Takeda's also-ran ALK drug Alunbrig aims to challenge Pfizer with new first-line data

Takeda US facility
Takeda is hoping to move Alunbrig into front-line ALK+ non-small cell lung cancer, where it would face off against formidable rivals. (Takeda)

Takeda's Alunbrig now sits in the back seat in ALK+ non-small cell lung cancer, behind rivals from Pfizer, Novartis and Roche. But the company has been pushing to change that, and on Wednesday, that effort got a leg up from new data.

In an interim analysis of a phase 3 trial called Alta-1L, Alunbrig bested Pfizer and Merck KGaA's Xalkori at fending off non-small cell lung cancer growth in ALK-positive, previously untreated patients. Buoyed by that showing, the Japanese drugmaker plans to start talking up its case for first-line use to regulators.

Takeda picked up Alunbrig in its $5.2 billion Ariad buyout last year, and when the drug won FDA approval last April, CEO Christophe Weber said he believes the drug “will become a best-in-class ALK inhibitor … with the potential to achieve peak annual sales of over $1 billion.”

Free Webinar

Striving for Zero in Quality & Manufacturing

Pharmaceutical and medical device manufacturers strive towards a culture of zero – zero hazards, zero defects, and zero waste. This webinar will discuss the role that content management plays in pharmaceutical manufacturing to help companies reach the goal of zero in Quality and Manufacturing.

To get there, though, it'll need to prove its worth against drugs from top cancer drugmakers—and not only the Pfizer and Merck team. Right now, Alunbrig is approved only for patients for whom Xalkori has failed. If the Takeda drug wins approval for previously untreated patients, Alunbrig will go up against not only Xalkori but also Novartis' Zykadia and Roche's Alecensa. Those drugs won their approvals in front-line ALK+ NSCLC in May 2017 and November 2017, respectively. 

RELATED: Takeda's Ariad deal pays off with blockbuster green light for Alunbrig 

The Alta-1L trial will continue until investigators tally up enough data "to demonstrate a minimum of six months [progression-free survival] improvement" over Pfizer and Merck KGaA's drug.

RELATED: Takeda CEO reassures investors worried the math on its $62B Shire buyout doesn't add up 

Meanwhile at Takeda, the company is proceeding with its $62 billion Shire buyout announced in April. The deal has caused some investor unease, and Weber had to answer questions at a recent investor meeting about the strength of Shire's hemophilia business in the face of new competition, according to the Financial Times.

Suggested Articles

Shionogi's newest antibiotic Fetroja has now earned the FDA's approval, but will a mortality-rate warning scuttle the drug's chances?

Novartis' Sandoz doubled down in Japan as Lupin retreated. Dr. Reddy's posted a loss tied to its Zantac recall. Aslan's varlitinib failed again.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.