Novartis posts BioItaLEE and China ribociclib results; registers three new studies

Novartis had a busy week of registry activity, with results posted on two ribociclib studies and three new trials registered across dermatology and cardiology.

• The Phase IIIb "BioItaLEE" study of ribociclib plus letrozole in HR+ HER2-negative advanced breast cancer, with a second-line arm of alpelisib plus fulvestrant in PIK3CA-mutant patients, is listed as terminated. Novartis terminated the trial early because the collected data were sufficient to perform the analysis stated for the primary endpoint.¹ The study enrolled 287 participants¹ and results were first posted this week.
• Results were also posted for a completed Phase 2 study of ribociclib in pre- and postmenopausal Chinese women with HR+, HER2-negative advanced breast cancer. Following a statistically significant progression-free survival benefit observed at the primary analysis and implementation of Protocol Amendment 5 dated 18-Oct-2022, participants and investigators were unblinded, and participants still receiving placebo were offered the option to cross over to ribociclib.² The trial enrolled 327 participants.²
• Novartis registered "EARLY-HS 2," an observational study assessing whether early secukinumab treatment reduces long-term disease burden in moderate-to-severe hidradenitis suppurativa. The aim of this study is to evaluate the effectiveness of early treatment with secukinumab in patients with moderate-to-severe hidradenitis suppurativa (HS) and assess its impact on disease progression using data from multiple European data sources.³ The study is not yet recruiting, with an estimated enrollment of 186 participants.³
• Novartis also registered "SEC-HOPE," a retrospective observational study of secukinumab retention in psoriasis patients with metabolic dysfunction-associated steatotic liver disease (MASLD). This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories.⁴ The study is recruiting, with an estimated enrollment of 150 participants.⁴
• A new Phase 4 trial in Saudi Arabia will compare inclisiran added to standard of care against standard of care alone in patients with recent acute coronary syndrome. The study aims to evaluate the effectiveness and safety of implementing a systematic augmented LDL-C management care pathway initiated in hospitals, comparing treatment with inclisiran on top of standard of care versus a high-intensity standard of care regimen alone.⁵ The trial is not yet recruiting, with an estimated enrollment of 300 participants.⁵