Takeda’s Alunbrig beats Pfizer’s Xalkori on PFS in ALK positive NSCLC

Takeda’s Alunbrig has beaten Pfizer's Xalkori on progression-free survival (PFS) in a Phase III trial testing its efficacy as a front-line treatment for ALK-positive lung cancer.

The ALTA-1L trial enrolled 275 patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) who had not had prior treatment with an ALK inhibitor.

Patients were given either Alunbrig (brigatinib) 180mg once daily (following a 90mg per day seven day lead in period) or Xalkori (crizotinib) 250mg twice daily.

Takeda didn’t reveal the data at this point but said an interim analysis showed that its drug demonstrated “a statistically significant improvement” in PFS compared to Xalkori.

Jesús Gomez-Navarro, vice president, Head of Oncology Clinical Research and Development, said the firm is “encouraged by the data”, and looks forward to “beginning discussions with regulatory authorities as we seek to expand Alunbrig’s indication into the frontline setting”.

Takeda also said that no new safety signals were revealed by the trial, and that data from the interim analysis would be submitted for presentation at an upcoming medical meeting.

In May last year Alunbrig was granted accelerated approved in the US as a second-line therapy for adults with ALK positive NSCLC, which equates to around 5 percent of the total NSCLC population. A green light in the first-line setting would significantly expand the drug’s target population.

26th July 2018

http://www.pharmatimes.com/