Roche (RHHBY - Free Report) announced positive top-line data from two phase III multicenter studies on allergic asthma drug, Xolair (omalizumab).
The two studies, POLYP 1 and POLYP 2, were evaluating Xolair for the treatment of adults with chronic rhinosinusitis with nasal polyps (CRSwNP), who have not adequately responded to intranasal corticosteroids.
Both the studies met the co-primary and key secondary endpoints. Xolair (omalizumab) significantly reduced nasal polyps and congestion symptoms in adults with chronic rhinosinusitis with nasal polyps in two phase III studies.
The results showed that Xolair, an injectable biologic medicine designed to target and block immunoglobulin E (IgE), was well tolerated, while safety profile was consistent with that observed in previous studies in patients with moderate to severe allergic asthma and chronic idiopathic urticaria (CIU).
Roche will discuss the results with the FDA soon. CRSwNP impacts up to 4% of the global population and the prevalence of the disease increases with age, thereby underlying the demand for such drugs. The label expansion of the drug for this indication should boost sales, given the demand.
Roche is making efforts to expand its portfolio beyond oncology into immunology. Apart from Xolair, the company’s immunology portfolio includes Actemra for rheumatoid arthritis, Rituxan for rheumatoid arthritis granulomatosis with polyangiitis and microscopic polyangiitis and for pemphigus vulgaris (PV), Pulmozyme for cystic fibrosis; and Esbriet for idiopathic pulmonary fibrosis (IPF). Roche has a collaboration agreement with Novartis (NVS - Free Report) for Xolair.
The company’s stock has gained 5.7% in the year so far against the industry's 2.9% decline.
Earlier, Roche announced positive additional results of a prespecified exploratory analysis from the phase III IMpower150 study at the American Society of Clinical Oncology (ASCO) annual meeting.
The results showed that the combination of Tecentriq, Avastin, carboplatin and paclitaxel (chemotherapy) provided patients suffering from chemotherapy-naïve, metastatic non-squamous non-small cell lung cancer (NSCLC) an overall survival (OS) advantage in baseline liver metastases compared with the combination of Avastin and chemotherapy.
The combination was approved by the FDA in December 2018 for the first-line treatment of adults with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. The European Commission approved the same in March 2019.
The performance of immuno-oncology drug, Tecentriq, has been strong, even though it faces stiff competition from Merck’s (MRK - Free Report) Keytruda and Bristol-Myers Squibb Company’s (BMY - Free Report) Opdivo in the NSCLC space.
Roche currently carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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