Continuing the reinvention of its cancer drug Gazyva as a treatment for immune-mediated diseases of the kidney—which resulted in a lupus nephritis nod last fall—Roche is touting new data that could tee up the antibody for a world-first approval.
In an early look at results from the late-stage Majesty study in adults with primary membranous nephropathy, Gazyva (obinutuzumab) helped significantly more patients achieve complete remission at the two-year mark compared with the immunosuppressant tacrolimus, Roche said in a Feb. 16 press release.
Gazyva’s performance enabled the trial to hit its primary endpoint, and key secondary endpoints further pointed to statistically significant and clinically meaningful outcomes on overall remission at Week 104 and complete remission at Week 76 of the study, the company said.
Safety was also on par with the known profile of Gazyva, which has spent most of its life as a treatment for chronic lymphocytic leukemia (CLL) and follicular lymphoma drug following an initial CLL green light back in 2013.
In announcing the trial win, Roche provided limited detail on the data, noting that it will present the results at an upcoming medical meeting. The company also plans to share the trial readout with regulators, including the FDA and the European Medicines Agency.
“These results demonstrate that Gazyva/Gazyvaro may help more people with primary membranous nephropathy achieve complete remission, maintain kidney function for longer and delay or potentially prevent the onset of life-threatening complications,” Levi Garraway, M.D., Ph.D., Roche’s chief medical officer and head of global product development, said of the Majesty results, referring to obinutuzumab by both its U.S. brand name and the commercial moniker used abroad.
Primary membranous nephropathy is a chronic autoimmune condition that affects some 88,000 people in the EU and more than 96,000 people in the U.S., by Roche’s estimates. The disease leads to potentially irreversible kidney damage and reduced kidney function, and up to 30% of people diagnosed will develop kidney failure over 10 years, according to the company. Patients who endure kidney failure must then turn to invasive treatments like dialysis or organ transplant.
There are no treatments specifically approved for primary membranous nephropathy at present, though drugs like ACE inhibitors are often used to manage high blood pressure and lower urine protein levels, and Roche’s own Rituxan—a CD20-targeting antibody like Gazyva—is relied on often as an off-label solution.
Roche figures Gazyva could shake up the treatment field by targeting the underling cause of primary membranous nephropathy, potentially helping maintain patients' kidney function for a longer span and preventing the onset of fatal disease complications.
Despite its deep oncology roots, Gazyva is amassing a growing body of evidence to support its potential in a range of immune-mediated diseases.
Last October, the drug broke into new territory with an FDA approval to treat adults with active lupus nephritis who are already taking standard therapy, with Roche arguing that the drug’s targeting of CD20—a protein found on certain types of B cells—could help protect the kidneys of lupus nephritis patients from further damage and slow or prevent kidney disease progression.
Just a few short weeks after that nod, Roche detailed a phase 3 win for Gazyva in systemic lupus erythematosus, which is the most common form of the condition.
And, in a further flurry of nephrology data drops last autumn, Roche pointed to a Gazyva win in a late-stage trial for a separate kidney condition, idiopathic nephrotic syndrome (INS). Roche has also said it is heading to regulators with those data, which found Gazyva helped more kids and young adults with INS achieve sustained remission after one year compared with the immunosuppressant mycophenolate mofetil.
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