Novartis, Harmonia move to Phase III trial to test Kisqali vs. Ibrance in patients with advanced breast cancer

Novartis said Monday it has started a collaboration with SOLTI Innovative Cancer Research (SOLTI) on HARMONIA, an international, randomized, Phase III, multicenter, open-label study of Kisqali (ribociclib) versus Ibrance (palbociclib),.

The team-up is for both in combination with endocrine therapy, in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with a HER2-enriched (HER2E) intrinsic subtype. HARMONIA is the first prospective Phase III trial to enroll patients selected by RNA-based molecular subtyping of their tumors and the first to directly compare two CDK4/6 inhibitors in patients with HR+/HER2- advanced breast cancer.

“The strength and consistency of the Kisqali overall survival data across the MONALEESA program reinforce there are differences among CDK4/6 inhibitors, and that Kisqali stands apart in its ability to help patients achieve their goal of more quality time,” said Susanne Schaffert, PhD, President, Novartis Oncology. “HARMONIA, a novel head-to-head trial, is a testament to our bold development approach and will provide evidence on the unique profile of Kisqali and its unmatched benefit for HR+/HER2- advanced breast cancer patients. We are grateful to be collaborating on this important study with leading academic research groups.”

The primary endpoint of HARMONIA is progression free survival (PFS), and the study will evaluate if Kisqali positively alters tumor biology, enabling a better response to endocrine therapy compared to Ibrance^®.

“HARMONIA will significantly advance clinical and translational knowledge to optimize the diagnosis and treatment of patients with advanced breast cancer,” said Aleix Prat, SOLTI President, Head of the Medical Oncology Department at Hospital Clínic of Barcelona, Head of the Translational Genomics Group and Targeted Therapies in Solid Tumors at IDIBAPS and Professor of Medicine at the University of Barcelona. “As an experienced academic research group in the field of oncology, we are proud to be pioneering this first-of-a-kind research on breast cancer at the RNA level to recognize the value of intrinsic subtypes, which impact patient outcomes in terms of incidence, survival and response to treatment.”

HARMONIA enrollment is expected to begin in Q1 2022. Patients with the basal-like subtype may also enroll. This exploratory cohort of patients will be treated with a chemotherapy-based regimen as these tumors behave more like triple-negative breast cancer.