Fasenra shows positive PhIII topline data for nasal polyps, tightening race with GSK's Nucala
The highly contested respiratory field just got even tighter Thursday.
AstraZeneca revealed topline data for a Phase III trial Thursday evaluating its Fasenra asthma therapy in a new indication — chronic rhinosinusitis with nasal polyps. The British drugmaker said the drug met both co-primary endpoints in patients who did not see improvement on the standard of care, reducing the size of nasal polyps and improving nasal blockage.
“Current treatments, such as intranasal or oral corticosteroids and surgery to remove polyps, do not fully address patient needs,” Mene Pangalos, EVP of biopharmaceuticals R&D, said in a statement.
In the trial, Fasenra demonstrated a “statistically significant improvement” in the endoscopic total nasal polyp score (NPS) and the nasal blockage score (NBS) compared to placebo, in patients with severe bilateral nasal polyposis who were still symptomatic despite standard of care treatment. Patients received injections of the drug or placebo every four weeks for the first three doses and every eight weeks afterward.
The study, lasting 56 weeks, enrolled 413 patients with randomized and double-blinded procedures, and showed a safety profile consistent with previous Fasenra data. Full data will be released at an upcoming conference.
Fasenra is an IL-5 inhibitor first approved in late 2017 as an add-on maintenance treatment to treat a severe form of asthma. It has been in development for even more indications, like other eosinophilic diseases and COPD, though it has not seen much success in the latter. The drug failed the second of two Phase III studies for COPD back in May 2018.
The FDA did, however, grant orphan drug designation for Fasenra in eosinophilic granulomatosis with polyangiitis in 2018 and hypereosinophilic syndrome and eosinophilic oesophagitis in 2019, two rare chronic immune diseases. In a small study testing the efficacy of Fasenra in HES, 9 of 10 HES patients in the active arm showed undetectable levels of eosinophils, compared to a drop of 50% or more in 3 patients in the placebo group.
Thursday’s results, as well as the additional ODDs, could give the pharma a boost in its competition with GSK’s Nucala and Sanofi/Regeneron’s Dupixent. Nucala posted positive topline results in the nasal polyps indication earlier this year and also targets the IL-5 receptor, while Dupixent, which inhibits IL-4 and IL-13, scored the indication’s first approval in June 2019.
Nucala is, so far, ahead of Fasenra in 2020 sales, pulling in $585 million globally in the first half of the year compared to AstraZeneca’s $426 million haul. Dupixent remains the leader of the pack, however, with more than $1.9 billion in sales for the first six months of 2020.