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16.05.2019 14:59:51

Press Release: Novartis data at ASCO and EHA demonstrate novel approaches to reimagining medicine in cancer and serious blood disorders

Novartis International AG / Novartis data at ASCO and EHA demonstrate

novel approaches to reimagining medicine in cancer and serious blood

disorders. Processed and transmitted by West Corporation. The issuer is

solely responsible for the content of this announcement.

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-- Overall survival results from MONALEESA-7 with Kisqali(R) (ribociclib)*

plus endocrine therapy in premenopausal women with HR+/HER2- advanced

breast cancer, to be presented at ASCO

-- Primary results of GEOMETRY study for capmatinib (INC280)** in

METVAR.ex14-mutated advanced non-small cell lung cancer (NSCLC) at ASCO

-- Five-year efficacy and safety updates for Tafinlar+Mekinist(R)

(dabrafenib + trametinib) in patients with BRAF V600-mutant unresectable

or metastatic melanoma, featured at ASCO

-- Both Congresses to highlight Tasigna (R) (nilotinib) treatment-free

remission trial updates after more than 3.7 years of follow-up and the

investigational compound asciminib (ABL001) combination data in chronic

myeloid leukemia (CML)

Basel, May 16, 2019 - Novartis will present data from across its

oncology portfolio at the upcoming 55th Annual Meeting of the American

Society of Clinical Oncology (ASCO), taking place May 31-June 4 in

Chicago; and the 24th Annual Congress of the European Hematology

Association (EHA), scheduled for June 13-16 in Amsterdam. The more than

100 abstracts to be presented underscore Novartis' relentless commitment

to addressing unmet needs in cancer and hematology through innovation

and research. Data will focus on a range of disease areas, including

breast cancer, lung cancer, melanoma and sickle cell disease, as well as

leukemias, other hematologic disorders and solid tumors.

"We are excited to share the latest information about our transformative

therapies in cancer and serious blood disorders at ASCO and EHA this

year," said Susanne Schaffert, CEO, Novartis Oncology. "New data will

showcase our scientific and patient-focused prowess across a range of

the most difficult-to-treat diseases in the world."

Novartis data at the 2019 ASCO Annual Congress will highlight the

following:

Kisqali overall survival results, and additional data on treatment

sequencing and patient reported outcomes in HR+/HER2- advanced breast

cancer:

-- Phase III MONALEESA-7 trial of premenopausal patients with HR+/HER2-

advanced breast cancer (ABC) treated with endocrine therapy +/-

ribociclib: Overall survival (OS) results [Abstract # LBA1008; Oral

presentation: Tuesday, June 4, 11:57 AM CDT]

-- Interim results in the full population from CompLEEment-1, a phase 3b

study of ribociclib and letrozole as first-line therapy for advanced

breast cancer in an expanded population [Abstract #1041; Sunday, June 2,

8:00 AM CDT]

-- Alpelisib (ALP) + endocrine therapy (ET) in patients with PIK3CA-mutated

hormone-receptor positive (HR+), human epidermal growth factor-2-negative

(HER2-) advanced breast cancer (ABC): First interim BYLieve results

[Abstract #1040; Sunday, June 2, 8:00 AM CDT]

-- Patient-reported outcomes (PROs) in patients with PIK3CA-mutated hormone

receptor-positive (HR+), human epidermal growth factor

receptor-2-negative (HER2-) advanced breast cancer (ABC) from SOLAR-1

[Abstract #1039; Sunday, June 2, 8:00 AM CDT]

-- Alpelisib (ALP) + fulvestrant (FUL) in patients with PIK3CA-mutated

hormone receptor-positive (HR+), human epidermal growth factor

receptor-2-negative (HER2-) advanced breast cancer (ABC): SOLAR-1 results

by therapy line and endocrine therapy resistance (ETR) [Abstract #1038;

Sunday, June 2, 8:00 AM CDT]

-- NATALEE: Phase 3 study of ribociclib (RIBO) + endocrine therapy (ET) as

adjuvant treatment in hormone receptor-positive (HR+), human epidermal

growth factor receptor 2-negative (HER2-) early breast cancer (EBC)

[Abstract #TPS597; Sunday, June 2, 8:00 AM CDT]

-- First-line ribociclib plus letrozole for postmenopausal women with

hormone receptor-positive (HR+), HER2-negative (HER2-) advanced breast

cancer (ABC): MONALEESA-2 long-term safety results [Abstract #1078;

Sunday, June 2, 8:00 AM CDT]

-- Continuous dosing ribociclib, everolimus, exemestane in HR+ and HER2-

advanced breast cancer post-progression on a CDK4/6 inhibitor [Abstract

#1016; Sunday, June 2, 8:00 AM CDT, Poster discussion: 11:15 AM CDT]

-- In-depth gene expression analysis of premenopausal patients with

HR+/HER2- advanced breast cancer (ABC) treated with ribociclib containing

therapy in the Phase III MONALEESA-7 trial [Abstract #1018; Sunday, June

2, 11:15 AM CDT, Poster discussion: 11:30 AM CDT]

Long-term and new analyses of the Tafinlar+Mekinist COMBI trials in

melanoma:

