Roche’s Alecensa has outperformed its main rival in a head-to-head trial, setting up regulatory filings as a first-line treatment for some patients with non-small cell lung cancer (NSCLC).
Alecensa (alectinib) is already approved as a second-line treatment for ALK-positive NSCLC after Pfizer’s Xalkori (crizotinib), but data from the ALEX trial now suggests Roche’s drug works better than its rival in previously untreated patients.
ALEX met its primary objective of significantly reducing the risk of disease worsening or death compared to Xalkori, mirroring the results of an earlier phase III trial conducted in Japan (J-ALEX), where Alecensa is sold by Roche subsidiary Chugai. Roche isn’t giving away the data just yet, saying it will present it at a medical conference later this year.
“We hope to bring Alecensa as an initial treatment for people with ALK-positive NSCLC as soon as possible and will discuss this data with global health authorities,” commented Sandra Horning, Roche’s chief medical officer.
The targeted treatment was approved in the EU in February, after getting its first green light in Japan in 2014 and entering the US market in the following year. It competes in the second-line setting with Novartis’ Zykadia (ceritinib), and later this year could see another rival in the form of Takeda’s brigatinib, acquired along with Ariad in a $5.2bn deal that closed in February.
Alecensa is already approved for first-line ALK-positive NSCLC in Japan, with Roche’s head of pharma Daniel O’Day claiming 60% market share in Xalkori-naïve patients in that market.
Moving into the first-line setting in other territories would give Roche a leg-up over its rivals and allow it to compete on an even footing with Xalkori, which brought in $561m for Pfizer last year, up 17% on 2015. Last year, Alecensa made sales of 182m Swiss francs ($180m) while Zykadia brought in 91m francs for Novartis, with sales shrinking in the fourth quarter.
Trying to set its product back on course, Novartis is also pursuing a first-line indication for Zykadia, and filed for approval of the drug in this setting – based on the ASCEND-4 data – in the US, EU and Japan towards the end of last year.