Dr. Dennis J. Slamon & Jamil Rivers: October 28, 2019

NEW DATA SHOW TREATMENT FOR ADVANCED BREAST CANCER DEMONSTRATES MORE LIFE

Breast Cancer Expert and Patient Discuss Latest Clinical Trial Data

 

Dr. Dennis J. Slamon

Director of Clinical/Translational Research of the Jonsson Comprehensive Cancer Center at UCLA

Jamil Rivers

Metastatic breast cancer patient

Approximately 30 percent of women diagnosed with earlier stages of breast cancer will eventually develop a form of the disease for which there is no cure – metastatic breast cancer.1 It is estimated that 155,000 people are currently living with metastatic breast cancer in the United States.2

Recently, MONALEESA-3 overall survival data in women with HR+/HER2- metastatic breast cancer was presented as a late-breaker oral presentation in the Presidential Symposium at the European Society for Medical Oncology (ESMO) Congress 2019. The study showed that Kisqali® (ribociclib) in combination with fulvestrant met the secondary endpoint of statistically significant improvement in overall survival, demonstrating a 28% risk reduction of death. The safety profile was consistent with previously reported primary trial results.3 The primary endpoint of the trial was progression-free survival, which was met at an earlier date.

Overall survival, referred to at times as the “gold standard” in cancer clinical trials, is challenging to achieve in HR+/HER2- advanced breast cancer, making these results truly an outstanding advancement for patients.

Dennis J. Slamon, MD, Director of Clinical/Translational Research, University of California, Los Angeles Jonsson Comprehensive Cancer Center, and lead researcher is available to discuss these new data and the implications on clinical practice.

Jamil is also available to discuss her personal experience living with the disease.

 

More about Dennis J. Slamon, MD

Dennis J. Slamon, M.D., Ph.D., serves as director of Clinical/Translational Research, and as director of the Revlon/UCLA Women’s Cancer Research Program at Jonsson Comprehensive Cancer Center. He is a professor of medicine, chief of the Division of Hematology/Oncology and executive vice chair for research for UCLA’s Department of Medicine.

More about Jamil Rivers

Jamil Rivers was diagnosed with metastatic breast cancer in 2018 at age 39. She is a dedicated advocate who uses her voice and experiences to help women facing challenges with the disease. Through her ongoing treatments, she continues to work full-time as CFO of a nonprofit organization and lives an active life. Jamil and her husband, Rick, have three children and reside in Drexel Hill, Pennsylvania.

About Kisqali® (ribociclib)

Kisqali® (ribociclib) is the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent and sustained efficacy compared to endocrine therapy alone4. Kisqali is the only targeted therapy, including CDK4/6 inhibitors, in combination with endocrine therapy to demonstrate significantly longer overall survival compared to endocrine therapy alone as initial endocrine-based treatment for advanced breast cancer in the MONALEESA-7 trial4. Overall survival follow-up is ongoing for the Phase III MONALEESA-2 trial.

Kisqali is approved for use in more than 75 countries around the world, including the United States and European Union member states. Kisqali was initially approved by the US Food and Drug Administration (FDA) in March 2017 and by the European Commission (EC) in August 2017, as initial endocrine-based therapy for postmenopausal women with HR+/HER2- locally advanced or metastatic breast cancer in combination with an aromatase inhibitor based on findings from the pivotal MONALEESA-2 trial. Based on MONALEESA-7, Kisqali was approved in combination with an aromatase inhibitor was approved for the treatment of pre-, peri- or postmenopausal women as initial endocrine based therapy. Based on MONALEESA-3, Kisqali was approved for use in combination with fulvestrant as both first- or second-line therapy in postmenopausal women by the FDA in July 2018 and by the EC in December 2018. Regulatory filings are underway with other health authorities worldwide4.

Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals4.

 

Kisqali® (ribociclib) Important Safety Information

KISQALI® (ribociclib) is a prescription medicine used in combination with an aromatase inhibitor as the first hormonal-based therapy to treat pre/perimenopausal and postmenopausal women and in combination with fulvestrant as the first hormonal-based therapy or following disease progression on hormonal 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. KISQALI can cause severe or life-threatening inflammation of the lungs. Patients should tell their health care provider right away if they experience breathing problems or chest pains. 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.

Important Safety Information continued on next page

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 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 white blood cell count decreases, nausea, infections, tiredness, diarrhea, vomiting, hair loss, headache, constipation, rash, and cough. The most common grade 3/4 side effects (incidence >5%) were low neutrophils, low leukocytes, abnormal liver function tests, and low lymphocytes. Abnormalities were observed in hematology and clinical chemistry laboratory tests.

Please see full Prescribing Information for KISQALI, available at www.kisqali.com.

References

1O’Shaughnessy, J. The Oncologist October 2005 vol. 10 Supplement 3 20-29. Available at http://theoncologist.alphamedpress.org/content/10/suppl_3/20.long.

2 Mariotto, Angela B., et al. “Estimation of the Number of Women Living with Metastatic Breast Cancer in the United States.” Cancer Epidemiology and Prevention Biomarkers 26.6 (2017): 809-815.

3 Slamon, DJ, et al. Overall survival (OS) results of the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor–positive (HR+), human epidermal growth factor 2–negative (HER2−) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Presented at the European Society of Medical Oncology (ESMO) Congress, September 29, 2019, Barcelona, Spain, Abstract# LBA7.

4 Novartis data on file.

Produced for: Novartis

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