-- Five-year analysis of dabrafenib plus trametinib (D+T) in patients with

BRAF V600-mutant unresectable or metastatic melanoma confirms long-term

benefit [Abstract #9507; Oral presentation: Tuesday, June 4, 11:57 AM

CDT]

-- The anti-PD-1 antibody spartalizumab (S) in combination with dabrafenib

(D) and trametinib (T) in previously untreated patients with advanced

BRAF V600-mutant melanoma: updated efficacy and safety from parts 1 and 2

of COMBI-i [Abstract #9531; Monday, June 3, 1:15 PM CDT]

-- Circulating tumor DNA (ctDNA) kinetics to predict survival in patients

with unresectable or metastatic melanoma treated with dabrafenib (D) or D

+ trametinib (T) [Abstract #9510; Oral presentation: Saturday, June 1,

3:24 PM CDT]

-- Tumor microenvironment (TME), longitudinal biomarker changes, and

clinical outcome in patients with advanced BRAF V600-mutant melanoma

treated with 1st-line spartalizumab (S) + dabrafenib (D) + trametinib (T)

[Abstract #9515; Monday, June 3, 1:15 PM CDT; Poster discussion: 4:30 PM

CDT]

-- Association between baseline disease characteristics and relapse-free

survival (RFS) in patients with BRAF V600-mutant resected stage III

melanoma treated with adjuvant dabrafenib (D) + trametinib (T) or placebo

(PBO) [Abstract #9582; Monday, June 3, 1:15 PM CDT]

Results from GEOMETRY study investigating capmatinib (INC280) in NSCLC:

-- Capmatinib (INC280) in METVAR.ex14-mutated advanced non-small cell lung

cancer (NSCLC): Efficacy data from the phase II GEOMETRY mono-1 study

[Abstract #9004; Oral presentation: Monday, June 3, 9:12 AM CDT]

Analyses on treatment of advanced solid tumors and hematologic

malignancies with spartalizumab (PDR001) in combination with other

agents:

-- Phase Ib study of MIW815 (ADU-S100) in combination with spartalizumab

(PDR001) in patients with advanced/metastatic solid tumors or lymphoma

[Abstract #2507; Oral presentation: Sunday, June 2, 10:12 AM CDT]

-- Phase II, open-label study of spartalizumab (PDR001) and LAG525 for

patients with advanced solid tumors and hematologic malignancies

[Abstract #2553; Saturday, June 1, 8:00 AM CDT]

A study evaluating Kymriah(R) (tisagenlecleucel)*** in follicular

lymphoma:

-- ELARA: A Phase 2, single-arm, multicenter, open-label trial investigating

the efficacy and safety of tisagenlecleucel in adult patients with

refractory/relapsed follicular lymphoma (r/r FL) [Abstract #TPS7573;

Monday, June 3, 8:00 AM CDT]

Long-term treatment-free remission (TFR) data, after Tasigna treatment

discontinuation, in patients with CML:

-- ENESTop 192-week results: treatment-free remission (TFR) in patients with

chronic myeloid leukemia in chronic phase (CML-CP) after stopping

second-line (2L) nilotinib (NIL) [Abstract #7005; Oral presentation:

Saturday, June 1, 4:24 PM CDT]

-- Treatment-free remission (TFR) following frontline (1L) nilotinib (NIL)

in patients with chronic myeloid leukemia in chronic phase (CML-CP):

192-week data from the ENESTfreedom study [Abstract #7013; Monday, June

3, 1:15 PM CDT, Poster discussion: 4:30 PM CDT]

Additional data presented at ASCO include:

-- The CANOPY Program: Canakinumab in patients with non-small cell lung

cancer (NSCLC) [Abstract #TPS9124; Sunday, June 2, 8:00 AM CDT]

-- CANOPY-A: A Phase 3 study of canakinumab as adjuvant therapy in patients

with surgically resected non-small cell lung cancer (NSCLC) [Abstract

#7013; Sunday, June 2, 8:00 AM CDT]

Advanced Accelerator Applications, a Novartis company and leader in

nuclear medicine theragnostics, will present additional analyses from

the NETTER-1 study evaluating Lutathera(R) (lutetium Lu 177

dotatate)**** in patients with progressive midgut neuroendocrine tumors:

-- Analyses of patient diaries in the NETTER-1 study of 177Lu-DOTATATE

versus high-dose octreotide in progressive midgut neuroendocrine tumors

[Abstract #4111; Monday, June 3, 8:00 AM CDT]

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

biosimilars, will present data for the company's biosimilar

pegfilgrastim:

-- Cost-minimization analysis for biosimilar pegfilgrastim in the

prophylaxis of chemotherapy induced (febrile) neutropenia and expanded

access based on budget neutral basis [Abstract #6645; Saturday, June 1,

1:15 PM CDT]

Additional data from Sandoz to be featured online by ASCO include:

-- A large multi-center, randomized, double-blind, crossover study in

healthy volunteers, comparing pharmacokinetics and pharmacodynamics of

Sandoz proposed biosimilar pegfilgrastim with EU and US reference

pegfilgrastim [online only]

Novartis data at the 2019 EHA Annual Congress will highlight the

following:

Retrospective data for investigational compound crizanlizumab (SEG101):

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May 16, 2019 09:00 ET (13:00 GMT)