Roche’s Gazyva is at it again. After an FDA nod in lupus nephritis marked a fresh chapter for the aging blood cancer blockbuster just two weeks ago, the drug is looking to solidify its position as a contender in the lupus treatment landscape with a positive trial result that could support an expansion into the most common type of lupus.
In Roche’s phase 3 Allegory study, the anti-CD20 monoclonal antibody cleared its primary and all secondary endpoints, proving its worth in patients who have systemic lupus erythematosus (SLE) and who are on standard therapy, Roche reported on Monday.
In the study, a higher percentage of patients taking Gazyva saw a minimum four-point improvement on the SLE responder index 4 (SRI-4) at one year compared to standard therapy. The SLE responder index is a common lupus trial tool that measures changes in disease severity, symptoms and physical condition to determine if a treatment can control disease activity, according to Roche.
Gazyva also met the bar on numerous secondary endpoints, including a six-point improvement in SLE disease activity score at 52 weeks, sustained corticosteroid control and SRI-4 score from week 40 to 52.
All told, the results are “unprecedented in demonstrating that by effectively controlling disease activity, Gazyva may delay or prevent further organ damage in people with SLE,” Roche’s chief medical officer and head of global product development, Levi Garraway, M.D., Ph.D., said in the company’s release.
SLE is a lifelong condition that can cause irreversible damage to the body’s major organs, prompting life-threatening complications, Garraway explained in the release. The company looks to make this “potentially transformative new standard of care” available “as quickly as possible,” he added.
Roche will share the detailed data at an upcoming medical meeting and with health authorities, including the FDA and the European Medicines Agency.
New moves for Gazyva
Gazyva has been marketed since 2013 as a treatment for patients with certain lymphoma and leukemia subtypes, but its advancements in autoimmune conditions are a more recent development. If approved in SLE, the drug would be the first anti-CD20 therapy that can directly target B cells, which is an underlying cause of the disease, according to Roche.
Late last month, Gazyva picked up a U.S. nod for active lupus nephritis, a potentially fatal kidney disease offshoot of SLE that impacts about half of the 3 million people worldwide who develop SLE.
The approval marked the start of the drug’s recent pivot, coming six years after its last indication as a combo blood cancer therapy with AbbVie’s Imbruvica. Last week, Roche followed up with positive phase 3 results in idiopathic nephrotic syndrome (INS), proving that Gazyva could help a younger age group achieve sustained remission after one year.
Making a big splash in the SLE market would require Gazyva to compete with lupus heavy hitters from GSK and AstraZeneca. GSK’s first broke a drought in the SLE field with its biologic Benlysta in 2011, with AZ’s Saphnelo following up ten years later.
Meanwhile, Gazyva is still growing its foothold in its long-held oncology indications, posting 16% sales growth (PDF) to 910 million Swiss francs (around $1.15 billion) for all of 2024, according to Roche’s latest annual report (PDF). The lupus nephritis nod could put it in line for sales of $1.7 billion by 2030, analysts at GlobalData have predicted.