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Novartis data at ASCO and EHA showcase latest oncology research and innovation, including in breast and prostate cancer

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Novartis Pharma  AG
Novartis Pharma AG
  • Latest in HR+/HER2- metastatic breast cancer, including data on CDK recycling with Kisqali® plus endocrine therapy, further MONALEESA-2 quality of life and overall survival analyses, and a new biomarker analysis of Piqray® plus fulvestrant

  • Data for Tafinlar® + Mekinist® in pediatric patients with BRAF V600 low-grade glioma to be featured in ASCO official press briefing

  • First release of 96-week data on Scemblix® in Ph+ CML in chronic phase patients previously treated with ≥2 prior tyrosine kinase inhibitors

  • Updated next-generation CAR-T T-Charge™ data, and five-year results from ELIANA trial in pediatric and young adult ALL treated with Kymriah®, the first ever CAR-T cell therapy approved

  • Data from nearly 130 abstracts from Novartis-sponsored and investigator-initiated trials demonstrates Novartis commitment to push the boundaries of science and harness the power of innovation in established and investigational therapies and novel combinations

Basel, May 12, 2022 — Novartis highlights data from across its oncology portfolio at the upcoming 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and the European Hematology Association (EHA) 2022 Hybrid Congress. With nearly 130 abstracts from Novartis-sponsored and investigator-initiated trials accepted, the data showcase research across over 20 compounds in key disease areas, including breast, lung and prostate cancers, leukemia, lymphoma, multiple myeloma and other blood disorders.

“We continue to push the boundaries of science with advanced therapies and novel combinations to help address the individual needs of patients,” said Marie-France Tschudin, President, Innovative Medicines International and Chief Commercial Officer, Novartis. “We are particularly excited about the latest data on CDK recycling with Kisqali, and first results for Tafinlar + Mekinist in a rare pediatric brain cancer.”

Key highlights of data accepted by ASCO:

Medicine

Abstract Title

Abstract Number/ Presentation Details

Kisqali® (ribociclib)*

A randomized phase II trial of fulvestrant or exemestane with or without ribociclib after progression on anti-estrogen therapy plus cyclin-dependent kinase 4/6 inhibition (CDK 4/6i) in patients (pts) with unresectable or hormone receptor positive (HR+), HER2 negative metastatic breast cancer (MBC): MAINTAIN trial

Abstract # LBA1004
Oral Presentation:
Saturday, June 4, 1:15 PM – 4:15 PM CDT



Kisqali® (ribociclib)*

Impact of ribociclib (RIB) dose modifications (mod) on overall survival (OS) in patients (pts) with HR+/HER2− advanced breast cancer (ABC) in MONALEESA (ML)-2

Abstract #1017
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT

Kisqali® (ribociclib)*

Quality of life (QOL) with ribociclib (RIB) plus aromatase inhibitor (AI) vs abemaciclib (ABE) plus AI as first-line (1L) treatment (tx) of hormone receptor–positive/human epidermal growth factor receptor–negative (HR+/HER2−) advanced breast cancer (ABC), assessed via matching-adjusted indirect comparison (MAIC)

Abstract #1015
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT

Piqray® (alpelisib)

Alpelisib (ALP) + Fulvestrant (FUL) in Patients (pts) With Hormone Receptor-Positive (HR+), Human Epidermal Growth Factor Receptor 2-Negative (HER2−), Advanced Breast Cancer (ABC): Biomarker (BM) Analyses by Next-Generation Sequencing (NGS) From the SOLAR-1 Study

Abstract #1006
Oral Presentation:
Saturday, June 4, 1:15 PM – 4:15 PM CDT

Piqray® (alpelisib)

Alpelisib (ALP) + endocrine therapy (ET) in patients (pts) with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2–), PIK3CA-mutated (mut) advanced breast cancer (ABC): Baseline biomarker analysis and progression-free survival (PFS) by duration of prior cyclin-dependent kinase 4/6 inhibitor (CDK4/6i) therapy in the BYLieve study

Abstract #1018
Poster Discussion:
Monday, June 6, 8:00 AM – 11:00 AM CDT



Scemblix® (asciminib)

Efficacy and safety results from ASCEMBL, a phase 3 study of asciminib vs bosutinib (BOS) in patients (pts) with chronic myeloid leukemia in chronic phase (CML-CP) after ≥2 prior tyrosine kinase inhibitors (TKIs): wk 96 update

Abstract #7004
Oral Presentation:
Tuesday, June 7, 9:45 AM – 12:45 PM CDT

Tafinlar® (dabrafenib) / Mekinist® (trametinib)

Primary analysis of a phase II trial of dabrafenib + trametinib (dab + tram) in BRAF V600–mutant pediatric low-grade glioma (pLGG)

Abstract #2002
Oral Presentation:
Monday, June 6, 11:30 AM – 2:30 PM CDT

Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617)

177Lu-PSMA-617 in PSMA-positive metastatic castration-resistant prostate cancer: prior and concomitant treatment subgroup analyses of the VISION trial

Abstract #5001
Oral Presentation:
Sunday, June 5, 8:00 AM – 11:00 AM CDT

Pluvicto™ (lutetium Lu 177 vipivotide tetraxetan)

Tolerability of 177Lu-PSMA-617 by treatment exposure in patients with metastatic castration-resistant prostate cancer (mCRPC): a VISION study subgroup analysis

