Genentech Xolair hits co-primary, key secondary endpoints for rhinosinusitis

Roche Group member Genentech announced that Xolair (omalizumab) has significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) in two phase III studies.

The company has revealed the positive topline data from two phase III multicentre studies assessing Xolair to treat adults with CRSwNP who have not adequately responded to intranasal corticosteroids.

According to the company, the Polyp 1 and Polyp 2 phase III trials achieve both co-primary endpoints and major secondary endpoints.

Xolair is an injectable biologic medicine developed to target and block immunoglobulin E (IgE). It also demonstrated to be better tolerated and the safety profile was consistent with that observed in earlier studies in people with moderate to severe allergic asthma and chronic idiopathic urticarial.

The co-primary endpoints of both studies were change from baseline in Nasal Polyp Score (NPS) and change from baseline in average daily Nasal Congestion Score (NCS) over 24 weeks

Xolair showed statistically significant and clinically relevant improvements in both of these co-primary outcomes, said the company.

The studies also achieved major secondary endpoints, including improvement in smell, post-nasal drip (posterior rhinorrhea score), runny nose (anterior rhinorrhea score) and the Sino-Nasal Outcome Test-22 (SNOT-22) health-related quality of life assessment.

Polyp 1 and Polyp 2 are replicate Phase III studies designed to assess the efficacy and safety of Xolair compared with placebo in adult patients with CRSwNP who have had an inadequate response to standard of care treatment.

Genentech’s Xolair achieves co-primary and key secondary endpoints in chronic rhinosinusitis study