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Published on 28 November 2012

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Novartis highlights key data

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Novartis will highlight more than 140 presentations on key data from its extensive oncology portfolio at the leading year-end scientific meetings devoted to haematology and breast cancer, demonstrating continued innovation in research and development efforts to advance the care of patients with cancer and rare diseases.
The American Society of Haematology (ASH) annual meeting in Atlanta, held December 8-11, will feature significant data across haematologic diseases including two-year follow-up data from Phase III trials of Jakavi® (ruxolitinib) in patients treated with Jakavi for myelofibrosis and data evaluating molecular response following treatment with Tasigna® (nilotinib) in patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) compared with Glivec® (imatinib)* therapy. In addition, updated data on Exjade® (deferasirox) in non-transfusion-dependent thalassemia (NTDT), as well as new data on the removal of cardiac iron in Beta-thalassemia major, will be presented.
Several studies of novel pipeline compounds will also be presented, including additional Phase I/II findings extending proof-of-concept data for the investigational therapy CTL019 (formerly known as CART-19)+ in patients with chronic lymphocytic leukaemia (CLL) and relapsed refractory acute lymphoblastic leukaemia (ALL).[1]
“For more than a decade, Novartis Oncology has discovered critical medicines for cancer patients by following the science,” said Hervé Hoppenot, President, Novartis Oncology. “The presentations at this year’s annual meetings show that our research and development pipeline has never been stronger, and we expect new breakthroughs that could lead to even more innovative therapies for patients.”
The CTRC-AACR San Antonio Breast Cancer Symposium (SABCS), held December 4-8, will showcase studies exploring therapy with the mTOR inhibitor Afinitor® (everolimus) and the investigational PI3K inhibitors BYL719 and BKM120 in patients with hormone receptor-positive (HR+), HER2/neu-negative (HER2-) advanced breast cancer.[2]
“Novartis is committed to helping fulfil the large unmet treatment need for patients with advanced breast cancer, and we are continuing to investigate the potential benefits and utility of Afinitor in this population,” said Alessandro Riva, Global Head, Oncology Development & Medical Affairs, Novartis Oncology. “The company will also showcase promising results from our pipeline of PI3K/mTOR inhibitors highlighting our commitment to ongoing exploration of compounds that impact key disease pathways.”
Highlights at ASH include:
  • Jakavi (ruxolitinib) – Long-term safety, efficacy and survival findings from COMFORT-II (COntrolled MyeloFibrosis Study With ORal JAK Inhibitor Treatment), a Phase III study comparing ruxolitinib with best available therapy for the treatment of myelofibrosis (ASH abstract #801; December 10, 6:45 PM EST). Long-term outcome of ruxolitinib treatment in patients with myelofibrosis: durable reductions in spleen volume, improvements in quality of life and overall survival advantage in COMFORT-I (ASH abstract #800; December 10, 6:30 PM EST).
  • Tasigna (nilotinib) – Two-year follow-up results from Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Complete Molecular Response (ENESTcmr), evaluating sustained deeper molecular response following a switch to Tasigna in patients with Ph+ CML in chronic phase who still had evidence of residual disease after two or more years of Glivec therapy (ASH abstract #694; December 10, 5:15 PM EST). Long-term landmark data from Evaluating Nilotinib Efficacy and Safety in Clinical Trials – Newly Diagnosed Patients (ENESTnd), correlating early molecular response and outcome of patients with Ph+ CML in chronic phase (ASH abstract #167; December 9, 5:30 PM EST). Four-year update from ENESTnd evaluating superiority of Tasigna vs. Glivec in patients with newly diagnosed Ph+ CML in chronic phase (ASH abstract #1676; December 8, 5:30 PM EST).
  • Exjade (deferasirox) – Two-year update to THALASSA, the first randomised, placebo-controlled study evaluating reduction of liver iron concentration and serum ferritin in patients with NTDT syndromes after treatment with deferasirox oral iron chelation therapy (ASH abstract #3258; December 10, 6:00 PM EST). First data from CORDELIA, the first head-to-head multicentre, randomised, open-label trial evaluating deferasirox compared with deferoxamine for the removal of cardiac iron in patients with Beta-thalassemia major and iron overload (ASH abstract #2124; December 9, 6:00 PM EST).
  • CTL019 (CART-19) – Outcomes and extended follow-up from a Phase I/II study in patients with advanced, refractory and high-risk CLL and relapsed refractory ALL treated with CART-19 cells (ASH abstract #717; December 10, 5:00 PM EST).
  • PKC412 (midostaurin) – First presentation from the pivotal Phase II study of PKC412 in patients with advanced systemic mastocytosis and mast cell leukaemia (ASH abstract #799; December 10, 6:15 PM EST).
  • LBH589 (panobinostat) – Updated results from PANORAMA-2 (PANobinostat ORAl in Multiple myelomA) Phase II study of LBH589 in combination with bortezomib (BTZ) and dexamethasone in patients with relapsed and BTZ-refractory multiple myeloma (ASH abstract #1852; December 8, 5:30 PM EST).
Highlights at SABCS include:
  • Afinitor (everolimus) – New data from a Phase II clinical trial evaluating Afinitor (everolimus) in combination with fulvestrant in postmenopausal women with HR+ advanced breast cancer who progressed on a previous endocrine therapy (SABCS abstract #P2-14-05; December 6, 7:00 AM CST) and an additional Phase II study evaluating the potential efficacy of Afinitor in combination with letrozole (SABCS abstract #P5-20-06; December 7, 5:00 PM CST). Final progression-free survival analysis of BOLERO-2 Phase III trial of Afinitor plus exemestane for postmenopausal women with HR+/HER2- advanced breast cancer after failure of letrozole or anastrazole (SABCS abstract #P6-04-02; December 8, 7:00 AM CST).
  • BYL719 – Preliminary results from a Phase I study of BYL719 in patients with PIK3CA mutant ER+ metastatic breast cancer (SABCS abstract #P6-10-07; December 8, 7:00 AM CST).
  • BKM120 – Abstract highlighting trial in progress BELLE-3 Phase III randomised study of PI3K inhibitor BKM120 in combination with fulvestrant in postmenopausal women with HR+/HER2- advanced breast cancer whose disease has progressed after treatment with an aromatase inhibitor and on or after an mTOR inhibitor (SABCS abstract #OT2-3-08; December 6, 5:00 PM CST).
  • LBH589 (panobinostat) – Pre-clinical data explores the potential utility of HDAC inhibition in triple-negative breast cancer alone and in combination with other agents (SABCS abstract #S3-7; December 6, 9:30 AM CST).
References
  1. American Society of Hematology. ASH Annual 2012 Meeting Program. Available at https://ash.confex.com/ash/2012/webprogram/start.html. Accessed November 2012.
  2. San Antonio Breast Cancer Symposium. SABCS Annual 2012 Meeting Program. Available at http://www.sabcs.org/ProgramSchedule/index.asp. Accessed November 2012.


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