- 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®* 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® (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 subtypes6. 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 alone6. 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 alone6. 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 cancer9-10.
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 treatment11-15. 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® 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/|
|Genomic profiling of PAM50-based intrinsic subtypes in HR+/HER2- advanced breast cancer across the MONALEESA studies17||PD2-05|
Wednesday, December 8 7:00am CT
|Analysis of first-line patients with de novo disease vs late relapse and all pts with vs without prior chemotherapy in the MONALEESA-3 trial18||P1-18-11|
Wednesday, December 8,
| || |
|Overall survival subgroup analysis by metastatic site from the Phase III MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with HR+/HER2- advanced breast cancer8||GS2-01|
Wednesday, December 8
|Circulating tumor DNA (ctDNA) dynamics in patients with hormone receptor positive HR+/HER2- advanced breast cancer treated in first line with ribociclib and letrozole in the BioItaLEE trial19||GS3-07|
Thursday, December 9
|Assessment of quality of life in patients with advanced breast cancer in clinical practice: a real-world multi-country survey16||P4-12-03|
Thursday, December 9
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® (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 cancer1-5.
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 EC20. Kisqali is approved in over 95 countries21.
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)22. 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 senescence21. 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-enriched21.
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.
Important Safety Information from the Kisqali EU SmPC
Kisqali® (ribociclib) is a prescription medicine approved in combination with an aromatase inhibitor as initial endocrine - based therapy in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer or fulvestrant as initial endocrine - based therapy or following disease progression on endocrine therapy in postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer. It is not known if Kisqali is safe and effective in children or adolescents. Kisqali can cause a heart problem known as QT prolongation. This condition can cause an abnormal heartbeat and may lead to death. Kisqali is not indicated for concomitant use with tamoxifen due to an increased risk of QT prolongation. Patients should tell their health care provider right away if they have a change in their heartbeat (a fast or irregular heartbeat), or if they feel dizzy or faint. Kisqali can cause serious liver problems. Patients should tell their health care provider right away if they get any of the following signs and symptoms of liver problems: yellowing of the skin or the whites of the eyes (jaundice), dark or brown (tea-colored) urine, feeling very tired, loss of appetite, pain on the upper right side of the stomach area (abdomen), and bleeding or bruising more easily than normal. Low white blood cell counts are very common when taking Kisqali and may result in infections that may be severe. Patients should tell their health care provider right away if they have signs and symptoms of low white blood cell counts or infections such as fever and chills. Before taking Kisqali, patients should tell their health care provider if they are pregnant, or plan to become pregnant as Kisqali can harm an unborn baby. Females who are able to become pregnant and who take Kisqali should use highly effective birth control during treatment and for at least 3 weeks after the last dose of Kisqali. Do not breastfeed during treatment with Kisqali and for at least 3 weeks after the last dose of Kisqali. Patients should tell their health care provider about all of the medicines they take, including prescription and over-the-counter medicines, vitamins, and herbal supplements since they may interact with Kisqali. Patients should avoid grapefruit or grapefruit juice while taking Kisqali. The most common side effects (incidence >=20%) include infections, white blood cell count decreases, headache, cough, nausea, tiredness, diarrhea, vomiting, constipation, hair loss and rash. The most common Grade 3/4 side effects (incidence >5%) were infections, low neutrophils, low leukocytes, low red blood cells, abnormal liver function tests, low lymphocytes, low phosphate levels and vomiting. Abnormalities were observed in hematology and clinical chemistry laboratory tests.
Please see full Prescribing Information for Kisqali, available at www.Kisqali.com.
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- Hortobagyi, et al. Overall survival (OS) results from the phase III MONALEESA (ML)-2 trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the European Society of Medical Oncology (ESMO) Congress, September 16-21, 2021, (Abstract #LBA17).
- Im, S. A. et al. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med 2019; 381:307-316.
- Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im S-A, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med. 2020;382(6):514–24.
- Slamon D, Neven P, Chia S, et al. Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2- advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 5, 2021, (Abstract #1001).
