Trial drug shows promise for metastatic breast cancer patients

(WZAW) -- Approximately 30% 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. It's estimated that 155,000 people are currently living with metastatic breast cancer in the United States.

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 Congress 2019. The study showed that Kisqali 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. 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.

Dr. Dennis J. Slamon, Director of Clinical/Translational Research at the University of California, Los Angeles Jonsson Comprehensive Cancer Center was the lead researcher in the trial. He joined the Deep Bench on Monday, along with Jamil Rivers, a metastatic breast cancer patient.

"This new class of drugs, ribociclib or Kisqali, has not only improved the time the disease is controled, 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," Dr. Slamon explained.

He said it's the most challenging stage of the disease.

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.

"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," Rivers said.

Kisqali is an oral pill, something that Rivers said allows her to spend less time in the hospital, as opposed to chemotherapy.

She added that it's not only important to her, but to the community at large, to be able to improve the survival odds even more.

Kisqali is the CDK4/6 inhibitor with the largest body of first-line clinical trial evidence demonstrating consistent and sustained efficacy compared to endocrine therapy alone. 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 trial. 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 in March 2017 and by the European Commission 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 worldwide.

For full prescribing information for Kisqali, visit www.kisqali.com