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Published on 1 June 2011

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Novartis highlights extensive data on oncology compounds

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  • Plenary presentation of Phase III study examining benefit of extended adjuvant treatment with Glivec® for three years vs. one year for patients with KIT+ GIST
  • Two positive Phase III studies of INC424 (ruxolitinib) in myelofibrosis, a severely debilitating blood cancer with limited treatment options
  • Sub-analysis from ENESTnd comparing Tasigna® to Glivec as first-line therapy in Ph+ CML-CP showing fewer mutations emerge with Tasigna than Glivec   
  • Data for novel PI3K inhibitor BEZ235 as well as TKI258 (dovitinib), LDE225 and LBH589 (panobinostat) showing strength and depth of pipeline

Novartis will showcase data from 140 abstracts on its current oncology products and investigational agents at the 47th Annual Meeting of the American Society of Clinical Oncology (ASCO). These data underscore the company’s commitment to developing treatments to improve the lives of patients with cancer.

“Through our commitment to R&D and collaborations with the scientific and patient communities, we continue to bring targeted treatments to patients living with cancer and other diseases for which there is an unmet need,” said Hervé Hoppenot, President, Novartis Oncology. “Our broad and deep portfolio of development programs gives us multiple opportunities to further advance treatments for the millions of patients and their families affected by these diseases.”

Highlighted at the ASCO meeting, taking place from June 3–7 in Chicago, will be results from key Phase III studies on Novartis products and compounds, including a trial on adjuvant treatment with Glivec® (imatinib) in patients following resection of KIT (CD117)-positive gastrointestinal stromal tumours (GIST) featured at the plenary session on June 5, and two pivotal studies of the Janus kinase (JAK) inhibitor, INC424 (ruxolitinib), in patients with myelofibrosis on June 6.

In addition, a study of patients with Philadelphia chromosome-positive chronic myeloid leukaemia in chronic phase (Ph+ CML-CP), showing patients on Tasigna® (nilotinib) are less likely to develop mutations than those taking Glivec, will be presented on June 6.

Also featured at the Annual Congress will be results from two sub-analyses of the landmark Medical Research Council Myeloma IX clinical trial comparing the effect of Zometa® (zoledronic acid) Injection versus clodronate, on overall survival, progression-free survival and skeletal-related events when used with first-line chemotherapy in newly diagnosed multiple myeloma patients. Final results of the international Phase IV study, REACT (RAD001 Expanded Access Clinical Trial in RCC), evaluating Afinitor® (everolimus) tablets for the treatment of advanced renal cell carcinoma following any available vascular endothelial growth factor targeted therapy, will also be presented.

Notable data about Novartis treatments at ASCO include:
Glivec – Two studies on Glivec in KIT+ GIST, including a Phase III trial examining the benefit of extended adjuvant treatment for three years versus one year with Glivec for patients following resection of their KIT+ GIST (ASCO abstract #LBA1; June 5, 1:45–2:00 PM CDT) and long-term follow up of the pivotal Phase II trial examining overall survival and progression-free rates in patients with metastatic and/or inoperable GIST treated for nearly 10 years with Glivec (ASCO abstract #10016; June 4, 8:00 AM–1:00 PM CDT).
INC424 – Data from two pivotal Phase III studies evaluating INC424 in patients with myelofibrosis after 48 weeks of treatment compared to best available therapy in the COMFORT-II trial (ASCO abstract #LBA6501; June 6, 9:45–10:00 AM CDT), and after 24 weeks of treatment compared to placebo in COMFORT-I (ASCO abstract#6500; June 6, 9:30–9:45 AM CDT).
Tasigna – Mutation analysis from ENESTnd comparing Tasigna to Glivec in patients withnewly diagnosed Ph+ CML in chronic phase (ASCO abstract #6502; June 6, 10:00–10:15 AM CDT) and ENESTnd 24-month update (ASCO abstract #6511; June 3, 2:00–6:00 PM CDT).
Zometa – Two new Myeloma IX analyses evaluate the impact of treatment initiation and duration, and baseline bone disease status, on the effect of Zometa versus clodronate on progression-free survival, overall survival and skeletal-related events when used with first-line chemotherapy in patients with newly diagnosed multiple myeloma (ASCO abstract #8011; June 5, 11:00–11:15 AM CDT; ASCO abstract #8010; June 5, 10:45–11:00 AM CDT), as well as Austrian Breast & Colorectal Cancer Study Group Trial 12 (ABCSG-12) long-term follow-up data examining the impact of adjuvant Zometa therapy on disease-free survival and overall survival in premenopausal women with endocrine-responsive early breast cancer based on patient and tumour characteristics (ASCO abstract #520; June 7, 8:00 AM–12:30 PM CDT).
Afinitor – Two Phase IV studies evaluating Afinitor treatment for advanced renal cell carcinoma following vascular endothelial growth factor targeted therapy (ASCO abstract #4601; June 5, 8:00 AM–12:00 PM CDT; ASCO abstract #4552; June 7, 8:00 AM–12:30 PM CDT), as well as data from three studies examining Afinitor as a treatment for certain patients with advanced neuroendocrine tumours, including two Phase III trials and one Phase I combination study with SOM230 (pasireotide) (ASCO abstract #4009; June 6, 2:00–6:00 PM CDT; ASCO abstract #4011; June 6, 2:00–6:00 PM CDT; ASCO abstract #4120; June 4, 8:00 AM–12:00 PM CDT).
BEZ235 – Phase I dose escalation study of PI3K inhibitor in patients with advanced solid tumours (ASCO abstract #3066; June 6, 8:00 AM–12:00 PM CDT).
TKI258 (dovitinib) – Two Phase II studies examining dovitinib in FGFR1 amplified and non-amplified advanced breast cancer and in patients with advanced renal cell carcinoma (ASCO abstract #508; June 5, 10:30–10:45 AM CDT; ASCO abstract #4551; June 7, 8:00 AM–12:30 PM CDT).
LDE225 – An updated safety, preliminary efficacy and pharmacokinetic/ pharmacodynamic analysis from a Phase I study of the smoothened inhibitor in advanced solid tumours (ASCO abstract #3062; June 6, 8:00 AM – 12:00 PM CDT).
LBH589 (panobinostat) – An update of a Phase Ib study of oral panobinostat in combination with bortezomib in patients with relapsed or relapsed and refractory multiple myeloma (ASCO abstract #8075; June 6, 1:00–5:00 PM CDT) and a Phase III trial in progress of panobinostat plus bortezomib in relapsed/refractory multiple myeloma: PANORAMA-1, which is currently enrolling (ASCO abstract #TPS227; June 6, 8:00 AM – 12:00 PM CDT).

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