New US approval for Takeda’s Alunbrig

US regulators have expanded the scope of Takeda's Alunbrig (brigatinib) to include first-line treatment of adults with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC).

The move is based on results from the Phase III ALTA 1L trial, which is evaluating the safety and efficacy of Alunbrig compared to crizotinib in adult patients with ALK+ locally advanced or metastatic NSCLC who have not received prior treatment with an ALK inhibitor.

After more than two years' follow-up, Alunbrig demonstrated superiority over crizotinib, 'with significant anti-tumour activity observed, especially in patients with baseline brain metastases', the firm said in a press release.

Alunbrig cut the risk of disease progression or death twofold compared with crizotinib, with a 24-month median progression-free survival (PFS) as assessed by a blinded independent review committee (BIRC) versus 11 months for crizotinib.

The drug also demonstrated a confirmed overall response rate (ORR) of 74% versus 62% for crizotinib, while results for intracranial ORR for patients with measurable brain metastases at baseline were 78% and 26%, respectively.

“As with many forms of lung cancer, ALK+ NSCLC is a complex and aggressive cancer that presents various treatment challenges for patients who are newly diagnosed, including those whose disease has spread to their brain,” said Andrea Stern Ferris, president and chief executive, LUNGevity Foundation.

“Having this option for newly diagnosed patients is exciting news for the ALK+ NSCLC community and adds to the remarkable progress we have witnessed in lung cancer treatment over the past decade.”