Anticipating Obinutuzumab’s Approval for Lupus Nephritis, with Richard Furie, MD

Patients with active lupus nephritis treated with obinutuzumab (Gazya/Gazyvaro) achieved achieving more complete renal responses than those receiving standard therapy alone.

These findings are from the phase 3 REGENCY trial, which has met its primary end point, with 46.4% of patients treated with obinutuzmab achieving complete renal response at 76 weeks compared to 33.1% of people treated with standard therapy alone (adjusted difference, 13.4%; 95% CI, 2.0 to 24.8; P = .0232).

The data primary investigator Richard Furie, MD, the Marilyn and Barry Rubenstein Chair in Rheumatology and Chief of the Division of Rheumatology at Northwell Health, and colleagues found no unexpected safety signals identified in the trial, but the obinutuzumab group did have a higher incidence of serious adverse events of mainly infections and events related to coronavirus disease 2019, emphasizing the importance of up-to-date vaccinations for this population.

HCPLive spoke Furie to learn more about the REGENCY trial and new questions that the findings may have prompted. He stressed that while the benefits of obinutuzumab may not be dramatic, they are clinically meaningful, and compared it to other milestone approvals of belimumab and voclosporin.

“I do think it will get an approval, and I do think people will be using it. We have been using it off label, because it's been approved since 2013 so for a patient with refractory disease, that's our go-to medicine. But we'll use it more extensively than just for that sub population,” Furie said.

Furie's relevant disclosures include Alexion Pharmaceuticals, Amgen, AstraZeneca, Biogen, Bristol-Myers Squibb, Eli Lilly, EMD Serono, galapagos, Genentech, GlaxoSmithKline, Janssen, Kezar Life Sciences. Kyowa Kirin, Kyverna Therapeutics, Merck, Novartis, Remegen, Sanofi, Takeda, and UCB.

REFERENCES

• Furie RA, Rovin BH, Garg JP. Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis. N Eng J Med. Published online February 7, 2025. doi:10.1056/NEJMoa2410965

• FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis. News release. Roche. March 5, 2025. Accessed March 17, 2025.