The meeting is hosted by the International Association for the Study of Lung Cancer (IASLC) Dec. 4-7 in Vienna, Austria. Ariad will contribute an oral presentation and three posters covering data from the trial.
Approximately 8 percent of patients with non-small cell lung cancer (NSCLC) have rearrangements in the ALK gene, which is thought to lead to the development of lung cancer. Currently, two ALK inhibitors are approved to treat patients with ALK-positive NSCLC, Xalkori (crizotinib) and Zykadia (ceritinib). The investigational ALK inhibitor brigatinib has recently emerged as a potential treatment for patients who are resistant to other ALK inhibitors.
The ALTA trial (NCT02094573) enrolled 222 patients with ALK-positive NSCLC who progressed during treatment with Xalkori. Patients were randomized to receive either 90 mg of brigatinib once daily, or 90 mg a day for seven days followed by 180 mg in a 28-day cycle.
The study also stratified patients according to the presence of brain metastasis at the start of the study and their response to the earlier Xalkori treatment.
The outcomes of the study were assessed both by Ariad and by an independent review committee. Although Ariad plans to report an additional three months worth of data at the meeting, current findings show that 53 percent of patients in the higher dose group responded to the treatment, according to the independent committee. In the lower dose group, the response rate was 48 percent.
The progression-free survival was 15.6 months in the high-dose group and 9.2 months in the low-dose group.
Ariad researchers will also report on data from the Phase 1/2 study (NCT01449461), adding to the data on brain metastasis obtained in the ALTA trial. In patients with measurable brain lesions, the intracranial objective response rate (ORR) was 53% in the Phase 1/2 trial, while in the ALTA trial, the intracranial ORR in the high-dose and low-dose groups was 67% and 42%, respectively.
The complete disappearance of brain lesions was seen in 35% in the Phase 1/2 trial, 18% in the high-dose group, and 7% in the low-dose groups. The brain progression-free survival ranged between 12.8 and 15.6 months.
“We are excited that updated data from the ALTA trial on brigatinib in patients with ALK-positive non-small cell lung cancer will be presented at WCLC this year,” Timothy P. Clackson, PhD, president of research and development and chief scientific officer at Ariad, said in a news release.
“We continue to be encouraged by the activity and safety profile seen in the ALTA trial, and especially the correlation between investigator and independent review assessments of response and response durability,” he added.
The U.S. FDA has accepted Ariad’s New Drug Application for brigatinib, and has granted the drug Priority Review status, setting an action date of April 29, 2017.
Ariad also plans to submit a Marketing Authorization Application for brigatinib to the European Medicines Agency in early 2017.