New Data Bolsters Cosentyx In AS & PsA; Humira Head-To-Head Planned
Executive Summary
Novartis AG has unveiled fresh data supporting the efficacy of its Cosentyx (secukinumab) drug in ankylosing spondylitis and psoriatic arthritis along with plans to compare that front-running anti-IL-17A agent against AbbVie Inc.'s anti-TNF competitor Humira (adalimumab) in head-to-head clinical trials.
New long-term clinical data on Novartis' Cosentyx suggest that the first-in-class interleukin-17 inhibitor may lead to higher responses than Humira does in improving the signs and symptoms of people living with ankylosing spondylitis and psoriatic arthritis at 52 weeks, according to the Swiss company.
The data were contained in scientific abstracts presented by it at the annual European Congress of Rheumatology (EULAR 2016) in London on June 8. Also presented were two-year data showing that up to 80% of ankylosing spondylitis (AS) patients on Cosentyx had no radiographic progression in the spine on x-ray assessment. A similar proportion of patients with psoriatic arthritis (84%), who were on Cosentyx for two years, also had no evidence of progression. The data were from two studies using the Matching-Adjusted Indirect Comparisons (MAIC) method for comparative effectiveness research. AS is part of a family of life-long inflammatory diseases that also includes psoriatic arthritis (PsA). It generally results in serious impairment of movement in the spine and physical function.
Data "Backs Cosentyx Gold Standard Bid"
"We believe Cosentyx should be the standard of care for patients with ankylosing spondylitis and psoriatic arthritis." – Novartis Global Drug Development Chief Vas Narasimhan
Novartis' head of drug development said the latest data back the therapy's bid to become the medical gold stand for AS and PsA. "We believe Cosentyx should be the standard of care for patients with ankylosing spondylitis and psoriatic arthritis. These data over two years shows it can prevent radiographic progression for these patients, really making it a potential gold standard therapy moving ahead," Vasant Narasimhan, who is also the group's chief medical officer, told Scrip in connection with the data's release.
Cosentyx is the first IL-17A inhibitor with positive Phase III results for the treatment of active AS and PsA and is and is now approved in Europe, the US, and other countries for these conditions. Cosentyx is also approved for the treatment of PsA and pustular psoriasis in Japan. Novartis now wants to enter Cosentyx in head-to-head trials against Humira, an established but older anti-TNF competitor.
"We believe we have a chance of being better than Humira so what we're going to do first is a head to head with Cosentyx in ankylosing spondylitis – including not only the signs and symptoms that are evaluated by the MAIC scoring systems but also radiographic progression to really show that Cosentyx is targeting the IL-17A pathway to prevent progression in ankylosing spondylitis. And a similar study in psoriatic arthritis will also be done using the same measurement standards," Narasimhan said.
The head-to-head trials will be randomized and are slated to begin around the end of this year or early in 2017, with a study read-out somewhere around 2019.
"The aims are to inform the medical community and support our labeling in key geographies. We want this therapy to be recognized as the gold standard. We believe it also should have that stature based on its safety profile and efficacy. But we think we should still generate additional randomized data to demonstrate that IL-17A should be positioned before TNF and that you don’t need to wait for a TNF failure but rather going straight to IL-17A, and that's our strategy and is what we'll seek to demonstrate going forward," Narasimhan told Scrip in an interview.
Datamonitor Healthcare analyst Chrstina Vasiliou said convincing physicians to use Cosentyx rather than Humira early in the AS and PsA treatment paradigms won't be easy. "Demonstrating superiority to Humira will undoubtedly strengthen its clinical profile but Datamonitor Healthcare expects physician familiarity with Humira to be Cosentyx’s greatest barrier to being positioned as a first-line biologic in AS and PsA, at least initially," she said. "Still, in psoriasis, Cosentyx has made a strong start and dermatologists are optimistic about its role in the treatment of psoriasis, particularly in light of the promising data from its Phase IIIb CLEAR study where it demonstrated superiority to the IL-12/23 inhibitor Stelara," she added.
Cosentyx's closest IL-17A rival is Eli Lilly & Co.'s Taltz (ixekizumab), which was approved by the FDA for adults with moderate-to-severe plaque psoriasis in March. The drug, which binds to the protein interleukin-17A, was previously recommended for approval for treating psoriasis in Europe in February 2016.
Lilly is gearing up for a second-quarter US launch of Taltz, and while the IL-17 inhibitor class has been well received in the dermatology community, Lilly faces a lot of competition and a challenging reimbursement environment.
Still, in February it was given the green light in Europe, further challenging Novartis' Cosentyx. Together the two IL-17A medicines are pushing back the treatment frontiers in this disease, raising the bar for their followers. And while both products are aiming to muscle in on the current standard of care, Johnson & Johnson's Stelara (ustekinumab), which superseded the older anti-TNFs in moderate to severe psoriasis, other products are on the way: a number of anti-IL23 agents are in late-stage development by Boehringer Ingelheim, Merck & Co and J&J.
Lilly's ixekizumab is currently in late-stage development for psoriatic arthritis and is already filed for this indication in Japan - but it does not appear to be in development in ankylosing spondylitis, leaving the field clear for Cosentyx in patients who do not respond adequately to other treatments.
Asked what other therapeutic areas Novartis might test Cosentyx in, the company's drug development head replied, "IL-17A probably have applications in a number of diseases. We are evaluating IL-17A in oncology, as well. So, we are evaluating IL-17A in other conditions, those being dermatological, oncology and, where appropriate, additional rheumatoidal indications."