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.
The company recruited 138 patients in Polyp 1 study, while 127 patients in the Polyp 2 study.
Roche and Genentech chief medical officer and global product development head: “The results from these pivotal studies provided further support that IgE plays a role in inflammatory and respiratory conditions, and showed that Xolair reduced the size of nasal polyps and associated symptoms that impact these patients’ quality of life.
“We plan to discuss these results with the FDA with the goal of bringing this new treatment option as soon as possible to people who do not experience relief with the current standard of care.”