ARIAD Pharmaceuticals recently presented updated data from an ongoing Phase 1/2 trial testing brigatinib, an investigational tyrosine kinase inhibitor, in patients with anaplastic lymphoma kinase positive (ALK+) non-small cell lung cancer (NSCLC) and other malignancies.
The results were presented at the 6th European Lung Cancer Conference (ELCC) in Geneva, Switzerland. ARIAD is focused on the treatment of various forms of chronic and acute leukemia, lung cancer, and other difficult-to-treat orphan cancers.
The primary endpoint of the Phase 1/2 trial was to assess patients’ overall response rate to the treatment, while the secondary endpoints included safety and tolerability, pharmacokinetic parameters, progression free survival, and overall survival.
The trial revealed anti-tumor activity in the 70 evaluable ALK+ NSCLC patients with prior crizotinib therapy who were treated with brigatinib in the study. The median progression-free survival (PFS) of these patients was found to be 13.4 months.
Moreover, tumor shrinkage was detected in all enrolled ALK+ NSCLC patients, and in 25 patients, lesion was reduced completely.
The most frequent treatment-related adverse effects included nausea (52 percent), fatigue (42 percent), diarrhea (40 percent), headache (33 percent), and cough (32 percent).
“The updated data from the Phase 1/2 trial of brigatinib show a one-year overall survival rate of 100 percent in crizotinib-naive patients, and 81 percent in patients with prior crizotinib treatment,” said Rafael Rosell, M.D., director of the Cancer Biology & Precision Medicine Program at Catalan Institute of Oncology, Germans Trias i Pujol Health Sciences Institute and Hospital in Barcelona, Spain, in a press release.
“In addition, the new data show predictable pharmacokinetics, with drug exposure increasing proportionally with dose. The Phase 1/2 trial has provided important long-term follow-up data on the safety and efficacy of this promising drug candidate,” Rosell said.
“As we continue to study brigatinib in the ongoing Phase 1/2 trial, the pivotal Phase 2 ALTA trial and the new Phase 3 ALTA 1L trial in the front-line setting, we are encouraged by the potential of this targeted drug candidate for patients with ALK positive NSCLC and are looking forward to an NDA [new drug application] submission later this year,” said Timothy P. Clackson, Ph.D., ARIAD’s chief scientific officer and president of research and development.
“The safety, [pharmacokinetic] and efficacy results reported with this update provide the potential for differentiation of brigatinib in the crizotinib-resistant patient population,” Clackson said.
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