GlobeNewswire

Novartis presents important overall survival and quality-of-life results across solid tumor portfolio, among other key data at ESMO

Share
  • New Kisqali® (ribociclib)* overall survival (OS) results from MONALEESA-2 trial in HR+/HER2− advanced breast cancer patients in the first-line setting

  • Health-related quality of life, pain and safety outcomes from phase III VISION trial of investigational radioligand therapy 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer

  • Data supporting upcoming regulatory filings for tislelizumab in people with squamous and non-squamous non-small cell lung cancer (NSCLC), and for alpelisib in people with PIK3CA-Related Overgrowth Spectrum (PROS)

  • Novartis to host virtual panel on access to quality cancer care in Europe, open to ESMO registered participants, as part of the company’s ongoing support for #EUnite initiative

Basel, August 30, 2021 — Novartis will present new data from its robust portfolio and pipeline of advanced therapeutic platforms in solid tumors, with more than 55 abstracts from Novartis-sponsored and investigator-initiated trials accepted at the upcoming European Society for Medical Oncology (ESMO) Congress 2021. The ESMO Congress will be held virtually September 16-21, 2021.

“At Novartis, we boldly push science further to make a meaningful difference to patients,” said Susanne Schaffert, PhD, President, Novartis Oncology. “With deeper analyses in overall survival and quality of life in breast and prostate cancer, as well as exciting research in other solid tumors, our data at ESMO demonstrates our ambition to transform lives and renew patients’ hope for the future.”

Key abstracts accepted by ESMO include:

  • Overall survival (OS) results from the phase III MONALEESA-2 (ML-2) trial of postmenopausal patients with hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2−) advanced breast cancer (ABC) treated with endocrine therapy (ET) ± ribociclib [Kisqali® (ribociclib)*; Late-breaker abstract presentation # LBA17; Proffered paper session: Sunday, Sept. 19, 2:10 PM CEST]

  • Association of quality of life (QoL) with OS in patients with HR+/HER2− ABC treated with ribociblib + ET in the ML-3 ML-7 trials [Kisqali; Abstract presentation # 233P; poster available: Monday, Sept. 13, 12:05 AM CEST]

  • Health-related QoL, pain and safety outcomes in the phase 3 VISION study of 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPR) [Abstract presentation # 576MO; mini oral presentation: Sunday, Sept. 19, 5:50 PM CEST]

  • EPIK-P1: Retrospective chart review study of patients with PIK3CA-related overgrowth spectrum (PROS) who have received alpelisib as part of a compassionate use programme [Late-breaker abstract presentation # LBA23; Proffered paper session: Friday, Sept. 17, 1:30 PM CEST]

  • RATIONALE 304: Tislelizumab plus chemotherapy (chemo) vs chemo alone as first-line (1L) treatment for non-squamous (non-sq) non-small cell lung cancer (NSCLC) in patients who are smokers vs non-smokers [Abstract presentation # 1290P; poster available: Monday, Sept. 13, 12:05 AM CEST]

  • RATIONALE 307: Tislelizumab plus chemo vs chemo alone as 1L treatment for advanced sqNSCLC in patients who were smokers vs non-smokers [Abstract presentation # 1297P; poster available: Monday, Sept. 13, 12:05 AM CEST]

Additional data presentations highlight the breadth of our pipeline and our ongoing commitment to discover and develop innovations that address unmet medical needs for patients with cancer: 

MedicineAbstract TitleAbstract Number
Prostate Cancer
177Lu-PSMA-617PSMAddition: a phase 3 trial to compare treatment with 177Lu-PSMA-617 plus standard of care (SOC) versus SOC alone in patients with metastatic hormone-sensitive prostate cancerAbstract presentation # 647TiP
Poster available: Thursday, Sept. 16, 08:30 AM CEST
177Lu-PSMA-617PSMAfore: a phase 3 study to compare 177Lu-PSMA-617 treatment with a change in androgen receptor pathway inhibitor in taxane-naïve patients with mCRPCAbstract presentation #648TiP
Poster available: Thursday, Sept. 16, 08:30 AM CEST

Breast Cancer
Piqray® (alpelisib)Antineoplastic therapies after alpelisib or placebo + fulvestrant in patients with HR+/HER2-, PIK3CA-mutated ABC: an analysis from SOLAR-1Abstract presentation # 309P
Poster available: Monday, Sept. 13, 12:05 AM CEST

Neuroendocrine Tumors (NET)
Lutathera® (lutetium Lu 177 dotatate)**The phase 3 NETTER-1 study of 177Lu-DOTATATE in patients with midgut neuroendocrine tumours: further survival analysesAbstract presentation # 1102P
Poster available: Friday, Sept. 17, 09:00 AM CEST
LutatheraA phase II trial to evaluate the safety and dosimetry of 177Lu-DOTA-TATE in adolescent patients with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumours, pheochromocytomas and paragangliomasAbstract presentation # 1122TiP
Poster available: Friday, Sept. 17, 09:00 AM CEST

With the unique opportunity to engage a variety of cancer care stakeholders in Europe, Novartis will also host an ESMO Industry Connect virtual panel on Monday, September 20, 8:00 AM CEST, under the #EUnite initiative, to discuss opportunities presented by the European Commission 'Europe's Beating Cancer Plan,' and practical steps to address inequalities in cancer care in the region. Featured panelists include:

  • Bettina Ryll – Board Member of the European Commission's Cancer Mission, Physician and Founder of Melanoma Patient Network Europe
  • Fatima Cardoso – Director Breast Unit, Champalimaud Clinical Centre; President, Advanced Breast Cancer Global Alliance
  • John Ryan – EU Commission, Deputy Director General for Health

More information and access to the event will be available to all registered congress participants.

