4:30 p.m.- 4:40 p.m. JST. The presentation will share updated safety and efficacy data from the trial as of February 21, 2017, which continue to support previously reported clinical results.
The randomized Phase 2 ALTA trial was designed to investigate the efficacy and safety of ALUNBRIG at two dosing regimens. Patients received either 90 mg of ALUNBRIG once daily (n = 112; 90 mg; Arm A) or 180 mg once daily following a seven-day lead-in of 90 mg once daily (n=110; 180 mg dosing regimen; Arm B).
“The data being presented at WCLC provide further evidence supporting the role of ALUNBRIG in the treatment of patients with advanced ALK-positive NSCLC,” said David Kerstein, M.D., Senior Medical Director and Global Clinical Lead for ALUNBRIG, Oncology Clinical Research, Takeda. “There continues to be an unmet need for the more than 30,000 patients diagnosed with this serious and rare form of lung cancer worldwide each year. We are encouraged by the updated data from the ALTA trial, which support the efficacy and safety of ALUNBRIG in a crizotinib-refractory population, at the dosing regimen that is being taken forward into ongoing and future clinical trials.”
“The updated data from the ALTA trial further support the clinical benefit of ALUNBRIG (brigatinib),” said Myung-Ju Ahn, M.D., Professor, Department of Hematology & Oncology, Samsung Medical Center. “I am especially encouraged by the efficacy seen in patients with brain metastases, cancer that has spread to the brain. The central nervous system is a common site for progression in this disease, with brain metastases occurring in up to 70 percent of patients after treatment with crizotinib. With the 180 mg dosing regimen of brigatinib, two-thirds of patients with measurable brain metastases had an intracranial response, with a median intracranial duration of response of 16.6 months.”
