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

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Overig advies 30/08/2021 10:25
- 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:

Medicine Abstract Title Abstract Number
Prostate Cancer
177Lu-PSMA-617 PSMAddition: 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 cancer Abstract presentation # 647TiP
Poster available: Thursday, Sept. 16, 08:30 AM CEST
177Lu-PSMA-617 PSMAfore: a phase 3 study to compare 177Lu-PSMA-617 treatment with a change in androgen receptor pathway inhibitor in taxane-naïve patients with mCRPC Abstract 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-1 Abstract 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 analyses Abstract presentation # 1102P
Poster available: Friday, Sept. 17, 09:00 AM CEST
Lutathera A 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 paragangliomas Abstract 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, 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

This press release contains forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995. Forward-
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* 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.

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