Novartis reports GCAptAIN study did not meet primary endpoint

Novartis (NVS) announced top-line results from the Phase 3 GCAptAIN study evaluating Cosentyx in adults with newly diagnosed or relapsing giant cell arteritis. In the study, Cosentyx was evaluated in combination with a 26-week steroid taper and compared to placebo plus a 52-week steroid taper. Cosentyx did not demonstrate a statistically significant improvement in sustained remission at Week 52 compared to placebo. While the secondary outcomes did not show statistical superiority, Cosentyx showed numerically better outcomes compared to placebo for cumulative steroid dose and steroid-related toxicity, the company stated. Safety in GCA was consistent with the known safety profile of Cosentyx, which is supported by robust evidence and 10 years of real-world data across its approved indications, the company added. Novartis will complete a full evaluation of the GCAptAIN data and share the results at a later date. “While the Phase III results of GCAptAIN did not replicate the positive outcomes observed in the Phase II trial, we remain committed to continuing to drive scientific progress and deepening the understanding of immune-mediated diseases,” said Shreeram Aradhye, M.D., President, Development and Chief Medical Officer, Novartis. “We are grateful to the patients, investigators, and teams who made this study possible and will continue focusing on addressing areas of unmet medical need.”