GlaxoSmithKline's Nucala is facing stiff competition from a suite of asthma competitors. But in nasal polyps––an indication where no IL-5 inhibitor has gone before––Nucala is hoping it can take the fight directly to Sanofi and Regeneron's blockbuster Dupixent.
Nucala added to standard of care cut the size of nasal polyps and level of nasal obstruction after 52 weeks of treatment, compared with standard of care alone in patients with chronic rhinosinusitis who had previously undergone surgery, according to phase 3 data released Friday.
In its Synapse trial, Nucala also extended patients' time until their first follow-up surgery during the 52-week trial by 57% over standard of care alone, GSK said. Nucala is now the only IL-5 inhibitor to show positive phase 3 data in nasal polyps, GSK said.
The British drugmaker will submit the data to regulators sometime this year, GSK said in a release.
Winning phase 3 data could help Nucala in its chase after Dupixent, the first biologic to score an FDA approval to treat nasal polyps.
In clinical testing, patients who took Dupixent experienced reductions in nasal polyp size and congestion and saw improvements in their ability to smell. Patients on the med also required less surgery and steroids.
About three-fourths of patients in testing “no longer required either corticosteroids or surgery, the current standards of care,” Regeneron Chief Scientific Officer George Yancopoulos said in a statement at the time. Dupixent is approved for patients who aren't controlled on the current standard of care.
Fifty-nine percent of study patients also had asthma, and those patients experienced better lung function, investigators found.
Meanwhile, Nucala is also locked in a heated battle with rival IL-5 drug Fasenra, from AstraZeneca, with both eyeing new approvals in hypereosinophilic syndrome (HES).
In November, phase 3 data showed Nucala cut the rate of disease flareups by half compared with placebo in HES patients after 32 weeks. Nucala was the first treatment to show it could reduce HES flares, which are marked by worsening symptoms or increasing numbers of the white blood cell eosinophil that requires stronger therapy.
Fasenra also works by inhibiting IL-5 to reduce eosinophil levels. In a 20-patient trial unveiled in April 2019, Fasenra cut HES patients’ blood eosinophil counts by at least half in 90% of patients after 12 weeks of treatment. By comparison, only 30% of placebo patients saw the same result.
Should both drugs win approval in HES, they'd be fighting over a small number of patients—smaller than the severe asthma variety Nucala and Fasenra are currently approved to treat.