For the second time in less than a year, Roche’s Alecensa topped Pfizer’s Xalkori as a first-line treatment in ALK-positive lung cancer, top-line results from a new trial show, adding to its case for an expanded approval—and for an impending showdown with Novartis in the same setting.
Alecensa is now cleared to target ALK+ patients who've failed on previous Xalkori therapy, but the new study showed it “significantly” improved progression-free survival versus the Pfizer drug in previously untreated patients. Roche plans to unveil the details at an upcoming medical meeting.
More importantly, the Swiss drugmaker plans to take the data to regulators as part of efforts to convert its current indication “to a full approval as an initial treatment,” according to an announcement.
“We hope to bring Alecensa as an initial treatment for people with ALK-positive NSCLC as soon as possible,” Roche chief medical officer Sandra Horning said in a statement.
The results follow the FDA’s decision last fall to grant the drug a breakthrough therapy designation in first-line ALK-positive NSCLC, setting it up for a quick approval if the data proves sufficient. Last May, a separate phase 3 study showed Alecensa reduced the risk of disease progression by 66% against Xalkori.
Also gunning to treat first-line ALK+ NSCLC is Novartis with its similarly targeted drug Zykadia. Back in September, Novartis posted data showing its med bested chemo in previously untreated ALK+ NSCLC patients.
At the time, Bank Vontobel analyst Stefan Schneider told Reuters that Roche had a leg up due to its study design, which pitted Alecensa against the standard of care, rather than chemo, as the Novartis trial did.
"Taken from the current data, we assume that Alecensa will be superior to Zykadia from an efficacy and safety perspective in the first-line ALK-positive non-small cell lung cancer,” he told the news service at the time.
Pfizer’s Xalkori first won its U.S. approval to treat ALK+ lung cancer back in 2011. The drug turned $561 million in worldwide sales last year. Alecensa won approval in the U.S. in December 2015 as a second-line ALK+ treatment behind Xalkori.