Press Release: Novartis data at ASH and SABCS show strength of pipeline and portfolio in hematology and oncology

Novartis International AG / Novartis data at ASH and SABCS show strength

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-- Additional analysis from pivotal Phase III SOLAR-1 clinical trial

studying investigational alpha-specific PI3K inhibitor BYL719 (alpelisib)

and fulvestrant in patients with PIK3CA-mutated HR+/HER2- advanced or

metastatic breast cancer

-- Longer term follow-up from global pivotal clinical trials ELIANA and

JULIET to be presented at ASH, reporting clinical impact of Kymriah(R) in

patients with r/r pediatric B-cell ALL and adult DLBCL

-- First data presentation for asciminib (ABL001), a chronic myeloid

leukemia compound evaluated in patients who are resistant to nearly all

targeted CML therapies

-- New post-hoc analysis of SUSTAIN study of crizanlizumab (SEG101)

evaluating the impact of treatment in vaso-occlusive crises in patients

with sickle cell disease

Basel, November 2, 2018 - Novartis will present new research that may

transform the way serious blood diseases and a certain type of breast

cancer are treated at the upcoming 60(th) American Society of Hematology

(ASH) Annual Meeting & Exposition in San Diego, December 1-4 and the

41(st) Annual San Antonio Breast Cancer Symposium (SABCS), December 4-8.

Nearly 150 abstracts will be presented across both congresses,

underscoring the strength of the Novartis pipeline and portfolio in

hematology and oncology.

"Novartis Oncology has a purpose-driven legacy built on an unwavering

commitment to help patients live better and longer lives," said Liz

Barrett, CEO, Novartis Oncology. "The breadth and depth of our data at

these scientific forums demonstrates how we are acting on our vision to

reimagine cancer in a meaningful way for patients by relentlessly

pursuing scientific advancements and exploring novel combination

treatment options to help those living with hard-to-treat diseases."

Novartis data at the 2018 ASH Annual Meeting will highlight the

following:

Updates on outcomes with Kymriah(R) (tisagenlecleucel) in adult relapsed

or refractory (r/r) patients with diffuse large b-cell lymphoma (DLBCL)

and pediatric and young adult patients with r/r acute lymphoblastic

leukemia (ALL)*:

-- Updated analysis of the efficacy and safety of tisagenlecleucel in

pediatric and young adult patients with relapsed/refractory acute

lymphoblastic leukemia [Abstract #895; Monday, December 3, 4:30 PM PT]

-- Sustained disease control for adult patients with relapsed or refractory

diffuse large b-cell lymphoma: an updated analysis of JULIET, a global

pivotal Phase 2 trial of tisagenlecleucel [Abstract #1684; Saturday,

December 1, 6:15 PM PT]

New post-hoc analysis of the SUSTAIN study evaluating crizanlizumab in

patients with sickle cell disease:

-- Established prevention of vaso-occlusive crises with crizanlizumab is

further improved in patients who follow the standard treatment regimen:

post-hoc analysis of the Phase II SUSTAIN study [Abstract #1082; Saturday,

December 1, 6:15 PM PT]

First reported data for investigational compound asciminib (ABL001) in

chronic myeloid leukemia (CML) patients with T315I genetic mutation that

causes resistance to most BCR-ABL tyrosine kinase inhibitors (TKIs)

approved to treat CML:

-- Asciminib (ABL001), a specific allosteric BCR-ABL1 inhibitor, in patients

with chronic myeloid leukemia and the T315I mutation in a Phase 1 trial

[Abstract #792; Monday, December 3, 4:00 PM PT]

New data evaluating dabrafenib and trametinib combination treatment in

hairy cell leukemia (HCL):

-- Treatment with combination of dabrafenib and trametinib in patients with

recurrent/refractory BRAF V600E-mutated hairy cell leukemia (HCL)

[Abstract #391; Sunday, December 2, 12:00 PM PT]

Data evaluating Promacta(R) /Revolade(R) (eltrombopag) in patients with

immune thrombocytopenia (ITP):

-- Bleeding related episodes, thrombotic events and platelet counts among

immune thrombocytopenia patients receiving second line therapy [Abstract

#2436; Sunday, December 2, 6:00 PM PT]

-- Treatment of ITP with eltrombopag in patients who have received prior

rituximab: a post hoc analysis of the EXTEND study [Abstract #1152;

Saturday, December 1, 6:15 PM PT]

Final results from the ITP World Impact Survey (I-WISh) about the burden

of disease and impact of ITP on patient quality of life and

productivity:

-- Patients with immune thrombocytopenia (ITP) frequently experience severe

fatigue but it is under-reported by physicians: Results from the ITP

World Impact Survey (I-WISh) [Abstract #2273; Saturday, December 1, 6:15

PM PT]

-- Patients with immune thrombocytopenia (ITP) experience impaired quality

of life (QoL), with negative effects on their daily activities, social

interactions, emotional well-being and working lives: Results from the

ITP World Impact Survey (I-WISh) [Abstract #4804; Monday, December 3,

6:00 PM PT]

