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ARTICLE | Clinical News

June 13 Clinical Quick Takes: Roche's Gazyva meets in Phase II for lupus; plus Boehringer/Lilly, Savara and more

June 14, 2019 12:11 AM UTC

Roche's Gazyva clears Phase II hurdle in lupus nephritis
Gazyva obinutuzumab from Roche (SIX:ROG; OTCQX:RHHBY) met the primary endpoint in the Phase II NOBILITY trial to treat lupus nephritis. Given in combination with standard of care, the mAb led to a higher rate of complete renal response than placebo. Recent clinical failures had cast doubt that B cell targeted agents alone are sufficient to treat the disease; Gazyva targets CD20, which is found on some B cells and is thought to work by attacking targeted cells directly while also stimulating other aspects of the immune system (see "Target Wide, Test Narrow in Lupus").

Tradjenta non-inferior to glimepiride for CV risk
Boehringer Ingelheim GmbH (Ingelheim, Germany) and Eli Lilly and Co. (NYSE:LLY) said DPP-4 inhibitor Tradjenta linagliptin was non-inferior to glimepiride in the CAROLINA cardiovascular outcomes trial. Among Type II diabetics in the study, 11.8% of those receiving Tradjenta experienced CV death, non-fatal myocardial infarction or non-fatal stroke (3P-MACE) vs. 12% for glimepiride, a sulfonylurea ATP-dependent KATP blocker; the study's primary endpoint measured time to first occurrence of 3P-MACE. Detailed data were reported at the American Diabetes Association meeting in San Francisco...