After collecting a handful of oncology approvals since its first leukemia nod in 2013, Roche’s Biogen-partnered Rituxan successor, Gazyva, is chasing new horizons in active lupus nephritis.
In a phase 3 study called REGENCY, a statistically higher proportion of lupus nephritis patients treated with biannual intravenous Gazyva doses and standard autoimmune disease therapy achieved complete renal responses at 76 weeks compared to those treated with standard therapy alone, Genentech reported Thursday. The trial enrolled a total of 271 participants.
Lupus nephritis, a kidney disease-related manifestation of the most common lupus type, systemic lupus erythematosus (SLE), has no cure. Up to one-third of patients (currently some 1.7 million worldwide) will develop end-stage kidney disease within ten years, with dialysis and kidney transplants serving as their only available treatment options, according to Genentech.
The potentially life-threatening disease primarily affects women, specifically women of color and women who are of “childbearing” age.
“Since dialysis or transplants are often required for patients with advanced kidney disease, these findings could represent an important step forward for people living with this devastating disease,” Roche's chief medical officer and head of global development, Levi Garraway, M.D., Ph.D., said in a company release.
The drug met certain secondary endpoints that looked at the proportion of patients who achieved complete renal responses with a successful reduction in corticosteroid use, plus proteinuric responses. But it fell short on secondary responses that looked at patients' mean change in estimated glomerular filtration rates, death or renal-related events and overall renal responses.
Roche is sharing the data with regulatory agencies with a goal of making the potential new treatment available “as soon as possible,” the company said in its release. Gazyva is also being studied in children and adolescents with lupus nephritis and patients with membranous nephropathy, childhood-onset idiopathic nephrotic syndrome and SLE.
The SLE market is currently populated by GSK’s blockbuster Benlysta and AstraZeneca’s newer offering Saphnelo. According to a recent report from Spherix Global Insights, the treatment landscape is poised for evolution with newer biologics angling to get in the field, including Biogen’s litifilimab, AbbVie’s Rinvoq and Bristol Myers Squibb’s Sotyktu.
Gazyva works by attaching to CD20, a protein found on certain types of B cells. As lupus nephiritis is a B cell driven disease, targeting the disease-causing cells could protect the kidneys from further damage and potentially slow or prevent progression to end-stage kidney disease, according to Roche.
Roche's Genentech and Biogen have a U.S. partnership for the drug, which scored its first approval in 2013 for chronic lymphocytic leukemia. Outside of its Gazyva collab, Biogen is working with UCB on another SLE candidate, dapirolizumab pegol.
Biogen and UCB this week reported a successful phase 3 study for that prospect and are now set to begin a second phase 3 trial to support a potential approval.