Press Release: Novartis: New Kisqali(R) data shows consistent overall survival benefit across genomic and clinical subtypes of interest in HR+/HER2- metastat...

-- Data from the MONALEESA Phase III program provide further evidence of the

unique profile of Kisqali, the CDK4/6 inhibitor with the longest reported

median overall survival (OS) in HR+/HER2- metastatic breast cancer (over

5 years) and proven OS benefit across patient subgroups1-5

-- Kisqali pooled data at the San Antonio Breast Cancer Symposium confirms

OS benefit across most common genomic intrinsic subtypes of HR+/HER2-

metastatic breast cancer, including the aggressive, ET-resistant

HER2-enriched subtype6

-- Data supports rationale for HARMONIA, the first prospective, head-to-head

Phase III trial seeking to identify the best therapeutic option between

Kisqali and Ibrance(R)* for patients with the HER2-enriched subtype

-- Kisqali remains the only CDK4/6i with consistent OS benefit across the

entire MONALEESA program, regardless of site and number of metastases,

prior treatment, endocrine partner, line of therapy or menopausal

status1-5,7-8

Basel, December 8, 2021 -- Novartis today announced new Kisqali(R) (ribociclib) data demonstrating a consistent overall survival (OS) benefit with Kisqali plus endocrine therapy (ET) across genomic subtypes of hormone receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer (mBC), similarly in the indolent as well as in the aggressive, endocrine therapy (ET)-resistant subtypes(6). The findings will be presented as a late-breaking oral presentation at the 2021 San Antonio Breast Cancer Symposium (SABCS).

"The overall survival benefit seen even in HER2-enriched adds to the body of evidence supporting the need to test the hypothesis that ribociclib may alter tumor biology, resulting in a better response to ET across common HR+/HER2- subtypes," said Aleix Prat, President of SOLTI, 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. "One of the most interesting aspects of these ribociclib data is the overall survival benefit seen across the spectrum of indolent, less proliferative disease compared to the aggressive and ET-resistant disease, assuring the overall survival benefit of ribociclib in patients regardless of their baseline prognosis."

A broad ad hoc exploratory analysis of nearly 1,000 tumor samples showed that Kisqali in combination with ET consistently provided significant OS benefit compared to ET alone across main intrinsic subtypes (Luminal A: n=542; HR=0.75; 95% CI: 0.58-0.96; p=.021; Luminal B: n=278; HR=0.69; 95% CI: 0.50-0.95; p=.023; and HER2-enriched: n=147; HR=0.60; 95% CI: 0.40-0.92; p=.018)(6). Patients with the HER2-enriched subtype associated with endocrine resistance and poor prognosis in HR+/HER2- breast cancer, achieved a significant improvement in median OS of 40.3 months compared to 29.4 months for ET alone(6). The longest survival benefit from Kisqali plus ET was seen in patients with the luminal A subtype, who achieved a median OS of 68.0 months compared to 54.6 months on ET alone(6). Patients with basal-like subtype, which is known to behave more like triple-negative breast cancer, had poorer OS outcomes in both the Kisqali combination and ET alone groups with a median OS of 19.4 months and 21.2 months, respectively (n=30; HR=1.89; 95% CI: 0.80-4.47; p=.148)(6). These data follow the biomarker analysis of the MONALEESA trials presented at SABCS 2020 and published in Journal of Clinical Oncology, in which Kisqali demonstrated-progression free survival (PFS) benefit across the most common intrinsic subtypes in metastatic breast cancer(9) (-10).

The four intrinsic subtypes of breast cancer (Luminal A, Luminal B, HER2-enriched and basal-like) have revealed critical differences in terms of incidence, survival and response to treatment(1) (1) (-1) (5). Additionally, the insights provided by genomic intrinsic subtypes complement and expand upon the information provided by standard clinical parameters and pathological markers.

"The consistent overall survival data presented at SABCS again show the unique profile of Kisqali, reinforcing the scientific rationale for initiating HARMONIA, the first Phase III, head-to-head trial evaluating Kisqali versus Ibrance(R) in HR+/HER2- metastatic breast cancer," said Susanne Schaffert, PhD, President of Novartis Oncology. "We know that for people living with metastatic breast cancer, quality of life in addition to extending life is so important to them, so we are excited to share meaningful outcomes from a global quality of life assessment."

Additional research of interest to be presented at SABCS includes the following:

Abstract Title Abstract Number/

Presentation Details

Genomic profiling of PAM50-based intrinsic subtypes PD2-05

in HR+/HER2- advanced breast cancer across the MONALEESA Wednesday, December 8 7:00am CT

studies(17)

--------------------------------------------------------------- --------------------------------

Analysis of first-line patients with de novo disease P1-18-11

vs late relapse and all pts with vs without prior Wednesday, December 8,

chemotherapy in the MONALEESA-3 trial(18) 7:00am CT

--------------------------------------------------------------- --------------------------------

Overall survival subgroup analysis by metastatic site GS2-01

from the Phase III MONALEESA-2 study of first-line Wednesday, December 8

ribociclib + letrozole in postmenopausal patients 8:45am CT

with HR+/HER2- advanced breast cancer(8)

--------------------------------------------------------------- --------------------------------

Circulating tumor DNA (ctDNA) dynamics in patients GS3-07

with hormone receptor positive HR+/HER2- advanced Thursday, December 9

breast cancer treated in first line with ribociclib 10:15am CT

and letrozole in the BioItaLEE trial(19)

--------------------------------------------------------------- --------------------------------

Assessment of quality of life in patients with advanced P4-12-03

breast cancer in clinical practice: a real-world multi-country Thursday, December 9

survey(16) 5:00pm -- 6:30pm CT

--------------------------------------------------------------- --------------------------------

Visit https://www.hcp.novartis.com/virtual-congress/sabcs-2021/ for the latest information from Novartis, including our commitment to the Oncology community, and access to our SABCS Virtual Scientific Program data presentations (for registered participants).

About Kisqali(R) (ribociclib)

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(1-5).

Kisqali is approved by the US Food and Drug Administration (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(20). Kisqali is approved in over 95 countries(21).

Novartis is continuing to reimagine cancer with additional trials 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)(2) (2). Novartis is collaborating with the Akershus University Hospital in Norway on the NEOLETRIB-trial, a neoadjuvant phase II trial studying the effects of Kisqali in HR+/HER2- early breast cancer including effects on the gut microbiota and senescence(21). Novartis is also collaborating with SOLTI, who is leading the Phase III HARMONIA clinical trial evaluating Kisqali compared to palbociclib in patients with HR+/HER2- advanced breast cancer with aggressive tumor biology, defined as HER2-enriched(21).

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

About Novartis in Advanced Breast Cancer

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.

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December 08, 2021 09:30 ET (14:30 GMT)