An investigational breast cancer drug shows promise with the recent MONALEESA-3 results. Overall survival data in women with HR+/HER2-metastatic breast cancer according to recent presentations at the Presidential Symposium at the European Society for Medical Oncology Congress 2019. Kisqali/ribociclib (Novartis) in combination with fulvestrant (AstraZeneca) demonstrated a 28% reduction in death meeting a secondary endpoint. The primary endpoint, progression-free survival, has been met at an earlier date while the safety profile has been consistent with previously reported results.
Metastatic Breast Cancer
Recent news from WSAW-TV 7 discusses the dangers and hope with breast cancer. 30% of women diagnosed at the earlier stages will develop into metastatic breast cancer where there is no cure. The news outlet reported recently that 155,000 people across America are living with metastatic breast cancer. About 271,000 will be diagnosed with breast cancer in the United States this year. About 6% already have a metastatic breast cancer when initially diagnosed. Approximately 42,260 will die from breast cancer this year. The 5-year survival rate is 27% for women and 25% for men.
The MONALEESA-3 had sponsor Novartis conduct a Phase III, multi-center, randomized double-blind, placebo controlled trial evaluating ribociclib in combination with fulvestrant for the treatment of postmenopausal women and men with hormone receptor positive HER2 negative, advanced breast cancer who received no or only one line of endocrine therapy for advanced breast cancer. Targeting 726 patients the Swiss trial sponsor identified 190 clinical investigational sites on multiple continents.
The Principal Investigator
The recent news showcases the ongoing promising findings streaming out of the study. Dr. Dennis J. Slamon, Director of Clinical/Translational Research at the University of California, Los Angeles Comprehensive Cancer Center, led the study. Along with a metastatic breast cancer patient named Jamil Rivers, he commented “This new class of drugs, ribociclib or Kisqali has not only improved the time the disease is controlled but it’s improved the overall survival in this group of patients who have metastatic breast cancer, which is the form of the disease where the cancer has traveled outside the breast, outside the lymph nodes in the region and involves other parts of the body.” This of course is a challenging and dangerous phase of the disease.
Jamil Rivers was diagnosed with metastatic breast cancer at 39 last year. Due to this life-changing experience she became a dedicated advocate, reported WSAW-TV 7. Along with Dr. Slamon, she discussed her experience with the disease and life on the treatment. She reports that living with metastatic breast cancer makes it a constant topic in the mind. She noted “Living with metastatic breast stage-4 cancer, everything begins to center around breast cancer, so every move I make, every step I take, I’m constantly having breast cancer on my mind.”
Truly exceptional Ms. Rivers works full-time as a CFO for a non-profit while caring for three kids and living an active life. She emphasized that the traditional chemotherapy treatment includes onerous side effects and hospital visits while Kisqali, an oral pill, makes it easier for her. Ms. Rivers emphasized that improving breast cancer survival is not only an individual quest but a community mission.
Approved in 75 countries (including the U.S. and Europe), it was initially approved by the U.S. Food and Drug Administration in March 2017 and by the European Commission in August 2017 for endocrine-based therapy for postmenopausal women with HR+HER2-locally advanced or metastatic breast cancer in combination with an aromatase inhibitor due to the results of the MONALEESA-2 study reported WSAW-TV 7.
Call to Action: If you or a loved one has been diagnosed with a metastatic breast cancer it could be beneficial to ask your physician to look into the MONALEESA-2 study results if they haven’t already done so. Note Dr. Dennis Slamon is a global expert in this field and UCLA Health would be a great place for another opinion. Dr. Slamon has been awarded Southern California “Super Doctor” 2019 status.