Novartis Pharmaceuticals Corporation ("Novartis") will showcase more than one hundred and sixty presentations on data from its robust oncology portfolio at two key medical congresses this month, demonstrating significant advances for patients with cancers and hematological diseases.
The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held from December 6-10, will feature data presentations from Phase III studies of Afinitor® (everolimus) tablets for investigational uses and Zometa® (zoledronic acid) 4mg/5mL Injection, as well as early-stage studies of the investigational drug BKM120, an inhibitor of PI3K, a key cancer pathway.
The American Society of Hematology (ASH) annual meeting in San Diego, held from December 10-13, will showcase key data for Tasigna® (nilotinib), Exjade® (deferasirox) and the investigational drug INC424 (ruxolitinib). Several early-stage studies will also be presented, including everolimus in Hodgkin lymphoma and Waldenstrom's macroglobulinemia and LBH589 (panobinostat) in relapsed and bortezomib (BTZ)-refractory multiple myeloma.
"These important data are examples of our research and development strategy to focus on significant unmet medical needs by targeting the fundamental mechanisms of disease," said Herve Hoppenot, President, Novartis Oncology. "Through our collaborations with the scientific and patient communities, we continue to advance our goal of transforming patients' lives."
Highlights at SABCS include:
- Everolimus – Updated data from the BOLERO-2 (Breast cancer trials of OraL EveROlimus) Phase III trial of everolimus in combination with exemestane for postmenopausal women with ER+HER2- advanced breast cancer who recurred or progressed while on or following previous treatment with the hormonal therapies letrozole or anastrozole (SABCS abstract #S3-7; December 8, 9:30 – 11:15AM).
- Zometa – ABCSG-12 (Austrian Breast & Colorectal Cancer Study Group Trial) long-term data will examine possible carry-over anticancer benefits of zoledronic acid three years after treatment completion in premenopausal women with endocrine-responsive early breast cancer receiving adjuvant goserelin and endocrine therapy (SABCS abstract #S1-2; December 7, 9:15 – 11:30AM) and five-year ZO-FAST (ZOmeta-Femara Adjuvant Synergy Trial) follow-up data on long-term overall survival outcomes among postmenopausal women with hormone receptor-positive early breast cancer receiving adjuvant zoledronic acid and letrozole (SABCS abstract #S1-3; December 7, 9:15 – 11:30AM).
- BKM120 – Two studies investigating the activity of BKM120, a pan-PI3K inhibitor, in advanced breast cancer: data from a trial evaluating the safety profile and clinical activity of BKM120 as a single agent for the treatment of patients with metastatic breast cancer (SABCS abstract #P3−16−01; December 8, 5:00 – 7:00PM) and data from a Phase I/II study evaluating BKM120 in combination with trastuzumab in patients with HER2 overexpressing metastatic breast cancer resistant to trastuzumab-containing therapy (SABCS abstract #PD09−03; December 9, 5:00 – 7:00PM).
Highlights at ASH include:
- Tasigna – ENESTnd (Evaluating Nilotinib Efficacy and Safety in Clinical Trials) 36-month update of the ENESTnd study comparing Tasigna to Gleevec® (imatinib mesylate) tablets in patients with newly diagnosed chronic phase Ph+ chronic myeloid leukemia (ASH abstract #452; December 12, 10:30AM – 12:00PM) and results from ENESTcmr trial assessing the efficacy and safety of switching patients with residual molecular disease on Gleevec treatment to Tasigna (ASH abstract #606; December 12, 2:45 – 4:15PM).
- Exjade – Data from the first randomized, placebo-controlled study evaluating the reduction of liver iron concentration and serum ferritin in patients with non-transfusion-dependent thalassemia after one year of treatment with Exjade oral iron chelation therapy (ASH abstract #902; December 13, 7:30 – 9:00AM) and data from a retrospective analysis of hematological response during iron chelation therapy in patients with myelodysplastic syndrome (MDS) and aplastic anemia with transfusional iron overload (ASH abstract #611; December 12, 2:45 – 4:15PM).
- INC424 – Data from multiple research programs will be presented, including two pivotal Phase III studies evaluating INC424 benefit versus placebo (COMFORT-I [COntrolled MyeloFibrosis study with ORal JAK inhibitor Therapy]) (ASH abstract #278; December 12, 7:00 – 8:30AM) and versus best available therapy (COMFORT-II) (ASH abstract #795; December 12, 4:30 – 6:00PM). These data will assess measures of spleen reduction, symptom improvement, health-related quality of life and overall survival.
- Everolimus – Results from a Phase II study evaluating everolimus as a monotherapy in relapsed/refractory Hodgkin lymphoma (ASH abstract #2717; December 11, 6:00 – 8:00PM) and data from a Phase I trial of everolimus in combination with rituximab or in combination with BTZ and rituximab in relapsed/refractory Waldenstrom's macroglobulinemia (ASH abstract #2705; December 11, 6:00 – 8:00PM).
- LBH589 – Results from PANORAMA-2 (PANobinostat ORAl in Multiple myelomA), a Phase II study of LBH589 in combination with BTZ and dexamethasone in patients with relapsed and BTZ-refractory multiple myeloma (ASH abstract #814; December 12, 4:30 – 6:00PM). Data from two trials in myelofibrosis: final results from a Phase I trial of prolonged low dose therapy with LBH589 in myelofibrosis patients (ASH abstract #794; December 12, 4:30 – 6:00PM) and a preclinical study of LBH589 in combination with INC424 in JAK2V617F-driven disease (ASH abstract #798; December 12, 4:30 – 6:00PM).