Novartis has announced positive topline data from two Phase III, multicentre studies evaluating omalizumab (Xolair®) 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.
CRSwNP is the inflammation of the nose and paranasal sinuses with the presence of nasal polyps on the lining of the nasal sinuses or nasal cavity.
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 outcomes1. 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.
“We are very pleased with the initial outcomes from the POLYP 1 and POLYP 2 trials. This is an important and exciting milestone for Xolair, which continues to help thousands of people around the world with severe allergic asthma and chronic spontaneous urticaria,” said John Tsai, Head of Global Drug Development and Chief Medical Officer, Novartis. “The results from these pivotal studies provide further evidence of the role of IgE in several inflammatory and respiratory conditions. Xolair reduces the amount of free IgE and in this study substantially reduced the size of nasal polyps and associated symptoms that impact the quality of life for patients with chronic rhinosinusitis with nasal polyps.”
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.
“Although the disease is not visible, people with nasal polyps may have significantly impaired quality of life – especially those with asthma who have increased nasal obstruction and loss sense of smell, which can impact the them physically, socially and mentally,“ said Professor Claus Bachert, Upper Airways Research Laboratory, Clinics ENT-Department, University Hospital Ghent, Belgium. “The results of these studies are an important step forward to improving the lives of these patients.”
Additional findings and detailed results of co-primary and secondary endpoints from these trials will be presented at an upcoming scientific congress.