New analyses evaluating Rydapt(R) (midostaurin) in patients with

FLT3-mutated acute myeloid leukemia (AML):

-- Prognostic impact of insertion site in acute myeloid leukemia with FLT3

internal tandem duplication: results from the RATIFY study [Abstract

#435; Sunday, December 2, 5:00 PM PT]

-- RATIFY: prognostic impact of FLT3 tyrosine kinase domain (TKD) and NPM1

mutation status in patients with newly diagnosed acute myeloid leukemia

(AML) treated with midostaurin or placebo plus standard chemotherapy

[Abstract #2668; Sunday, December 2, 6:00 PM PT]

-- RADIUS: A phase 2 randomized trial investigating standard of care +/-

midostaurin after allogeneic stem cell transplant in FLT3-ITD-mutated AML

[Abstract #662; Monday, December 3, 10:45 AM PT]

New data evaluating Exjade(R) /Jadenu(R) (deferasirox) in patients with

low- and int-1-risk myelodysplastic syndromes (MDS) and chronic iron

overload:

-- Safety and efficacy, including event-free survival, of deferasirox versus

placebo in iron-overloaded patients with low- and int-1-risk

myelodysplastic syndromes (MDS): outcomes from the randomized,

double-blind TELESTO study [Abstract #234; Saturday, December 1, 5:15 PM

PT]

New data evaluating Jakavi(R) (ruxolitinib)** for patients with

polycythemia vera who are resistant to or intolerant of hydroxyurea:

-- Long-term efficacy and safety (5 Years) in RESPONSE, a Phase 3 study

comparing ruxolitinib (rux) with best available therapy (BAT) in

hydroxyurea (HU)-resistant/intolerant patients (pts) with polycythemia

vera (PV) [Abstract #1753; Saturday, December 1, 6:15 PM PT]

Additional data presented at ASH include:

-- Complete responses in relapsed/refractory acute myeloid leukemia (AML)

patients on a weekly dosing schedule of XmAb14045, a CD123 x CD3 T

cell-engaging bispecific antibody: initial results of a phase 1 study

[Abstract #763; Monday, December 3, 2:45 PM PT]

Sandoz, a Novartis division and the pioneer and global leader in

biosimilars will present data for the company's pegfilgrastim,

filgrastim and rituximab biosimilars:

-- Cost simulation for the US of febrile neutropenia hospitalization due to

pegfilgrastim on-body injector failure compared to single-injection

pegfilgrastim and daily injections with reference and biosimilar

filgrastim in non-Hodgkin lymphoma [Abstract #2251; Saturday, December 1,

6:15 PM PT]

-- Subcutaneous versus intravenous rituximab in non-Hodgkin lymphoma treated

with R-CHOP: economic modeling for the US [Abstract #4776; Monday,

December 3, 6:00 PM PT]

Novartis data at the 2018 SABCS Annual Symposium will highlight the

following:

New data evaluating Kisqali(R) (ribociclib)*** in broad range of

patients with hormone receptor positive, human epidermal growth factor

receptor-2 negative (HR+/HER2-) advanced breast cancer:

-- Biomarker analysis by baseline circulating tumor DNA alterations in the

MONALEESA-3 study [Abstract #PD2-05; Wednesday, December 5, 5:00 PM CT]

-- Ribociclib + endocrine therapy in patients with hormone receptor-positive,

HER2-negative advanced breast cancer presenting with visceral metastases:

Subgroup analysis of phase III MONALEESA trials [Abstract #P6-18-07;

Saturday, December 8, 7:00 AM CT]

-- Ribociclib with endocrine therapy for premenopausal patients with hormone

receptor-positive, HER2-negative advanced breast cancer: Biomarker

analyses from the phase III randomized MONALEESA-7 trial [Abstract

#PD2-08; Wednesday, December 5, 5:00 PM CT]

-- Ribociclib treatment benefit in patients with advanced breast cancer with

>=1 dose reduction: Data from the MONALEESA-2, -3, and -7 trials

[Abstract #P6-18-06; Saturday, December 8, 7:00 AM CT]

Additional updates on investigational treatments, BYL719 (alpelisib) and

LSZ102:

-- Alpelisib + fulvestrant for advanced breast cancer: Subgroup analyses

from the Phase III SOLAR-1 trial [Abstract #GS3-08; Thursday, December 6,

11:15 AM CT]

-- Phase 1/1b study of novel oral selective estrogen receptor degrader

(SERD) LSZ102 for estrogen receptor-positive (ER+) advanced breast cancer

(ABC) with progression on endocrine therapy (ET) [Abstract #PD1-08;

Wednesday, December 5, 5:00 PM CT]

Sandoz will present US real-world evidence data surrounding

cost-effectiveness through use of the company's biosimilar

filgrastim-sndz:

-- Potential Medicare beneficiary out-of-pocket cost reductions through use

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November 02, 2018 17:15 ET (21:15 GMT)