Novartis to highlight long-term data, innovative pipeline for patients with hematologic diseases and breast cancer at ASH and SABCS

• Multiple studies evaluating deep molecular response with Tasigna® versus Glivec® in Ph+ CML patients
• Overall survival data from Jakavi® Phase III trials in patients with the debilitating blood cancer, myelofibrosis
• Hematology pipeline innovations in acute lymphoblastic leukemia, chronic lymphocytic leukemia, advanced systemic mastocytosis and multiple myeloma
• Updates on advanced breast cancer portfolio at SABCS, including Afinitor® and investigational compounds BKM120 and BYL719

Novartis will present updates on its broad cancer portfolio with more than 240 abstracts at the upcoming American Society of Hematology (ASH) annual meeting and CTRC-AACR San Antonio Breast Cancer Symposium (SABCS). Presentations will provide key scientific evidence for targeted treatments in chronic myeloid leukemia (CML), myelofibrosis (MF) and advanced breast cancer, as well as emerging information on pipeline compounds^1,2.

“Cancer treatment has been revolutionized by targeted therapies, which have established a highly successful approach to the management of many cancers,” said Hervé Hoppenot, President, Novartis Oncology. “At this exciting time in cancer research, we are presenting new long-term findings on well-established, targeted therapies while also reporting early data on innovative treatment approaches and compounds in areas of high unmet patient need, including acute lymphoblastic leukemia, chronic lymphocytic leukemia and advanced breast cancer.”

Novartis Oncology has 24 pivotal trials underway and more than 25 new molecular entities in development targeting key oncogenic pathways and covering a wide range of mutations.

The ASH annual meeting in New Orleans, held December 7-10, will feature data assessing the overall survival rates for Jakavi® (ruxolitinib) in MF, and multiple studies evaluating deep molecular responses with Tasigna® (nilotinib) compared with Glivec® (imatinib)[*] therapy in a variety of appropriate Philadelphia chromosome-positive CML (Ph+ CML) patient populations¹. Novartis Oncology will also share updated efficacy data on Exjade® (deferasirox) in transfusion-dependent thalassemia major patients with severe cardiac iron overload[1]. Pipeline advances will also be presented, including additional outcomes data in patients with relapsed, refractory acute lymphoblastic leukemia (ALL) and relapsed, refractory chronic lymphocytic leukemia (CLL) treated with chimeric antigen receptor (CAR) modified T cells directed against CD19 (CTL019)¹.

At CTRC-AACR SABCS, held December 10-14, Novartis Oncology will present data for its mTOR inhibitor Afinitor® (everolimus) and provide updates on the clinical development of investigational PI3K inhibitors BKM120 (buparlisib) and BYL719 in breast cancer².

Highlights at ASH include:

Tasigna (nilotinib)

• Long-term, five-year update from the ENESTnd study evaluating superiority of Tasigna versus Glivec in patients with newly diagnosed Ph+ CML in chronic phase (Abstract #92; December 8, 5:15 PM)
• Three-year data from the ENESTcmr study evaluating sustained deep 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 (Abstract #94; December 8, 5:45 PM)
• LASOR, a Phase III study comparing the efficacy of Tasigna to Glivec in patients with Ph+ CML in chronic phase who have a suboptimal cytogenetic response to Glivec (Abstract #95; December 8, 6:00 PM)

Jakavi (ruxolitinib)

• Long-term pooled overall survival results from the COMFORT-I and COMFORT-II Phase III trials studying the safety and efficacy of Jakavi in patients with MF (Abstract #2820; December 8, 6:30 PM)
• Long-term overall survival results from COMFORT-I with responses reported through 132 weeks (Abstract #396; December 9, 11:45 AM)
• New analyses of COMFORT-II survival data examining the impact of Jakavi on patients with low- and high-risk molecular mutations (Abstract #107; December 8, 6:00 PM)
• An evaluation of overall survival among COMFORT-II patients compared to a historical control group of MF patients (Abstract #4066; December 9, 6:00 PM)
• Baseline characteristics and symptom burden in the RESPONSE trial, a Phase III study comparing safety and efficacy of Jakavi with best available treatment in polycythemia vera patients (Abstract #4071; December 9, 6:00 PM)

Exjade (deferasirox)

