Novartis Pharma SAE (Novartis Egypt) has announced final overall survival (OS) results for the Phase III MONALEESA-2 study. The study evaluated ribociclib in combination with letrozole compared to a placebo plus letrozole in postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative (HR+/HER2-) advanced or metastatic breast cancer with no prior systemic treatment for advanced disease.
“Breast cancer is the most common form of cancer among Egyptian women affecting up to 34%. Approximately 15 – 20% of these breast cancers are diagnosed at the metastatic stage.[i] Metastatic breast (stage IV) cancer is a breast cancer that has spread beyond the breast to other parts of the body, such as the lungs, liver, bones, or brain,” said Dr. Alaa Kandil, Professor of Clinical Oncology, Faculty of Medicine, Alexandria University.
“Overall survival is the ultimate goal that patients and oncologists seek in the treatment of advanced breast cancer. The overall survival (OS) rate is the length of time patients live after they are first diagnosed or begin treatment. It is a measure used to determine the effectiveness of new medications or therapeutic approaches. Today we discuss the overall survival results with ribociclib from the Phase III MONALEESA-2 study after a median follow-up of over six and a half years, the longest for any CDK4/6 inhibitor trial to date. This data is expected to change the way we practice medicine in advanced breast cancer,” added Dr. Kandil.
“The final analysis of the MONALEESA-2 trial evaluating ribociclib in combination with letrozole in the first line setting showed that after five years, the postmenopausal women with HR+/HER2- advanced breast cancer treated had more than a 50% chance of survival.2 This remarkable ribociclib overall survival data is highly encouraging and represents the longest reported median survival from a randomized trial in HR+/HER2- advanced breast cancer,” Dr Hamdy Abdel Azim, Professor of Clinical Oncology, Faculty of Medicine, Cairo University, said.
“In addition to that, a 12-month delay ‘in time to chemotherapy’ was observed with ribociclib (median 50.6 vs. 38.9 months) compared to those taking letrozole alone. This life extension, while also maintaining a good quality of life, is great news for our patients and is the building block for further progress,” Dr. Abdel Azim added.
In MONALEESA-2, the primary endpoint progression-free survival (PFS) was met at the initial analysis where ribociclib significantly improved progression free survival by 44%.
“The MONALEESA program continues to transform advanced breast cancer treatment, demonstrating remarkable consistency in terms of results, with three different phase III studies showing a significant improvement in overall survival for advanced hormonal breast cancer patients, regardless of the patients’ menopausal status, the extent of their metastases or whether it was a first or second line of therapy ,,[ii],” Dr Ahmed Hassan, Assistant Professor of Clinical Oncology, Faculty of Medicine, Ain Shams University and Member of the Women’s Health Outreach Program (WHOP), said.
“Under the umbrella of the Egyptian Presidential Women’s Health Initiative, the Ministry of Health has introduced new treatment protocols for advanced breast cancer, making the best-in-class and most innovative medications available throughout Egypt. This is a transformative milestone in the treatment of advanced breast cancer – especially over the past two years – and an old dream that has come true,” Dr. Hassan added, “the Ministry of Health is paying increased attention to women with advanced breast cancer with the priority of minimizing the numbers of advanced breast cancer patients and providing all the support possible in terms of detection, examination, and treatment. This is even more applicable following the introduction of innovative targeted therapies, which offer patients new hope,” he added.
“The ultimate objective for all types of advanced cancer treatments is to slow down disease progression and help manage the disease effectively, while enabling patients to enjoy their regular lives for the longest time possible. In recent years, we have seen significant advancements in the management and treatment of breast cancer. There is a focus on targeted therapies that better meet the unique needs of patients with different types of breast cancer, and improve their life expectancy,” Dr. Heba El Zawahry, Professor of Medical Oncology, National Cancer Institute, Cairo University, said.
“When treatment offers long overall survival—and in this case, the longest ever reported in HR+/HER2- advanced breast cancer—patients have more time to be with their families and loved ones and, to pursue whatever makes them happy. This treatment gives them real hope while allowing them to maintain a good quality of life instead of obliging them to endure the intolerable sufferings of chemotherapy,” Dr. Heba El Zawahry added.
“Our mission is to improve and extend the lives of those with cancer and reimagine a world where advanced breast cancer becomes a manageable disease. As we reimagine medicine and strive for cure, our MONALEESA program continues to push boundaries by demonstrating that ribociclib is unique in its ability to give people living with advanced breast cancer more time,” Dr Sherif Amin, General Manager of Oncology at Novartis Pharma (Egypt, Morocco and Tunisia), said, “the clinical trial results we are sharing with you have shown incredible promise. As of today, ribociclib is the first treatment to achieve significant overall survival results of over five years when used in combination with hormone therapy,” he added.
“For people with advanced hormonal breast cancer, these data are not just numbers, they mean additional life milestones. However, we will not rest as we continue to investigate the full potential of ribociclib to patients. Our commitment to collaborating with the Ministry of Health under the umbrella of the presidential campaign remains steadfast,” Dr. Sherif Amin added.
