Apr 26, 2023
  • Primary analysis of NATALEE, the first and only positive Phase III study of a CDK4/6 inhibitor in a broad population of patients with stage II and III HR+/HER2- early breast cancer at risk of recurrence, including those with no nodal involvement, to be presented

  • New analyses from the Pluvicto VISION trial in prostate cancer and the JDQ443 KontRASt-01 trial in KRAS G12C-mutated lung cancer among 40+ Novartis abstracts accepted at ASCO, underscoring strength of Novartis oncology portfolio and therapeutic platforms

Basel, April 26, 2023 — Novartis will present new data from its oncology portfolio at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting, including advancements in breast cancer, prostate cancer and lung cancer from more than 40 Novartis-sponsored and investigator-led trials. Primary results from the NATALEE trial evaluating Kisqali® (ribociclib) plus endocrine therapy in patients with stage II and stage III hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2-) early breast cancer at risk of cancer recurrence, regardless of nodal involvement, will be presented.

“We look forward to sharing the primary analysis from the Phase III NATALEE trial of Kisqali in the investigational setting in a broad population of patients with early-stage breast cancer at ASCO,” said Shreeram Aradhye, M.D., President, Global Drug Development and Chief Medical Officer, Novartis. “These promising data, together with other key updates, illustrate how we continue to advance our pipeline in oncology, with the potential to help address the significant unmet needs of patients living with cancer.”

Key highlights of data accepted by ASCO include:

Medicine   Abstract Title   Abstract Number/ Presentation Details   
Kisqali® (ribociclib)*  

Phase III NATALEE trial of ribociclib + endocrine therapy as adjuvant treatment in patients with HR+/HER2− early breast cancer

Abstract #LBA500
Oral presentation:
Friday, June 2, 2:45 – 5:45pm CDT
Kisqali® (ribociclib)*   Outcomes with first-line (1L) ribociclib (RIB) + endocrine therapy (ET) vs physician’s choice combination chemotherapy (combo CT) by age in pre/perimenopausal patients (pts) with aggressive HR+/HER2- advanced breast cancer (ABC): A subgroup analysis of the RIGHT Choice trial

Abstract #1063
Poster available:
Sunday, June 4, 8:00 – 11:00am CDT
Kisqali® (ribociclib)*  

Ribociclib (RIB) vs. palbociclib (PAL) in patients (pts) with hormone receptor-positive/HER2-negative/HER2-Enriched (HR+/HER2-/HER2-E) advanced breast cancer (ABC): A head-to-head phase III study. HARMONIA SOLTI-2101 / AFT-58

Abstract #TPS1125
Poster available:
Sunday, June 4, 8:00 – 11:00am CDT
Pluvicto® (lutetium Lu 177 vipivotide tetraxetan)

Building a predictive model for outcomes with [177Lu]Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer using VISION data: Preliminary results

Abstract #5028
Poster available:
Saturday, June 3, 8:00 – 11:00am CDT
Pluvicto® (lutetium Lu 177 vipivotide tetraxetan) Tumor dosimetry of [177Lu]Lu-PSMA-617 for the treatment of metastatic castration-resistant prostate cancer: results from the VISION trial sub-study

Abstract #5046
Poster available:
Saturday, June 3, 8:00 – 11:00am CDT
JDQ443 KontRASt-01 update: Safety and efficacy of JDQ443 in KRAS G12C-mutated solid tumors including non-small cell lung cancer (NSCLC)

Abstract #9007 
Oral presentation:
Tuesday, June 6, 9:45am – 12:45pm CDT   

PHE885 Updated phase I study results of PHE885, a T-Charge manufactured BCMA-directed CAR-T cell therapy, for patients (pts) with r/r multiple myeloma (RRMM) Abstract #8004
Oral presentation:
Saturday, June 3, 1:15 – 4:15pm CDT

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*Kisqali was developed by the Novartis Institutes for BioMedical Research (NIBR) under a research collaboration with Astex Pharmaceuticals.

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