- Tripathy D, Im S-A, Colleoni M, et al, Updated overall survival (OS) results from the phase III MONALEESA-7 trial of pre- or perimenopausal patients with HR+/HER2- advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib. Presented at the San Antonio Breast Cancer Symposium, December 9, 2020. Abstract #PD2-04.
- Carey L et al. Correlative analysis of overall survival by intrinsic subtype across the MONALEESA-2, -3, and -7 studies of ribociclib + endocrine therapy in patients with HR+/HER2- advanced breast cancer. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Abstract #GS2-00.
- Yardley, Denise, A. et. al. Overall survival (OS) in patients (pts) with advanced breast cancer (ABC) with visceral metastases (mets), including those with liver mets, treated with ribociclib (RIB) plus endocrine therapy (ET) in the MONALEESA (ML) -3 and -7 trials. Presented at the American Society of Clinical Oncology (ASCO) meeting (Abstract #1054).
- O’Shaughnessy J et al. Overall survival subgroup analysis by metastatic site from the Phase III MONALEESA-2 study of first-line ribociclib + letrozole in postmenopausal patients with HR+/HER2- advanced breast cancer. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Abstract #GS2-01.
- Prat A et al. Correlative biomarker analysis of intrinsic subtypes and efficacy across the MONALEESA Phase III studies. Presented at the San Antonio Breast Cancer Symposium, December 9, 2020. Abstract #GS1-04.
- Prat A. et al. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Onc. (2021) doi: 10.1200/JCO.20.02977.
- Carey, L. A. et al. Race, breast cancer subtypes, and survival in the Carolina Breast Cancer Study. JAMA Med. Assoc. (2006) doi:10.1001/jama.295.21.2492.
- Bernard, P. S. et al. Supervised risk predictor of breast cancer based on intrinsic subtypes. J Clin Oncol (2009) doi:10.1200/JCO.2008.18.1370.
- Prat, A. et al. Response and survival of breast cancer intrinsic subtypes following multi-agent neoadjuvant chemotherapy. BMC Med. 13, 1–11 (2015).
- Llombart-Cussac, A. et al. HER2-enriched subtype as a predictor of pathological complete response following trastuzumab and lapatinib without chemotherapy in early-stage HER2-positive breast cancer (PAMELA): an open-label, single-group, multicentre, phase 2 trial. Lancet Oncol. (2017) doi:10.1016/S1470-2045(17)30021-9.
- Prat, A. et al. Prognostic Value of Intrinsic Subtypes in Hormone Receptor-Positive Metastatic Breast Cancer Treated With Letrozole With or Without Lapatinib. JAMA Oncol. (2016) doi:10.1001/jamaoncol.2016.0922.
- Cardoso F et al. Assessment of quality of life (QOL) in patients with advanced breast cancer (ABC) in clinical practice: a real-world multi-country survey. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Abstract #P4-12-03.
- Prat A et al. Genomic profiling of PAM50-based intrinsic subtypes in HR+/HER2- advanced breast cancer (ABC) across the MONALEESA (ML) studies. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Abstract # PD2-05.
- De Laurentiis M et al. Analysis of first-line (1L) patients (pts) with de novo disease vs late relapse and all pts with vs without prior chemotherapy (CT) in the MONALEESA-3 (ML-3) trial. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Abstract # P1-18-11.
- Bianchini G et al. Circulating tumor DNA (ctDNA) dynamics in patients with hormone receptor positive (HR+)/HER2 negative (HER2-) advanced breast cancer (aBC) treated in first line with ribociclib (R) and letrozole (L) in the BioItaLEE trial. Presented at the San Antonio Breast Cancer Symposium, December 7-10, 2021. Abstract #GS3-07.
- Kisqali (ribociclib) Prescribing information. East Hanover, New Jersey, USA: Novartis Pharmaceuticals Corporation; July 2020.
- Novartis Data on File. Novartis Pharmaceuticals Corp: 2021.
- Novartis Pharmaceuticals and Translational Research in Oncology (2018, December 7 - 2026, May 29). A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer (NATALEE). Identifier NCT03701334. https://clinicaltrials.gov/ct2/show/NCT03701334.
*Ibrance® is a registered trademark of Pfizer Inc.
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