COPENHAGEN, Denmark--Pfizer’s kidney-cancer fighter Sutent is an aging drug--but it may just have one more label expansion up its sleeve.
Among patients with localized kidney cancer that’s been surgically removed--a group considered high-risk for relapse--the med bested placebo in a Phase III study at improving disease-free survival, the New York pharma giant announced at the ESMO 2016 Congress.
Investigators followed patients for 5 years who had taken either Sutent or placebo for one year, and at that 5-year mark, median disease-free survival in the Sutent arm was 6.8 years, versus 5.6 years for placebo.
That result is “pretty significant, when you think about disease-free survival being improved by more than a year,” Pfizer chief development officer of oncology Mace Rothenberg told FiercePharma in an interview at ESMO.
It also makes the study, dubbed S-TRAC, the first positive adjuvant renal cell cancer trial ever. “This, I think, is a very important, really paradigm-changing, treatment-changing trial for these patients,” he said.
Pfizer has already gotten in touch with regulators to discuss the data, and it’s hoping to add a label expansion “sooner rather than later,” Rothenberg said.
But the New York drugmaker isn’t stopping there. It’s also testing follow-up kidney cancer med Inlyta--approved in 2012--in the same setting in a similar Phase III trial. Only with Inlyta, because the med has a different side effect profile than Sutent does, patients can stay on therapy for up to three years instead of up to one--potentially spelling stronger adjuvant sales.
“You can’t ever feel complacent, especially when it comes to oncology,” Rothenberg said. “The field is moving forward rapidly, expectations of new treatments are also rising pretty rapidly--so we’re constantly challenging ourselves to keep up with that or to lead that change.”
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