Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced positive results from the pivotal Phase III ALLEGORY study, demonstrating that Gazyva®/Gazyvaro® (obinutuzumab) significantly reduces disease activity and the risk of flares in adults with systemic lupus erythematosus (SLE). SLE is a complex autoimmune disease that can lead to long-term organ damage and a significantly reduced quality of life.
The study successfully met its primary endpoint, with 76.7% of patients treated with Gazyva plus standard therapy achieving a statistically significant improvement in the SLE Responder Index 4 (SRI-4) at week 52. This is compared to 53.5% in the patients receiving placebo plus standard therapy (p<0.001).
Addressing High Unmet Need in SLE
In systemic lupus erythematosus, the immune system mistakenly attacks the body’s own tissues. B-cells play a central role in this process by producing autoantibodies and driving chronic inflammation. If left unmanaged, SLE can cause irreversible damage to the kidneys, heart, and lungs.
The results from the ALLEGORY trial are a major milestone for the lupus community, which has long faced a shortage of high-efficacy treatment options,
Gazyva’s ability to achieve deep B-cell depletion translated into superior clinical outcomes, including a significant reduction in the need for high-dose steroids.
Levi Garraway, Roche’s Chief Medical Officer
Read More: Roche’s Gazyva/Gazyvaro Gets U.S. FDA Approval for Lupus Nephritis Treatment
Detailed Clinical Findings
The ALLEGORY study showcased Gazyva’s superiority over placebo across multiple clinical measures:
- SRI-4 Response (Primary Endpoint): 76.7% for Gazyva vs. 53.5% for placebo (23.1% difference).
- Reduced Flare Risk: Gazyva reduced the risk of severe SLE flares by 42% compared to placebo over the 52-week period (HR: 0.58).
- Steroid Sparing: Significantly more patients in the Gazyva arm (80%) were able to taper their oral corticosteroid dose to ≤7.5 mg/day, compared to the placebo arm (54.1%).
- Stringent Response (SRI-6): 68.9% of Gazyva-treated patients achieved a more rigorous SRI-6 response, emphasizing the depth of the treatment’s impact.
Safety Summary
The safety profile observed in the ALLEGORY study was consistent with the known profile of Gazyva in other indications. The most frequently reported adverse events were infusion-related reactions (IRRs) and infections, which were generally manageable. No new or unexpected safety signals were identified during the study.
Roche plans to submit these data to global regulatory authorities, including the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), later this year.
Primary Endpoint Results (Week 52)
The primary goal was the percentage of patients achieving the SLE Responder Index 4 (SRI-4), a composite endpoint requiring clinical improvement without worsening in other organ systems.
| Endpoint | Gazyva + SOC (n=151) | Placebo + SOC (n=152) | Difference (95% CI) | P-value |
| SRI-4 Response Rate | 76.7% | 53.5% | 23.1% (12.5–33.6) | p < 0.001 |
Key Secondary Endpoints
The trial demonstrated superiority across all pre-specified secondary outcomes, emphasizing the depth and sustainability of the response.
| Secondary Measure | Gazyva + SOC | Placebo + SOC | HR / Diff (95% CI) | P-value |
| BICLA Response | 62.0% | 40.1% | 21.9% (10.8–32.9) | p < 0.001 |
| SRI-6 Response | 68.9% | 38.9% | 30.0% (19.2–40.7) | p < 0.001 |
| Clinical Remission (DORIS) | 35.1% | 13.8% | 21.2% (11.8–30.5) | N/A |
| Low Disease Activity (LLDAS) | 57.6% | 25.0% | 32.6% (22.3–43.0) | N/A |
| Steroid Reduction (≤7.5mg) | 80.0% | 54.1% | 30.2% (15.3–45.1) | p < 0.001 |
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