Sitting down with… Mari Scheiffele, Novartis

Mari Scheiffele is the General Manager for Oncology in the UK & Ireland at Novartis, responsible for launching innovative oncology therapies that can help to change the lives of people living with different types of cancer. She speaks to Lu Rahman about her passion for working with her teams to deliver innovative medicines to patients in need. Previously, Scheiffele was Global Head, Strategy for Novartis Oncology, with responsibilities for long-term strategy, portfolio management and digital technologies. Scheiffele has also been Corporate Director and Head, Specialty Pharmaceuticals for Novartis Pharma Japan. LR: The American Society of Clinical Oncology virtual congress (ASCO) was held recently - what were some of the highlights for Novartis? MS: ASCO is such an important milestone for the industry, it is a time where we get to see the latest advancements and innovations in cancer treatments which is inspiring. This year’s theme ‘Equity. Every Patient. Everywhere’, is a good reminder that we need to work together to make treatments and healthcare solutions accessible to all. At ASCO we presented two strong pieces of data in breast cancer and for radioligand therapy in prostate cancer. The results of the MONALEESA-3 trial which is analysing the efficacy and safety of treating postmenopausal women with HR+/HER2- advanced breast cancer with fulvestrant +/- ribociclib, were promising. In this study the ribociclib arm demonstrated statistically significant longer median overall survival when compared with the placebo arm.i The updated exploratory analysis of MONALEESA-3 trial that we presented at ASCO reported the longest overall survival benefit seen in a CDK4/6 inhibitor + fulvestrant in this population of women to date.ii We know that there is a need for additional treatment options. In the UK, around 55,000 women are diagnosed with breast cancer each year.iii 30% of women with earlier stages of breast cancer will develop advanced disease.iv We are driving forward advances in advanced breast cancer with our bold approach to improve patient outcomes. LR: What have been some highlights for you this year in terms of Novartis’ work in oncology? MS: There have been many, this year has presented everyone with hurdles to overcome. Working for Novartis means that we are constantly curious and are always inspired by innovation. Our innovative solutions help to address some of society’s biggest healthcare challenges and as such, lockdown and COVID-19 didn’t stop us from bringing new treatments to people living with breast cancer, as well as other cancers. Novartis is pursuing a combination of four treatment platforms in oncology, which harnesses targeted therapies, radioligand therapy, cell and gene therapy, and immunotherapy, the only pharmaceutical company to do so. The data presented at ASCO from across our platforms is a great example of how working together as a team, within Novartis, with patient advocacy groups and regulatory bodies we can provide renewed hope and help to improve the lives of people living with cancer. LR: What is Novartis’ heritage with the development of medicines for breast cancer? MS: For more than 25 years, Novartis have been at the forefront of driving scientific advancements and improving clinical practice in collaboration with the global breast cancer community. With one of the most diverse breast cancer pipelines globally and the largest number of compounds in development, we lead the industry in discovery of new therapies and combinations. We pride ourselves on forming pioneering and productive partnerships that transform the lives of patients. Our relationships with patient advocacy groups have helped us to better understand the needs of people living with breast cancer. Wherever possible we are focused on developing new treatments that are aligned to patient’s needs, not only from a medical perspective but that are also supported more holistically through our work in disease awareness. We have historically done this through our partnerships with patient advocacy groups and local healthcare systems. We believe to bring new medicines to patients we all need to work together collaboratively and with care. What impact has the development of new treatments in the breast cancer space had on those affected by it? People living with advanced breast cancer can face many challenges, including maintaining a balance between quality of life and disease progression, these are incredibly important concerns and providing patients with treatment options that could help to aid that is vital. With advanced breast cancer being an incurable disease, something that is important to us when we are developing medicines is not only to think about disease progression, but also ensuring a patient’s quality of life is at the forefront too. LR: It appears as though there is an unmet need in the secondary breast cancer space, what do you think can be done to close the gap? MS: It is important to recognise that in order to bring treatments to people living with secondary breast cancer we must work collaboratively with all stakeholders. It is a team effort, our relationships with patient groups help us to inform the challenges patients face which in turn informs how we develop treatments. As the number one sponsor of clinical trials in the UK, we are also working closely with the scientific community to try to address the current unmet need. LR: Advanced breast cancer has been difficult to treat, with the introduction of Cyclin dependent kinase 4 and 6 (CDK4/6) inhibitors, what do you think the future of treating advanced breast cancer could look like? MS: We are inspired by people living with breast cancer to revolutionise the research, development and innovation of medicines like CDK4/6 inhibitors that can help to improve and extend lives. Novartis has a diverse breast cancer pipeline and the largest number of compounds in development. Our broad portfolio means we can apply our expertise and innovations across multiple disease areas for better patient outcomes. References i Slamon, D., Overall survival (OS) results of the phase III MONALEESA-3 trial of postmenopausal patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor 2-negative (HER2−) advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB). Annals of Oncology. October 2019, 30(5), v856-857. ii Slamon D, Neven P, Chia S, et al, Updated overall survival (OS) results from the Phase III MONALEESA-3 trial of postmenopausal patients (pts) with HR+/HER2− advanced breast cancer (ABC) treated with fulvestrant (FUL) ± ribociclib (RIB. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, June 5, 2021, (Abstract #1001). iii Cancer Research UK . Breast cancer incidence (invasive) statistics. Available from: http://www.cancerresearchuk.org/health-professional/cancer-statistics/statistics-by-cancer-type/breast- cancer#heading-Zero . iv O'Shaughnessy J. Extending survival with chemotherapy in metastatic breast cancer. The Oncologist. October 200