• Two-year results from CORDELIA, the first head-to-head multicenter, randomized, open-label trial evaluating Exjade compared with deferoxamine for the removal of cardiac iron in patients with beta-thalassemia major (Abstract #1018; December 7, 5:30 PM)
• Twelve-month data from the HYPERION study investigating the combination therapy of deferasirox-deferoxamine in treating transfusion-dependent thalassemia patients with severe cardiac siderosis (Abstract #2257; December 8, 6:30 PM)
• Forty-eight-month results from five-year non-interventional registry of lower-risk MDS patients with transfusional iron overload comparing survival and acute myeloid leukemic transformation status in chelated and non-chelated patients (Abstract #2775; December 8, 6:30 PM)

PKC412 (midostaurin)

• Quality of life results and updated duration of response and overall survival data of PKC412 in patients with advanced systemic mastocytosis (Abstract #106; December 8, 5:45 PM)

CTL019 (CART-19)

• Additional outcomes from long-term follow-up in children and adults with relapsed, refractory ALL treated with CTL019 (Abstract #67; December 8, 5:00 PM)
• Outcomes from Phase I/II long-term follow-up and dose optimization studies in patients with relapsed, refractory CLL treated with CAR modified T cells directed against CD19 (CTL019) (Abstract #4162; December 9, 6:00 PM; Abstract #873; December 10, 8:00 AM)

LDE225 (sonidegib)

• Preclinical study of disease modifying effects of the combination of JAK2 and Hedgehog inhibitors in the treatment of myelofibrosis (Abstract #666; December 9, 5:45 PM)

LBH589 (panobinostat)

• Progression-free survival and overall survival data from PANORAMA-II, a Phase II study of panobinostat, bortezomib and dexamethasone in patients with relapsed and bortezomib-refractory multiple myeloma (Abstract #1970; December 7, 5:30 PM)
• Identification of the recommended Phase II dose of ruxolitinib plus panobinostat in patients with primary myelofibrosis, post-polycythemia vera or post-essential thrombocythemia MF (Abstract #4045; December 9, 6:00 PM)

Highlights at SABCS include:

Afinitor (everolimus)

• Updates on Afinitor in HR+/HER2 negative advanced breast cancer include a BOLERO-2 study analysis characterizing patient responses to everolimus plus exemestane (Abstract #P2-16-17; December 12, 7:30 AM)
• New BOLERO-3 study analyses looking at the impact of a combination therapy including everolimus, trastuzumab and vinorelbine on safety and quality of life in HER2 positive advanced breast cancer patients who are resistant to trastuzumab and have been pre-treated with a taxane (Abstract #P3-15-03; December 12, 5:00 PM; Abstract #P4-12-18; December 13, 7:30 AM)
• Additional analysis of BOLERO-3 evaluating efficacy of the everolimus combination therapy in a subset of Asian patients will be presented (Abstract #P4-12-19; December 13, 7:30 AM)

BKM120

• A Trials in Progress poster presentation of the Phase II BELLE-4 study of BKM120 in combination with paclitaxel in patients with HER2 negative locally advanced or metastatic breast cancer, with or without PI3K activation (Abstract #OT2-6-07; December 12, 5:00 PM)
• A Trials in Progress poster presentation of the Phase II NeoPHOEBE study of BKM120 in combination with trastuzumab and paclitaxel in patients with HER2 positive, PIK3CA mutated and PIK3CA wild-type primary breast cancer (Abstract #OT2-6-08; December 12, 5:00 PM)

BYL719

• Phase I data of BYL719 in combination with fulvestrant in patients with PIK3CA mutated estrogen-receptor positive (ER+) breast cancer (Abstract #P2-16-14; December 12, 7:30 AM)

Throughout ASH and SABCS, Novartis Oncology will host dedicated webpages (http://www.novartisoncology.com/newsroom/featured-news/ash-meeting-2013.jsp; http://www.novartisoncology.com/newsroom/featured-news/sabcs-2013.jsp) that will provide unique insights and perspectives into emerging areas of cancer care and research.

References

1. American Society of Hematology. ASH Annual 2013 Meeting Program. Available at: https://ash.confex.com/ash/2013/webprogram/start.html
2. San Antonio Breast Cancer Symposium. SABCS Annual 2013 Meeting Program. Available at: http://www.sabcs.org/ProgramSchedule/index.asp