Date: 2016-04-11
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Ariad Pharmaceuticals (USA - MA)
Product: brigatinib (AP26113)
Action
mechanism: kinase inhibitor/tyrosine kinase inhibitor. Brigatinib (AP26113) is an investigational, targeted cancer medicine discovered internally at ARIAD Pharmaceuticals, Inc. It is in development for the treatment of patients with ALK+ NSCLC that is resistant to crizotinib. Brigatinib received Breakthrough Therapy designation from the FDA in October 2014 on the basis of an ongoing Phase 1/2 trial.
Disease: ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously been treated with an ALK inhibitor
Therapeutic area: Cancer - Oncology
Country: Australia, Austria, Canada, Denmark, Finland, France, Germany, Hong Kong, Italy, Republic of Korea, Luxembourg, The Netherlands, Norway, Singapore, Spain, Sweden, Switzerland, Taiwan, UK, USA
Trial
details: The ALTA 1L (ALK in Lung Cancer Trial of BrigAtinib in 1st Line) trial is designed to assess the efficacy of brigatinib in comparison to crizotinib based on evaluation of the primary endpoint of progression free survival (PFS). The primary endpoint of the trial is progression free survival (PFS), per RECIST criteria as assessed by a blinded Independent Review Committee (BIRC). Tumor response assessments will be performed every eight weeks. Key secondary endpoints include objective response rate (ORR), intracranial ORR, intracranial PFS, duration of response, overall survival (OS), safety and tolerability. Health related quality of life data will also be assessed.(NCT02737501)
Latest
news: * On April 11, 2016, Ariad Pharmaceuticals announced the initiation of a randomized, first-line Phase 3 clinical trial of brigatinib, its investigational anaplastic lymphoma kinase (ALK) inhibitor, in adult patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who have not previously been treated with an ALK inhibitor. The ALTA 1L trial is a randomized, open-label, multicenter, international study that is designed to compare the efficacy and safety of brigatinib to crizotinib in adult patients with ALK+ NSCLC who have not previously received an ALK inhibitor. The trial is expected to be conducted at approximately 150 investigational sites in North America , Europe and the Asia Pacific region. Patients in the trial must be at least 18 years of age, have stage IIIB or stage IV NSCLC with ALK rearrangement, have received no more than one regimen of systemic anticancer therapy in the locally advanced or metastatic setting, and have not received prior therapy with an ALK inhibitor. Approximately 270 patients are expected to be randomized one-to-one to receive brigatinib (90 mg given orally once daily for seven days followed by escalation to 180 mg once daily) or crizotinib (250 mg given orally twice daily). ARIAD expects to complete patient enrollment in the ALTA 1L trial in 2018.
