CHICAGO—Novartis’ Zykadia just won the right to challenge Pfizer’s Xalkori for the first-line ALK-positive lung-cancer crown. But the way Roche sees it, that crown is Alecensa’s for the taking, as soon as it can nab an FDA approval, too.
Monday at the American Society of Clinical Oncology annual meeting, the Swiss drugmaker’s contender posted data showing it could beat Xalkori at cutting down the risk of disease worsening or death by more than 53%. Both drugs are targeted at lung tumors with an ALK gene rearrangement.
“Nobody imagined it would be possible to delay advanced lung cancer progression by this much. Most targeted therapies for lung cancer are associated with a median progression-free survival of roughly 12 months,” lead study investigator Alice Shaw said in a statement.
Alecensa also led when it came to preventing brain metastases, which are more common among ALK-positive patients because it’s “such an aggressive tumor,” Dietmar Berger, Roche’s global head of clinical development in hematology and oncology, said in an interview. Patients in the Alecensa group recorded just a 9% incidence of brain metastases at the 12-month mark, while 41% of patients in the Xalkori arm developed them.
Overall, the data “are really clear in the sense that, in my view, this will become, or is, the new standard of care for first-line,” Berger said.
It’s not the first time Alecensa has topped the Pfizer drug in a phase 3 study; that was May 2016, when Alecensa reduced the risk of disease progression by 66% versus its Pfizer opponent. And in doing so, Berger pointed out, it became the only ALK inhibitor to beat an in-class rival head-to-head.
But Xalkori isn’t the only ALK product Alecensa has to contend with. Novartis’ Zykadia recently picked up an FDA approval as a first-line treatment, and Takeda has rolled out its own entrant, Alunbrig. Pfizer is also testing an ALK/ROS1 candidate, lorlatinib, which is now in phase 3 and “has shown encouraging results in an early clinical study,” a company spokeswoman said in a statement.