Novartis to highlight advances in blood, breast cancer research at ASH and SABCS 2014

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Novartis will highlight more than 250 abstracts demonstrating advances in blood and breast cancer research at the upcoming American Society of Hematology (ASH) annual meeting December 6-9, and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS) December 9-13. Presentations will highlight cell and gene therapy research, approaches to targeting multiple pathways at once to treat various cancers and established safety and efficacy with long-term data from the hematology portfolio.

"Novartis continues to pioneer innovative therapies across our broad and diverse portfolio as we work to improve the lives of patients living with cancer. At ASH and SABCS, we'll share long-term safety and efficacy data on several targeted therapies and present findings on novel treatment approaches including pipeline combinations and personalized cell therapy," said Alessandro Riva, MD, Global Head, Novartis Oncology Development and Medical Affairs. "As ASH begins, we are reminded of how far we've come since the unprecedented Gleevec data unveiled exactly 15 years ago – a turning point in precision oncology. With our robust cancer pipeline, we look forward to many more years of meaningful progress for people living with cancer."

Novartis and the University of Pennsylvania's Perelman School of Medicine (Penn) have an exclusive global collaboration to research, develop and commercialize CAR T cell therapies for the investigational treatment of cancers. At ASH, key data on investigational chimeric antigen receptor (CAR) therapy CTL019 will be presented including:

  • T Cells Engineered with a Chimeric Antigen Receptor (CAR) Targeting CD19 (CTL019) Have Long Term Persistence and Induce Durable Remissions in Children with Relapsed, Refractory ALL (ASH Abstract #380; December 8, 10:45 AM PST)
  • Phase IIa Trial of Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed or Refractory CD19+ Lymphomas (ASH Abstract #3087; December 7, 6:00 PM PST)
  • Refractory Cytokine Release Syndrome in Recipients of Chimeric Antigen Receptor (CAR) T Cells (ASH Abstract #2296; December 7, 6:00 PM PST)
  • Randomized, Phase II Dose Optimization Study of Chimeric Antigen Receptor Modified T Cells Directed Against CD19 (CTL019) in Patients with Relapsed, Refractory CLL (ASH Abstract #1982; December 6, 5:30 PM PST)

Combination therapy to simultaneously target multiple cancer pathways is another research focus for Novartis, with data presented at ASH exploring combination strategies across a range of hematological cancers, including1:

  • Efficacy and Safety Based on Duration of Treatment of Panobinostat plus Bortezomib and Dexamethasone in Patients with Relapsed or Relapsed and Refractory Multiple Myeloma in the Phase III PANORAMA 1 Study (ASH Abstract #4742; December 8, 6:00 PM PST)
  • Efficacy, Safety, and Confirmation of the Recommended Phase II Dose of Ruxolitinib Plus Panobinostat in Patients With Intermediate or High-Risk Myelofibrosis (ASH Abstract #711; December 8, 6:45 PM PST)
  • HARMONY: An Open-Label, Multicenter, 2-arm, Dose-Finding Phase Ib Study of the Combination of Ruxolitinib and Buparlisib (BKM120) in Patients With Myelofibrosis (MF) (ASH Abstract #710; December 8, 6:30 PM PST)
  • Phase Ib Dose-Escalation Study of Sonidegib (LDE225) in Combination With Ruxolitinib (INC424) in Patients With Myelofibrosis (ASH Abstract #712; December 8, 7:00 PM PST)

Data from new combination strategies presented at SABCS includes the latest findings on Afinitor® (everolimus) in HR+ and HER2+ advanced or metastatic breast cancer:

  • Subgroup analysis on efficacy in the routine treatment - Results of the 2nd interim analysis of BRAWO, the non-interventional trial "Breast Cancer Treatment with Everolimus and Exemestane for HR+ Women" (SABCS Abstract # P5-19-12; December 12, 5:00 PM CDT)
  • Everolimus in combination with exemestane in hormone receptor-positive locally advanced or metastatic breast cancer patients progressing on prior non-steroidal AI (NSAIs): Ballet study (CRAD001YIC04) (SABCS Abstract # P5-19-02; December 12, 5:00 PM CDT)
  • Phase III, randomized, double-blind, placebo-controlled multicenter trial of daily everolimus plus weekly trastuzumab and paclitaxel as first-line therapy in women with HER2+ advanced breast cancer: BOLERO-1 (SABCS Abstract #S6-01; December 12, 3:15 PM CDT)

Novartis will also be presenting safety and efficacy data, including long-term studies, at ASH from its hematology portfolio:

  • Efficacy and Safety of Nilotinib (NIL) vs Imatinib (IM) in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase: Long-Term Follow-Up of ENESTnd (ASH Abstract #4541; December 8, 6:00 PM PST)
  • Relationship Between Chelation and Clinical Outcomes in Lower-Risk Patients With Myelodysplastic Syndrome: Registry Analysis at 5 Years (US CPO) (ASH Abstract #1350; December 6, 5:30 PM PST)
  • Safety and Efficacy of Ruxolitinib in an Open-Label, Multicenter, Single-Arm, Expanded-Access Study in Patients With Myelofibrosis: an 1144-Patient Update (ASH Abstract #3197; December 7, 6:00 PM PST)

Other pipeline studies of note being presented at ASH and SABCS include:

  • Phase I Study Update of the Novel Pan-Pim Kinase Inhibitor LGH447 in Patients with Relapsed/Refractory Multiple Myeloma (ASH Abstract #301; December 8, 7:00 AM PST)
  • ABL001, a Potent Allosteric Inhibitor of BCR-ABL, Prevents Emergence of Resistant Disease When Administered in Combination with Nilotinib in an in Vivo Murine Model of Chronic Myeloid Leukemia (ASH Abstract #398; December 8, 10:45 AM PST)
  • An Open-Label Phase II Study of Buparlisib (BKM120) in Patients with Relapsed and Refractory Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma or Follicular Lymphoma (ASH Abstract #1718; December 6, 5:30 PM PST)
  • Midostaurin (PKC412) in Patients with Advanced Systemic Mastocytosis: Results from the Fully Accrued Global Phase II CPKC412D2201 Trial (ASH Abstract #636; December 8, 5:45 PM PST)
  • The Signature Program, a Distinctive Tissue Agnostic Trial Model for Molecularly Pre-Selected Hematological and Solid Tumor Patients (ASH Abstract #4818; December 8, 6:00 PM PST)
  • A Phase I study of BKM120 and fulvestrant in postmenopausal women with estrogen receptor positive metastatic breast cancer (SABCS Abstract # PD5-6; December 12, 5:00 PM CDT)
  • Phase I trial: PI3Kα inhibitor BYL719 plus aromatase inhibitor (AI) for patients with hormone receptor-positive (HR+) metastatic breast cancer (MBC) (SABCS Abstract # PD5-3; December 12, 5:00 PM CDT)
  • Phase I study of the PI3Kα inhibitor BYL719 plus fulvestrant in patients with PIK3CAaltered and wild type ER+/HER2– locally advanced or metastatic breast cancer (SABCS Abstract # PD5-5; December 12, 5:00 PM CDT)
  • Phase Ib/II study of LEE011 and BYL719 and letrozole in ER+, HER2–breast cancer: safety, preliminary efficacy and molecular analysis (SABCS Abstract # P5-19-24; December 12, 5:00 PM CDT)


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