Breaking News: Positive New Survivor Numbers in Pivotal Phase III Clinical Trial of Treatment for Advanced Breast Cancer

In the last 25 years, the five-year overall survival rate for patients with metastatic breast cancer has sadly improved by less than 5 percent. 

Metatastatic breast cancer, also referred to as stage IV or advanced breast cancer, is a type of breast cancer that has spread beyond the breast and nearby lymph nodes to other locations in the body, including the bones, lungs, liver or brain.

Between 20 and 30 percent of all breast cancers diagnosed in the U.S. become metastatic, according to the National Cancer Institute. While some stage IV breast cancer patients survive this type of cancer for longer periods of time, patients typically live approximately two years. 

But the results of a new Phase III study are giving breast cancer patients new hope.

At the European Society for Medical Oncology (ESMO) Congress 2019, Novartis, the Swiss pharmaceutical company, announced results today from its Monaleesa-3 clinical trial showing that its breast cancer drug, Kisqali (ribociclib) achieved statistically significant improvement in overall survival.

Kisqali, whose generic name is ribociclib, is one of several CDK4/6 inhibitors currently used in combination with hormone therapy to treat hormone receptor-positive, HER2-negative metastatic breast cancer in combination with fulvestrant, a so-called a selective estrogen receptor degrader.

The Kisqali combination demonstrated a significant improvement in survival with a 28% reduction in risk of death.  At 42 months, estimated rates of survival were 58% for Kisqali combination treatment and 46% for fulvestrant alone.

Kisqali in combination with fulvestrant has a median cancer progression-free survival of 33.6 months compared to 19.2 months in the placebo arm. The data shows that Kisqali is distinct from other inhibitors of CDK4, which is a major driver of breast cancer progression and inhibiting. Inhibiting CDK4 has been shown to block the growth of breast cancer cells

“Seen now in two Phase III trials, ribociclib [Kisqali] consistently and significantly prolongs life among premenopausal and post-menopausal women, and in combination with an aromatase inhibitor and fulvestrant,” says Dennis J. Slamon, MD, director of clinical/translational research, University of California, Los Angeles Jonsson Comprehensive Cancer Center.

“These results arm oncologists with more evidence to make a confident treatment choice for their hormone receptor-positive metastatic breast cancer patients.” 

Making A Confident Treatment Choice 

Approximately 155,000 individuals in the US are living with metastatic breast cancer. The Monaleesa-3 trial evaluated efficacy and safety of Kisqali plus fulvestrant in postmenopausal women with hormone-receptor positive, human epidermal growth factor receptor-2 negative (HR+/HER2-) advanced or metastatic breast cancer.

HR+/HER2 means the metastatic breast cancer is fueled by one of two hormones: estrogen or progesterone. HER2- means that you have normal amounts of HER2 protein in your tumors. 

The largest trial to evaluate a CDK4/6 inhibitor plus fulvestrant as initial therapy in postmenopausal women, Monaleesa-3 included women with no prior endocrine therapy, including those diagnosed from the beginning, women who relapsed within 12 months of adjuvant therapy, and women who progressed on endocrine therapy for advanced disease. 

Survivor and Patient Advocate Pleased With Trial Result 

Kelly Lange (right) has been living with metastatic breast cancer for 17 years. An advocate for patients, she has volunteered with METAvivor Research and Support since 2009 and has served as president and treasurer for the organization. 

“I am thrilled at the results of the MONALEESA-3 trial. Our community is desperate for life extending therapies,” says Kelly, who lives with her husband in Annapolis, MD. 

“This trial shows there is new hope for the HR+/HER2- subgroup of women and men living with metastatic breast cancer. Longer survival may allow a young mother to see her child go off it to kindergarten, or a grandmother to meet her first grandchild. We need more successes like this one for all of us living with this disease.” 

Oncologists Should Practice Evidence-Based Medicine 

Kisqali’s overall survival numbers are superior to what has been shown from Ibrance, the Pfizer drug that is currently the most prescribed CDK4/6 inhibitor on the market. 

John Tsai, MD, head of global drug development and chief medical officer at Novartis, says 
physicians should “practice evidence-based medicine” in their choice of breast cancer treatments for their patients.

“It comes down to physicians are used to using Ibrance,” says Tsai, adding that he is hoping this trial “will convince physicians to actually use ribociblib [Kisqali] versus the other agents.”

Says Susanne Schaffert, PhD, president, Novartis Oncology, “We are committed to helping give these women more life and are reimagining a world where metastatic breast cancer becomes a curable disease.”