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Published on 29 May 2013

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Novartis abstracts in breast, lung and blood cancers

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Novartis will present new findings in the treatment of advanced cancers and other diseases with 170 abstracts at two prominent medical meetings. Research across the extensive Novartis product portfolio and pipeline showcases the progress in advancing care for patients with cancer and haematological diseases.
Clinical data from multiple compounds will be featured at the 49th Annual Meeting of the American Society of Clinical Oncology (ASCO) including Afinitor® (everolimus), Tasigna® (nilotinib) and the pipeline compound LDK378.[1] The 18th Congress of the European Hematology Association (EHA) will showcase data from JakaviTM (ruxolitinib), Tasigna and Exjade® (deferasirox).[2]
“With a pipeline of more than 25 new molecular entities, we are at the forefront of a new era in oncology drug development, working towards advances for cancer patients,” said Hervé Hoppenot, President, Novartis Oncology. “These data demonstrate our progress in furthering research and development through a highly-targeted approach, matching specific compounds to pathways that are involved in many difficult-to-treat cancers.”
Data highlights include:
Studies examining Afinitorin advanced breast cancer at ASCO
  • BOLERO-3 study evaluating potential safety and efficacy of Afinitor in combination with trastuzumab and vinorelbine in women with HER2 positive advanced breast cancer who are resistant to trastuzumab and have been pre-treated with a taxane  (abstract #505; June 2, 9:15 AM)
  • Updates on Afinitor in hormone receptor-positive (HR+) advanced breast cancer, including BOLERO-2 sub-analyses (abstract #553, abstract #557, abstract #558, abstract #561; June 1, 1:15 PM) and a late-breaker examining genetic variations and their potential correlation with benefit (abstract #LBA509; June 3, 1:15 PM)
Survival data from Jakaviin myelofibrosis and analysis on bone marrow fibrosis
  • At EHA: Three-year data evaluating overall survival advantage, as well as impact on spleen volume and safety from the Jakavi Phase III COMFORT-II clinical trial program (abstract #S1111; June 16, 8:00 AM)
  • At ASCO and EHA: First evidence of the effect of Jakavi on bone marrow fibrosis in myelofibrosis patients at 24 and 48 months from a Phase I/II trial (ASCO abstract #7030; June 4, 8:30 AM; EHA abstract #S591; June 15, 4:15 PM)
Multi-year studies of Tasigna in patients with Ph+ CML
  • At ASCO and EHA: Two-year follow-up results from the ENESTcmr study evaluating sustained deep molecular response following a switch to Tasigna in patients with Philadelphia chromosome-positive chronic myeloid leukaemia (Ph+ CML) in chronic phase who still had evidence of residual disease after two or more years of Glivec® (imatinib)* therapy (ASCO abstract #7053; June 2, 8:00 AM; EHA abstract #P133; June 14, 5:45 PM)
  • At ASCO and EHA: Four-year update from the ENESTnd study evaluating molecular response rates of Tasigna compared to Glivec in patients with newly diagnosed Ph+ CML in chronic phase (ASCO abstract #7052; June 2, 8:00 AM; EHA abstract #P712; June 15, 5:45 PM)
  • At ASCO: ENESTnd landmark data correlating early molecular responses in patients with newly diagnosed Ph+ CML in chronic phase with long-term outcomes (abstract #7054; June 2, 8:00 AM)
  • At EHA: Phase II GIMEMA study evaluating the sustainability of deep molecular response at five years in patients treated frontline with Tasigna (abstract #P141; June 14, 5:45 PM)
Survival data from PROMID study of Sandostatin® LAR® in NET at ASCO
  • Follow-up analysis from the PROMID trial evaluating overall survival in patients with metastatic midgut neuroendocrine tumours (NET) taking Sandostatin LAR Depot (octreotide acetate for injectable suspension) vs. placebo (ASCO abstract #4030; June 3, 1:15 PM)
First-in-human study of LDK378 in ALK+ metastatic NSCLC at ASCO
  • Updated data from the first-in-human Phase I trial of LDK378, a selective inhibitor of the cancer target anaplastic lymphoma kinase (ALK), in patients with ALK+ metastatic non-small cell lung cancer (abstract #8010; June 3, 10:15 AM). In March, the US Food and Drug Administration (FDA) granted LDK378 Breakthrough Therapy designation, a status intended to expedite the development and review of drugs that treat serious or life-threatening conditions
Multi-year analysis of iron overload association with morbidity risk in untreated thalassemia intermedia patients at EHA
  • Analysis of association between iron overload and morbidity risk in patients with thalassemia intermedia, a form of non-transfusion-dependent thalassemia (NTDT), over an 11-year period. This retrospective study examined 52 patients with no history of transfusion or iron chelation, from comprehensive care centres in Italy, Lebanon, Oman, Iran and Egypt (abstract #S1172; June 16, 10:30 AM)
Additional pipeline research in melanoma, breast cancer and solid tumours at ASCO
  • Initial results from a Phase I study of LGX818 in patients with BRAF V600 mutant advanced or metastatic melanoma (abstract #9028; June 3, 8:00 AM)
  • Preliminary results from a Phase Ib/II open-label, dose-escalation study of LGX818 + MEK162** in BRAF V600-dependent advanced solid tumours (abstract #9029; June 3, 8:00 AM)
  • Results from the first in-human study of the PI3K inhibitor BYL719 in patients with PIK3CA mutant ER-positive metastatic breast cancer (abstract #2531; June 4, 8:00 AM)
References
  1. American Society of Clinical Oncology. ASCO Annual ’13 Meeting Program. Available at: http://abstracts2.asco.org/. Accessed May 2013.
  2. European Hematology Association. EHA Annual Meeting Program. Available at: https://b-com.mci-group.com/EventProgramme/EHA18.aspx. Accessed May 2013.


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