Abstract #5047
Poster available:
Monday, June 6, 1:15 PM – 4:15 PM CDT

Locametz® (kit for the preparation of gallium Ga 68 gozetotide injection)**

68Ga-PSMA-11 PET baseline imaging as a prognostic tool for clinical outcomes to 177Lu-PSMA-617 in patients with mCRPC: a VISION sub-study

Abstract #5002
Oral Presentation:
Sunday, June 5, 8:00 AM – 11:00 AM CDT

Lutathera® (lutetium Lu 177 dotatate)***

Effectiveness and safety of re-treatment with lutetium Lu 177 dotatate in patients with progressive neuroendocrine tumors in the United States: a retrospective real-world study

Abstract #e16215

Key highlights of data accepted by EHA:

Medicine

Abstract Title

Abstract Number/ Presentation Details

Scemblix® (asciminib)

Efficacy and safety results from ASCEMBL, a phase 3 study of asciminib vs bosutinib in patients with chronic myeloid leukemia in chronic phase after ≥2 prior tyrosine kinase inhibitors: week 96 update

Abstract #S155
Oral Presentation:
Sunday, June 12, 11:30 AM – 12:45 PM CEST

Scemblix® (asciminib)

Asciminib provides durable molecular responses in patients (Pts) with chronic myeloid leukemia in chronic phase (CML-CP) with the T315I mutation: Updated efficacy and safety data from a Phase 1 trial

Abstract #P704
Poster Available:
Friday, June 10, 4:30 PM – 5:45 PM CEST

Kymriah®
(tisagenlecleucel)

Tisagenlecleucel in pediatric and young adult patients (Pts) with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL): Final analyses from the ELIANA study

Abstract #S112
Oral Presentation:
Sunday, June 12, 11:30 AM – 12:45 PM CEST

YTB323

Phase I study of YTB323, a chimeric antigen receptor (CAR)-T cell therapy manufactured using T-Charge™, in patients with relapsed/refractory diffuse large B-cell lymphoma

Abstract #S212
Oral Presentation:
Saturday, June 11, 11:30 AM – 12:45 PM CEST

PHE885

Phase I study data update of PHE885, a fully human BCMA-directed CAR-T cell therapy manufactured using the T-Charge™ platform for patients with relapsed/refractory (R/R) multiple myeloma (MM)

Abstract #P1446
Poster Available:
Friday, June 10, 4:30 PM – 5:45 PM CEST

Sabatolimab

First results of a Phase II study (STIMULUS-AML1) investigating sabatolimab + azacitidine + venetoclax in patients with newly diagnosed acute myeloid leukemia

Abstract #P582
Poster available:
Friday, June 10, 4:30 PM – 5:45 PM CEST

Promacta/Revolade®
(eltrombopag)

Sustained response off treatment in eltrombopag-treated patients with ITP who are refractory or relapsed after first-line steroids: primary analysis of the phase II TAPER trial

Abstract #S292
Oral Presentation
Saturday, June 11, 11:30 AM – 12:45 PM CEST

Product Information
For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartisoncology.com/news/product-portfolio.

Disclaimer
This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as “potential,” “can,” “will,” “plan,” “may,” “could,” “would,” “expect,” “anticipate,” “seek,” “look forward,” “believe,” “committed,” “investigational,” “pipeline,” “launch,” or similar terms, or by express or implied discussions regarding potential marketing approvals, new indications or labeling for the investigational or approved products described in this press release, or regarding potential future revenues from such products. You should not place undue reliance on these statements. Such forward-looking statements are based on our current beliefs and expectations regarding future events, and are subject to significant known and unknown risks and uncertainties. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those set forth in the forward-looking statements. There can be no guarantee that the investigational or approved products described in this press release will be submitted or approved for sale or for any additional indications or labeling in any market, or at any particular time. Nor can there be any guarantee that such products will be commercially successful in the future. In particular, our expectations regarding such products could be affected by, among other things, the uncertainties inherent in research and development, including clinical trial results and additional analysis of existing clinical data; regulatory actions or delays or government regulation generally; global trends toward health care cost containment, including government, payor and general public pricing and reimbursement pressures and requirements for increased pricing transparency; our ability to obtain or maintain proprietary intellectual property protection; the particular prescribing preferences of physicians and patients; general political, economic and business conditions, including the effects of and efforts to mitigate pandemic diseases such as COVID-19; safety, quality, data integrity or manufacturing issues; potential or actual data security and data privacy breaches, or disruptions of our information technology systems, and other risks and factors referred to in Novartis AG’s current Form 20-F on file with the US Securities and Exchange Commission. Novartis is providing the information in this press release as of this date and does not undertake any obligation to update any forward-looking statements contained in this press release as a result of new information, future events or otherwise.

About Novartis
Novartis is reimagining medicine to improve and extend people’s lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world’s top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 108,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

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# # #

* Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.
† Investigator-initiated trial
** Locametz is a registered trademark of Advanced Accelerator Applications, a Novartis company.
*** Lutathera is a registered trademark of Advanced Accelerator Applications, a Novartis company.

Novartis Media Relations
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Novartis External Communications
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anja.von_treskow@novartis.com



Amy Wolf
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Michael Billings
Novartis Oncology Communications
+1 862 778 8656 (direct)
+1 201 400 1854 (mobile)
michael.billings@novartis.com



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Novartis US External Communications
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Julie.masow@novartis.com

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