Additional details on Novartis-sponsored abstracts and activities, and access to the presentations will be available on https://www.hcp.novartis.com/virtual-congress/esmo-2021/, starting on September 16.

Product Information
Approved indications for products vary by country and not all indications are available in every country. The product safety and efficacy profiles have not yet been established outside the approved indications. Because of the uncertainty of clinical trials, there is no guarantee that compounds will become commercially available with additional indications.

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 109,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.

Novartis is on Twitter. Sign up to follow @Novartis at https://twitter.com/novartisnews
For Novartis multimedia content, please visit https://www.novartis.com/news/media-library
For questions about the site or required registration, please contact media.relations@novartis.com

# # #

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

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

Anja von Treskow
Novartis External Communications
+41 79 392 8697 (mobile)
anja.von_treskow@novartis.com



Julie Masow
Novartis US External Communications
+1 862 579 8456
Julie.masow@novartis.com
Fiona Phillips
Novartis Oncology Communications
+1 862 217 9396
fiona.phillips@novartis.com

Novartis Investor Relations
Central investor relations line: +41 61 324 7944
E-mail: investor.relations@novartis.com

CentralNorth America
Samir Shah+41 61 324 7944Sloan Simpson+1 862 345 4440
Thomas Hungerbuehler+41 61 324 8425Alina Levchuk+1 862 778 3372
Isabella Zinck+41 61 324 7188Parag Mahanti+1 973-876-4912
To view this piece of content from www.globenewswire.com, please give your consent at the top of this page.
To view this piece of content from ml-eu.globenewswire.com, please give your consent at the top of this page.

About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Palette Life Sciences lanserar ny varumärkeswebbplats med USA:s portfölj17.9.2021 18:09:14 CEST | Pressemelding

Varumärkesuppdatering för USA och globala kommersiella produkter för behandling av ouppfyllda medicinska behov SANTA BARBARA, Kalifornien och STOCKHOLM, Sverige, Sept. 17, 2021 (GLOBE NEWSWIRE) -- Palette Life Sciences, ett helt integrerat globalt företag inom biovetenskap som arbetar för att förbättra patientutfall, lanserade idag sin nyligen uppdaterade webbplats Palettelifesciences.com. Webbplatsen har ett uppdaterat företagsvarumärke som stöder alla produkter i Palette Life Sciences-portföljen, och som fokuserar på minimalt invasiva behandlingar inriktade på ouppfyllda medicinska behov vid strålbehandling och interventionella onkologiska ingrepp, urologiska/urogynekologiska sjukdomar och kolorektala tillstånd. ”Vi inom Palette är stolta över vår förstklassiga produktportfölj som ger hopp åt dem med ouppfyllda medicinska behov”, säger Per G. Langö, Chief Executive Officer och Board Director för Palette Life Sciences. ”När vi bytte varumärke på vår webbplats övervägde vi hur vi bäst

Prosafe SE: bp charters Safe Zephyrus in 202217.9.2021 17:40:15 CEST | Press release

BP Exploration Operating Company Limited ('bp') has chartered the Safe Zephyrus to provide gangway connected operations to support the Seagull project at the ETAP central processing facility in the UK North Sea. The firm duration of the contract, starting Q1 2022, is 10 months with up to four months of options. The Safe Zephyrus is one of the world's most advanced and versatile accommodation vessels, complying with stringent rules in both UK and Norway and with a strong focus on reducing emissions by optimising the engine load. The value of the contract firm duration is USD 35.5 million, and the firm duration including options value is USD 49.3 million. Prosafe is a leading owner and operator of semi-submersible accommodation vessels. The company is listed on the Oslo Stock Exchange with ticker code PRS. For more information, please refer to www.prosafe.com 17 September 2021 Prosafe SE For further information, please contact: Jesper K. Andresen, CEO Phone: +47 51 65 24 30 / +47 907 65 

