Press Release: 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(R)

-- Data from VISION study reporting associations between magnitude of PSA

decline from baseline and clinical outcomes with Pluvicto(R) 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(R) (ribociclib)* Pooled exploratory analysis of survival in patients Abstract #205P

(pts) with HR+/HER2- advanced breast cancer (ABC) Poster Session

and visceral metastases (mets) treated with ribociclib Saturday, September 10

(RIB) + endocrine therapy (ET) in the MONALEESA (ML)

trials

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

Kisqali(R) (ribociclib)* HARMONIA SOLTI-2101 / AFT-58: A head-to-head phase Abstract # 272TiP

III study comparing ribociclib (RIB) and palbociclib Poster Session

(PAL) in patients with hormone receptor-positive/HER2-negative/HER2-Enriched Saturday, September 10

(HR+/HER2-/HER2-E) advanced breast cancer (ABC)

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

Piqray(R) (alpelisib) BYLieve trial (alpelisib [ALP] + endocrine therapy Abstract #222P

[ET]) versus real-world (RW) standard of care (SOC) Poster Session

in patients (pts) with PIK3CA-mutated (mut), hormone Saturday, September 10

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)

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

Tislelizumab Final Analysis of RATIONALE-301: Randomized, Phase Abstract #LBA36

3 study of tislelizumab versus sorafenib as first-line Proffered Paper Session

treatment for unresectable hepatocellular carcinoma Saturday, September 10

09:15 -- 09:25 AM CEST

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

Tislelizumab Tislelizumab (TIS) versus docetaxel (TAX) as second- Abstract #1031P

or third-line therapy in previously treated patients Poster Session

(pts) with locally advanced non-small cell lung cancer Monday, September 12

(NSCLC): Asian versus non-Asian subgroup analysis

of the RATIONALE-303 study

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

Pluvicto(TM) (lutetium (177) Lu vipivotide tetraxetan) Association between prostate-specific antigen decline Abstract #1372P

(formerly referred to as (177) Lu-PSMA-617) and clinical outcomes in patients with metastatic Poster Session

castration-resistant prostate cancer in the VISION Sunday, September 11

trial

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

Pluvicto(TM) (lutetium (177) Lu vipivotide tetraxetan) Radiographic progression-free survival correlation Abstract #1374P

with patient-relevant outcomes: a post hoc analysis Poster Session

of time-to-event endpoints of the VISION trial Sunday, September 11,

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

Prostate Cancer Quality of life across three countries using a large-scale, Abstract #1401P

fully digital survey of patients with prostate cancer Poster Session

Sunday, September 11

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

Canakinumab CANOPY-A: phase III study of canakinumab (CAN) as Abstract #LBA49

(ACZ885) adjuvant therapy in patients (pts) with completely Proffered Paper Session

resected non-small cell lung cancer (NSCLC) Sunday, September 11

09:20 -- 09:30 AM CEST

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

Vijoice(R) (alpelisib) Clinical benefit of alpelisib in pediatric patients Abstract #468P

with PIK3CA-related overgrowth spectrum (PROS): an Poster Session

EPIK-P1 analysis Monday, September 12

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

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August 30, 2022 01:15 ET (05:15 GMT)