Roche targets Gazyva expansion with phase 3 lupus nephritis success

Roche's Biogen-partnered drug, Gazyva, is targeting new territories in the treatment of active lupus nephritis, following a series of oncology approvals since its initial nod for leukemia in 2013. In a phase 3 study named REGENCY, Gazyva demonstrated a statistically significant increase in the number of lupus nephritis patients achieving complete renal responses when administered biannually with standard autoimmune disease therapy. This was compared to the outcomes of patients receiving only the standard therapy. The study involved 271 participants.

Lupus nephritis is a serious kidney disease manifestation of systemic lupus erythematosus (SLE), the most common type of lupus. There is currently no cure for lupus nephritis. A concerning statistic from Genentech highlights that up to one-third of lupus nephritis patients, approximately 1.7 million globally, will progress to end-stage kidney disease within a decade. These patients often resort to dialysis or kidney transplants as their only viable treatment options. The disease predominantly affects women, particularly women of color and those of childbearing age.

Roche's chief medical officer, Levi Garraway, M.D., Ph.D., emphasized the significance of these findings. He pointed out that given the severe nature of advanced kidney disease and the limited treatment options involving dialysis or transplants, these results could mark a significant advancement for individuals suffering from this debilitating condition.

In addition to achieving certain secondary endpoints related to reduced corticosteroid use and improved proteinuric responses, Gazyva fell short in other secondary measures. These included the mean change in estimated glomerular filtration rates, death or renal-related events, and overall renal responses. Roche is currently collaborating with regulatory agencies to expedite the availability of this new potential treatment.

Beyond lupus nephritis, Gazyva is under investigation for its efficacy in children and adolescents with lupus nephritis, patients with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome, and SLE. The SLE treatment market is already competitive, featuring major players like GSK’s Benlysta and AstraZeneca’s Saphnelo. According to Spherix Global Insights, the landscape is on the brink of transformation with new biologics, including Biogen’s litifilimab, AbbVie’s Rinvoq, and Bristol Myers Squibb’s Sotyktu, vying for space.

Gazyva operates by binding to CD20, a protein located on certain B cells. Since lupus nephritis is driven by B cells, targeting these cells may help protect the kidneys from further harm and potentially slow the progression to end-stage kidney disease. Roche's Genentech and Biogen have partnered in the U.S. for Gazyva, which received its initial approval in 2013 for chronic lymphocytic leukemia.

Moreover, Biogen is collaborating with UCB on another SLE candidate, dapirolizumab pegol. This week, Biogen and UCB announced a successful phase 3 study for this candidate and are planning a second phase 3 trial to support a potential future approval.