Rare Disease Report

New Data Supports Safety and Efficacy of Alunbrig in Lung Cancer

OCTOBER 16, 2017
Mathew Shanley
This morning, Takeda Pharmaceutical Company Limited announced that data from the Phase 2 ALTA (ALK in Lung Cancer Trial of AP26113) clinical trial will be presented in an oral session at the International Association for the Study of Lung Cancer (IASLC) 18th World Conference on Lung Cancer.

The meeting is the world’s largest dedicated to lung cancer and other thoracic malignancies, and the data, which evaluates Alunbrig (brigatinib) in patients with locally advanced or metastatic anaplastic lymphoma kinase-positive (ALK+) non-small cell lung cancer (NSCLC) who have progressed on crizotinib, continue to support previously exhibited clinical benefits.

According to the American Cancer Society, NSCLC accounts for an estimated 85% of all new cases of lung cancer, and genetic studies indicate that chromosomal rearrangements in ALK are key drivers in a subset of patients. ALK+ NSCLC often progresses in the central nervous system (CNS), and brain metastases present in approximately 70% of patients after treatment with crizotinib.

“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 in a press release. “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 Phase 2 ALTA trial was randomized and intended to investigate the safety and efficacy of Alunbrig at 2 dosing regimens: 90 mg once daily (n = 112; 90 mg; Arm A) or 180 mg once daily following a 7-day lead-in of 90 mg once daily (n = 110; 180 mg dosing regimen; Arm B).

Via the press release, Myung-Ju Ahn, M.D., Professor, Department of Hematology & Oncology, Samsung Medical Center said: “The updated data from the ALTA trial further support the clinical benefit of ALUNBRIG (brigatinib). 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.”

Because of the positive results of the study, Takeda remains committed to the development of novel therapies for people living with ALK+ NSCLC. The drug is currently being studied in the Phase 3 ALTA 1L trial to evaluate its safety and efficacy when compared to crizotinib in patients with locally advanced or metastatic ALK+ NSCLC who have never received previous treatment with an ALK inhibitor.

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