Roche/Genentech’s Gazyva Poised to Transform Lupus Nephritis Treatment After Positive Phase III Results

EXTON, PA, Oct. 10, 2024 (GLOBE NEWSWIRE) — While GSK’s Benlysta (belimumab) and Aurinia’s Lupkynis (voclosporin) have been important advances in the treatment arsenal for lupus nephritis (LN), a serious complication of systemic lupus erythematosus (SLE), there remains a substantial unmet need for additional effective therapies to address this challenging condition. According to 154 US rheumatologists and nephrologists surveyed in August as part of Spherix’s RealTime Dynamix: Lupus Nephritis (US) service, patients with high persistent proteinuria, steroid dependence, rapidly declining GFR, frequent flares, and significant extra-renal manifestations represent the most pressing unmet needs for new treatment options in lupus nephritis. 

Roche’s recent Phase III REGENCY trial results for Gazyva (obinutuzumab) suggest the therapy could directly address these needs. Gazyva, a CD20-directed cytolytic antibody, met its primary endpoint by demonstrating a significantly higher proportion of patients achieving complete renal response (CRR) at 76 weeks when combined with standard therapy, compared to standard therapy alone. Additionally, the secondary endpoints revealed that Gazyva not only improved proteinuric response but also enabled successful corticosteroid reduction—offering potential relief for patients struggling with persistent proteinuria and steroid dependence, two key challenges highlighted by specialists.  

B-cell depletion is widely regarded as a key approach in LN management, with nephrologists particularly emphasizing the importance of this mechanism in treating the condition. If approved by the FDA, Gazyva would become only the second biologic indicated for LN, alongside Benlysta. Despite the emergence of newer therapies such as AstraZeneca’s Saphnelo (anifrolumab) for SLE and Aurinia’s Lupkynis for LN, Benlysta continues to dominate the lupus market, bolstered by its long-standing presence, favorable safety profile, dual administration options (intravenous and subcutaneous), and approvals for both SLE and LN. 

However, some specialists describe Benlysta’s efficacy as modest, and many believe Gazyva could offer an advancement in treating LN. While Gazyva may take time to gain market share due to Benlysta’s entrenched position and strong track record, the promising results from its Phase III trial in LN hint at its potential to outperform in key areas. Although its Phase III trial in SLE won’t conclude until late 2025, Gazyva’s impact on LN patients—particularly in improving musculoskeletal and dermatologic manifestations—could possibly become evident sooner, potentially accelerating its uptake in both LN and SLE treatment. 

Meanwhile, Lupkynis, a novel calcineurin inhibitor, has carved out a niche for itself in LN patients with high, persistent proteinuria. Spherix’s Patient Chart Dynamix: LN audit (US) indicates that, compared to Benlysta and rituximab, Lupkynis is the go-to treatment for this patient subset. Notably, Lupkynis patients present with higher proteinuria levels at initiation than those on Benlysta, underscoring its perceived strength in these cases. However, with Gazyva demonstrating improvements in proteinuria in the REGENCY trial, Roche’s new contender could soon rival Lupkynis for this patient population.  

Roche will have a window to compete with Benlysta and Lupkynis in LN before facing potential new competition from AZ’s Saphnelo and Novartis’ ianalumab, with their Phase III trials in LN expected to conclude in 2026 and 2027, respectively. If approved, Spherix will commence its Launch Dynamix: Gazyva in LN service which will provide monthly pulses on key performance indicator benchmarking, augmented by 6 quarterly deep dives, including qualitative interviews, for the first 18 months of launch. 

RealTime Dynamix is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. 

Patient Chart Dynamix is an independent, data-driven service unveiling real patient management patterns through rigorous analysis of large-scale patient chart audits. Insights reveal the “why” behind treatment decisions, include year over year trending to quantify key aspects of market evolution, and integrate specialists’ attitudinal & demographic data to highlight differences between stated and actual treatment patterns. 

Launch Dynamix is an independent service providing monthly benchmarking of newly launched products for the first eighteen months of commercial availability, augmented by a quarterly deep dive into promotional activity, barriers to uptake, and patient types gravitating to the launch brand. 

About Spherix Global Insights   

Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle.  

The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community.  

As a trusted advisor and industry thought leader, Spherix’s unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth.  

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NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight’s analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release.

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