Latest innovations in development for patients with blood disorders and breast cancer

News Hour:

Novartis will present data demonstrating the latest advancements from its oncology research program at the 58^th American Society of Hematology (ASH) Annual Meeting & Exposition, San Diego, December 3-6, and the San Antonio Breast Cancer Symposium (SABCS), San Antonio, December 6-10. Presentations will focus on a number of cancers, including leukemia, lymphoma, myelofibrosis and breast cancer, as well as chronic iron overload. The data reinforce Novartis’ dedication to developing transformative therapies and treatment strategies to improve and extend the lives of people living with these diseases.

 “Novartis continues to invest in not only creating new medicines for underserved patient communities, but also in redefining cancer treatment goals,” said Bruno Strigini, CEO, Novartis Oncology. “Our ASH and SABCS data, including personalized cell and targeted therapies of the future, underscore our core belief in treating each patient as an individual, not just the disease.”

 Most notable among Novartis’ clinical data to be featured at the two meetings are from the ongoing registrational trials for investigational CTL019* and LEE011** (ribociclib). The CTL019 data will be included in upcoming regulatory submissions. Novartis also recently received US Food and Drug Administration Priority Review for LEE011 (ribociclib) plus letrozole as first-line treatment for postmenopausal women with HR+/HER2- advanced or metastatic breast cancer, based on results from the MONALEESA-2 study.

• Analysis of a Global Registration Trial of the Efficacy and Safety of CTL019 in Pediatric and Young Adults with Relapsed/Refractory Acute Lymphoblastic Leukemia (ALL) (Abstract #221, Oral Presentation, Saturday, December 3, 5:00 pm PST)
• First-Line Ribociclib Plus Letrozole in Patients with De Novo HR+/HER2- Advanced Breast Cancer (ABC): A Subgroup Analysis of the MONALEESA-2 Trial (Abstract #P4-22-05, Poster Presentation, Friday, December 9, 7:30 – 9:00 am CST)
• First-Line Ribociclib Plus Letrozole in Patients with HR+/HER2- Advanced Breast Cancer (ABC) Presenting with Liver and/or Lung Metastases or Bone-Only Disease: A Subgroup Analysis of the MONALEESA-2 trial (Abstract #P4-22-16, Poster Presentation, Friday, December 9, 7:30 – 9:00 am CST)

 Novartis will also be presenting safety, efficacy and quality of life data at ASH from its hematology portfolio, including an investigational use for Tasigna^® (nilotinib). Five-year pooled overall survival data for Jakavi^® (ruxolitinib) in patients with myelofibrosis and patient-reported health-related outcomes from patients with chronic immune thrombocytopenia taking Revolade^® (eltrombopag) will also be presented.

• Treatment-Free Remission in Patients with Chronic Myeloid Leukemia in Chronic Phase According to Reasons for Switching from Imatinib to Nilotinib: Subgroup Analysis from ENESTop (Abstract #792, Oral Presentation, Monday, December 5, 11:45 am PST)
• A Pooled Overall Survival Analysis of 5-Year Data from the COMFORT-I and COMFORT-II Trials of Ruxolitinib for the Treatment of Myelofibrosis (Abstract #3110, Poster Presentation, Sunday, December 4, 6:00 – 8:00 pm PST)
• The Impact of Myeloproliferative Neoplasms (MPNs) on Patients’ Quality of Life and Productivity: Results from the International MPN LANDMARK Survey (Abstract #4267, Poster Presentation, Monday, December 5, 6:00 – 8:00 pm PST)
• Patient-Reported Health-Related Quality of Life Improves Over Time in Patients with Chronic Immune Thrombocytopenia Receiving Long-Term Treatment with Eltrombopag (Abstract #3750, Poster Presentation, Monday, December 5, 6:00 – 8:00 pm PST)

 Sandoz, a Novartis division, the pioneer and global leader in biosimilars, will present pivotal Phase III safety and efficacy data for its proposed biosimilar rituximab. 

• A Phase III Efficacy and Safety Study of the Proposed Rituximab Biosimilar GP2013 versus Rituximab in Patients with Previously Untreated Advanced Follicular Lymphoma (Abstract #1809, Poster Presentation, Saturday, December 3, 5:30 – 7:30 pm PST)