Two phase III trials of Xolair meet primary endpoints in chronic rhinosinusitis.

Novartis announced positive topline data from two phase III, multicenter studies evaluating Xolair (omalizumab) for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have not adequately responded to standard-of-care (intranasal corticosteroids). Omalizumab, an injectable biologic treatment designed to target and block immunoglobulin E (IgE), met both co-primary endpoints and key secondary endpoints across both POLYP 1 and POLYP 2 phase III trials. The co-primary endpoints of POLYP 1 and POLYP 2 were change from baseline in Nasal Polyp Score (NPS) and change from baseline in average daily Nasal Congestion Score (NCS) over 24 weeks. Omalizumab demonstrated statistically significant and clinically relevant improvements in both of these co-primary outcomes.

Key secondary endpoints met include Sino-nasal Outcome Test-22 (SNOT-22) for health-related quality of life (HRQoL), the University of Pennsylvania Smell Identification Test (UPSIT) for sense of smell, posterior and anterior rhinorrhea scores for post-nasal drip and runny nose respectively. In the studies, omalizumab was generally well tolerated with overall adverse events rates comparable to those observed in previous phase III trials in patients with moderate and severe allergic asthma and chronic spontaneous urticaria. Additional findings and detailed results of co-primary and secondary endpoints from these trials will be presented at an upcoming scientific congress.

POLYP 1 and POLYP 2 are replicate phase III studies designed to determine the efficacy and safety of omalizumab compared with placebo in adult patients with CRSwNP who have had an inadequate response to standard-of-care treatment. Both trials were randomized, multicenter, double-blind and placebo-controlled. POLYP 1 involved 138 patients and POLYP 2 involved 127 patients, with and without a history of surgery. The primary outcomes for both trials were change from baseline in average daily nasal congestion score at Week 24, and change from baseline in nasal polyp score to week 24. Patients in the studies were administered either omalizumab or placebo by subcutaneous injection every two to four weeks.