NovartisNVS

Novartis (NVS) is active in oncology research, with a focus on treatments for various conditions. Their drug COSENTYX is indicated for moderate to severe plaque psoriasis in patients 6 years and older, active ankylosing spondylitis (AS) in adults, and pediatric psoriatic arthritis. In Trial PsO7, COSENTYX demonstrated an 83% PASI 75 response. Safety findings for COSENTYX include an incidence rate of Grade 1 and 2 low neutrophil counts of 2.2% and 2.0%. In pediatric patients, CTCAE Grade ≥2 neutropenia incidence was 4% for COSENTYX, compared to 0% for placebo. For secukinumab 300 mg, Grade 2 neutropenia was 2.4% and Grade 3 neutropenia was 0.7%. In Study P12301, neutrophil abnormalities Grade 2 were 2.3% in the secukinumab group versus 1.6% in the placebo group, and Grade 3 were 0.4% in both groups. The proportion of grade 2 or more severe leukopenias or neutropenias for pooled secukinumab group in study A2303 was 3.9%, compared to 6.3% for etanercept.

Another drug, ceritinib, has been studied, with safety findings including 11.1% of patients with lipase elevations (any grade) in Study A2301. In the same study, 15.3% of patients experienced bradycardia events (all grades). Pancreatitis grouped AEs (all grades) were 11.6% in Study A2301, with grade 3/4 pancreatitis grouped AEs at 7.9%. ILD/pneumonitis AEs (all grades) were 2.1% in Study A2301. Grade 3/4 hepatotoxicity was observed in 49.2% of patients in Study A2301. Decreased absolute lymphocytes (any grade) were observed in 109 patients in the ceritinib group in Study A2301, with 15 patients experiencing grade 3 decreased absolute lymphocytes and 5 patients experiencing grade 4 decreased absolute lymphocytes. In a pooled dataset, 642 patients had decreased absolute lymphocytes (any grade), with 167 patients having grade 3 and 31 patients having grade 4. Grade 3/4 SAEs related to ceritinib treatment were 12.2% in Study A2301.