Novartis Pharma AG: Novartis presents new data in breast and prostate cancer at ESMO

• Overall survival results from pooled exploratory analysis of MONALEESA trials in patients with aggressive HR+/HER2- advanced breast cancer treated with Kisqali

• Data from VISION study reporting associations between magnitude of PSA decline from baseline and clinical outcomes with Pluvicto in patients with mCRPC

• Overall survival and safety findings for first-line tislelizumab in unresectable hepatocellular carcinoma from RATIONALE 301, the eighth positive clinical trial readout for tislelizumab

Basel, August 30, 2022 - Novartis will showcase new data from across its oncology portfolio at the European Society for Medical Oncology (ESMO) Congress 2022 with over 35 accepted abstracts from Novartis-sponsored and investigator-initiated trials including new data in advanced breast cancer and metastatic castration-resistant prostate cancer.

"We are excited to share the data being presented across our portfolio of cancer therapies, which reinforce our commitment to pursuing every possible approach to address the urgent and significant unmet medical needs of people living with cancer," said Jeff Legos, Executive Vice President, Global Head of Oncology & Hematology Development, Novartis. "Our presentations at ESMO will highlight our continued dedication to advancing innovative treatment options for these critical diseases."

Key highlights of data accepted by ESMO:

Medicine	Abstract Title	Abstract Number/ Presentation Details
Kisqali (ribociclib)*	Pooled exploratory analysis of survival in patients (pts) with HR+/HER2- advanced breast cancer (ABC) and visceral metastases (mets) treated with ribociclib (RIB) + endocrine therapy (ET) in the MONALEESA (ML) trials ?	Abstract #205P Poster Session Saturday, September 10
Kisqali (ribociclib)*	HARMONIA SOLTI-2101 / AFT-58: A head-to-head phase III study comparing ribociclib (RIB) and palbociclib (PAL) in patients with hormone receptor-positive/HER2-negative/HER2-Enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC)†	Abstract # 272TiP Poster Session Saturday, September 10
Piqray (alpelisib)	BYLieve trial (alpelisib [ALP] + endocrine therapy [ET]) versus real-world (RW) standard of care (SOC) in patients (pts) with PIK3CA-mutated (mut), hormone receptor-2 positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced 3 breast cancer (ABC) who progressed on cyclin-dependent kinase 4/6 inhibitor (CDKi) 4 therapy (tx)	Abstract #222P Poster Session Saturday, September 10
Tislelizumab?	Final Analysis of RATIONALE-301: Randomized, Phase 3 study of tislelizumab versus sorafenib as first-line treatment for unresectable hepatocellular carcinoma	Abstract LBA36 Proffered Paper Session Saturday, September 10 09:15 - 09:25 AM CEST
Tislelizumab?	Tislelizumab (TIS) versus docetaxel (TAX) as second- or third-line therapy in previously treated patients (pts) with locally advanced non-small cell lung cancer (NSCLC): Asian versus non-Asian subgroup analysis of the RATIONALE-303 study	Abstract #1031P Poster Session Monday, September 12
Pluvicto (lutetium 177Lu vipivotide tetraxetan) (formerly referred to as 177Lu-PSMA-617)	Association between prostate-specific antigen decline and clinical outcomes in patients with metastatic castration-resistant prostate cancer in the VISION trial	Abstract #1372P Poster Session Sunday, September 11
Pluvicto (lutetium 177Lu vipivotide tetraxetan)	Radiographic progression-free survival correlation with patient-relevant outcomes: a post hoc analysis of time-to-event endpoints of the VISION trial	Abstract #1374P Poster Session Sunday, September 11,
Prostate Cancer	Quality of life across three countries using a large-scale, fully digital survey of patients with prostate cancer	Abstract #1401P Poster Session Sunday, September 11
Canakinumab (ACZ885)	CANOPY-A: phase III study of canakinumab (CAN) as adjuvant therapy in patients (pts) with completely resected non-small cell lung cancer (NSCLC)	Abstract LBA49 Proffered Paper Session Sunday, September 11 09:20 - 09:30 AM CEST
Vijoice (alpelisib)	Clinical benefit of alpelisib in pediatric patients with PIK3CA-related overgrowth spectrum (PROS): an EPIK-P1 analysis	Abstract #468P Poster Session Monday, September 12

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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

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