GSK's depemokimab reduces polyps in phase 3 trials, adding weight to upcoming filing

GSK’s blockbuster hopes for depemokimab remain on track after the investigational long-acting asthma treatment has also been shown to reduce nasal polyps in a pair of phase 3 trials.

The ANCHOR-1 and ANCHOR-2 trials together recruited a total of 528 patients with chronic rhinosinusitis with nasal polyps (CRSwNP)—an inflammatory disease of the nose sinuses that obstructs sinuses and nasal passages—who received either 100 mg depemokimab or placebo. Both studies hit their co-primary endpoints of demonstrating that depemokimab improved the total endoscopic nasal polyp score at 52 weeks as well as the mean nasal obstruction score from weeks 49 to 52.

GSK is saving detailed data for a future medical conference, but the British Big Pharma did add that the overall incidence and severity of treatment-emergent adverse events across both trials were similar in the depemokimab and placebo cohorts.

Depemokimab is a monoclonal antibody that blocks human interleukin-5 (IL-5) binding to its receptor, and GSK pointed out in this morning’s release that IL-5 is present at high levels in nasal polyp tissue and is a key cytokine in immune system-related inflammation.

The antibody’s extended half-life and affinity for binding with IL-5 could allow depemokimab to be dosed just once every six months to treat CRSwNP, suggested GSK. In contrast, Sanofi and Regeneron’s Dupixent, Novartis’ Xolair and GSK’s own Nucala are all approved to CRSwNP at a dosing schedule in the two- to four-week range.

Today’s phase 3 wins continue a clinical winning streak for depemokimab this year that also saw the drug halve the number of asthma attacks in a pair of late-stage studies. GSK is planning to use data from all four studies as part of its approval submissions to regulators.

Phase 3 trials in other IL-5-mediated diseases, namely eosinophilic granulomatosis and hypereosinophilic syndrome, are ongoing.

GSK has been touting depemokimab as one of its 12 potential blockbuster launches of the coming years, with the asthma drug expected to generate peak yearly sales of 3 billion pounds sterling ($3.9 billion) if approved.

“Globally millions of people suffer from uncontrolled CRSwNP, the majority of whom will exhibit markers of type 2 inflammation,” Kaivan Khavandi, Ph.D., global head of respiratory/immunology R&D at GSK, explained in the Oct. 14 release. “These patients have high corticosteroid exposure and often experience recurrence of nasal polyps following surgery.”

“We're very encouraged by the results from the ANCHOR studies, which demonstrate the potential for depemokimab to offer targeted and sustained suppression of a key inflammatory pathway underlying nasal polyp growth and nasal obstruction,” Khavandi added. “Today’s data, along with recent phase 3 data in severe asthma, will be used in regulatory filings around the world.”