Takeda's Alunbrig scores nod for earlier lung cancer use, but a Roche showdown awaits

Takeda’s Alunbrig has arrived in previously untreated, ALK-positive non-small cell lung cancer. But there’s plenty of competition waiting to greet it at the door.

The FDA approved the Takeda med Friday based on results from a phase 3 trial showing Alunbrig could cut patients’ risk of disease progression or death by 51% compared with Pfizer’s Xalkori at the 25-month treatment mark.

RELATED: Takeda eyes Alunbrig earlier lung cancer use as 2-year data trounce Pfizer’s Xalkori

And in the population of patients with brain metastases—who make up about 30% to 40% of the ALK-positive pool—the drug cut the risk of brain disease progression by 69%. At the two-year mark, median progression-free survival hadn’t been reached, while Xalkori suppressed tumor growth for just 5.9 months.

“We’re extremely proud of the positive results Alunbrig has shown for newly diagnosed ALK-positive NSCLC patients, particularly those with brain metastases,” Teresa Bitetti, president of Takeda’s global oncology business unit, said in a statement.

The green light is a big break for Alunbrig, which has until now been confined to later lines of therapy. For Takeda’s 2019 fiscal year, the drug pulled in ¥7.2 billion ($66.9 million).

RELATED: ASCO: Roche's Alecensa stays on top of Xalkori with long-term survival showing

The thing is, Xalkori is no longer the drug to beat in first-line, ALK-positive NSCLC after 2017 go-aheads for Roche’s Alecensa and Novartis’ Zykadia. Of those two, it’s Alecensa that’s run away with the market, generating CHF 876 million ($906 million) in 2019 on the back of data showing it could slash the risk of disease worsening or death by more than 53% against Xalkori.

And recently, Alecensa turned up more data that could help keep it on top. The drug showed it could help patients live longer, with 62.5% of Alecensa patients still alive at the five-year mark versus just 45.5% of the Xalkori group.