Press Release: Novartis to present new oncology data at ESMO 2023 demonstrating practice-changing innovation in advanced prostate and early breast cancer

-- Key data from the Phase III PSMAfore trial has been selected for a

Presidential session; PSMAfore is investigating PluvictoTM (INN: lutetium

(177Lu) vipivotide tetraxetan) in the pre-chemotherapy setting for

patients with PSMA-positive metastatic castration-resistant prostate

cancer (mCRPC)

-- New analysis of key subgroups of clinical interest from NATALEE

reinforces the potential of Kisqali(R) (ribociclib) plus endocrine

therapy (ET) to consistently reduce the risk of cancer recurrence across

a broad population of patients with stage II and stage III HR+/HER2-

early breast cancer, including those with no nodal involvement

Basel, October 5, 2023 -- Novartis will present new data from 29 Novartis and investigator-led abstracts at the European Society for Medical Oncology (ESMO) Congress 2023, highlighting latest developments from across its oncology portfolio and addressing unmet needs of patients diagnosed with some of the most prevalent cancers, including prostate and breast.

Key data from the Phase III PSMAfore trial investigating Pluvicto(TM) (INN: lutetium (177Lu) vipivotide tetraxetan) as an earlier line of treatment for patients with prostate-specific membrane antigen (PSMA)-positive metastatic castration-resistant prostate cancer (mCRPC) who have not been exposed to a taxane-containing regimen will be presented. PSMAfore met its primary endpoint of radiographic progression-free survival (rPFS) in December 2022, and data collection for the key secondary endpoint of overall survival (OS) is ongoing. Data from the primary rPFS analysis and the second interim OS analysis will be presented at ESMO.

"Metastatic prostate cancer has a five-year survival rate of about 30 percent, and patients who progress despite taking androgen-receptor pathway inhibitor therapy need additional treatment options with reduced toxicity," said Jeff Legos, Executive Vice President, Global Head of Oncology and Hematology Development at Novartis. "Pluvicto is the first and only approved, targeted radioligand therapy to significantly extend life in patients with mCRPC who have been treated with ARPI therapy and taxane-based chemotherapy. We look forward to sharing new data from the Phase III PSMAfore trial, which adds to the growing body of evidence demonstrating the potential of our radioligand therapy platform in earlier lines of therapy."

Key highlights of data accepted by ESMO include:

Medicine Abstract title Presentation Number / Presentation Details

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

Pluvicto(TM) Phase 3 trial of [177Lu]Lu-PSMA-617 in taxane-naïve Presentation Number #LBA13

(lutetium Lu 177 patients with metastatic castration-resistant prostate Presidential 3 (Proffered Paper session):

vipivotide cancer (PSMAfore) Monday, October 23,

tetraxetan) 17:10 -- 17:22 CEST

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

Pluvicto(TM) First real life data on [177Lu]Lu-PSMA-617: Descriptive Presentation Number #1814P

(lutetium Lu 177 analysis on the largest metastatic castration-resistant Poster available:

vipivotide prostate cancer (mCRPC) cohort treated in early access Sunday, October 22,

tetraxetan) in France 9:00 -- 17:00 CEST

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

Pluvicto(TM) Enzalutamide and 177Lu-PSMA-617 in poor-risk metastatic, Presentation Number #LBA84

(lutetium Lu 177 castration-resistant prostate cancer (mCRPC): a randomized Proffered Paper session:

vipivotide phase 2 trial: ENZA-p (ANZUP 1901) Friday, October 20,

tetraxetan) 16:40 -- 16:50 CEST

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

Pluvicto(TM) Prognostic value of neutrophil-to-lymphocyte ratio Presentation Number #1838P

(lutetium Lu 177 and lymphopenia in patients with metastatic castration-resistant Poster available:

vipivotide prostate cancer (mCRPC) treated with [177Lu]Lu-PSMA-617: Sunday, October 22,

tetraxetan) VISION post-hoc analysis 9:00 -- 17:00 CEST

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

Pluvicto(TM) Association of health-related quality of life with Presentation Number #1810P

(lutetium Lu 177 efficacy outcomes in the VISION study of patients Poster available:

vipivotide with metastatic castration-resistant prostate cancer Sunday, October 22,

tetraxetan) 9:00 -- 17:00 CEST

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

Pluvicto(TM) Molecular features of circulating tumour cells (CTCs) Presentation Number #1825P

(lutetium Lu 177 associate with response to 177Lu PSMA 617 plus pembrolizumab Poster available:

vipivotide for metastatic castration resistant prostate cancer Sunday, October 22,

tetraxetan) (mCRPC). 9:00 -- 17:00 CEST

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

Kisqali(R) Invasive disease-free survival (iDFS) across key subgroups Presentation Number #LBA23

(ribociclib)* from the Phase III NATALEE study of ribociclib (RIB) Mini oral session:

+ a nonsteroidal aromatase inhibitor (NSAI) in patients Monday, October 23,

(pts) with HR+/HER2- early breast cancer (EBC) 17:05 -- 17:10 CEST

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

Kisqali(R) First-line ribociclib (RIB) + endocrine therapy (ET) Presentation Number #402P

(ribociclib)* vs combination chemotherapy (combo CT) in aggressive Poster available:

HR+/HER2- advanced breast cancer (ABC): a subgroup Saturday, October 21,

analysis of patients (pts) with or without visceral 9:00 -- 17:00 CEST

crisis from the Phase II RIGHT Choice study

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

Kisqali(R) Quality of life (QOL) analysis from the Phase II RIGHT Presentation Number #456P

(ribociclib)* Choice study of first-line ribociclib (RIB) + endocrine Poster available:

therapy (ET) vs combination chemotherapy (combo CT) Saturday, October 21,

in aggressive HR+/HER2- advanced breast cancer (ABC) 9:00 -- 17:00 CEST

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

Lutathera(R) A Prospective Phase II Single-Arm Trial on Neoadjuvant Presentation Number #1186MO

(lutetium Lu 177 Peptide Receptor Radionuclide Therapy (PRRT) with Mini oral session:

dotatate) 177Lu-DOTATATE Followed by Surgery for Pancreatic Sunday, October 22,

Neuroendocrine Tumors (NeoLuPaNET) 17:25 -- 17:30 CEST

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October 05, 2023 01:15 ET (05:15 GMT)