Novartis Announces Collaboration on HARMONIA, a Phase 3, Head-to-Head Trial Evaluating Kisqali Versus Ibrance in Patients With HR+/HER2- Advanced Breast Cancer

Novartis recently announced a collaboration with SOLTI Innovative Cancer Research (SOLTI) on HARMONIA, an international, randomized, Phase 3, multicenter, open-label study of Kisqali (ribociclib) versus Ibrance (palbociclib), 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 3 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.

Kisqali is the CDK4/6 inhibitor with the largest body of clinical trial evidence demonstrating consistent and superior overall survival benefit compared to endocrine therapy alone. Overall survival results were presented previously: MONALEESA-7 (ASCO 2019) and MONALEESA-3 (ESMO 2019) and MONALEESA-2 (ESMO 2021); MONALEESA-7 and MONALEESA-3 were published in the New England Journal of Medicine, with updated exploratory analyses presented at SABCS 2020 and ASCO 2021, demonstrating Kisqali plus endocrine therapy significantly extends life in pre/perimenopausal or postmenopausal women with HR+/HER2- advanced breast cancer.

Kisqali is approved by the US FDA and by the European Commission (EC) as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor. Kisqali in combination with an aromatase inhibitor is approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine-based therapy, and also indicated for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA and by the EC. Kisqali is approved in over 95 countries.

Novartis is continuing to reimagine cancer with an additional trial of Kisqali. NATALEE is a large confirmatory clinical trial of Kisqali with endocrine therapy in the adjuvant treatment of HR+/HER2- early breast cancer being conducted in collaboration with Translational Research In Oncology (TRIO).

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Novartis tackles breast cancer with superior science, collaboration and a passion for transforming patient care. We’ve taken a bold approach to our research by including patient populations often neglected in clinical trials, identifying new pathways or mutations that may play a role in disease progression and developing therapies that not only maintain, but also improve, quality of life for patients. Our priority over the past 30 years and today is to deliver treatments proven to improve and extend lives for those diagnosed with advanced breast cancer.