Study showed that Novartis Kisqali in combination with letrozole reduce risk of disease progression or death by 43 percent.

 

Earlier this year, the Health Sciences Authority in Singapore approved Novartis Kisqali as a first-line treatment option for post-menopausal women with advanced or metastatic breast cancer. The approval follows the results of Phase III MONALEESA-2 trial which was conducted at many global sites, including the National Cancer Centre Singapore (NCCS).

The MONALEESA-2 study demonstrated a significantly longer duration of progression-free survival by reducing the risk of disease progression or death by 43 percent among those receiving Kisqali in combination with letrozole. As early as eight weeks after starting treatment, Kisqali was associated with an earlier and sustained tumor shrinkage and reduction in pain. Three out of every four (76 percent) patients receiving Kisqali in combination with letrozole saw a reduction in tumor size, as compared to 67 percent of the patients receiving letrozole alone.

Advanced or stage IV metastatic breast cancer is the most advanced stage of breast cancer that has spread beyond the breast to other parts of the body, such as the brain, bones or liver. Treatment at this stage is not curative but aims at improving quality of life and prolongation of life. In Singapore, 910 Singaporean women were diagnosed between 2011 and 2015, a 32-percent increase from 697 Singaporean women between 2006 and 2010.

Among nine Singaporean patients from NCCS who were enrolled in the MONALEESA-2 study was Christina Ng, “I was diagnosed with advanced breast cancer in 2014 after a scan revealed cancerous nodules in my lungs. At the point of the diagnosis, I was experiencing excruciating pain in my underarm which rendered me immobile at times because the pain could last up to more than an hour each time it occurred.”

She added: “With a leap of faith, I decided to take part in the clinical trial in August 2014 after my doctor told me about it. The results have been very heartening. The mass at my underarm has shrunk by 90 percent and I no longer experience the pain. I am very grateful to have the time to do the things I enjoy and for all the moments with my husband and two children.”

Dr Yap Yoon Sim, senior consultant, NCCS, principal investigator of MONALEESA-2 study and Global Steering Committee member, shared: “The MONALEESA-2 study has proven that Kisqali in combination with letrozole helps to shrink the tumor more effectively, and patients may experience better relief of symptoms such as pain. This is a significant breakthrough that promises to improve the outcomes for patients with advanced breast cancer, keeping the tumour under control for longer duration than anti-hormone treatment alone.”

Following the approval by the US Food and Drug Administration (FDA) in March 2017, Kisqali, in combination with aromatase inhibitor, was added to the National Comprehensive Cancer Network Clinical Practice Guidelines in Oncology (NCCN Guidelines) as a category 1 treatment option for post-menopausal metastatic breast cancer patients.

According to an article by RTT News, common side effects of Kisqali are infections, abnormally low count of a type of white blood cell (neutropenia), a reduction in the number of white cells in the blood (leukopenia), headache, cough, nausea, fatigue, diarrhoea, vomiting, constipation, hair loss and rash. Warnings also include the risk of a heart problem known as QT prolongation that can cause an abnormal heartbeat and may lead to death, serious liver problems, and low white blood cell counts that may result in infections that may be severe.

As part of the robust MONALEESA clinical trial programme, Novartis continues to assess the safety and efficacy of Kisqali plus letrozole with an expanded patient population. Approximately 60 breast cancer patients in Singapore – which includes nine Singaporean patients from the MONALEESA-2 study – were treated with Kisqali in various clinical trials across multiple disease subtypes and study sites in Singapore.

 

---