Novartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer


  • Key data from the Phase III PSMAfore trial has been selected for a Presidential session; PSMAfore is investigating PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan) in the pre-chemotherapy setting for patients with PSMA-positive metastatic castration-resistant prostate cancer (mCRPC)
  • New analysis of key subgroups of clinical interest from NATALEE reinforces the potential of Kisqali® (ribociclib) plus endocrine therapy (ET) to consistently reduce the risk of cancer recurrence across a broad population of patients with stage II and stage III HR+/HER2- early breast cancer, including those with no nodal involvement

Basel, October 5, 2023 — Novartis will present new data from 29 Novartis and investigator-led abstracts at the European Society for Medical Oncology (ESMO) Congress 2023, highlighting latest developments from across its oncology portfolio and addressing unmet needs of patients diagnosed with some of the most prevalent cancers, including prostate and breast.

Key data from the Phase III PSMAfore trial investigating PluvictoTM (INN: lutetium (177Lu) vipivotide tetraxetan) as an earlier line of treatment for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have not been exposed to a taxane-containing regimen will be presented. PSMAfore met its primary endpoint of radiographic progression-free survival (rPFS) in December 2022, and data collection for the key secondary endpoint of overall survival (OS) is ongoing. Data from the primary rPFS analysis and the second interim OS analysis will be presented at ESMO.

“Metastatic prostate cancer has a five-year survival rate of about 30 percent, and patients who progress despite taking androgen-receptor pathway inhibitor therapy need additional treatment options with reduced toxicity,” said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology Development at Novartis. “Pluvicto is the first and only approved, targeted radioligand therapy to significantly extend life in patients with mCRPC who have been treated with ARPI therapy and taxane-based chemotherapy. We look forward to sharing new data from the Phase III PSMAfore trial, which adds to the growing body of evidence demonstrating the potential of our radioligand therapy platform in earlier lines of therapy.”

Key highlights of data accepted by ESMO include:

Medicine Abstract title Presentation Number / Presentation Details
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Phase 3 trial of [177Lu]Lu-PSMA-617 in taxane-naïve patients with metastatic castration-resistant prostate cancer (PSMAfore) Presentation Number #LBA13
Presidential 3 (Proffered Paper session):
Monday, October 23,
17:10 – 17:22 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) First real life data on [177Lu]Lu-PSMA-617: Descriptive analysis on the largest metastatic castration-resistant prostate cancer (mCRPC) cohort treated in early access in France Presentation Number #1814P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Enzalutamide and 177Lu-PSMA-617 in poor-risk metastatic, castration-resistant prostate cancer (mCRPC): a randomized phase 2 trial: ENZA-p (ANZUP 1901) Presentation Number #LBA84
Proffered Paper session:
Friday, October 20,
16:40 – 16:50 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Prognostic value of neutrophil-to-lymphocyte ratio and lymphopenia in patients with metastatic castration-resistant prostate cancer (mCRPC) treated with [177Lu]Lu-PSMA-617: VISION post-hoc analysis Presentation Number #1838P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Association of health-related quality of life with efficacy outcomes in the VISION study of patients with metastatic castration-resistant prostate cancer Presentation Number #1810P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Pluvicto (lutetium Lu 177 vipivotide tetraxetan) Molecular features of circulating tumour cells (CTCs) associate with response to 177Lu PSMA 617 plus pembrolizumab for metastatic castration resistant prostate cancer (mCRPC). Presentation Number #1825P
Poster available:
Sunday, October 22,
9:00 – 17:00 CEST
Kisqali® (ribociclib)* Invasive disease-free survival (iDFS) across key subgroups from the Phase III NATALEE study of ribociclib (RIB) + a nonsteroidal aromatase inhibitor (NSAI) in patients (pts) with HR+/HER2- early breast cancer (EBC) Presentation Number #LBA23
Mini oral session:
Monday, October 23,
17:05 – 17:10 CEST
Kisqali® (ribociclib)* First-line ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in aggressive HR+/HER2- advanced breast cancer (ABC): a subgroup analysis of patients (pts) with or without visceral crisis from the Phase II RIGHT Choice study Presentation Number #402P
Poster available:
Saturday, October 21,
9:00 – 17:00 CEST
Kisqali® (ribociclib)* Quality of life (QOL) analysis from the Phase II RIGHT Choice study of first-line ribociclib (RIB) + endocrine therapy (ET) vs combination chemotherapy (combo CT) in aggressive HR+/HER2- advanced breast cancer (ABC) Presentation Number #456P
Poster available:
Saturday, October 21,
9:00 – 17:00 CEST
Lutathera® (lutetium Lu 177 dotatate) A Prospective Phase II Single-Arm Trial on Neoadjuvant Peptide Receptor Radionuclide Therapy (PRRT) with 177Lu-DOTATATE Followed by Surgery for Pancreatic Neuroendocrine Tumors (NeoLuPaNET) Presentation Number #1186MO
Mini oral session:
Sunday, October 22,
17:25 – 17:30 CEST


Product Information

For full prescribing information, including approved indications and important safety information about marketed products, please visit https://www.novartis.com/about/products.

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; 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 a focused innovative medicines company. Every day, we work to reimagine medicine to improve and extend people’s lives so that patients, healthcare professionals and societies are empowered in the face of serious disease. Our medicines reach more than 250 million people worldwide.

Reimagine medicine with us: Visit us at https://www.novartis.com and connect with us on LinkedIn, Facebook, X/Twitter and Instagram.

# # #

*Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

Novartis Media Relations
E-mail: media.relations@novartis.com

 
   
Central   North America  
Richard Jarvis +41 79 584 2326 Julie Masow +1 862 579 8456
Anja von Treskow +41 79 392 9697 Michael Meo +1 862 274 5414
Anna Schäfers+41 79 801 7267Marlena Abdinoor+1 617 335 9525
Switzerland      
Satoshi Sugimoto+41 79 619 2035  
       
Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

 
 
Central   North America  
Samir Shah +41 61 324 7944 Sloan Simpson +1 862 345 4440
Nicole Zinsli-Somm +41 61 324 3809 Parag Mahanti +1 973 876 4912
Isabella Zinck +41 61 324 7188 Jonathan Graham +1 201 602 9921
Imke Kappes+41 61 324 8269  


Attachments

Media release (PDF).pdf