Novartis Initiates Head-to-Head Trial of Secukinumab Versus Sandoz Adalimumab Biosimilar

Novartis announced today that it is initiating the SURPASS trial, a head-to-head clinical trial of secukinumab (Cosentyx) versus a proposed biosimilar adalimumab (referencing Humira and being developed by Sandoz, a Novartis division) in patients with ankylosing spondylitis (AS). Secukinumab, a targeted biologic therapy that inhibits IL-17A—a cytokine involved in inflammation of entheses—plays a role in both AS and psoriatic arthritis (PsA).

The trial will be the largest randomized, controlled study of a biologic treatment in AS, and is a 1-year, parallel-group, 3-arm study. In the first arm, patients will receive 150 mg of secukinumab subcutaneously (SC); in the second arm, patients will receive 300 mg of SC secukinumab; in the third, patients will receive 40 mg of SC adalimumab. The study’s primary endpoint is the proportion of patients with no spinal radiographic structural progression at 2 years.

The SURPASS trial is part of a larger clinical program for secukinumab, which includes the EXCEED trial, a head-to-head clinical trial of secukinumab monotherapy versus reference Humira monotherapy in patients with PsA. The EXCEED trial is currently recruiting, and will assess the superiority of secukinumab in terms of the American College of Rheumatology 20% improvement criteria (ACR20) at 52 weeks as the primary endpoint.

"The EXCEED and SURPASS head-to-head trials are addressing important clinical questions solving residual uncertainty for patients with PsA and AS," said Robert Landewé, MD, PhD, professor of rheumatology in the Amsterdam Rheumatology and Clinical Immunology Center and Zuyderland Medical Center. "These data would add to the body of evidence to underline the benefit of different biologic pathways for physicians,” added Landewé.

News of the SURPASS trial follows the release of November 2017 data that supported switching from the reference Humira to Sandoz’s proposed adalimumab biosimilar. Phase 3 confirmatory data showed that there were no clinically meaningful differences in efficacy, safety, or immunogenicity between patients who switched between the reference drug and the biosimilar multiple times versus patients who received the biosimilar alone.

Despite the Sandoz adalimumab biosimilar’s potential to eventually capture a share of the market for Humira, Novartis’ Cosentyx has already become a top-selling medicine after its 2015 launch, having crossed the $1 billion sales threshold in 2016.