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK COVERED BONDS17.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-23BondsSWEDBANK HYPOTEK AB: 192. SE0010133207. 2023-03-15 STADSHYPOTEK AB: 1591, SE0013882644, 2026-06-01 SWEDISH COVERED BOND: 146, SE0013381571, 2025-06-11 SKANDINAVISKA ENSKILDA: 581, SE0013102043, 2026-12-16 LANSFORSAKRINGAR HYPOTEK: 520, SE0014694659, 2027-09-15 DANSKE HYPOTEK AB: 2312, SE0011116474, 2023-12-20 NORDEA HYPOTEK AB: 5536, SE0013358439, 2026-09-16 Bid date2021-09-23Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)192: 400 mln SEK +/-200 mln SEK 1591: 1900 mln SEK +/-950 mln SEK 146: 700 mln SEK +/-350 mln SEK 581: 500 mln SEK +/-250 mln SEK 520: 600 mln SEK +/-300 mln SEK 2312: 500 mln SEK +/-250 mln SEK 5536: 400 mln SEK +/-200 mln SEK Highest permitted bid volume (corresponding nominal amount)192: 400 mln SEK per bid 1591: 1900 mln SEK per bid 146: 700 mln SEK per bid 581: 500 mln SEK per bid 520: 600 mln SEK per bid 2312: 500 mln SEK per bid 5536: 400 mln SEK per bid Lowest permitted bid volume (co

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK GOVERNMENT BONDS17.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-24BondsSWEDISH GOVERNMENT: 1056. SE0004517290. 2032-06-01 SWEDISH GOVERNMENT: 1053, SE0002829192, 2039-03-30 Bid date2021-09-24Bid times09.00-10.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)1056: 500 mln SEK +/-250 mln SEK 1053: 750 mln SEK +/-350 mln SEK Highest permitted bid volume (corresponding nominal amount)1056: 500 mln SEK per bid 1053: 750 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 10.15 (CET/CEST) on the Bid dateDelivery and payment date2021-09-28Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-09-17 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between the English translation and the Swedish language version, the Swedish language version shall prevail. Complete terms and conditions c

CONDITIONS FOR RIKSBANK REVERSED AUCTIONS SEK TREASURY BILLS17.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-22BillsSWEDISH T-BILL: SE0015244405. 2021-12-15 SWEDISH T-BILL: SE0016102057, 2022-06-15 SWEDISH T-BILL: SE0016787204, 2022-09-21 Bid date2021-09-22Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SE0015244405: 1000 mln SEK +/-500 mln SEK SE0016102057: 1000 mln SEK +/-500 mln SEK SE0016787204: 500 mln SEK +/-250 mln SEK Highest permitted bid volume (corresponding nominal amount)SE0015244405: 1000 mln SEK per bid SE0016102057: 1000 mln SEK per bid SE0016787204: 500 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2021-09-24Delivery of billsTo the Riksbank's account in Euroclear Sweden AB's securities settlement system 1 4948 6383 Stockholm, 2021-09-17 This is a translation of the special terms and conditions published on www.riksbank.se. In the case of any inconsistency between t

CONDITIONS FOR THE RIKSBANK´S PURCHASES OF COMMERCIAL PAPER17.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-22CertificateCommercial paper issued in SEK by non-financial companies with their registered office in Sweden and with a remaining maturity of up to six months on the Bid date. i.e. with the latest maturity date as of 2022-03-22 Delivery may not be made in commercial paper purchased by the Counterparty from the issuer less than one week prior to the date for announcing the Special terms, i.e. the purchase may not have been made after 2021-09-10 BidsCounterparties may make one bid per Credit rating class and maturity class. Bids are made to tel 08-696 69 70 and confirmed by e-mail to EOL@riksbank.se.Bid date2021-09-22Bid times09.00-09.30 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)SEK 4 billionHighest permitted bid volume (corresponding nominal amount)The total bid volume from one Counterparty for the two Credit rating classes may not exceed SEK 4 billion. No bid may contain Commercial paper in excess of SEK 250 million issued by the s

CONDITIONS FOR RIKSBANK BID PROCEDURE KOMMUNINVEST BONDS17.9.2021 16:20:00 CEST | Press release

Bid procedure, 2021-09-21BondsKOMMUNINVEST I SVERIGE: 2505. SE0011414010. 2025-05-12 KOMMUNINVEST I SVERIGE: 2611, SE0012569572, 2026-11-12 KOMMUNINVEST I SVERIGE: 2805, SE0015660139, 2028-05-12 KOMMUNINVEST I SVERIGE: G23, XS1897258098, 2023-06-01 BidsBids on interest and volume are entered via Bloomberg Bond Auction SystemBid date2021-09-21Bid times10.00-11.00 (CET/CEST) on the Bid dateRequested volume (corresponding nominal amount)2505: 1250 mln SEK +/-650 mln SEK 2611: 1000 mln SEK +/-500 mln SEK 2805: 500 mln SEK +/-250 mln SEK G23: 250 mln SEK +/-150 mln SEK Highest permitted bid volume (corresponding nominal amount)2505: 1250 mln SEK per bid 2611: 1000 mln SEK per bid 2805: 500 mln SEK per bid G23: 250 mln SEK per bid Lowest permitted bid volume (corresponding nominal amount)SEK 50 million per bidExpected allocation timeNot later than 11.15 (CET/CEST) on the Bid dateDelivery and payment date2021-09-23Delivery of bondsTo the Riksbank's account in Euroclear Sweden AB's securities