COPENHAGEN, DENMARK--The positive data for Novartis' lung-cancer fighter Zykadia (ceritinib) just keep rolling in.
In a Phase III study of ALK-positive lung cancer patients previously treated with Pfizer’s Xalkori (crizotinib), the med topped chemo at staving off disease progression, Novartis said at the ESMO 2016 Congress.
It’s the first Phase III study to examine whether Zykadia (ceritinib) could beat out chemo in those whose disease had progressed after taking Xalkori, lead study author Giorgio Scagliotti said in a statement, and it “opens up a new treatment paradigm after crizotinib failure.”
“It would be logical now to give a sequence of active drugs, starting with crizotinib in first line and moving to ceritinib in second line,” he said.
Both drugs treat non-small cell lung cancer patients with a rare genetic abnormality, a rearrangement on the ALK gene. An estimated 2% to 7% of NSCLC patients are ALK-positive, the FDA says.
Novartis is looking for a Zykadia boost as it dukes it out with crosstown rival Roche, which makes a newer competitor, Alecensa. Despite Zykadia’s earlier arrival, Alecensa is leading on the sales front, with $74 million through the first half of this year compared with $48 million for the Novartis drug.
And Alecensa is ahead in the quest to take on Xalkori in previously untreated patients, too. Earlier this month, the Roche product nabbed a "breakthrough" designation from the FDA in patients who haven’t yet been treated with ALK inhibitors, putting it in line for a speedy approval.
Zykadia is not far behind in that race, however. Last month, Novartis posted data supporting its own first-line nod, showing that Zykadia could trump standard chemo at improving progression-free survival in patients who've not yet used an ALK inhibitor.
Novartis rolled out more good Zykadia news at ESMO, too. It unveiled Phase II results in patients with ALK+ metastatic NSCLC who had yet to try post-chemo therapy with an ALK inhibitor, and the med extended progression-free survival by a median 18.4 months.
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