30.08.2021 07:14

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

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-- New Kisqali(R) (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(R)

(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:

Medicine Abstract Title Abstract Number

---------------- --------------------------------------------------------------- ----------------------------------------------------

Prostate Cancer

---------------------------------------------------------------------------------------------------------------------------------------

(177) PSMAddition: a phase 3 trial to compare treatment Abstract presentation # 647TiP

Lu-PSMA-617 with (177) Lu-PSMA-617 plus standard of care (SOC) Poster available: Thursday, Sept. 16, 08:30 AM CEST

versus SOC alone in patients with metastatic hormone-sensitive

prostate cancer

---------------- --------------------------------------------------------------- ----------------------------------------------------

(177) PSMAfore: a phase 3 study to compare (177) Lu-PSMA-617 Abstract presentation #648TiP

Lu-PSMA-617 treatment with a change in androgen receptor pathway Poster available: Thursday, Sept. 16, 08:30 AM CEST

inhibitor in taxane-naïve patients with mCRPC

---------------- --------------------------------------------------------------- ----------------------------------------------------

Breast Cancer

---------------- --------------------------------------------------------------- ----------------------------------------------------

Piqray(R) Antineoplastic therapies after alpelisib or placebo Abstract presentation # 309P

(alpelisib) + fulvestrant in patients with HR+/HER2-, PIK3CA-mutated Poster available: Monday, Sept. 13, 12:05 AM CEST

ABC: an analysis from SOLAR-1

---------------- --------------------------------------------------------------- ----------------------------------------------------

Neuroendocrine Tumors (NET)

---------------------------------------------------------------------------------------------------------------------------------------

Lutathera(R) The phase 3 NETTER-1 study of (177) Lu-DOTATATE in Abstract presentation # 1102P

(lutetium Lu 177 patients with midgut neuroendocrine tumours: further Poster available: Friday, Sept. 17, 09:00 AM CEST

dotatate)** survival analyses

---------------- --------------------------------------------------------------- ----------------------------------------------------

Lutathera A phase II trial to evaluate the safety and dosimetry Abstract presentation # 1122TiP

of (177) Lu-DOTA-TATE in adolescent patients with Poster available: Friday, Sept. 17, 09:00 AM CEST

somatostatin receptor-positive gastroenteropancreatic

neuroendocrine tumours, pheochromocytomas and paragangliomas

---------------- --------------------------------------------------------------- ----------------------------------------------------

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

(MORE TO FOLLOW) Dow Jones Newswires

August 30, 2021 01:15 ET (05:15 GMT)

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