Takeda’s Alunbrig improves PFS in phase 3 lung cancer trial

The study achieved its primary endpoint at the first pre-specified interim analysis, with Alunbrig showing a statistically significant improvement in PFS compared against crizotinib in adults with anaplastic lymphoma kinase-positive (ALK+) locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not received a prior ALK inhibitor.

Takeda has designed the study to evaluate the efficacy and safety of Alunbrig in comparison to crizotinib based on assessment of the primary endpoint of PFS, or length of time from the start of treatment that a patient lives without the disease getting worse.

At present, Alunbrig has not secured approval as frontline therapy.

Alunbrig’s ALTA-1L study is a global, ongoing, randomized, open-label, comparative and multicenter trial that recruited 275 patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor.

Patients secured either Alunbrig180 mg once daily with seven-day lead-in at 90 mg once daily or crizotinib 250 mg twice daily.

The PFS is the primary endpoint and secondary endpoints include objective response rate (ORR) per RECIST v1.1, intracranial ORR, intracranial PFS, overall survival (OS), safety and tolerability.

Alunbrig is a targeted cancer medicine discovered by Ariad Pharmaceuticals, and it was acquired by Takeda in February 2017.

In April 2017, Alunbrig secured accelerated approval from the US Food and Drug Administration (FDA) for ALK+ metastatic NSCLC patients who have progressed on or are intolerant to crizotinib

Takeda oncology clinical research and development head and vice president Dr Jesús Gomez-Navarro said: “This represents a major milestone for the ALUNBRIG program. Our goal with ALUNBRIG is to improve the lives of patients with ALK+ NSCLC by furthering the available therapeutic options.

“We are encouraged by the data, which demonstrated a statistically significant improvement in progression-free survival versus crizotinib in patients with ALK+ advanced NSCLC, and look forward to beginning discussions with regulatory authorities as we seek to expand ALUNBRIG’s indication into the frontline setting.”